Chip technology company Marvell Technology, Inc. (MRVL.US) last leaped 7% in pre-market trading on Monday (8th), last reported at USD281.88.

Index operator S&P Dow Jones Indices announced that Marvell Technology, Inc. and electronics manufacturer Flex Ltd. (FLEX.US) will be added to the S&P 500 Index, with the changes taking effect at the open of US trading on Monday, June 22.

Flex Ltd. gained 3.3% in pre-market trading, last at USD156.98. The Campbell's Company (CPB.US) and Pool Corporation (POOL.US) will be removed from the index at the same time.
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SAN FRANCISCO and SUZHOU, China, June 8, 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 oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, presented multiple clinical and preclinical results of its innovative metabolic and obesity pipeline at the 2026 American Diabetes Association's^® (ADA) Scientific Sessions. This includes three clinical oral presentations of mazdutide (GCG/GLP-1 dual agonist) across adults with type 2 diabetes and obesity, adults with obesity and adolescents with obesity, as well as preclinical data from its IBI3032 and IBI3042, as next‑generation oral daily and weekly GLP‑1 receptor agonists, along with IBI3040 (a novel amylin analog) and IBI3046 (an INHBE-targeting siRNA). Innovent Biologics' differentiated pipeline aims to provide scientific and comprehensive treatment options for weight management and metabolic comorbidities through offering superior tolerability, reduced muscle loss, convenient dosing, durable efficacy, and integrated comorbidity management.

Below is a summary of its early-stage pipeline results:

IBI3032 (daily oral small-molecule GLP-1) Preclinical and Phase 1 Clinical Study Results

Preclinical results:

ADA Reference: IBI3032: An Orally Bioavailable Nonpeptidic GLP-1 Receptor Agonist Advancing Through Phase 1 Clinical Trials (Abstract No.: 1678-P)

IBI3032 is a novel, orally bioavailable non-peptidic GLP-1R agonist discovered via structure-based design, and has now advanced into Phase 1 clinical trials in both China and the United States.

IBI3032 exhibited potent activation of the human GLP-1R (EC₅₀ = 0.53 nM) with high selectivity and minimal β-arrestin recruitment. IBI3032 demonstrated favorable cross‑species pharmacokinetics and a robust preclinical efficacy profile. Pharmacokinetic studies revealed high oral exposure in cynomolgus monkeys, with a bioavailability of 24.5% and a half-life of 6.3 hours.

Importantly, compared to the marketed small‑molecule GLP‑1R agonist Orforglipron, IBI3032 demonstrates significantly superior weight‑loss efficiency—achieving markedly greater body weight loss at half of the dose in preclinical models. In a 28-day study in hGLP-1R knock-in DIO mice, oral IBI3032 produced dose-dependent body weight loss relative to vehicle (1 mg/kg: -1.8%; 6 mg/kg: -8.0%; 12 mg/kg: -10.8%). In a 28-day cynomolgus monkey study, once-daily oral administration of IBI3032 (1 mg/kg) produced 11.2% body weight loss versus vehicle.

This differentiated profile supports its potential as a best‑in‑class oral therapy. Collectively, these findings underscore IBI3032 as a next‑generation oral GLP‑1R agonist that combines true oral convenience, low‑dose efficacy, and accelerated global clinical development.

Phase 1 clinical results:

ADA Reference: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI3032, a Novel Oral Nonpeptide GLP-1 Receptor Agonist: Single- and Multiple-Ascending Dose Studies in Chinese Adults (Abstract No.: 1690-P)

Preclinical studies indicate IBI3032 has a higher oral exposure than other marketed oral small‑molecule GLP‑1 in cynomolgus monkeys and shows encouraging efficacy signals for weight loss in obese cynomolgus monkeys. Based on these preclinical findings, two Phase 1 studies were designed to preliminarily assess the human dose range, weight-loss efficacy signals, and safety and tolerability of IBI3032, further validate the hypothesis of potent weight loss at low doses, and provide key data to inform the subsequent clinical trial design.

Study Design: The single-ascending dose (SAD) study recruited 40 eligible participants with/without overweight or obesity (BMI 20–40 kg/m²) to receive once-daily single doses of IBI3032 at 0.3 mg, 1.0 mg, 3.0 mg and 6.0 mg. The multiple-ascending dose (MAD) study recruited a total of 79 overweight/obese participants (BMI 24–40 kg/m²) to receive once-daily oral IBI3032 for 4 weeks per protocol-specified dose titration ranging from 0.6 mg to 10 mg, aiming to evaluate multiple dose-escalation titration regimens.

