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2026-05-31
21:00
HARMONi-6 Demonstrates Significant Overall Survival Benefit (HR=0.66): Ivonescimab Plus Chemotherapy Superior to PD-1 Plus Chemotherapy in First-Line sq-NSCLC Landmark Results to Be Presented at ASCO 2026 Plenary Session

CHICAGO, May 31, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") today announced that ivonescimab, the Company's first-in-class PD-1/VEGF bispecific antibody, has achieved a statistically significant and clinically meaningful improvement in overall survival (OS) as a first-line treatment for patients with advanced squamous non-small cell lung cancer (sq-NSCLC) in the Phase III HARMONi-6 (AK112-306) study. These landmark findings will be featured in a Plenary Session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. Professor Shun Lu, Director of the Lung Cancer Center at Shanghai Chest Hospital and Principal Investigator of HARMONi-6, presented the data in an oral Plenary Session presentation.

This marks the first time a China-originated investigational oncology drug has been selected for the ASCO Plenary Session in the society's 61-year history. This moment is a definitive testament to the ivonescimab regimen's role in ushering cancer immunotherapy into the '2.0 Era'.

The HARMONi-6 study results were simultaneously published in The Lancet.

The HARMONi-6 study enrolled a total of 532 patients. Among them, approximately 63% had centrally located squamous tumors, 39.0% had PD-L1 TPS <1%, and 33.8% had multi-site metastases, liver metastases, or brain metastases. At the pre-specified interim analysis, as assessed by the Independent Data Monitoring Committee (IDMC), the study met its key secondary endpoint of overall survival (OS), demonstrating both clinically a meaningful and statistically significant benefit.

As of the data cutoff date of February 27, 2026, with a median follow-up of 21.36 months:

34% reduction in the risk of death - ivonescimab plus chemotherapy significantly prolonged OS

  • In the intent-to-treat (ITT) population, ivonescimab plus chemotherapy reduced the risk of death by 34% versus tislelizumab plus chemotherapy (HR=0.66 [95% CI: 0.50–0.87], P=0.0017(<0.0049). Median OS was 27.9 months in the ivonescimab arm (the final death event in this arm caused the Kaplan-Meier curve to drop sharply to the median, thereby producing the mOS estimate) versus 23.7 months in the control arm.
  • The 12-month OS rate was 78.9% with ivonescimab plus chemotherapy versus 72.2% in the control arm, and the 24-month OS rate was 64.7% versus 48.6%, respectively. The survival benefit continued to widen over time, reflecting a more durable and clinically meaningful long-term survival advantage.

Consistent OS benefit across all prespecified subgroups

  • OS benefit with ivonescimab was observed consistently regardless of PD-L1 expression status: HR=0.68 in the PD-L1 TPS ≥1% subgroup and HR=0.64 in the TPS <1% subgroup; HR=0.67 in the PD-L1 TPS 1–49% subgroup and HR=0.64 in the TPS ≥50% subgroup.
  • The OS benefit was also consistent across subgroups defined by metastatic burden: HR=0.47 in patients with ≥3 metastatic sites and HR=0.69 in those with liver metastases.

Comparable subsequent anticancer therapy between the two arms

Proportions of patients in the two groups who subsequently received immunotherapy: 13.9% in the treatment group vs 19.2% in the control group; proportions receiving targeted therapy: 12.4% vs 17.3%; proportions receiving ADC therapy: 4.5% vs 5.6%; proportions participating in other clinical trials: 0.8% vs 2.3%.

Favorable safety profile comparable to tislelizumab plus chemotherapy

  • Grade ≥3 treatment-related adverse events (TRAEs) occurred in 69.2% of patients in the ivonescimab arm and 58.9% in the control arm.
  • Rates of adverse events leading to treatment discontinuation or death were similar between arms.

At the prespecified interim analysis for progression-free survival (PFS), ivonescimab plus chemotherapy had already demonstrated a clinically meaningful and statistically significant improvement in PFS compared with tislelizumab plus chemotherapy, with a median PFS of 11.1 months versus 6.9 months (HR=0.60 [95% CI: 0.46–0.78], P<0.0001).

Professor Shun Lu, Principal Investigator of HARMONi-6, Director of the Lung Cancer Center at Shanghai Chest Hospital and Tenured Professor:

"HARMONi-6 is the first global Phase III study in lung cancer to show statistically significant improvements in both OS and PFS compared with PD-1 plus chemotherapy. It is also the first in sq-NSCLC to achieve dual OS and PFS success through a pre-specified hypothesis test. The results significantly reduced the risk of death and disease progression, with consistent benefits across all subgroups, while enabling patients to maintain better quality of life for longer.

These strong head-to-head data redefine the gold standard for first-line sq-NSCLC treatment and fill a major clinical gap for anti-angiogenic therapy in this setting. We look forward to ivonescimab delivering broader benefits to patients worldwide as a next-generation immuno-oncology therapy."

Dr. Yu Xia, Founder, Chairwoman, President and CEO of Akeso:

"Today, we are thrilled to announce that ivonescimab plus chemotherapy has successfully challenged PD-1 plus chemotherapy, achieving both clinically meaningful and statistically significant improvements in overall survival (OS) and progression-free survival (PFS). We extend our sincere gratitude to all investigators, clinical teams, and patients who participated in this study. Thanks to their efforts, Chinese patients with advanced sq-NSCLC are the first to benefit from this innovative, safe, and highly effective global therapy.

Prior to ivonescimab, no therapy had successfully challenged the dominance of PD-1-based regimens in a head-to-head Phase III trial. Ivonescimab has already demonstrated dual OS and PFS benefits in EGFR-mutant non-squamous NSCLC after TKI failure, becoming the first immunotherapy approved in this setting. It has also shown superior PFS versus pembrolizumab monotherapy in first-line PD-L1-positive NSCLC. These results have generated strong global anticipation for next-generation therapies. Since its launch, ivonescimab has been widely adopted by clinicians and patients.

PD-1 plus chemotherapy is currently the most broadly used first-line regimen in oncology. Following our previous success versus pembrolizumab monotherapy, the HARMONi-6 study now demonstrates for the first time that ivonescimab plus chemotherapy can achieve dual superiority in both OS and PFS over PD-1 plus chemotherapy. This landmark result solidifies ivonescimab's position as a next-generation cornerstone of cancer immunotherapy.

