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2026-03-24
10:44
KELUN-BIOTECH ANNOUNCED 2025 ANNUAL RESULTS: MULTIPLE PRODUCTS SUCCESSFULLY LAUNCHED WITH TIERED PIPELINE READY FOR TAKE-OFF

  • Revenue amounted to approximately RMB2057.92 million, and gross profit amounted to approximately RMB1478.78 million, representing a year-on-year increase.
  • R&D Expenses was approximately RMB1319.68 million.
  • Loss for the period was RMB381.97 million, adjusted annual loss[1] was approximately RMB211.28 million.
  • Cash and financial assets[2] amounted to approximately RMB4559.36 million, with ample cash reserves.
  • The debt-to-asset ratio[3] further declined to 18.7%.

1. Calculated by deducting equity-settled share-based payment from profit/(loss) for the period.

2. Comprises cash and cash equivalents, restricted deposits, financial assets measured at fair value through profit or loss and financial assets measured at amortized cost.

3. Calculated by dividing the total liabilities by the total assets.

CHENGDU, China, March 24, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Pharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", Stock Code: 6990.HK) announced its audited consolidated results for the year ended 31 December 2025 (the "Reporting Period").

Kelun-Biotech is leveraging its core strengths and proprietary OptiDC™ technology platform to continue deepening its presence in the ADC and novel DC drug field. The company is actively advancing cutting-edge modalities including bispecific ADCs, RDCs, iADCs, and DACs, building a differentiated pipeline with strong global competitiveness. At the same time, Kelun-Biotech is steadily advancing product commercialization, achieving transformational growth across its business. To date, the company has four products with eight indications approved for marketing in China, including Sacituzumab Tirumotecan (佳泰莱®), Trastuzumab Botidotin (舒泰莱®), Tagitanlimab (科泰莱®), and Cetuximab N01 (达泰莱®). Among them, three products with five indications have been included in the 2025 National Reimbursement Drug List (NRDL), establishing a fully integrated drug development ecosystem that spans R&D through commercialization.

As of now, the company has built a robust pipeline of more than 30 drug candidates, with over 10 in the clinical stage, and are gradually expanding into broader non-oncology therapeutic areas such as autoimmune diseases and metabolic disorders. Looking ahead, the company will leverage its innovative and differentiated pipeline to deliver high-quality therapeutic solutions for major unmet medical needs worldwide.

Core ADC Products' Commercialization Realized to Solidify Long-term Performance Foundation 

Sac-TMT (sacituzumab tirumotecan, TROP2 ADC) (also known as SKB264/MK-2870) (佳泰莱®)

TNBC:

  • The Company received marketing authorization in China from the NMPA for sac-TMT in adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting).
  • The Company has initiated a Phase 3 registrational study of sac-TMT monotherapy versus ICC for 1L advanced TNBC.

HR+/HER2- BC:

  • In February 2026, a new indication application for sac-TMT for the treatment of adult patients with HR+/HER2- BC who have received prior endocrine therapy (ET) and at least one line of chemotherapy in advanced setting has been approved for marketing by the NMPA.
  • A Phase 3 registrational study of sac-TMT versus ICC for treatment of patients with HR+/HER2- BC who received prior ET is in progress.

EGFR-mutant NSCLC:

  • In March 2025, the Company received marketing authorization in China from the NMPA for sac-TMT for the treatment of adult patients with EGFR mutant-positive NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. This is the first TROP2 ADC drug approved for marketing in LC globally.
  • In October 2025, the company received marketing authorization in China from the NMPA for sac-TMT for the treatment of adult patients with EGFR mutant-positive NSCLC who progressed after treatment with EGFR-TKI therapy. This is the first ADC globally to show an OS benefit compared with platinum doublet chemotherapy and be approved for advanced NSCLC following progression on only TKI therapy (2L).
  • The Phase 3 registrational study of sac-TMT combined with osimertinib as first-line treatment of EGFR-mutant NSCLC and a Phase 2 study of sac-TMT monotherapy or in combination with osimertinib as neoadjuvant therapy for EGFR-mutant NSCLC are in progress.

EGFR-wild type NSCLC:

  • The Phase 3 registrational study of sac-TMT in combination with KEYTRUDA®[1] (pembrolizumab) versus pembrolizumab as first-line treatment of PD-L1 positive NSCLC met its primary endpoint. This is the first Phase 3 clinical trial of ADC combined with immune checkpoint inhibitor to achieve its primary endpoint in the first-line treatment of NSCLC.
  • In January 2026, sac-TMT in combination with pembrolizumab for the first-line treatment of PD-L1 positive NSCLC were granted Breakthrough Therapy Designation by the NMPA.
  • The Phase 3 registrational study of sac-TMT in combination with pembrolizumab as first-line treatment of PD-L1 negative NSCLC is in progress.

Other indications: The company is actively exploring the potential of sac-TMT both as a monotherapy and in combination with other therapies for treating other solid tumors, including GC, EC, CC, OC, UC, CRPC, HNSCC, and TC, etc.

Trastuzumab botidotin (HER2 ADC, also known as A166, 舒泰莱®)

  • In October 2025, trastuzumab botidotin was approved for marketing by the NMPA for adult patients with HER2+ BC who have received one or more prior anti-HER2 therapy. This is the first domestically developed HER2 ADC approved for 2L+ HER2+ BC in China.
  • An open, multicenter Phase 2 clinical study of trastuzumab botidotin in the treatment of HER2+ BC that previously received a topoisomerase inhibitor ADC is in progress.

Key Clinical Data Highlighted at International Academic Conferences and in Top Journals

  • Results from the Phase 3 study of sac-TMT for the treatment of 2L EGFR-mutant NSCLC were selected for LBA and presented as an oral report in the Presidential Symposium session at the 2025 ESMO Congress. Sac-TMT achieved statistically significant and clinically meaningful improvements in ORR, PFS, and OS compared to chemotherapy. The study findings were published simultaneously online at the New England Journal of Medicine and in the first issue of 2026.
  • Results from the study of sac-TMT for the treatment of 3L EGFR-mutant NSCLC were presented as an oral report at the ASCO Annual Meeting and published at the British Medical Journal. The final OS analysis of this study will be selected for LBA and presented as a mini oral report at the 2026 ELCC.
  • Results from the Phase 3 study of sac-TMT for the treatment of 2L+ HR+/HER2-BC were selected for LBA and presented as an oral report at the 2025 ESMO Congress.
  • Results from the Phase 3 study of trastuzumab botidotin for the treatment of 2L+ HER2+ BC were selected for LBA and presented as an oral report at the 2025 ESMO Congress.