Clinical Study Findings:

• Linear pharmacokinetics properties support once-daily oral administration: After a single oral dose, IBI3032's systemic exposure (AUC_inf and C_max) increased in an approximately dose-proportional manner across 0.3–6 mg dose range; peak plasma concentration (T_max) occurred 5–12 hours post-dose. Its terminal elimination half-life is (T_1/2) approximately 2 days, which supports a once-daily dosing regimen. Pharmacokinetics (PK) parameters after 4 weeks of sequential titration in MAD were consistent with SAD and exhibited linear PK characteristics.
• Overall manageable safety profile: IBI3032 showed a manageable safety profile in both SAD and MAD studies; nearly all treatment-emergent adverse events were mild to moderate, with no treatment-related serious adverse events reported. No cases of acute pancreatitis, acute kidney injury, acute gallbladder disease, major adverse cardiovascular events, thyroid C-cell hyperplasia or thyroid carcinoma were reported in either study.
• Gradual dose titration balances weight-loss efficacy and treatment tolerability: Four-week cohort comparisons within MAD study demonstrated that low starting dose with stepwise dose escalation enables substantial weight reduction alongside meaningful improvement in gastrointestinal tolerability. In the cohort starting at 0.6 mg with seven-step escalation to 9 mg (n=12), 4-week treatment led to an average 10.11% body weight reduction after 4 weeks, while vomiting incidence remained at 8.3%. Compared with other cohorts utilizing the aggressive escalation approach with high starting doses and large dose increments, this slow titration regimen with lower initial dose, smaller incremental jumps and prolonged escalation cycle lowers gastrointestinal adverse event risk while retaining weight-lowering efficacy, providing evidence for future clinical dosing regimen development.

Ongoing Development in Phase 1: Additional Phase 1 clinical study of IBI3032 is ongoing to further explore and refine optimal dose titration schemes. Leveraging its differentiated attributes of superior oral exposure and low effective therapeutic dose, the program aims to validate the molecule's potential of potent weight loss under acceptable safety and tolerability.

IBI3040 (novel Amylin) Preclinical Results

ADA Reference: IBI3040, a Novel Amylin Analog, Induces Superior Weight Loss in Preclinical Models (Abstract No.: 3077-LB)

IBI3040 is a highly potent agonist of the amylin and calcitonin (CTR) receptors. In a 2-week study in DIO rats, IBI3040 at 2 and 10 nmol/kg Q3D resulted in dose-dependent reductions in body weight of 8.82% and 11.11%, respectively, compared to vehicle-treated rats. In another study, the combination of IBI3040 and semaglutide resulted in a greater weight reduction of −14.7%, whereas monotherapy with IBI3040 or semaglutide produced weight losses of −10.12% and −3.01% in DIO rats, respectively, indicating an additive effect of the combined treatment. Compared to cagrilintide, IBI3040 displays a favorable PK profile, high solubility, and stability without fibril formation at physiological pH (7-8).

IBI3040 demonstrates superior receptor activation, robust weight loss effects compared to cargrilintide and eloralintide, and synergistic potential with semaglutide, supporting its development as a next-generation amylin analog for obesity treatment.

IBI3042 (weekly oral small-molecule GLP-1) Preclinical Results

ADA Reference: IBI3042: A Novel Oral Once-Weekly Small-Molecule GLP-1 Receptor Agonist for Type 2 Diabetes and Obesity (Abstract No.: 2543-P)

IBI3042 is potentially the world's first once-weekly oral small-molecule GLP-1 receptor agonist candidate entering clinical studies by the end of 2026. The weekly dosing potential is offering a compelling new option for patients seeking a more convenient and manageable long-term treatment for type 2 diabetes and obesity.

IBI3042 exhibited GLP-1R activation in cAMP assays, but showed no β-arrestin recruitment in NanoBiT assays. In human GLP-1 receptor knock-in (GLP-1R KI) mice, IBI3042 (0.4 mg/kg P.O.) maintained significant glucose-lowering effects for at least 7 days, outperforming Orforglipron at the same dose.