The success of HARMONi-6 gives us even greater confidence to leverage global resources, fully unlock ivonescimab's potential, reshape treatment paradigms, and deliver more effective and safer solutions to patients worldwide."

Ivonescimab is currently being evaluated in more than 30 clinical settings across a wide range of tumors, including 15 Phase III trials, seven of which are head-to-head studies versus PD-1/PD-L1 therapies. The positive results from HARMONi-6 further strengthen its differentiated clinical profile. In partnership with Summit Therapeutics, Akeso remains fully committed to advancing the global development of ivonescimab to maximize its therapeutic benefit for patients worldwide.

About Akeso

Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has established a robust R&D innovation ecosystem centered on its Tetrabody antibody technology platform, AI-powered drug R&D platform, Dual-Shield ADC technology platform, Dual-Lock T-cell engager (TCE) technology platform, Tissue-Smart siRNA/mRNA technology platform, and cell therapy technology platforms. Supported by a global-standard GMP manufacturing infrastructure and a highly efficient, integrated commercialization model, the company has evolved into a globally competitive biopharmaceutical focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 27 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise.

Forward-Looking Statements

This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.

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08:00
Sacituzumab Tirumotecan (sac-TMT) in Combination with Pembrolizumab for First-Line Treatment of PD-L1-Positive NSCLC Published in The Lancet

CHENGDU, China, May 31, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company", 6990.HK) announced today that the results of the Phase III clinical study OptiTROP-Lung05, evaluating the company's trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870)(佳泰莱®) in combination with pembrolizumab (KEYTRUDA®[1], MSD's anti-programmed cell death protein 1 (PD-1) antibody) as first-line treatment for Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS)≥1% non-small cell lung cancer (NSCLC), have been published in the prestigious international medical journal The Lancet (IF=88.5)[2]. The co-senior authors are: Professor Caicun Zhou from Shanghai East Hospital, Tongji University; and Dr. Junyou Ge, Director of the National Engineering Research Centre of Targeted Biologics. The co‑first authors are: Professor Anwen Xiong from Shanghai East Hospital, Tongji University; Professor Wenxiu Yao from Sichuan Cancer Hospital; Professor Wei Zheng from Shengjing Hospital, China Medical University; Professor Yan Yu from Harbin Medical University Cancer Hospital; Professor Peng Chen from Tianjin Medical University Cancer Institute and Hospital; Professor Hua Zhong from Shanghai Chest Hospital; and Dr. Junyou Ge, Director of the National Engineering Research Centre of Targeted Biologics. The study findings were also selected for an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #8506, Lung Cancer – Metastatic Non-Small Cell).

(Published online May 29, 2026; DOI:10.1016/S0140-6736(26)00968-2)
(Published online May 29, 2026; DOI:10.1016/S0140-6736(26)00968-2)

OptiTROP-Lung05 is a randomized, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of sac-TMT in combination with pembrolizumab versus pembrolizumab alone as first-line treatment for patients with locally advanced or metastatic PD-L1 TPS≥1% NSCLC.

The interim analysis results show that compared with pembrolizumab monotherapy, the combination of sac-TMT and pembrolizumab significantly prolongs progression-free survival (PFS) and reduces the risk of disease progression or death, with a hazard ratio (HR) of 0.35. Consistent PFS benefits were observed across all prespecified subgroups, including by PD-L1 expression level and histological type, with PFS HRs of 0.47 and 0.28 for the PD-L1 TPS ≥50% and 1–49% subgroups, respectively, and PFS HRs of 0.28 and 0.44 for the non-squamous and squamous subgroups, respectively. A positive trend in overall survival (OS) was also observed, with an HR of 0.55. Furthermore, the overall safety profile of sac-TMT in combination with pembrolizumab was manageable, consistent with the established safety profiles of sac-TMT alone or pembrolizumab alone, and no new safety signals identified.

This is the first Phase III trial of an ADC combined with an immune checkpoint inhibitor to meet its primary endpoint in the first line treatment of NSCLC, and for the first time demonstrate that "ADC+IO" combination of sac-TMT plus pembrolizumab has the potential to achieve survival benefit as first‑line therapy for NSCLC. The publication of these findings in The Lancet further signifies that the clinical and academic value of this combination therapy has received internationally recognized validation.

[1] KEYTRUDA® (pembrolizumab) is a registered trademark of Merck Sharp & Dohme LLC (MSD), a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
[2] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)00968-2/fulltext

About sac-TMT(佳泰莱®)

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors and genitourinary tumors, among others. Sac-TMT is developed with a unique, bifunctional linker that maximizes payload delivery to tumor cells both through its irreversible connection with the anti-TROP2 monoclonal antibody sacituzumab and its pH-sensitive cleavage from a belotecan-derivative topoisomerase I inhibitor payload in the lysosome, with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).

To date, four indications for sac-TMT have been approved and marketed in China for: 1) unresectable locally advanced or metastatic triple‑negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting); 2) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy and platinum-based chemotherapy; 3) epidermal growth factor receptor (EGFR) mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy; 4) unresectable or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) (Immunohistochemistry (IHC) 0, IHC 1+ or IHC 2+/In Situ Hybridization (ISH)-) BC who have received prior endocrine therapy and at least one line of chemotherapy in advanced setting. The first two indications above have been included in China's National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinically meaningful benefits to a greater number of patients with BC and NSCLC. Additionally, sac-TMT has been granted six Breakthrough Therapy Designations (BTDs) by the National Medical Products Administration (NMPA).

Sac-TMT is the world's first TROP2 ADC drug approved for marketing in lung cancer. A new indication application for sac-TMT in combination with pembrolizumab (KEYTRUDA®) as first‑line treatment for locally advanced or metastatic NSCLC who have PD-L1 TPS≥1% and are EGFR-negative and anaplastic lymphoma kinase (ALK)-negative has been accepted for review by the NMPA, and has entered the priority review and approval process. As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD is evaluating 17 ongoing global Phase III clinical studies of sac-TMT as a monotherapy or in combination with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.

About Kelun-Biotech

Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical, which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects have been approved for marketing, 1 project is in the new drug application (NDA) stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://en.kelun-biotech.com/.