Sustained Value Release of ADCs Under Development with Tiered Advancement of Innovation Pipeline

Phase 2 clinical stage

SKB315 (CLDN18.2 ADC):

  • The Phase 1b clinical trial of SKB315 is in progress, for the treatment of GC/GEJC/PDAC, etc.
  • Results of a Phase 1 study of SKB315 in patients with advanced solid tumors including GC/GEJC were presented at 2025 ESMO Congress in October 2025.

SKB410/MK-3120 (Nectin-4 ADC):

  • Its partner MSD has launched 4 global Phase 1/2 clinical trial of SKB410/MK-3120 in advanced solid tumor including bladder cancer, etc.

SKB571/MK-2750 (novel bsADC): The Phase 2 clinical trial in China is ongoing.

SKB518 (novel ADC with a potential FIC target): The Phase 2 clinical trials are ongoing in China.

SKB500 (novel ADC): The Phase 2 study is ongoing in China.

Phase 1 clinical stage

SKB107 (RDC)[2]: The Phase 1 study is ongoing.

SKB535/MK-6204 (novel ADC with potential FIC target): The Phase 1 clinical trial for SKB535 is ongoing in China.

SKB445 (novel ADC with potential FIC target): The Phase 1 clinical trials for SKB445 is ongoing in China.

SKB105/CR-003 (ITGB6 ADC): In January 2026, an IND application was approved by the CDE of NMPA for the treatment of advanced solid tumor. A Phase 1/2 trial is ongoing in China.

Strategic Layout of Non-DC Assets with Focus on Combination Therapy & Indication Expansion

Drug candidates for oncology

  • Tagitanlimab (PD-L1 mAb, also known as A167) (科泰莱®): In January 2025, the Company received marketing authorization of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of NPC from NMPA. Tagitanlimab is the first PD-L1 mAb globally to receive authorization for the first-line treatment of NPC.
  • In May 2025, the results of a Phase 3 clinical study of tagitanlimab in combination with cisplatin and gemcitabine for the first-line treatment of NPC were presented at the ASCO Annual Meeting.

Cetuximab N01 (EGFR mAb, also known as A140) (达泰莱®):

  • In February 2025, the Company received marketing authorization in China from the NMPA for Cetuximab N01 Injection used in combination with FOLFOX or FOLFIRI regimens for first-line treatment of RAS wild-type mCRC.

Lunbotinib Fumarate Capsules (RET inhibitor, also known as A400/EP0031)(宁泰莱®)[3]

  • An NDA was accepted for review by the CDE of the NMPA of China for the 1L+ treatment of RET-fusion positive NSCLC.
  • The company is also conducting a Phase 1b/2 clinical study for RET+ MTC and solid tumor in China.
  • Ellipses Pharma is progressing their phase 2 clinical study globally outside of China.
  • In May 2025, results from the Phase 1 study of Lunbotinib Fumarate Capsules in patients with advanced RET-mutant MTC were presented at the ASCO Annual Meeting.

SKB118/CR-001 (PD-1/VEGF bsAb):

  • In January 2026, Crescent Biopharma announced the regulatory clearance of the IND application for SKB118 by FDA to initiate its global ASCEND Phase 1/2 clinical trial for the treatment of advanced solid tumors, and the first patient has been dosed in February, 2026.
  • The company is planning to initiate the Phase 1/2 clinical study for SKB118 in China in the first half of 2026.

Drug candidates for autoimmune diseases

SKB378/WIN378 (TSLP mAb):

  • In January 2025, an IND application for SKB378 for the treatment of COPD was approved by the NMPA.
  • Its collaboration partner, Windward Bio, has launched the Phase 2 POLARIS global trial in patients with asthma.

SKB575 (TSLP/undisclosed target bsAb): In March 2026, an IND application for SKB575 for the treatment of atopic dermatitis was approved by the NMPA.

Drug candidates for other non-oncology diseases

SKB336 (FXI/FXIa mAb): The company completed Phase 1 clinical trial in China.

Multiple Products First Included in National Reimbursement Drug List with Accelerated Market Coverage 

In 2025, the Company witnessed an explosive growth in the commercialization of its innovative achievements. The Company has also filed an NDA for Lunbotinib Fumarate Capsules and expects to commence its commercialization in the second half of 2026 or the first half of 2027, subject to regulatory communications and marketing approval. To date, the company's initial commercial product portfolio, consisting of five products, has taken shape.

Supported by national innovation policies, the Company has successfully secured the first-time inclusion of three of its commercialized products, namely 佳泰莱®, 科泰莱® and 达泰莱®, in the National Reimbursement Drug List (國家醫保藥品目錄), which officially took effect on January 1, 2026, and is expected to benefit more patients faster and better.

Steady Advancement of Global Collaboration and Comprehensive Strength Authoritatively Recognized

Collaboration with MSD: As at the date of this announcement, MSD is evaluating initiated 17 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other agents for several types of cancer, including BC, LC, gynecological cancers, GI cancer and GU cancer. In addition to sac-TMT, the company is also collaborating with MSD on certain ADC assets to continuously explore favorable ADC pipeline portfolios.

Collaboration with Ellipses Pharma: The Company has deepened its collaboration with Ellipses Pharma on A400/EP0031, which has cleared by the FDA to progress into Phase 2 clinical development. As at December 31, 2025, a total of 39 clinical sites in the United States, Europe and UAE were set up for Lunbotinib Fumarate Capsules.

Collaboration with Windward Bio: In January 2025, the Company and Harbour BioMed had entered into an exclusive license agreement with Windward Bio, under which the Company and Harbour BioMed granted Windward Bio an exclusive license for the research, development, manufacturing and commercialization of SKB378/WIN378 globally (excluding Greater China and several Southeast and West Asian countries). Windward Bio has launched the Phase 2 POLARIS global trial in patients with asthma.

Collaboration with Crescent Biopharma. In December 2025, the company and Crescent Biopharma entered into a strategic collaboration for SKB105/CR-003 and SKB118 (a PD1 x VEGF bsAb, also known as CR-001). Under the collaboration, the company granted Crescent Biopharma exclusive rights to research, develop, manufacture and commercialize SKB105/CR-003 in the United States, Europe and all other markets outside of Greater China. In return, the compamy obtained exclusive rights from Crescent Biopharma to research, develop, manufacture and commercialize SKB118/CR-001 in Greater China.

In January 2026, Crescent Biopharma announced the regulatory clearance of the IND application for SKB118 by FDA to initiate its global ASCEND Phase 1/2 clinical trial for the treatment of advanced solid tumors, and the first patient has been dosed in February, 2026.