In diet-induced obese (DIO) humanized GLP-1 receptor knock-in mice, IBI3042 at 1 mg/kg twice weekly showed comparable efficacy to Orforglipron 1.5 mg/kg once daily, while the 3 mg/kg twice-weekly dose demonstrated superior efficacy. In contrast, Orforglipron at 3 mg/kg twice weekly showed no notable efficacy.

In obese cynomolgus monkeys, IBI3042 produced robust, dose-dependent body weight reduction with twice-weekly oral dosing (1.5–4.5 mg/kg). The 1.5 mg/kg twice-weekly regimen achieved efficacy comparable to Orforglipron 1 mg/kg once daily, while the 4.5 mg/kg twice-weekly regimen demonstrated superior body weight reduction. Furthermore, the 7 mg/kg once-weekly regimen also matched the efficacy of Orforglipron 1 mg/kg once daily.

These compelling results position IBI3042 as a promising once-weekly oral treatment for obesity and type 2 diabetes, delivering a significantly more convenient and effective dosing option for patients.

IBI3046 (novel INHBE siRNA) Preclinical Results

ADA Reference: IBI3046, an INHBE siRNA, Enables High Quality and Long-Lasting Weight Control in Preclinical Study (Abstract No.: 2662-P)

IBI3046 is an INHBE-silencing RNAi therapeutic designed to enhance adipose lipolysis with sustained effects.

IBI3046 demonstrated potent and durable mRNA knockdown in hINHBE KI mouse model. In the efficacy study, IBI3046 resulted in a 13% reduction in body weight and a 50% decrease in fat mass relative to control. In combination therapy, IBI3046 administered with a low dose of GLP-1RA achieved 20% body weight loss and a 80% reduction in fat mass. Combining IBI3046 with GLP-1RAs may synergistically enhance fat loss while mitigating key limitations of current anti-obesity regimens. In addition, IBI3046 extended the duration of suppressed weight regain following drug withdraw.

IBI3046 enables Q3M-6M dosing, offering diabetes and obesity patients improved adherence and quality of life for glucose and weight control, thereby can potentially redefine the standard of metabolic disease management.

Dr. Lei Qian, Chief R&D Officer (General Biomedicine) of Innovent, stated, "At this year's ADA Scientific Sessions, we are pleased to present a series of new data in obesity and metabolic diseases, which is an important step in establishing Innovent as an emerging leader and innovator in this field. The multiple oral presentations of mazdutide, across adults with type 2 diabetes and obesity, adults with obesity and adolescents with obesity, further highlight its differentiated profile as a GCG/GLP‑1 dual receptor agonist in terms of weight loss, glycemic control and metabolic benefits. In addition, the data on IBI3032 (oral daily GLP-1 small molecule), IBI3042 (oral weekly GLP-1 small molecule), IBI3040 (amylin) and IBI3046 (INHBE siRNA) represent key progresses of our next‑generation obesity pipeline with global potential, which are designed to address unmet needs around tolerability, muscle preservation, dosing convenience, durability of weight loss and management of obesity‑related comorbidities."

About Innovent

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 1 asset under NMPA review, 4 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 Eli Lilly, Roche, Takeda, 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.

Forward-looking statement

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 Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company 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 the Company 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 the Company'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, the Company's competitive environment and political, economic, legal and social conditions.

The Company, the Directors and the employees of the Company 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 materialise or turn out to be incorrect.

DUNDALK, Ireland, June 8, 2026 /PRNewswire/ -- WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that its Ireland site won the "Overall Excellence in Life Sciences" award, the highest recognition at the 2026 Life Sciences Industry Awards. The company also was named the winner of the "Life Sciences Team of the Year" and won the "Outstanding Contribution Award." The Life Sciences Industry Awards are among Ireland's foremost industry recognition programs, celebrating excellence, innovation, and leadership across the country's pharmaceutical, biotechnology, medical device, and broader life sciences sectors.

The company was shortlisted across eight award categories, reflecting the breadth of capabilities and achievements demonstrated by its Ireland site. Among the honors received, WuXi Biologics' Manufacturing Science & Technology (MSAT) Team was named Life Sciences Team of the Year and subsequently selected for the Overall Excellence in Life Sciences award, recognizing the team's exceptional contributions to advancing manufacturing science, technology transfer, operational performance, and delivery excellence.

The recognition further reinforces WuXi Biologics Ireland's position as a strategic hub within the company's global network and highlights its continued commitment to quality, innovation, operational excellence, and sustainable growth. As demand for high-quality biologics manufacturing continues to grow, the Ireland site remains focused on delivering flexible and reliable solutions that support global clients across the development and commercialization lifecycle.