Information Provided by PR Newswire [Disclaimer]
2026-05-30
22:01
The Results of Phase III OptiTROP-Lung05 Study of Sacituzumab Tirumotecan (sac-TMT) Presented as an ASCO Oral Presentation and Simultaneously Published in The Lancet

CHENGDU, China, May 30, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company", 6990.HK) announced today that at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, the results of the Phase III clinical study OptiTROP-Lung05, evaluating the company's TROP2 ADC sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870)(佳泰莱®) in combination with pembrolizumab (KEYTRUDA®[1], MSD's anti-programmed cell death protein 1 (PD-1) antibody) as first-line treatment for Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS)≥1% non-small cell lung cancer (NSCLC), was presented as an oral presentation by Professor Caicun Zhou from Shanghai East Hospital, Tongji University (Abstract #8506, Lung Cancer – Metastatic Non-Small Cell).


Sac-TMT is designed with a unique, bifunctional linker and differentiated belotecan-derivative payload. The linker is conjugated via cysteine, which maximizes payload delivery to tumor cells both through its irreversible connection with the high-affinity and targeting anti-TROP2 monoclonal antibody sacituzumab and its pH-sensitive cleavage from a moderately toxic novel topoisomerase I inhibitor payload in the lysosome, with a drug-to-antibody-ratio (DAR) of 7.4.


In the OptiTROP-Lung05 study, a total of 413 patients were randomized (1:1) to receive either sac-TMT in combination with pembrolizumab or pembrolizumab monotherapy.


As of the data cutoff date (September 29, 2025), with a median follow‑up of 10.5 months, the study demonstrated that:

  • Progression-free survival (PFS) showed statistically significant and clinically meaningful benefit in sac-TMT plus pembrolizumab compared with pembrolizumab alone. The median PFS assessed by blinded independent central review (BICR) was not reached (NR) vs 5.7 months (HR=0.35; 95% CI: 0.26-0.47; p<0.0001). The 12-month PFS rate was 62.4% vs 29.0%.


  • Consistent benefit across prespecified subgroups: In patients with PD‑L1 TPS ≥50% and TPS 1–49%, the PFS HRs were 0.47 (95% CI: 0.29–0.77) and 0.28 (95% CI: 0.19–0.41), respectively. In patients with non‑squamous and squamous NSCLC, the PFS HRs were 0.28 (95% CI: 0.18–0.43) and 0.44 (95% CI: 0.29–0.66), respectively.



  • Overall survival (OS) was not yet mature but showed a positive trend: median OS was NR vs 14.5 months (HR = 0.55; 95% CI: 0.36–0.85). The 12‑month OS rate was 80.4% vs 68.9%.
  • The combination group showed improvements over pembrolizumab monotherapy group in objective response rate (ORR) (70.2% vs 42.0%), deep response rate (49.0% vs 25.9%), and 12-month duration of response rate (77.7% vs 59.4%).


The incidence of grade ≥3 treatment-emergent adverse events (TEAEs) was higher in the combination group, primarily driven by the expected hematologic adverse events of sac-TMT. Incidence of discontinuation of pembrolizumab due to TEAEs was similar in both groups. No sac-TMT-related deaths occurred. Adverse events of special interest (AEOSIs) were consistent with the known safety profiles of each individual agent, and no new safety signals were identified.

The interim analysis results show that sac-TMT plus pembrolizumab significantly prolonged PFS and reduced the risk of disease progression or death compared with pembrolizumab alone, with consistent PFS benefits observed across all prespecified subgroups (including PD‑L1 expression levels and histological subtypes). A positive trend in OS was also observed. Furthermore, the overall safety profile of sac-TMT in combination with pembrolizumab was manageable, consistent with the established safety profiles of sac-TMT alone or pembrolizumab alone.

Notably, the findings of OptiTROP-Lung05 have been simultaneously published in The Lancet(Impact Factor=88.5), indicating that its clinical and academic value has received dual recognition from a leading international academic conference and an authoritative journal.


Professor Caicun Zhou, the national leading principal investigator from Shanghai East Hospital, Tongji University, said: "The positive results of the OptiTROP‑Lung05 study are encouraging. The study not only supports the application of sac‑TMT in an earlier-line setting for lung cancer, but also provides evidence of the 'ADC+IO' synergistic strategy being evaluated in the first-line setting for PD‑L1‑positive advanced NSCLC, potentially bringing a new option to a broad population of patients with lung cancer."

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


About sac-TMT(佳泰莱®)

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors and genitourinary tumors, among others. Sac-TMT is developed with a unique, bifunctional linker that maximizes payload delivery to tumor cells both through its irreversible connection with the anti-TROP2 monoclonal antibody sacituzumab and its pH-sensitive cleavage from a belotecan-derivative topoisomerase I inhibitor payload in the lysosome, with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).

To date, four indications for sac-TMT have been approved and marketed in China for: 1) unresectable locally advanced or metastatic triple‑negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting); 2) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy and platinum-based chemotherapy; 3) epidermal growth factor receptor (EGFR) mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy; 4) unresectable or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) (Immunohistochemistry (IHC) 0, IHC 1+ or IHC 2+/In Situ Hybridization (ISH)-) BC who have received prior endocrine therapy and at least one line of chemotherapy in advanced setting. The first two indications above have been included in China's National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinically meaningful benefits to a greater number of patients with BC and NSCLC. Additionally, sac-TMT has been granted six Breakthrough Therapy Designations (BTDs) by the National Medical Products Administration (NMPA).

Sac-TMT is the world's first TROP2 ADC drug approved for marketing in lung cancer. A new indication application for sac-TMT in combination with pembrolizumab (KEYTRUDA®) as first‑line treatment for locally advanced or metastatic NSCLC who have PD-L1 TPS≥1% and are EGFR-negative and anaplastic lymphoma kinase (ALK)-negative has been accepted for review by the NMPA, and has entered the priority review and approval process. As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD is evaluating 17 ongoing global Phase III clinical studies of sac-TMT as a monotherapy or in combination with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.

About Kelun-Biotech

Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical, which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects with 8 indications have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects with 5 indications approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://en.kelun-biotech.com/.