Continuous Improvement of ESG Capabilities to Consolidate the Foundation for Sustainable Development

Through the establishment and continuous improvement of the ESG governance structure, the Company comprehensively enhances ESG performance ability and ensures the Company's sustainable development. In May 2025, the company was awarded "Best ESG" by Extel. In March 2026, the Company had received a rating of "AA" in the MSCI ESG Rating Assessment.

Outlook

In 2026, Kelun-Biotech will continue to drive innovation and strengthen its operational capabilities, steadily advancing towards becoming a world-class biopharmaceutical company. Specifically, the Company will implement the following development strategies: advancing differentiated pipelines targeting indications with significant medical needs; innovating on and optimizing payload-linker strategies and novel DC designs and structures, while expanding applications in non-oncology diseases; enhancing its end-to-end drug development and commercialization capabilities; expanding business landscape and strategic partnerships and improve our capabilities for the development, registration and commercialization of our products in ex-China market; and optimizing its operational systems with the aim of becoming a leading global biopharmaceutical company.

About Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (referred to as "Kelun-Biotech" Stock Code: 6990.HK) is a subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd., specializing in the R&D, manufacturing, commercialization, and global collaboration of innovative biological drugs and small molecule drugs. The Company focuses on addressing unmet clinical needs both globally and in China, with a strategic emphasis on major disease areas such as oncology, autoimmune disorders, and metabolic diseases. It is dedicated to building an international platform for drug R&D and industrialization, with the aim of becoming a global leader in the innovative drug sector. Currently, Kelun-Biotech has over 30 key innovative drug projects, including 4 projects covering 8 indications that have received market approval, 1 project at the NDA stage, and more than 10 projects in clinical trials. The Company has also successfully established its internationally renowned proprietary ADC and novel conjugated drug platform, OptiDCTM, with 2 ADC projects covering 5 indications approved for market launch, and several ADC or novel conjugated drug projects in clinical or preclinical development.

[1] KEYTRUDA® (Pembrolizumab) is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

[2] Jointly developed by us and the Affiliated Hospital of Southwest Medical University (西南醫科大學附屬醫院)

[3]  Trade name to be approved by NMPA

 

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08:00
The Phase 3 Registration STAR Study of Efdamrofusp Alfa (IBI302) Met its Primary Endpoint, Making it the First Self-developed Extended-interval Treatment for nAMD in China

  • 73% of participants achieved Q16W dosing interval; Furthermore, nearly 60% of the participants held the potential to extend the dosing interval to Q20W.

SAN FRANCISCO and SUZHOU, China, March 24, 2026 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, announces that the Phase 3 clinical study (STAR) of efdamrofusp alfa injection (recombinant human vascular endothelial growth factor receptor [VEGFR]/human complement receptor 1 [CR1] fusion protein, R&D code: IBI302) in the Chinese patients with neovascular age-related macular degeneration (nAMD) has met the 52-week primary endpoint. Efdamrofusp alfa demonstrated non-inferiority to aflibercept in vision improvement, while also showing the clinical advantage of extended 16-week dosing intervals and the potential to reduce the risk of macular atrophy (MA).

STAR (NCT05972473) is a Phase 3 clinical study evaluating the efficacy and safety of IB302 8 mg in Chinese participants with nAMD. A total of 600 participants were randomized in a 1:1 ratio to the IBI302 8 mg group and the aflibercept 2 mg group. Both groups received 3 loading doses administered every 4 weeks. After the completion of the loading doses, participants in the IBI302 8 mg group were administered at Q16W, Q12W, or Q8W intervals based on the disease activity assessment at Weeks 16 and 20. Participants in the aflibercept 2 mg group completed the subsequent treatment at Q8W intervals. The study lasts for 100 weeks, and the primary endpoint is the change from baseline in the best corrected visual acuity (BCVA) of the study eye at Week 52. The randomization stratification factors in this study were: the presence or absence of Type 2 choroidal neovascularization (CNV) on optical coherence tomography (OCT) in the study eye, and whether the study eye had previously received anti-VEGF treatment.

The study enrolled 600 participants (including 65% treatment-naïve participants) with a baseline mean BCVA of 58.1 ETDRS letters and a baseline mean central subfield thickness (CST) of 420.75 μm.

The study results showed that in nAMD patients receiving IBI302 8 mg,

  • Visual acuity improvement non-inferior to aflibercept: The study met the primary endpoint. At Week 52, the least squares mean estimate (SE) of the mean BCVA change from baseline in the IBI302 8 mg and aflibercept 2 mg groups was 10.37 (0.547) and 10.11 (0.545) ETDRS letters, respectively.
  • Extension of dosing interval: Approximately 86% of participants in the IBI302 8 mg group achieved a dosing interval of Q12W or above during the maintenance period; 72.8% of participants achieved a dosing interval of Q16W. At Week 52, approximately 95% of the participants receiving the Q12/16W dosing maintained their interval without requiring retreatment. Furthermore, 56.3% of the participants showed no disease activity at Week 24, demonstrating the potential to extend the dosing interval to Q20W.

Table 1. Dosing intervals in Phase 3 trials of efdamrofusp alfa and faricimab (cross-trial indirect comparison)


Efdamrofusp alfa

Faricimab[i]

Dosing interval

STAR

TENAYA

LUCERNE

≥Q12W (%)

86.2

79.7

77.8

Q16W (%)

72.8

45.7

44.9

  • Improvement in anatomical efficacy endpoints: The proportion of participants with no intraretinal fluid and no subretinal fluid in the fovea at Week 16 was comparable between the two groups, and the improvements from baseline in the change in CST from baseline and other anatomical endpoints were similar at Week 52.
  • Potential to inhibit macular atrophy (MA): At Week 52, the incidence of MA in the IBI302 8 mg group and aflibercept 2 mg group was 1.5% and 2.9%, respectively. The incidence of MA after IBI302 treatment was 50% lower than that in the aflibercept group, and the trend was consistent with the results of Phase 2 studies, suggesting that IBI302 has the potential to inhibit MA.
  • Favorable safety: The overall incidence of AEs in the IBI302 8 mg group were comparable to those in the aflibercept 2 mg group. Most ocular adverse events were mild to moderate and resolved after observation or routine management.

The follow-up of this study is still ongoing, and the complete data will be published in future academic conferences or peer-reviewed academic journals.