These latest honors build upon a series of major milestones achieved by the Ireland site in recent years, including HPRA GMP authorization and EMA approval for commercial manufacturing of innovative biologic products. Since commencing operations, the WuXi Biologics Ireland site has established itself as one of Europe's most advanced single-use biologics manufacturing facilities, earning international recognition for its operational excellence, innovation, and sustainability performance.  

Other accolades the Ireland site has received include the ISPE Facility of the Year Award and the Operational Excellence in Life Sciences Award. All together, these achievements underscore the site's growing role in supporting global biologics development and commercial manufacturing while contributing to the continued advancement of Ireland's thriving life sciences ecosystem.

WuXi Biologics' global manufacturing footprint spans China, the United States, Ireland, Germany, and Singapore, with 24 drug substance (DS) facilities and 18 drug product (DP) facilities currently in operation. This network provides integrated dual-sourcing solutions spanning DS and DP — from clinical development through commercial-scale manufacturing — at the highest levels of quality. As of 2025, WuXi Biologics had successfully passed 46 regulatory inspections worldwide, including 22 conducted by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), achieving a 100% success rate with no critical findings and no data integrity issues.

About WuXi Biologics

WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide*.

With over 13,000 employees in China, the United States, Ireland, Germany, and Singapore — including experts and scientists in biologics R&D and manufacturing, technology innovation, and operational excellence — WuXi Biologics leverages its technologies and expertise to deliver efficient, cost-effective, and scalable biologics solutions tailored to meet clients' needs. By embedding digital capability and infrastructure across the full biopharmaceutical value chain, the company turns data, computation, and prediction into transparent client experience, faster development, intelligent operations, and more efficient manufacturing. As of April 30, 2026, WuXi Biologics is supporting 982 integrated client projects, including 78 in Phase III and 25 in commercial manufacturing, with complex modalities representing more than half of the entire project portfolio.

WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while demonstrating exemplary Environmental, Social and Governance (ESG) practices. Committed to creating shared value, it collaborates with all stakeholders to foster positive social and environmental impacts, and promote responsible practices that empower the entire value chain.

For more information about WuXi Biologics, please visit: www.wuxibiologics.com.

*The winner of the "2026 Biologics CDMO of the Year" (Large CDMOs) (Life Science Connect / Outsourced Pharma)
*The winner of the "2026 Best Contract Development & Manufacturing Organization Award" (ABEA)

Contacts
Business
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NVIDIA Corporation (NVDA.US) is collaborating with LG Group to develop humanoid robots and data centers, said CEO Jensen Huang.

Both parties are working together to research motor technologies and mechanical systems, aiming to integrate the future of humanoid robots with robotics technologies, he said. The two companies will also jointly build next-generation data centers.
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US semiconductor stocks plunged last Friday (5th). This morning (8th), Samsung Electronics shares once sank below KRW300,000 and last dived more than 7% at KRW305,000, while SK Hynix shares dropped below KRW2 million and were last down 3.86%.

Jensen Huang, CEO of NVIDIA Corporation (NVDA.US), who is visiting Seoul, said that AI-related stocks are now very cheap and shareholders should be pleased as there could be even greater upside in the future.

Huang stated that demand for AI will continue to mushroom and that the future is very bright. It has become an established fact that AI will serve as core global infrastructure.

Earlier, NVIDIA reached a cooperation agreement of more than two years with SK Hynix, which can be extended. Under the agreement, NVIDIA chips will be produced at SK Hynix’s wafer fabrication plants and used by SK Telecom to support AI development.
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NVIDIA Corporation (NVDA.US) and SK Hynix announced a multi-year technology partnership agreement, building on years of close joint R&D to advance next-generation memory technologies, accelerate the construction of global AI factories, and speed up semiconductor design and manufacturing.

The agreement provides supply support for advanced memory to address extended R&D cycles, advanced manufacturing processes and capital investments, thereby sustaining the build-out of global AI factories. SK Hynix will collaborate with NVIDIA to develop memory for the Vera Rubin AI supercomputer, Vera CPU, RTX Spark-powered personal computers, and the Jetson Thor robotics computing platform.