Information Provided by PR Newswire [Disclaimer]
12:30
2026 ASCO | 蘆康沙妥珠單抗(sac-TMT) III期OptiTROP-Lung05研究成果於ASCO口頭報告和《柳葉刀》同步發佈

成都2026年5月30日 /美通社/ -- 2026年5月30日,四川科倫博泰生物醫藥股份有限公司(下稱「科倫博泰」或「公司」 6990.HK)宣佈,在美國芝加哥舉行的2026年美國臨床腫瘤學會(ASCO)年會上,同濟大學附屬東方醫院周彩存教授以口頭報告形式公佈了TROP2 ADC蘆康沙妥珠單抗(sac-TMT,亦稱SKB264/MK-2870)(佳泰萊®)聯合帕博利珠單抗(可瑞達®[1],默沙東的抗程序性細胞死亡蛋白-1(PD-1)單抗)一線治療程序性細胞死亡配體1(PD-L1)腫瘤細胞陽性比例分數(TPS)≥1%非小細胞肺癌(NSCLC)的III期OptiTROP-Lung05研究結果(摘要編號#8506,肺癌-轉移性非小細胞)。


蘆康沙妥珠單抗(sac-TMT)採用獨特雙功能連接子以及基於貝洛替康衍生物的差異化有效載荷設計。其連接子通過半胱氨酸偶聯,一方面與具有高親和力及靶向效應的TROP2單抗沙妥珠單抗結合,另一方面在溶酶體中可從中等毒性新型拓撲異構酶I抑制劑有效載荷pH敏感裂解,最大限度將有效載荷遞送至腫瘤細胞,藥物抗體比(DAR)達到7.4。


在OptiTROP-Lung05研究中,共有413例患者被隨機(1:1)分配接受蘆康沙妥珠單抗(sac-TMT)聯合帕博利珠單抗或帕博利珠單抗單藥治療。


於數據截止時間(2025年9月29日),中位隨訪10.5個月,研究數據顯示:

  • 蘆康沙妥珠單抗(sac-TMT)聯合帕博利珠單抗組的無進展生存期(PFS)相較於帕博利珠單抗單藥組顯示出統計學意義和臨床意義的顯著改善。由盲態獨立中心評審(BICR)評估的中位PFS為尚未達到(NR) vs 5.7個月(HR=0.35; 95% CI: 0.26-0.47; p<0.0001),12個月PFS率為62.4% vs 29.0%。


  • 預設各亞組獲益一致:在PD-L1 TPS≥50%及TPS 1-49%患者中,PFS HR分別為0.47 (95% CI: 0.29-0.77)和0.28 (95% CI: 0.19-0.41);在非鱗狀和鱗狀NSCLC患者中,PFS HR分別為0.28 (95% CI: 0.18-0.43)和0.44 (95% CI: 0.29-0.66)。


 


  • 總生存期(OS)尚未成熟但顯示積極獲益趨勢:中位OS分別為NR vs 14.5個月(HR=0.55;95% CI: 0.36-0.85);12個月OS率為80.4% vs 68.9%。
  • 聯合治療組較帕博利珠單抗單藥組提高了客觀緩解率(ORR)(70.2% vs 42.0%)、深度緩解率(49.0% vs 25.9%) 及12個月持續緩解率(77.7% vs 59.4%)。


聯合治療組≥3級治療期間不良事件(TEAEs)發生率更高,主要是由蘆康沙妥珠單抗預期發生的血液學不良事件所致;兩組因TEAEs導致帕博利珠單抗永久停藥的發生率相似,未發生蘆康沙妥珠單抗相關的死亡;特別關注的不良事件(AEOSIs)與各試驗藥物已知的不良反應譜一致,未發現新的安全性信號。

期中分析結果表明,相較於帕博利珠單抗單藥,蘆康沙妥珠單抗(sac-TMT)聯合帕博利珠單抗可顯著延長PFS並降低疾病進展或死亡風險,且預設的各亞組中(包括PD-L1表達水平、組織學類型)均表現出一致的PFS獲益;同時已觀察到OS的獲益趨勢。聯合治療組整體安全性可控,且與蘆康沙妥珠單抗(sac-TMT)單藥或帕博利珠單抗單藥已建立的安全性特徵一致。

值得關注的是,OptiTROP‑Lung05研究成果已同步刊登國際頂刊《柳葉刀》(The Lancet, 影響因子IF=88.5),說明其臨床價值與學術價值已獲得國際一流學會及權威期刊的雙重認可。


全國牽頭主要研究者、同濟大學附屬東方醫院周彩存教授表示:「OptiTROP-Lung05研究取得的積極結果令人振奮。不僅為蘆康沙妥珠單抗在肺癌治療中的『應用前移』提供了循證證據,更率先驗證了『ADC+IO』協同策略在PD-L1陽性晚期NSCLC一線治療中的可行性,有望為廣大肺癌患者帶來全新的生存希望。」

[1] 可瑞達®(帕博利珠單抗)為美國新澤西州羅威市默克公司的附屬公司Merck Sharp & Dohme LLC (默沙東)的註冊商標

關於蘆康沙妥珠單抗(sac-TMT)(佳泰萊®)

作為公司的核心產品,蘆康沙妥珠單抗(sac-TMT)是一款公司擁有自主知識產權的新型TROP2 ADC,針對NSCLC、乳腺癌(BC)、胃癌(GC)、婦科腫瘤及泌尿生殖系統腫瘤等晚期實體瘤。蘆康沙妥珠單抗(sac-TMT)採用獨特雙功能連接子開發而成。該連接子一方面通過與抗TROP2單抗沙妥珠單抗形成不可逆結合,另一方面在溶酶體中可從貝洛替康衍生物拓撲異構酶I抑制劑有效載荷pH敏感裂解,從而最大限度將有效載荷遞送至腫瘤細胞,藥物抗體比(DAR)達到7.4。蘆康沙妥珠單抗(sac-TMT)通過重組抗TROP2人源化單克隆抗體特異性識別腫瘤細胞表面的TROP2,其後被腫瘤細胞內吞併於細胞內釋放有效載荷KL610023。KL610023作為拓撲異構酶I抑制劑,可誘導腫瘤細胞DNA損傷,進而導致細胞週期阻滯及細胞凋亡。此外,其亦於腫瘤微環境中釋放KL610023。鑒於KL610023具有細胞膜滲透性,其可實現旁觀者效應,即殺死鄰近的腫瘤細胞。

於2022年5月,公司授予默沙東(美國新澤西州羅威市默克公司的商號)在大中華區(包括中國內地、香港、澳門及台灣)以外的所有地區開發、使用、製造及商業化蘆康沙妥珠單抗(sac-TMT)的獨家權利。