Professor Xiaodong Sun, Principal Investigator of the Study, Director of the Eye Center, Deputy Director of National Center for Clinical Ophthalmology, Deputy Director of Shanghai General Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, stated: " As the Principal Investigator, I am delighted to witness the outstanding performance of IBI302 in the STAR study. Although anti-VEGF agents are the first-line therapy for nAMD, the requirement for frequent intravitreal injections and follow-up visits severely compromises patient adherence and quality of life. A key direction in current drug development is exploring multi-target therapeutic strategies and achieving extended dosing intervals to alleviate the treatment burden on patients. As the world's first innovative anti-VEGF/anti-complement dual-target molecule, IBI302 met the primary endpoint in the Phase 3 STAR study, demonstrating non-inferiority to aflibercept in vision improvement (an average gain of approximately 10.37 letters). Furthermore, most participants were able to achieve a personalized dosing interval of every 12 weeks or longer. Notably, over 70% of these patients could maintain a 16-week dosing interval, significantly reducing the number of injections. This is the first domestically developed novel anti-VEGF fusion protein for ophthalmic use in China to demonstrate the capability of a 16-week dosing interval in a Phase 3 study. We also observed the potential of IBI302 in reducing the incidence of new-onset macular atrophy. We look forward to the timely regulatory approval of this innovative therapy, bringing an alternative treatment option to nAMD patients in China and worldwide. The 2-year results will also be continuously observed to explore the effect on MA inhibition"

Dr. Lei Qian, Chief R&D Officer of General Biomedicine of Innovent, stated, "We are delighted that our innovative ophthalmic drug candidate, efdamrofusp alfa, has achieved a breakthrough in the Phase 3 STAR study. Efdamrofusp alfa demonstrated vision improvement comparable to aflibercept and enabled over 70% of participants to maintain a personalized dosing interval of every 16 weeks, significantly alleviating the treatment burden on patients. Concurrently, the study observed that efdamrofusp holds a potential advantage in inhibiting macular atrophy. These encouraging results lay a solid foundation for subsequent development. We will actively prepare to submit a New Drug Application (NDA), striving to provide a more convenient, patient-friendly, and highly efficacious treatment option for nAMD patients as early as possible. Meanwhile, we will comprehensively advance the lifecycle management and strategic layout of our ophthalmic products, focusing on therapies with a faster onset of action, more durable efficacy, and superior long-term treatment benefits (such as lowering the incidence of macular atrophy and achieving a more complete resolution of retinal edema). Our goal is to bring a greater number of high-quality, innovative ophthalmic drugs to the vast population of patients with nAMD and other fundus diseases."

About Efdamrofusp Alfa (IBI302)

IBI302 is a recombinant fully human bispecific fusion protein of Innovent Biologics with global proprietary rights. The N- terminal is a VEGF domain that can bind to the VEGF family, block VEGF-mediated signaling pathway, inhibit vascular epithelium proliferation and angiogenesis, and improve vasopermeability and reduce leakage. The C- terminal of IBI302 is the complement binding domain that can inhibit the activation of the classic pathway and alternative pathway of complement through the specific binding of C3b and C4b, and reduce the inflammatory response mediated by the complement. IBI302 may exert its therapeutic effect by inhibiting both VEGF-mediated angiogenesis and complement activation pathways.

About Innovent Biologics

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 18 products in the market. It has 5 assets in Phase 3 or pivotal clinical trials and 14 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Lilly, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center.

Guided by the motto, "Start with Integrity, Succeed through Action" Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.

Statement:

Innovent does not recommend the use of any unapproved drugs/indications.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.

Reference:

[i] Heier, Jeffrey S et al. Lancet (London, England) vol. 399,10326 (2022): 729-740.

 

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07:16
MIIT Hopes Apple, Qualcomm & Broadcom Continue Deepening Presence in CN Mkt

Li Lecheng, Minister of China's Ministry of Industry and Information Technology (MIIT), along with Vice Ministers Xin Guobin and Xiong Jijun, recently met in Beijing with Apple CEO Tim Cook, Qualcomm President and CEO Cristiano Amon, Broadcom President and CEO Hock Tan, and other top executives from multinational enterprises. All of them have attended the China Development Forum 2026.

The MIIT officials stated that China will further deepen comprehensive reforms, continuously expand high-level opening-up, and create a first-class business environment that is market-oriented, law-based, and internationalized. China hopes multinational enterprises will continue to deepen their presence in the Chinese market and collaborate with upstream and downstream companies in China's industrial chain for innovative growth, achieving mutually beneficial and win-win development.
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04:04
DJIA Swells 1,000 Pts Once and Ends Up 631 Pts, as US-Iran Talks Productive; Cyclicals Lead Gains

US President Donald Trump announced on Monday that negotiations between the US and Iran went swimmingly, and the US will suspend attacks on Iranian power plants and energy infrastructure.

US bourse bounced back drastically Monday, with the DJIA surging over 1,000 points at one point, closing up 631 points or 1.4% at 46,208. The S&P 500 finished up 74 points or 1.2% at 6,581. The Nasdaq settled 299 points or 1.4% higher at 21,946.

Cyclical stocks such as industrials and banks soared, with Morgan Stanley (MS.US) and JP Morgan (JPM.US) up 1-2%, and construction equipment stock Caterpillar (CAT.US) up 3%.

Techs also rebounded, with NVIDIA (NVDA.US) rising over 1%, and Apple (AAPL.US) growing over 1% after announcing that WWDC26 will be held on June 8.
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01:41
Apple Announces WWDC26 to be Held on Jun 8

Apple (AAPL.US) announced on Monday that its annual WWDC26 will be held online from June 8 to 12. Following last year's series of visual adjustments to its systems, the market is eyeing Apple's advancements in AI technology, particularly the AI upgrade of Siri.

This year's conference will highlight the latest updates across Apple's platforms, including advancements in AI technology and new software and development tools. During the conference, more than 100 video sessions and interactive labs will be available, allowing developers to interact directly with engineers and designers.

The WWDC26 will be streamed live on the Apple Developer app, the official website, and YouTube channel, while in China, it will be broadcast via the Bilibili (BILI.US) platform.
~



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00:53
Apple Plans to Introduce Ads in Maps App to Expand Service Rev.

Sources said that Apple (AAPL.US) is set to introduce advertisements in its Maps app as early as this month to expand its service revenue, according to foreign media report on Monday.

The advertising model will be similar to that of Alphabet (GOOG.US)'s Google Maps, allowing merchants and brands to bid for ad slots against search queries, the report added.