The two companies will apply AI technologies to semiconductor chip design and manufacturing, leveraging NVIDIA CUDA-X libraries and NVIDIA PhysicsNeMo to accelerate semiconductor simulation, TCAD processes and internal engineering codes.

SK Hynix will integrate NVIDIA Omniverse, OpenUSD scene optimization and NVIDIA cuOpt to advance digital twin technology for factories, enabling fully autonomous wafer fabrication plant operations.
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NVIDIA Corporation (NVDA.US) Founder and CEO Jensen Huang will visit South Korea today (5th) and meet with the heads of several major South Korean enterprises, Yonhap News Agency reported, citing NVIDIA and industry sources. This marks his first trip to South Korea in seven months since his last visit in late October last year.

Huang is purportedly expected to enter the country via Gimpo Airport at around 1 p.m. local time and attend a dinner this evening with leaders of major South Korean conglomerates.

Attendees are set to include SK Group Chairman Chey Tae-won, Hyundai Motor Group Chairman Euisun Chung, LG Group Chairman Koo Kwang-mo, and NAVER Board Chairman Lee Hae-jin.
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DENVER, June 4, 2026 /PRNewswire/ -- XPENG (NYSE: XPEV, HKEX: 9868), a leading China-based high-tech company, kicks off its key presence at CVPR 2026 (The IEEE/CVF Conference on Computer Vision and Pattern Recognition). Dr. Xianming Liu, Head of General Intelligence Center at XPENG, spoke at the inaugural Workshop on Deployment of Foundation Models for Embodied AI (WDFM-EAI), sharing insights with global counterparts including Tesla, NVIDIA and Waymo. This marks XPENG's third attendance at the prestigious conference.

From Technical Concept to Mass Production: VLA2.0 Achieves Key Technical Breakthrough

Dr. Xianming Liu systematically deconstructed the evolution of XPENG's physical AI technology system, from concept validation and technical refinement to full-scale mass production. First unveiled at CVPR 2025, XPENG's in-house foundation model has now achieved a critical leap: VLA2.0 has entered formal mass production, marking an industry-leading closed loop from pre-research to commercial deployment. Within its first month, VLA2.0 set an industry milestone with over 50% assisted driving mileage share, establishing a new benchmark in China's assisted driving sector.

First Technical Blueprint for World Model Unveiled, Advancing Physical-World Foundation Models

Dr. Xianming Liu introduced the world model as another core pillar of XPENG's foundation model system. XPENG is developing a world model capable of Deliberative Reasoning, Controllable Generation, and Long-Horizon Forecasting. Rather than competing, the world model and VLA2.0 complement each other: VLA2.0 learns "how to act" from human driving, while the world model learns "how the world changes after an action" by predicting future states and scene evolution. Together, they form XPENG's Physical-World Foundation Model, essentially pursuing the same goal: building a sufficiently powerful foundation model for the physical world.

XPENG specifies these three core capacities as essential for qualified world models and autonomous driving. Its R&D team has published three papers: X-World, X-Foresight, X-Cache, detailing corresponding R&D approaches.

Continuing Validation of Scaling Law: XPENG Accelerates Large-Scale Rollout of Physical AI

In the 12 months ending March this year, XPENG's cluster delivered a 1,010% uplift in per-GPU training efficiency and a 4,360% gain in single-job training efficiency, while GPU hardware utilization climbed from 40% to 90%, matching benchmarks set by top-tier global AI firms.

As VLA2.0's capabilities continue to expand, XPENG is accelerating the large-scale deployment of its core Physical AI applications: VLA2.0, Robotaxi, and Humanoid Robots. The IRON humanoid robot is progressing toward mass production by the end of 2026, with plans to enter XPENG's offline stores as a shopping guide in Q1 2027.

Appendix: XPENG World Model Related Academic Papers

X-World Paper: https://arxiv.org/pdf/2603.19979

X-World Official Site: https://x-world-1.github.io/

X-Cache Paper: https://arxiv.org/abs/2604.20289

X-Cache Official Site: https://x-cache-1.github.io/en/

X-Foresight Paper: https://arxiv.org/abs/2605.24892

X-Foresight Official Site: https://x-foresight-1.github.io/en/

About XPENG
Founded in 2014, XPENG is a leading Chinese AI-driven mobility company that designs, develops, manufactures, and markets Smart EVs, catering to a growing base of tech-savvy consumers. With the rapid advancement of AI, XPENG aspires to become a global leader in AI mobility, with a mission to drive the Smart EV revolution through cutting-edge technology, shaping the future of mobility.