截至目前,蘆康沙妥珠單抗(sac-TMT)的4項適應症已於中國獲批上市,分別用於:1)既往至少接受過2種系統治療(其中至少1種治療針對晚期或轉移性階段)的不可切除的局部晚期或轉移性三陰性乳腺癌(TNBC);2)經表皮生長因子受體-酪氨酸激酶抑制劑(EGFR-TKI)和含鉑化療治療後進展的表皮生長因子受體(EGFR)基因突變陽性的局部晚期或轉移性非鱗狀NSCLC;3)經EGFR-TKI治療後進展的EGFR基因突變陽性的局部晚期或轉移性非鱗狀NSCLC;4)既往接受過內分泌治療且在晚期疾病階段接受過至少一線化療的不可切除或轉移性的激素受體陽性(HR+)且人類表皮生長因子受體2陰性(HER2-) (免疫組織化學(IHC) 0、IHC 1+或IHC 2+/原位雜交(ISH)-) BC;其中前2項適應症已經被納入醫保範圍,將為更多乳腺癌和非小細胞肺癌患者帶來臨床獲益。此外,蘆康沙妥珠單抗(sac-TMT)已獲國家藥品監督管理局(NMPA)授予6項突破性療法認定(BTD)。

蘆康沙妥珠單抗(sac-TMT)是全球首個在肺癌適應症獲批上市的TROP2 ADC藥物。蘆康沙妥珠單抗(sac-TMT)用於聯合帕博利珠單抗(可瑞達®)一線治療PD-L1腫瘤比例分數(TPS)≥1%的EGFR基因突變陰性和間變性淋巴瘤激酶(ALK)陰性的局部晚期或轉移性NSCLC的新增適應症上市申請已獲NMPA受理,並被納入優先審評審批程序。目前,科倫博泰已在中國開展9項註冊性臨床研究。默沙東已啟動17項正在進行的蘆康沙妥珠單抗(sac-TMT)作為單藥療法或聯合帕博利珠單抗或其他抗癌藥物用於多種類型癌症的全球性III期臨床研究(這些研究由默沙東申辦並主導)。

關於科倫博泰

四川科倫博泰生物醫藥股份有限公司(簡稱「科倫博泰」,股票代碼:6990.HK)是科倫藥業控股子公司,專注於創新生物技術藥物及小分子藥物的研發、生產、商業化及國際合作。公司圍繞全球和中國未滿足的臨床需求,重點佈局腫瘤、自身免疫和代謝等重大疾病領域,建設國際化藥物研發與產業化平台,致力於成為在創新藥物領域國際領先的企業。公司目前擁有30餘個重點創新藥項目,其中4個項目8個適應症已獲批上市,1個項目處於NDA階段,10餘個項目正處於臨床階段。公司成功構建了享譽國際的專有ADC及新型偶聯藥物平台OptiDCTM,已有2個ADC項目5個適應症獲批上市,多個ADC或新型偶聯藥物產品處於臨床或臨床前研究階段。更多信息請訪問官網https://kelun-biotech.com/

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12:29
2026 ASCO | 富馬酸侖博替尼(A400/EP0031)治療RET融合陽性NSCLC的關鍵研究數據發佈

成都2026年5月30日 /美通社/ -- 2026年5月30日,四川科倫博泰生物醫藥股份有限公司(下稱「科倫博泰」或「公司」,6990.HK)宣佈,在美國芝加哥舉行的2026年美國臨床腫瘤學會(ASCO)年會上,廣東省人民醫院周清教授以口頭報告形式公佈了新一代選擇性轉染過程中重排(RET)抑制劑富馬酸侖博替尼(A400/EP0031,寧泰萊®[1])用於治療晚期RET融合陽性非小細胞肺癌(NSCLC)的關鍵II期研究結果(摘要編號#8505,肺癌—轉移性非小細胞)。基於此項研究結果,富馬酸侖博替尼用於治療RET融合陽性的局部晚期或轉移性NSCLC成人患者的新藥上市申請(NDA)已獲中國國家藥品監督管理局(NMPA)受理。


該研究共納入71例既往接受過含鉑化療及免疫治療的患者(經治患者)及92例既往未接受過系統治療的患者(初治患者),截至2025年10月29日,中位隨訪時間為22.6個月和20.7個月。


 


經獨立審查委員會(IRC)確認的ORR在初治患者中為81.3%(95% CI: 71.8-88.7) ,在經治患者中為87.1%(95% CI: 77.0-93.9)。


在初治患者中,中位持續緩解時間(mDOR)與中位無進展生存期(mPFS)均未達到;在經治患者中,mDOR為25.7個月,mPFS為27.5個月。


 


在40例基線存在中樞神經系統(CNS)轉移的患者中(根據神經腫瘤學腦轉移瘤反應評估(RANO-BM)標準進行IRC評估),顱內完全緩解(CR)為30%,疾病控制率(DCR)為92.5%(95% CI: 79.6–98.4)。


安全性方面,富馬酸侖博替尼耐受性良好,治療相關不良事件(TRAEs)主要為1-2級。因治療相關不良事件導致的停藥率為1.2%,未報告治療相關死亡事件。

研究表明,富馬酸侖博替尼在RET融合陽性NSCLC中展現出強勁且持久的臨床療效,無論治療線數如何,其療效在總體預後較差的患者人群中均得到驗證。在基線存在可測量CNS轉移的患者中,亦觀察到較好的CNS療效。整體安全性可控,未出現新的安全性信號。

主要研究者廣東省人民醫院周清教授表示:「從2023年ASCO首次報告Ⅰ期研究,到今天公佈關鍵Ⅱ期結果,我們見證了富馬酸侖博替尼從早期探索到確證性研究的紮實進階。關鍵Ⅱ期研究顯示,無論在初治還是經治的RET融合陽性NSCLC患者,富馬酸侖博替尼均能帶來深度且持久的緩解,尤其在基線CNS轉移患者中展現出卓越的顱內療效。作為新一代選擇性RET抑制劑,其有望為患者提供重要的治療新選擇。」

[1] 商品名待NMPA批准

關於富馬酸侖博替尼(A400/EP0031,寧泰萊® )

富馬酸侖博替尼是一款新型新一代選擇性RET抑制劑,開發用於治療NSCLC、甲狀腺髓樣瘤(MTC)以及其他RET變異的實體瘤。富馬酸侖博替尼用於治療RET融合陽性的局部晚期或轉移性NSCLC成人患者的NDA已獲NMPA受理。公司亦在中國進行一項其用於治療RET+實體瘤的Ib/II期臨床研究。