For example, a restaurant could bid for a search term like 'sushi', and the highest bidder would appear at the top of the search results when users look for related catering options. Yelp (YELP.US) also uses a similar model.
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2026-03-23
21:15
WuXi XDC Delivers Exceptional Performance in 2025, Reinforcing Global Leadership in Bioconjugate CRDMO

  • Revenue increased by 46.7% YoY to RMB 5,944 million
  • Gross profit surged by 72.5% YoY to RMB 2,139 million, with its margin of 36.0%, a 5.4 percentage points increase compared to 2024
  • Adjusted net profit increased by 69.9% YoY to RMB 1,559 million, with its margin of 26.2%, a 3.6 percentage points increase compared to 2024(excluding net interest income and exchange impact)
  • The total global customer base expanded to over 640 companies, and 14 out of the TOP 20 global pharmaceutical companies have partnered with us
  • The total number of iCMC projects reached to 252, with 70 newly signed iCMC projects
  • The robust PPQ pipeline: Secured 18 PPQ projects with 10 new PPQ projects added in 2025
  • The total backlog grew to US$1.49 billion, representing a strong 50.3% YoY growth
  • Winner of "Best CDMO" and "Best CRO" Awards: Three consecutive "Best CDMO" Awards from 2023 to 2025 at World ADC Awards, and "Best CRO" Awards at 2025 World ADC Awards

SHANGHAI, March 23, 2026 /PRNewswire/ -- WuXi XDC Cayman Inc. (the "WuXi XDC" or the "Group", stock code: 2268.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO) focused on the bioconjugate market, is pleased to announce its annual results for 2025 (the "Reporting Period").

Management Discussion on 2025 Annual Results and Recent Events (Jan to March 2026)

  • Rapid Growth - As a leading player in the thriving, innovative global bioconjugates industry, the Group has maintained its rapid business growth by providing world-class bioconjugates CRDMO integrated services and empowering its global partners to accelerate and transform ADC and broader bioconjugate development.
  • Strategic M&A - Beyond strong operational results, we advanced two strategic M&A initiatives that elevated our extensive capabilities and expanded our global footprint, enabling us to better serve the global customers. (including the Suzhou site from the acquisition of BioDlink, and the Hefei site acquisition)
  • Technology Engine - Breakthrough advancements across our WuXiDARx™, X-LinC, and WuXiTecan-1 & WuXiTecan-2 platforms are accelerating the development of next-generation bioconjugates, positioning us at the forefront of innovation and drive value creation.
  • Recent Events - To further advance our evolving growth strategy and strengthen our next phase of expansion, we continue to scale and innovate across our payload-linkers platform.
    • Jiangyin site: we have planned a new manufacturing facility as our Jiangyin site. This strategic investment establishes scalable production capabilities for emerging novel payload-linkers, including dual-payloads, AOC, and as well as the PPQ batches supply for late-stage projects. 5x the volume of payload-linker production compared to current level at Wuxi site
    • Technology platform-driven value creation: We have invested consistently in R&D innovation to unlock potential value. In February, we entered into a new flagship strategic collaboration with Earendil Labs, to out-licensing our proprietary WuXiTecan-2, with total potential consideration of up to US$885 million, including upfront, milestone and royalty payments.

Financial Highlights for Annual Results of 2025

Revenue

The Group's revenue increased by 46.7% YoY to RMB 5,944 million for the year ended December 31, 2025. This increase was primarily attributable to (i) the growth in the number of customers and projects, driven by continued active development of the global ADC and broader bioconjugates market, (ii) the increasing market share through the Group's established position as a leading ADC CRDMO service provider in that market, and (iii) the steady advancement of the Group's projects into later stages.

Gross Profit and Its Margin

The Group's gross profit increased by 72.5% YoY to RMB 2,139 million, with a gross profit margin of  36.0% for the year ended December 31, 2025, and a 5.4 percentage points increase compared to that of 2024. This improvement is driven by (i) the enhanced overall operation and manufacturing efficiency, (ii) the utilization ratio of production facilities continued to improve, mainly due to strong customer demand, and (iii) the successful ramp-up of operating production lines including BCM2 L2 and DP3.

Adjusted Net Profit and Its Margin

The Group's adjusted net profit increased by 69.9% YoY to RMB 1,559 million, demonstrating the strong profit growth momentum of the Group's core operating business. The margin of adjusted net profit was 26.2% for the year ended December 31, 2025, and a 3.6 percentage points increase compared to that of 2024.

Customers and Projects Highlights for Annual Results of 2025

  • We have continuously expanded our customer base, reaching a cumulative total of 643, through strong customer-enabling empowerment.
  • The "Enable, Follow, and Win the Molecule" strategy continued to drive sustained and rapid project growth. The total number of integrated projects ("iCMC projects") is 252, with a record 70 newly signed integrated projects.
  • The Group has successfully secured over 18 PPQ projects, with 10 new PPQ projects added in 2025.
  • The Group has a diversified project base covering both innovative ADC and broader bioconjugate ("XDC") projects. The total number of integrated ADC projects reached 226, and the number of integrated XDC projects increased to 26.
  • In 2025, the Group explored over 5,600 molecules of multiple modalities, including bispecific ADCs, dual-payload ADCs, degrader-antibody conjugates (DAC), antibody-oligonucleotide conjugates (AOC), antibody-peptide conjugates (APC), lysosome-targeting chimaeras (LYTAC), etc.

Fully Integrated R&D Technology Platform for Annual Results of 2025

The Group strives to empower customers with cutting-edge conjugation and payload-linker technologies, along with extensive expertise in bioconjugate development capabilities to fulfill diverse R&D requirements.

WuXiDARx™

  • The proprietary WuXiDARx™ technology aims to meet customers' demands for highly homogeneous ADCs with a wide range of DAR values at clinically validated conjugation sites.
  • WuXiDARx™ technology enables dual-payload ADC generation via native interchain cysteine sites without antibody engineering or enzymatic conjugation, offering a streamlined, cost-effective single-platform solution.
  • The platform has successfully facilitated customers to bring 8 ADC pipelines from preclinical stage to clinical stage.
  • WuXiDAR2™ offers narrow DAR distribution with a simple process; WuXiDAR1™ combines the process of WuXiDAR2™ with thiol-rebridging connector to produce homogeneous DAR1 which could be potentially developed in AOCs/APCs.

X-LinC

  • The proprietary X-LinC technology could potentially enhancing ADC stability and therapeutic window since the data demonstrated that it significantly improves plasma stability by replacing the maleimide connector.

WuXiTecan

  • The Group is developing its proprietary payload and hydrophilic linker to enable ADCs with better stability, hydrophilicity, and tolerability.
  • The newly launched WuXiTecan-1 and WuXiTecan-2 platforms have demonstrated excellent efficacy and safety profiles in preclinical studies. Notably, WuXiTecan-2 based dual-payload (MMAE+WuXiTecan-2) ADC achieved enhanced anti-tumor efficacy in CDX model.
  • Customers are actively evaluating the performance of WuXiTecan‑1 and WuXiTecan‑2, with potential collaborations under discussion involving our proprietary payloads featuring novel mechanisms of action and multi‑payload platform.