To enhance the customer experience, XPENG develops its full-stack advanced driver-assistance system (ADAS) technology and intelligent in-car operating system in-house, along with core vehicle systems such as the powertrain and electrical/electronic architecture (EEA). Headquartered in Guangzhou, China, XPENG also operates key offices in Beijing, Shanghai, Silicon Valley, and Amsterdam. Its Smart EVs are primarily manufactured at its facilities in Zhaoqing and Guangzhou, Guangdong province.

XPENG is listed on the New York Stock Exchange (NYSE: XPEV) and Hong Kong Exchange (HKEX: 9868).
For more information, please visit https://www.XPENG.com/.

Contacts:
For Media Enquiries:
XPENG PR Department
Email: [email protected]

• 雲頂新耀將獲得倍捷欣®在亞太地區（東南亞、印度、韓國、澳大利亞、新西蘭、中國香港、中國澳門及中國台灣地區）的臨床開發及商業化權益。
• 根據相關協議，雲頂新耀將向天廣實支付人民幣2,300萬元的首付款，以及最高不超過人民幣1.86億元的銷售里程碑款。天廣實可獲得該產品在亞太地區的銷售毛利額分成款項。
• 此次合作將進一步強化雲頂新耀在腎科及自身免疫疾病等領域的亞太市場佈局，並與現有腎科管線形成協同效應。

上海2026年6月4日 /美通社/ -- 雲頂新耀（HKEX 1952.HK，以下簡稱「公司」），一家專注於創新藥研發、臨床開發、製造及商業化的生物製藥公司，今日宣佈與北京天廣實生物技術股份有限公司（以下簡稱「天廣實」）達成商業化授權許可合作協議，獲得倍捷欣^®（MIL62，通用名：奧妥珠單抗β注射液）在亞太地區（東南亞、印度、韓國、澳大利亞、新西蘭、中國香港、中國澳門及中國台灣地區）的臨床開發及商業化權益。

此次合作將進一步強化雲頂新耀在腎科及自身免疫疾病等領域的亞太市場佈局，並與現有腎科管線形成協同效應。公司將依托已獲驗證的臨床開發及商業化能力，加速推動倍捷欣®的市場准入與商業化進程，持續釋放亞太區域的增長潛力，並推進公司在全球創新藥市場的長期戰略發展。

根據相關協議，雲頂新耀將向天廣實支付人民幣2,300萬元的首付款，以及最高不超過人民幣1.86億元的銷售里程碑款。天廣實可獲得該產品在亞太地區的銷售毛利額分成款項。

倍捷欣^®是天廣實自主研發的創新型第三代CD20抗體藥物，已於2026年2月在中國獲批上市，用於治療視神經脊髓炎譜系疾病（NMOSD），成為全球首款治療該疾病的CD20抗體，也是中國在該領域的首款國產藥物。倍捷欣^®用於治療原發性膜性腎病（PMN）的新藥上市申請亦處於中國國家藥監局的「優先審評審批」階段，有望成為全球首款獲批的PMN特效藥物。此外，倍捷欣®正在進行的臨床III期試驗覆蓋系統性紅斑狼瘡（SLE）以及濾泡性淋巴瘤（FL）多個治療領域，並具備向其他自身免疫性疾病持續拓展的潛力。

雲頂新耀董事會主席吳以芳表示：「我們非常高興能與天廣實就倍捷欣^®達成此次合作。倍捷欣^®不僅是全球首款獲批治療NMOSD的CD20抗體，也是一款具有差異化優勢和廣闊市場前景的創新藥，在腎科及自身免疫疾病領域展現出顯著的臨床潛力。

此次合作將進一步豐富雲頂新耀在腎科及自身免疫領域的產品佈局，並與現有管線形成良好的協同效應。依托公司已建立並持續強化的臨床開發及商業化能力，我們有信心加速推進倍捷欣®在亞太地區的開發與商業化進程，推動其盡快惠及更多患者，讓創新療法更快轉化為臨床可及性，並進一步提升公司在亞太及全球創新藥市場的影響力。」