2021年3月,本公司向總部設在英國的國際腫瘤藥物開發公司Ellipses Pharma Limited授出在大中華區及部分亞洲國家之外開發、製造及商業化此藥物的獨家授權。2024年4月,富馬酸侖博替尼獲美國食品藥品監督管理局(FDA)批准進入II期臨床研究(NCT05443126),目前正在美國、英國、歐盟和阿聯酋入組患者,評估該藥物作為單藥及聯合化療在RET融合陽性晚期NSCLC中的療效。

關於科倫博泰

四川科倫博泰生物醫藥股份有限公司(簡稱「科倫博泰」,股票代碼:6990.HK)是科倫藥業控股子公司,專注於創新生物技術藥物及小分子藥物的研發、生產、商業化及國際合作。公司圍繞全球和中國未滿足的臨床需求,重點佈局腫瘤、自身免疫和代謝等重大疾病領域,建設國際化藥物研發與產業化平台,致力於成為在創新藥物領域國際領先的企業。公司目前擁有30餘個重點創新藥項目,其中4個項目8個適應症已獲批上市,1個項目處於NDA階段,10餘個項目正處於臨床階段。公司成功構建了享譽國際的專有ADC及新型偶聯藥物平台OptiDCTM,已有2個ADC項目5個適應症獲批上市,多個ADC或新型偶聯藥物產品處於臨床或臨床前研究階段。更多信息請訪問官網https://kelun-biotech.com/

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2026-05-29
22:10
XtalPi Receives Second Payment from DoveTree; First Oncology Asset Advances into IND-Enabling Studies

BOSTON, May 29, 2026 /PRNewswire/ -- XtalPi (2228.HK), an AI- and robotics- powered drug discovery platform, announced that its strategic collaboration with innovative biopharmaceutical company DoveTree Medicines Unus Inc. has achieved substantial progress, and that XtalPi has received the second payment under the agreement.

Since the two parties entered into a collaboration in June 2025 with a total possible aggregate value of up to US $5.99 billion if resulting in an approved product directed to each of the targets of interest to DoveTree, the partnership has made significant progress. All patents related to the pipeline from the initial upfront payment of US$51 million have now been fully transferred to DoveTree. One preclinical candidate (PCC) has advanced into IND-enabling studies. According to the agreement, XtalPi has now received the second payment of US$19 million. The two parties will further deepen discovery collaboration with agreed priorities and continuously accelerate translation from discovery to clinical development.

XtalPi's proprietary dynamic conformation precision modeling platform uses quantum physics algorithms and AI-driven multiscale molecular simulations as dual engines. Rather than relying on static crystal structures, it simulates more complete processes of a target protein's conformational dynamics in a physiologically relevant environment at atomic-level precision. This allows the platform to accurately capture transiently exposed allosteric sites and PPI interfaces that traditional methods often miss, providing high-resolution structural insights that guide molecular design with both speed and accuracy.

Meanwhile, XtalPi's integrated drug discovery platform—combining AI, physics-based design, and automation-driven synthesis and optimization—seamlessly connects molecular virtual screening with physical synthesis, accelerating the feedback loop between design and validation. Based on structural information generated by the dynamic conformation model, XtalPi has established predictive models for protein complexes used in hit compound screening, enabling highly efficient virtual screening. High-potential molecules with superior drug-like properties are then evaluated for synthesizability and synthetic routes by the company's proprietary SureRXN reaction prediction model, after which a fleet of automated robotic workstations conduct parallel synthesis and activity testing, forming a high-throughput closed-loop iteration of "Design–Make–Test–Analyze" (DMTA).

This system can synthesize and test 3,000–4,000 novel molecules within 2–3 months, with a synthesis success rate consistently above 80%. Even when facing entirely new targets with extremely limited prior data, the platform can rapidly accumulate high-quality empirical data within a very short timeframe, continuously driving algorithm optimization and molecular evolution. This end-to-end capability — from mechanistic insight to physical delivery — brings historically intractable targets onto a significantly de-risked preclinical development trajectory, with the potential to accelerate their transformation into clinically actionable assets.

The momentum of the XtalPi–DoveTree collaboration programs is built on the strengths of both partners: DoveTree brings deep expertise in target biology, translational medicine, and modality innovation, while XtalPi is redefining the efficiency and scalability of molecular discovery through AI and automation.

The combined strengths of the two companies not only enable new drug discovery programs to advance rapidly from initiation to the clinic, but also ensure that these programs address high unmet medical needs by tackling highly validated, difficult-to-drug targets with clear paths to clinical translation and commercialization.

XtalPi is eligible to receive future milestones and royalties, allowing the long-term value of its AI platform to be realized through pipeline expansion and advancement.

Dr. Gregory Verdine, Founder and CEO of DoveTree, stated:

"XtalPi has built an impressive platform operating at the convergence of AI, physics-based molecular design, and automation-driven synthesis and optimization. These integrated capabilities have the potential to improve both the speed and quality of discovery efforts against challenging biological targets. We are pleased with the progress of the collaboration to date and look forward to advancing additional programs toward clinical development."

Dr. Wen Shuhao, Chairman of XtalPi, stated:

"Our collaboration with DoveTree continues to generate verifiable results. This not only validates the advantages of our technological pathway, but also gives us strong conviction as we scale the pipeline. XtalPi has already established a complete closed loop from target discovery to PCC across multiple real-world R&D projects. Our focus now is on systematically extending this approach to a broader set of high-value targets, delivering innovation with a higher probability of success for the industry, and pushing the boundaries of what can be achieved in drug discovery."

About DoveTree Medicines

DoveTree is an innovative biopharmaceutical company focused on developing first-in-class therapies for diseases with significant unmet clinical needs. The company was founded and is led by scientist and entrepreneur Dr. Gregory Verdine, and leverages deep insights into biology together with advanced artificial intelligence technologies to explore novel therapeutic approaches and accelerate the development of transformative medicines. DoveTree is named after the Davidia involucrata — also known as the Dove Tree — a rare ancient plant native to Yunnan, China. The company integrates the frontier R&D innovation and mature pharmaceutical market of the United States with China's rapidly emerging R&D ecosystem and innovative pipeline assets, like the beautiful and flourishing "Dove Tree," bringing new hope to human health.