Capacity Expansion & Business Operation Updates for Annual Results of 2025

  • The total number of full-time employees increased to 2,662 in the Group, driven by rapid business growth and the Group's capacity expansion.
  • All the Group's manufacturing operations are conducted in accordance with the GMP regulations set by the FDA, EMA, and NMPA. The Group has completed over 200 GMP audits from global customers, including 20 audits by EU Qualified Persons.
    • Wuxi site: Further increased its integrated manufacturing capacities. The DP5 and DP6 facility in Wuxi is currently under construction.
    • Singapore site: On track to begin GMP release in 2026 1H, driven by solid overseas customer demand. This state-of-the-art site expands our global manufacturing footprint and reinforces our "China + Singapore" dual sourcing strategy, delivering enhanced supply security and operational agility for customers worldwide.
    • Shanghai site: Further investments in the discovery and technology frontier as global R&D center.
  • Executed two strategic acquisitions aligned with core growth objectives, significantly strengthening manufacturing and R&D capabilities:
    • Suzhou site: the acquisition of BioDlink further enhances our integrated bioconjugate production covering mAb, DS and DP, and expands our customer base and project pipelines.
    • Hefei site: the acquisition expands our expertise in peptide and oligonucleotide synthesis, enabling accelerated development of novel conjugates.
  • The Group was named the winner of "Best CDMO" for the third consecutive year in 2023, 2024 and 2025, as well as "Best CRO" at the 2025 World ADC Awards.
  • The Group also received multiple awards from the 2025 Extel ranking in diverse categories, signifying our commitment to high-quality corporate governance and investor interactions.
  • The Group is committed to strengthen ESG governance and received top-tier ratings in ESG rankings, reflecting our exceptional performance in corporate responsibility, risk management, and ethical business conduct.

CEO Comment

Dr. Jimmy Li, CEO of WuXi XDC, stated, "2025 was a transformative year for WuXi XDC, as we solidified our leadership in global biconjugate CRDMO market and completed several key strategic initiatives: we expanded our production capacity footprint through 'organic expansion + strategic acquisition' and established our Singapore site, which is expected to achieve GMP release in the first half of 2026, building a truly global supply chain system. Recently, we also entered into a technology licensing partnership for WuXiTecan-2, helping our clients accelerate bioconjugates development and realize the value resonance of our proprietary technology platforms. Looking ahead to 2026, we will continue to uphold our unwavering commitment to innovation, operational excellence, and collaboration with our clients. We will empower our customers with continuous evolution, bring breakthrough therapies to more patients worldwide, and lead the development of the industry."

Key Financials Ratios (For the Year Ended December 31)

Key Financials (RMB Mn)

2025

2024

YoY%

Revenue

[5,944]

4,052

[46.7%]

Gross Profit 

[2,139]

1,240

[72.5%]

Margin (%)

[36.9%]

30.6 %

Adjusted Net Profit 

[1,559]

917

[69.9%]

Margin (%)

[26.2%]

22.6 %

About WuXi XDC

WuXi XDC Cayman Inc. ("WuXi XDC", stock code: 2268.HK) is a leading global CRDMO focused on bioconjugate market. It provides end-to-end contract research, development and manufacturing services for ADC and broader bioconjugates. For more information about WuXi XDC, please visit: www.wuxixdc.com 

Contacts

Investor: [email protected]
Media: [email protected]
BD: [email protected]

Forward-Looking Statements

This presentation may contain certain "forward-looking statements" which are not historical facts, but instead are predictions about future events based on our beliefs as well as assumptions made by and information currently available to our management. Although we believe that our predictions are reasonable, future events are inherently uncertain, and our forward-looking statements may turn out to be incorrect. Our forward-looking statements are subject to risks relating to, among other things, the ability of our service offerings to compete effectively, our ability to meet timelines for the expansion of our service offerings, and our ability to protect our customers' intellectual property. Our forward-looking statements in this presentation speak only as of the date on which they are made, and we assume no obligation to update any forward-looking statements except as required by applicable law or listing rules. Accordingly, you are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. All forward-looking statements contained herein are qualified by reference to the cautionary statements set forth in this section.

Use of Adjusted Financial Measures (Non-IFRS Measures)

The Group defines "adjusted net profit attributable to owners of the Company" as net profit attributable to owners of the Company after elimination of share-based compensation expense as non-cash expenditure, net foreign exchange loss or gain as non-operating item, non-recurring/one-off transaction costs as non-operating item, and net of interest income and finance costs as non-operating item. We believe that the adjusted financial measures used in this presentation are useful for understanding and assessing underlying business performance and operating trends, and we believe that management and investors may benefit from referring to these adjusted financial measures in assessing our financial performance by eliminating the impact of certain unusual and non-recurring items that we do not consider indicative of the performance of our business. However, the presentation of these non-IFRS financial measures is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with IFRS. You should not view adjusted results on a stand-alone basis or as a substitute for results under IFRS, or as being comparable to results reported or forecasted by other companies.

 

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11:51
A股上市和提高分紅比例:光大環境(0257.HK)2025年報背後的估值修復邏輯

香港2026年3月23日 /美通社/ -- 2026年3月中旬,全國兩會勝利閉幕,綠色燃料首次被寫入政府工作報告,標誌著獨立自主的能源戰略已上升至國家戰略高度。此外,國家能源局最新數據顯示,2025年我國原油對外依存度升至73%,同比再增0.7個百分點,能源自主可控的壓力持續加大。疊加近期國際地緣政治風險,全球各國正重新審視能源獨立的戰略重要性。在此背景下,可再生能源產業勢必將迎來全球性的高速增長需求,垃圾發電在其中或將佔有重要的一席之地。生活垃圾發電,已是城市不可或缺的「清道夫」和「能量補充站」,並成為城市環境管理及能源基礎設施的剛需組成部分。這種價值也獲得了政策層面的高度認可,國家發展改革委和能源局將生活垃圾焚燒發電納入可再生能源綠色電力證書(「綠證」)的核發範圍。在日益注重環保和可持續發展的當下,行業龍頭企業將是最大的受益者之一。

作為全球最大垃圾發電投資運營商,光大環境(0257.HK)就是其中的佼佼者。近期,光大環境公佈2025年全年業績。以公司環保能源板塊為例,2025年,該板塊為集團貢獻淨盈利為港幣約45億元,較2024年同比增長17%。其中,累計投資落實項目284個,總投資約人民幣1014億元,另承接各類輕資產業務。這些項目設計規模年處理生活垃圾逾5500萬噸、年上網電量逾190億千瓦時、年處理餐廚及廚餘垃圾逾300萬噸以及年供熱供汽近200萬噸。