天廣實總裁陳魯寧表示：「我們非常欣喜與雲頂新耀達成倍捷欣®在亞太地區的合作。倍捷欣^®作為全球首款獲批治療NMOSD的CD20靶向藥物，也是潛在全球首款治療PMN的特效藥物，擁有非常出色的產品競爭力與市場潛力。自產品上市以來，倍捷欣^®在中國大陸地區已經取得了優異的商業化成績，此次合作將進一步強化倍捷欣^®在整個亞太市場的商業化網絡與品牌影響力，為中國大陸以外的更多腎科及自身免疫性疾病患者帶來「欣」希望。」

倍捷欣^®目前已在腎科及多個自身免疫疾病領域展現出顯著的臨床及治療價值，並具備廣闊的適應症拓展潛力。其在NMOSD、PMN及SLE等疾病領域的持續佈局與進展，有望為患者帶來更多創新治療選擇。

NMOSD是一種高復發率、高致殘率的中樞神經系統自身免疫性疾病，多發於青壯年女性。該病通常為急性或亞急性起病，可迅速進展，約90%的患者在三年內經歷復發，嚴重者可導致失明甚至癱瘓。倍捷欣^®在單藥治療中顯示出降低復發風險的顯著優勢，並在療效數據中展現出優異表現，凸顯其作為單藥療法的臨床價值與治療便利性。

PMN是成人腎病最常見的病理類型，約30%-40% 的患者在5-15年內可能進展為終末期腎病。目前全球範圍內尚無獲批的特效藥。臨床III期研究顯示，倍捷欣^®單藥治療在臨床完全緩解、免疫學完全緩解及臨床緩解等各項指標上均展現出顯著優勢。此外，倍捷欣®具有良好的安全性和耐受性，並且給藥週期便捷，患者初始治療後，每六個月僅需進行一次靜脈注射，可顯著降低治療負擔，同時有助於提升長期依從性。

SLE是一種慢性系統性自身免疫疾病，倍捷欣®目前處於臨床III期研究階段，具有24–28周的長給藥間隔優勢，可滿足患者對長效治療方案的臨床需求，有望為SLE患者提供更優治療選擇。

關於倍捷欣^®

倍捷欣^®（MIL62，通用名：奧妥珠單抗β注射液）是具有獨特市場競爭地位的第三代CD20抗體，已在中國獲批上市（藥品批准文號：國藥准字S20260011），用於治療視神經脊髓炎譜系疾病（NMOSD），為全球首款治療NMOSD的CD20靶向藥物，亦為中國首個獲批該適應症的國產藥物。

針對原發性膜性腎病（PMN）治療的倍捷欣^®已於2025年10月被中國國家藥品監督管理局納入「突破性治療」藥物品種，成為首款在腎病治療領域獲得該認定的國產藥物，其新藥上市申請正處於「優先審評審批」階段，有望成為全球首款獲批用於治療PMN的特效藥物。

關於雲頂新耀

雲頂新耀是一家專注於創新藥研發、臨床開發、製造和商業化的生物製藥公司，致力於滿足全球市場尚未滿足的醫療需求。雲頂新耀的管理團隊在中國及全球領先製藥企業擁有深厚的專長和豐富的經驗。公司在浙江嘉善擁有具備商業化規模的全球生產基地，並依據中國、美國及歐盟標準建立了完善的GMP生產質量管理體系。

公司聚焦自身免疫、眼科、急重症及CKM（心血管、腎臟及代謝）等疾病治療領域，已打造集全渠道商業化體系與藥品全生命週期商業化能力於一體的商業化平台，並以擁有全球權益的自研mRNA平台為基礎，持續推進mRNA in vivo CAR-T與mRNA腫瘤疫苗等現有管線，同時通過引進及生態孵化潛力平台，拓展研發能力，同時強化全球化佈局，加快國際化發展進程。更多信息，請訪問公司官網：www.everestmedicines.com。

關於天廣實

北京天廣實生物技術股份有限公司專注於創新型抗體靶向藥物研發及產業化，致力於為自身免疫性疾病及腫瘤患者帶來創新的治療方案。公司將免疫學及生物學的科學突破轉化為新型抗體靶向療法，針對存在大量醫療需求缺口和市場潛力的各種自身免疫性疾病和腫瘤市場進行產品開發和技術創新。公司是國家級高新技術企業、北京市專精特新中小企業、北京市重點實驗室、北京市工程實驗室，並設有企業博士後工作站和院士專家工作站。