About XtalPi

XtalPi Holdings Limited ("XtalPi," HKEX: 2228) was founded in 2015 by physicists from the Massachusetts Institute of Technology (MIT). The company is a technology platform focused on quantum physics–based and AI-driven innovation in drug and materials discovery. By integrating quantum physics, artificial intelligence, cloud computing, and large-scale automation, XtalPi provides research and development solutions and services to global pharmaceutical, materials science, consumer products, energy, and advanced chemicals industries.

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20:23
Xtep Recognized for Leading Position in the global running shoes market in 2025 as Industry Advances Toward Professionalization and Scenario Segmentation

XIAMEN, China, May 29, 2026 /PRNewswire/ -- In recent years, the global athletic footwear market has maintained steady sales volume growth. This expansion is driven by the escalating consumer demand for superior comfort, advanced functionality, and everyday versatility, coupled with technological breakthroughs in midsole materials and manufacturing processes toward high performance, lightweight structures, and sustainability. Concretely, global athletic footwear sales volume has expanded from 4.57 billion pairs in 2021 to 5.30 billion pairs in 2025. In the Chinese market*, the growing popularity of marathons and road running events among the general public has further catalyzed the expansion of the professional racing shoes and related running gear segments. Against this backdrop, Xtep has distinguished itself with market leadership that has been independently validated.

Based on independent market research conducted by Frost & Sullivan on the global and Chinese running shoes and sportswear industries, Xtep has been awarded three prestigious market leadership recognitions: " Leading Position in global running shoes market based on sales volume in 2025."; " Ranked No.1 in China by Marathon Running Shoes Wearing Rate for 3 consecutive years(2023-2025)"; and " Ranked Top 3 among Chinese Sportswear brands. (Measured by Sales value of 2025)." From the scale of event sponsorships and depth of runner services to on-track product performance, Xtep's comprehensive cultivation in the running domain has received definitive validation from international authoritative research institutions and the global market. To understand how Xtep achieved these milestones, it is essential to first examine the broader running shoe industry—its product categories, evolution, and current market drivers.

Running Shoe Market: An Overview

Running shoes are purposefully designed athletic footwear engineered to deliver superior cushioning, support, stability, and breathability. Their core value proposition lies in joint protection, running efficiency enhancement, and multi-scenario adaptability. Categorized by function, the market comprises stability, racing, and cushioned running shoes; based on application scenarios, the product portfolio is divided into road running shoes, treadmill and indoor athletic shoes, and trail running shoes.

The global running shoe industry has evolved through three distinct epochs: the Performance-Oriented Era (Pre-1980s–2000), during which products primarily served competitive sports with a core focus on functional enhancements; the Technological Iteration & Mass Expansion Era (2000–2015), characterized by major upgrades in core technologies such as cushioning, support, and lightweight engineering, alongside the popularization of running among the general fitness public; and the Segmented Scenarios & Brand Premiumization Era (2020–Present), where consumer preferences have shifted toward specialized niches and platform-based technological innovations, steering the industry toward high performance, multi-scenario utility, and strategic brand differentiation.

Echoing global megatrends, China's running shoe industry has undergone a parallel upgrade from rudimentary features to specialization, scenario-specific design, and robust brand positioning. Since 2000, international brands have accelerated their market entry into China, while domestic powerhouses such as Xtep, Anta, and Li-Ning have steadily risen, propelling the Chinese running shoe market into its own era of technological iteration and mass-market expansion.

Market Drivers of the Running Shoe Industry

Driven by the widespread adoption of healthy lifestyles and the continuous momentum of marathons and road running events, market demand within the running shoe industry has been continuously unleashed. In 2024, a total of 749 road running races were hosted nationwide, drawing a cumulative total of over 7.04 million participants. In 2025, the racing landscape pivoted toward optimizing quality while rationalizing quantity, with 594 events held throughout the year, attracting 6.399 million participants. The mainstream popularization of these events has significantly expanded the runner baseline, thereby generating sustainable growth in demand for professional running shoes, functional apparel, and supporting gear.

The competitive landscape of the running shoe industry is pivoting from basic functionalities to a holistic competition encompasses technological platforms, product matrices, and multi-scenario adaptability. As marathons serve as a crucial testing ground for the product capabilities of professional footwear, domestic running shoes have seen a continuous surge in their wearing rate, brand exposure, and word-of-mouth reputation on the race tracks in recent years. An increasing number of runners are opting for domestic professional running shoes for both daily training and competitive races, underscoring the growing market endorsement of domestic brands regarding racing performance, wearing experience, and product stability.


 


Xtep Builds a Comprehensive Professional Running Ecosystem to Fully Meet the Needs of Both Elite and Mass Runners


Since establishing its strategic focus on running in 2007, Xtep has consistently deepened its footprint in the running track. Driven by technological R&D, oriented by runner needs, and supported by professional services, Xtep has constructed an industry-leading professional running ecosystem characterized by all-scenario coverage and all-population adaptability, cementing its status as a premier brand in China's running domain. Adhering to innovation-driven and independent R&D, Xtep has consolidated four core running technologies: XTEP FIT Technology, which leverages over 300,000 Chinese foot shape data points to establish China's largest foot shape database, crafting shoe lasts tailored to the Chinese populace; XTEP DURA Technology, which pioneers the use of marathon-grade CPU materials coupled with AI gait analysis to design outsole patterns, achieving a wear-resistant and anti-slip lifespan of over 2,000 kilometers; XTEP ACE+ Technology, which utilizes a supercritical foaming process with a dual-density "soft upper, resilient lower" golden combination design, delivering an outstanding resilient and elastic underfoot feel to help runners accelerate; and Xtep's proprietary XTEP POWER Technology Matrix, which innovatively applies aerospace-grade PI fibers and basalt fibers to running shoes, effectively resolving the industry pain point of carbon fiber brittleness and fracture, thereby providing runners with more powerful propulsion and long-lasting stability. These four technological platforms act synergistically to form the technical bedrock of Xtep's professional running footwear.