報告期內,公司堅持「內外並舉」, 增量空間持續打開。於境內鞏固優勢、拓展ToB新賽道。中標海南三亞垃圾發電項目五期,落地首個生物質天然氣項目,供熱供汽量同比增長;於境外在中亞突破、東南亞深耕。在烏茲別克斯坦有2個垃圾發電項目落地(3,000噸/日),中標泰國、馬來西亞設備供貨項目;設立越南、印尼、中亞代表處。全年新簽項目總投資超人民幣30億元,輕資產業務合同總額近13億元,國際化佈局從「點狀突破」轉向「區域深耕」。

環保水務板塊,即在新加坡和香港兩地上市的光大水務(U9E.SG及1857.HK),在2025年為集團貢獻淨盈利為港幣約6億元,較2024年同比下降26%。聚焦的「泛水」領域,共投資落實項目172個,總投資近人民幣 319億元,另承接各類輕資產業務。這些項目設計規模(含委託運營處理規模)為年處理污水約23.5億立方米、年供中水近1.2億立方米、年供水約3.1億立方米。

綠色環保板塊,即在香港主板上市的光大綠色環保(1257.HK)在2025年為集團貢獻淨盈利港幣約8700萬元,由2024年的淨虧損狀態轉為淨盈利。截至2025年12月31日,光大綠色環保共投資落實項目143個,總投資近人民幣307億元,設計規模為年處理生物質原材料近826萬噸、年處理生活垃圾逾400萬噸、年處置危固廢逾200萬噸,年供熱供汽逾600萬噸。

作為世界知名環境集團,整體來看,公司2025年創造收入約港幣275萬元,同比降9%,權益持有人應占盈利約港幣39億元,同比增長16%。從股價觀察,此前公司在5港元附近盤整近半年,市盈率(動)估值為6.93倍,對應股息率4.82%,屬低估高息狀態。去年11月,公司發佈公告啟動「回A上市」,此舉一方面可以拓寬融資渠道,另一方面可以提高公司估值水平。相較於港股的較低估值,A股垃圾發電板塊平均市盈率約為20倍,溢價率為185%,估值差價明顯,相信後市對港股估值有一定的帶動作用。

此外,光銀國際證券預測公司2025年資本開支縮減至35-45億水平,低於市場預期,而「國補」資金又回收加速,預計2025年經營現金流為港幣101億元,較2024的77.5億提升30%,將進一步提升公司的分紅派息比例,加強投資者回報。評級「買入」,目標價5.77港元。綜合來看,公司股價具備一定的估值修復空間。

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10:48
CMBI Drops HORIZONROBOT-W (09660.HK) TP to $10 on High Growth Potential/ Unique Positioning

HORIZONROBOT-W (09660.HK) has high growth potential and a unique positioning, CMBI released a research report saying. Following the launch of the HSD solution, its management raised the guidance for the CAGR of revenue over the next few years from 50% to 60%.

The broker believed that HORIZONROBOT-W, with its increasing market share in the urban NOA solution, upcoming cabin-driving fusion solutions, pilot operation of robotaxis, and collaboration with global tier-1 suppliers to expand overseas markets, possesses unique value and should enjoy a valuation premium.

The Company planned to launch the Agentic CAR cabin-driving fusion system chip this year, with mass production expected by the end of 2026, coinciding with the launch of Qualcomm (QCOM.US)'s SA8797, indicating competitiveness.

HORIZONROBOT-W also planned to start pilot operations of robotaxis with ecosystem partners in 3Q26, showcasing comprehensive autonomous driving capabilities.

Therefore, CMBI dropped its target price from $12.3 to $10, based on a projected 13x PS ratio for 2027, similar to Nvidia (NVDA.US)'s valuation level, with rating kept at Buy.
~


AAStocks Financial News
Website: www.aastocks.com

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10:24
Everest Medicines Enters into Asset Purchase Agreement with Corxel Pharmaceuticals to Develop and Commercialize CARDAMYST™ (Etripamil) Nasal Spray in Greater China

SHANGHAI, March 23, 2026 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that it has entered into an Asset Purchase Agreement with Corxel Pharmaceuticals Hong Kong Limited ("CORXEL"). Under the agreement, the Company has acquired the rights to develop, manufacture, and commercialize CARDAMYST™ (etripamil) nasal spray in Greater China, including Chinese Mainland, Hong Kong, Macao and Taiwan region.

Under the terms of the agreement, Everest will pay CORXEL an upfront payment of US$30 million (equivalent to approximately RMB344,895,000), as well as potential development milestone payments of up to US$20 million (equivalent to approximately RMB137,958,000). As part of this agreement, Everest will be assigned and transferred rights, interests, claims, duties, obligations and liabilities (other than certain excluded liabilities) under the Milestone License Agreement entered into by CORXEL in May 2021 and certain related ancillary agreements.

CARDAMYST™ (etripamil) nasal spray is a novel, rapid-acting calcium channel blocker as administered as needed via a convenient, portable nasal spray. It offers rapid onset of action, favorable tolerability, and the potential for at-home self-administration, enhancing patient accessibility. In December 2025, CARDAMYST was approved by the U.S. Food and Drug Administration (FDA), becoming the first and only self-administered nasal spray in more than 30 years capable of converting paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. As a rapid-acting treatment option, CARDAMYST can be self-administered outside the emergency department or other healthcare settings, enabling patients to actively manage episodes and gain greater control over their condition. In addition to its approved indication for PSVT, etripamil nasal spray is also under clinical development for atrial fibrillation with rapid ventricular response (AFib-RVR). Phase II trials have shown encouraging results, and Phase III trials are planned, with the potential to further extend its therapeutic impact to a broader patient population.

In China, the New Drug Application (NDA) for etripamil nasal spray was accepted by the National Medical Products Administration (NMPA) on January 17, 2025 and is expected to receive approval in the third quarter of 2026.

PSVT is characterized by abnormalities in the heart's electrical system that cause sudden unexpected and often severely symptomatic episodes of rapid heart rate. There are currently no approved self-administered, fast-acting, non-injectable therapies for acute PSVT, leaving patients with limited treatment options beyond emergency care. Approximately 2.3 to 4 per 1,000 individuals are affected by PSVT, representing an estimated 3 to 6 million patients in China.

AFib-RVR is a type of irregular heart rhythm, characterized by an irregular and elevated heart rate. Its onset is typically gradual, episodes are less likely to terminate spontaneously, and the condition tends to recur, significantly increasing the risk of thromboembolism and serious complications such as stroke and heart failure. In China, atrial fibrillation affects an estimated 1.6% of the population, representing nearly 20 million patients, and is expected to increase with an aging population. Both PSVT and AFib-RVR are associated with a loss of control and a significant psychological burden for patients.

Driven by its 2030 Strategy, and led by Mr. Yifang Wu, Chairman of the Board, Everest is accelerating growth through a dual-engine approach that combines strategic business development partnerships with in-house R&D. This transaction further strengthens Everest's expanding cardiovascular franchise, building on recent strategic initiatives and reinforcing the Company's disciplined approach to constructing focused therapeutic verticals with meaningful lifecycle expansion potential. Through continued advancement of its pipeline and product portfolio globally, Everest aims to deliver innovative therapies to more patients, create sustainable long-term value, and advance its position to become a leading global biopharmaceutical company.

"We are pleased to collaborate with CORXEL, this agreement marks an important step in our continued expansion in the cardiovascular field and a meaningful milestone in advancing our growth 2030 strategy," said Mr. Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "PSVT is a large and significantly underserved market in China, with no fast-acting, non-injectable, self-administered therapies approved for the acute treatment of PSVT. CARDAMYST provides an innovative on-demand treatment option that empowers patients to manage episodes anytime and anywhere. It is currently the only therapy designed for at-home self-administration to enable the acute termination of PSVT and AFib-RVR episodes, addressing a significant unmet medical need among patients in China. We will leverage our clinical development expertise and established commercialization platform to accelerate its advancement and future launch in Greater China, while further strengthening our cardiovascular franchise and unlocking its broader potential across atrial arrhythmias."

"Since acquiring the rights to develop and commercialize etripamil nasal spray in 2021 in Greater China, CORXEL has quickly rolled out its clinical development program and submitted its NDA application following positive topline data from the China Phase 3 trial for treating PSVT. This demonstrates CORXEL's strong execution capability in developing innovative medicines with speed and quality," said Ms. Sandy Mou, Board Executive Director and Chief Executive Officer of CORXEL. "We are pleased with the purchase agreement with Everest Medicines,and are confident that Everest, with its deep expertise in cardiovascular therapeutics and strong commercialization capabilities, is the ideal partner to successfully bring etripamil nasal spray to clinical practice and benefit patients in China. This agreement also allows CORXEL to further focus its resources on advancing the global development of its core pipeline."

The NDA for etripamil nasal spray was accepted by the NMPA based on data from the pivotal global Phase 3 RAPID study and the China Phase 3 JX02002 study. Both trials met their primary endpoints. In the JX02002 study, a greater number of patients receiving etripamil achieved the conversion to sinus rate within 30 minutes, compared with placebo (hazard ratio [HR] = 3.02; p=0.0005). Overall, the treatment emergent adverse events (TEAEs) were comparable between the etripamil and placebo groups. Notably, no serious adverse events (SAEs) were reported within 24 hours of etripamil administration in either Phase 3 trial. 

The FDA approval of CARDAMYST was supported by a robust clinical program that included safety data from more than 1,800 participants across more than 2,000 PSVT episodes. This included the Phase 3 RAPID trial, a global, randomized, double-blind comparison of etripamil versus placebo, published in The Lancet in 2023. The RAPID trial achieved its primary endpoint, with 64% of participants who self-administered etripamil (N=99) converting from supraventricular tachycardia (SVT) to sinus rhythm within 30 minutes compared with 31% on placebo (N=85) (HR = 2.62; p<0.001). The median time to conversion was 17 minutes (95% CI: 13.4, 26.5) for etripamil versus 54 minutes (95% CI: 38.7, 87.3) for placebo. The most common adverse events (≥5%) were generally mild-to-moderate and transient in nature, including local-site nasal discomfort, nasal congestion, rhinorrhea, throat irritation, and epistaxis. Fewer than 2% of participants discontinued therapy due to adverse events. 

Etripamil nasal spray is also under clinical development for AFib-RVR. In the randomized, controlled Phase 2 ReVeRA study, etripamil demonstrated rapid and significant reduction in ventricular rate in patients with AFib‑RVR, achieving its primary endpoint. A greater number of patients receiving etripamil achieved a ventricular rate of less than 100 bpm (58.3%) than those receiving placebo (4%). The safety profile was consistent with previous studies.

About CARDAMYST™(etripamil) Nasal Spray

Etripamil is a novel calcium channel blocker developed by Milestone Pharmaceuticals Inc. (Nasdaq: MIST). It is designed as a rapid-response therapy for episodic cardiovascular conditions. As a self-administered nasal spray, etripamil has the potential to shift treatment from emergency department-based care to a patient-managed setting. In May 2021, JIXING (now CORXEL) and Milestone entered into an exclusive license agreement for the development and commercialization of investigational drug etripamil for PSVT and other cardiovascular indications in Greater China ("Milestone License Agreement").  

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative pharmaceutical products that address critical unmet medical needs for patients in global markets. The management team of Everest Medicines has deep expertise and an extensive track record both in China and with leading global pharmaceutical companies.

The Company's therapeutic areas of focus include autoimmune, ophthalmology, critical care, and CKM (cardiovascular, kidney, and metabolic) diseases. Everest Medicines has developed a fully integrated commercialization platform that combines omnichannel commercial capabilities with end-to-end product lifecycle management. Leveraging its proprietary mRNA platform, the Company is advancing its existing pipeline, including mRNA in vivo CAR-T and mRNA cancer vaccines, while selectively expanding into additional high-value therapeutic areas with blockbuster potential, and accelerating its global expansion. For more information, please visit the Company's website: www.everestmedicines.com.

About CORXEL

CORXEL is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for patients with cardiometabolic conditions around the world. CORXEL is led by an experienced management team that has a strong track record of identifying, in-licensing and developing attractive clinical product candidates directed at validated targets with proven mechanisms of action (MoAs). CORXEL's diverse portfolio of clinical-stage product candidates has the potential to redefine treatment standards and address key limitations of current therapies for multiple cardiometabolic indications. CORXEL is developing selective small molecule compounds across the cardiometabolic spectrum with the lead product candidate CX11, an oral small molecule GLP-1 RA under clinical development for obesity and overweight conditions and T2DM, JX10, a thrombolytic and anti-inflammatory agent for acute ischemic stroke and CX12, an oral small molecule amylin RA under pre-clinical development. CORXEL also has additional small molecule programs in development targeting validated obesity targets. 

For further information about CORXEL, please visit www.corxelbio.com 

Forward-Looking Statements

This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.

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