In terms of product matrix, Xtep centers on its flagship "Champion Edition Collection" to build a comprehensive running shoe portfolio spanning elite racing, progressive training, and mass jogging. Among them, the 160X Champion Edition series has undergone multiple generations of iterations. As of 2025, it has empowered 141 Chinese athletes to clinch 620 marathon championships, becoming one of the most iconic domestic racing shoes on the marathon circuit. On March 1, 2026, at the Tokyo Marathon, Xtep's running brand ambassador, Feng Peiyou, wearing the Xtep 160X 7.0 PRO in the "Champion Sonata" colorway, shattered the national men's marathon record with a time of 2 hours, 05 minutes, and 58 seconds, ushering Chinese marathons into the "2:05 Era." Concurrently, models such as the 360X (the world's first flexible carbon plate running shoe), the 260X (an all-around competitive training powerhouse), and the AirFlow (a flagship cushioned running shoe) collectively form a comprehensive product lineup covering everyone from elite racers to mass fitness enthusiasts. Notably, Xtep running shoes have secured the No.1 ranking in China by Marathon Running Shoes Wearing Rate for 3 consecutive years(2023-2025)*.

Furthermore, Xtep continues to champion China's road running cause, having sponsored over 1,000 marathon events nationwide, making it the brand with the highest number of marathon sponsorships in China. Xtep has established 71 running clubs, serving over 2.5 million "Xtep Runners" members. Concurrently, through its proprietary IPs such as the "Chinese Running Race & Mass Running" initiative (jointly launched with the Chinese Athletics Association since 2019) and the "321 Running Festival," Xtep has constructed a one-stop runner service ecosystem encompassing professional gear, training courses, community activities, and event services.

1. Sourced from Frost & Sullivan's 2025 Independent Global Running Shoes Market Research Report.

2. Sourced from Frost & Sullivan's 2025 Independent China Marathon Market Research Report.

Information Provided by PR Newswire [Disclaimer]
15:28
Zoomlion Accelerates Global Agricultural Machinery Deployment with Hybrid and Intelligent Product Advances

CHANGSHA, China, May 29, 2026 /PRNewswire/ -- Zoomlion is accelerating the global rollout of new energy and intelligent agricultural machinery, using major exhibitions in Turkey, South Africa, Thailand, Brazil, and China to showcase hybrid tractors, intelligent harvesters and crop-specific mechanization solutions aligned with agriculture's shift toward greener, smarter, and more mechanized operations.

A customer experiences Zoomlion’s DV3504 hybrid tractor at NAMPO Harvest Day 2026 in South Africa on May 12.
A customer experiences Zoomlion’s DV3504 hybrid tractor at NAMPO Harvest Day 2026 in South Africa on May 12.

Hybrid tractors emerged as the Company's key showcase products across multiple markets. The DV3504 and DQ2604 featured prominently in Turkey and South Africa which highlighted Zoomlion's push to position hybrid machinery as a practical solution for large-scale farming and lower fuel consumption. In Turkey, the tractors made their full debut at the Konya Agriculture Fair, where Zoomlion emphasized their performance in high-load applications such as deep tillage, supported by its self-developed MiDD distributed intelligent electric drive system and dynamic energy control technology. In South Africa, the DV3504 became a centerpiece of the Company's presentation at the Nampo show, which drew interest for its combination of power, intelligent operation and energy-saving performance.

Brazil marked another milestone, with Zoomlion making its first appearance at Agrishow and formally launching the DV3504 for the local market. The Company positioned the tractor around Brazil's green agriculture trend and the operating needs of large-scale soybean and corn farming, while also signaling further regional investment through its local subsidiary and manufacturing base.

Beyond tractors, Zoomlion is using localized solutions to address crop-specific mechanization needs. At AGRITECHNICA ASIA 2026 in Bangkok, the Company launched the C600 sugarcane combine harvester as part of a broader solution for Southeast Asia's sugarcane sector. Designed for Thailand's planting density and terrain, the C600 integrates harvesting, conveying, defoliation, and cleaning, while its Z-Pilot intelligent management system incorporates autonomous driving and intelligent scheduling technologies. Zoomlion also presented supporting tractors and implements to form a full-process sugarcane mechanization solution.

At the Xinjiang International Agricultural Machinery Expo, Zoomlion further underscored the role of intelligent new energy technologies in its upgrade strategy. The Company introduced nine hybrid products, including the DH7-6000, which it described as the world's first tandem hybrid grain combine harvester. According to Zoomlion, the machine delivers lower energy consumption and higher operating efficiency than conventional equipment.

Taken together, the exhibitions show how Zoomlion is linking hybrid and intelligent technology with more localized agricultural solutions, while continuing to advance its "high-end, international, new energy" strategy in global markets.

Information Provided by PR Newswire [Disclaimer]
11:22
LI AUTO-W Steadily Advancing Globalisation Strategy; Official Entry into Middle East and Central Asia Markets in 3Q

The Intelligent Driving 9.0 version powered by LI AUTO-W (02015.HK)'s self-developed Mahe M100 chip achieved a major upgrade compared with version 8.0, Xie Yan, Chief Technology Officer of LI AUTO-W (02015.HK), said. Version 9.0 is the first intelligent driving system fully running on the Group's in-house chip. It is ranked among the first tier in the highly competitive industry, though this marks only the beginning, the CTO said. The Group aims in 2H26 to benchmark its performance against Tesla, Inc. (TSLA.US) FSD Beta version 14.

On international expansion, President Ma Donghui said LI AUTO-W's globalisation strategy is progressing steadily. In overseas markets, the Group is adopting a phased expansion approach, flexibly choosing between establishing subsidiaries to develop dealer networks or appointing exclusive general distributors based on local market size and competitive landscape. It aims to leverage leading local partners to rapidly build an integrated service system covering sales, delivery and after-sales support.

Ma added that LI AUTO-W's brand and products continue to gain recognition in overseas markets. In the Middle East and Central Asia markets, the L-series extended-range models will serve as the main offerings, with official entry into these markets in 3Q26. In 2H26, the Group will also launch the all-electric I6 model in the European market. For right-hand-drive markets, a right-hand-drive version of the Mega will be introduced by the end of this year in core Asia-Pacific regions such as Hong Kong and Singapore.
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AASTOCKS Financial News
Website: www.aastocks.com

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10:45
LG Electronics Shares Once Spike 27% on Launch of Android Automotive Solutions

LG Electronics announced the launch of a series of innovative automotive products built on Google technology, sending its shares up by as much as 27% today (29th).

LG Electronics said its new suite of solutions is based on the Android Automotive operating system, featuring a single-chip design capable of simultaneously controlling multiple displays of different sizes, distinguishing it from traditional in-vehicle systems.

The company noted that the solution helps automakers sharply reduce the cost of deploying multi-screen in-car systems.
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AASTOCKS Financial News
Website: www.aastocks.com

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