前瞻性聲明

本新聞稿所發佈的信息中可能會包含某些前瞻性表述，乃基於本公司或管理層在做出表述時對公司業務運營情況及財務狀況的現有看法、相信、和現有預期，可能會使用「將」、「預期」、「預測」、「期望」、「打算」、「計劃」、「相信」、「預估」、「確信」及其他類似詞語進行表述。這些前瞻性表述並非對未來業績的保證，會受到風險、不確性及其他因素的影響，有些乃超出本公司的控制範圍，難以預計。因此，受我們的業務、競爭環境、政治、經濟、法律和社會情況的未來變化及發展等各種因素及假設的影響，實際結果可能會與前瞻性表述所含資料有較大差別。本公司及各附屬公司、各位董事、管理人員、顧問及代理未曾且概不承擔更新該稿件所載前瞻性表述以反映在本新聞稿發佈日後最新信息、未來項目或情形的任何義務，除非法律要求。

SAN FRANCISCO and SUZHOU, China, June 4, 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 oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that the international multi-center Phase 3 clinical study (G-HOPE-001, NCT06238843) of arcotatug tavatecan (IBI343; Takeda R&D code: TAK-921, an innovative TOPO1i CLDN18.2 ADC) has completed the per-protocol first interim analysis and reached the primary endpoint. Arcotatug tavatecan demonstrated excellent efficacy and a tolerable safety profile in the treatment of advanced gastric cancer. Based on the positive clinical results, Innovent has submitted the new drug application (NDA) for arcotatug tavatecan to the National Medical Products Administration (NMPA) of China, for the treatment of previously treated locally advanced unresectable or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma (G/GEJA) who have received at least two prior systemic therapies. This application has been accepted with priority review.

Arcotatug tavatecan is a biomarker-guided, CLDN18.2-targeted ADC developed as a precision medicine for the treatment of CLDN18.2-expressing cancers. It is designed to selectively deliver a high-potency exatecan payload (TOPO1i) to tumor cells via a cleavable linker, and incorporates Fc silencing to minimize off-tumor toxicities. It is the world's first CLDN18.2 ADC to be submitted for regulatory review.

The G-HOPE-001 study is an international, multicenter, randomized, open-label Phase 3 clinical trial conducted in China and Japan to evaluate the efficacy and safety of IBI343 monotherapy vs. investigator-selected therapy in subjects with previously treated, Claudin 18.2-positive, locally advanced unresectable or metastatic G/GEJA who have received at least two prior systemic therapies. The primary endpoints of the study are PFS and overall survival (OS). The clinical study data are planned to be published in future academic conferences or journals.

Professor Lin Shen, Director of Department of Gastrointestinal Oncology, Beijing Cancer Hospital, said: " We are delighted to see that the pivotal Phase 3 clinical trial of arcotatug tavatecan has been successfully conducted in China and Japan, and achieved its primary endpoint at the first interim analysis. This marks a major breakthrough in targeted precision therapy for gastrointestinal oncology. Meanwhile, the NDA for arcotatug tavatecan has been accepted by the NMPA. The excellent efficacy and manageable safety profile of this product will potentially bring new standardized treatment options and help the adoption of precision diagnosis and treatment for gastrointestinal tumors with targeted therapies."

"Arcotatug tavatecan is a next-generation ADC drug targeting CLDN18.2," said Professor Kohei Shitara, Director of the Department of Gastrointestinal Oncology, National Cancer Center Hospital East. "Clinical study data showed that Arcotatug tavatecan has good overall safety and tolerability, and a low incidence of gastrointestinal-related toxicity. At the same time, it has shown potential and encouraging anti-tumor therapeutic effects in patients with gastric cancer/gastroesophageal junction adenocarcinoma who have high expression of CLDN18.2. The G-HOPE-001 study completed the first interim analysis according to the established study protocol and successfully reached the preset primary endpoint of progression-free survival, which laid a solid foundation for subsequent clinical application."

Dr. Hui Zhou, Chief R&D Officer (oncology pipeline) of Innovent Biologics, said, " Patients with advanced gastric cancer generally have a poor prognosis after initial lines of treatment and are prone to rapid disease progression. There is a lack of effective subsequent treatment options, with median survival of only around six months, highlighting a significant and urgent unmet clinical need. We are excited that the international multicenter Phase 3 study of Arcotatug tavatecan has successfully met its primary endpoint of progression-free survival and that the marketing application in China has been accepted. We look forward to this innovative therapy offering a new and more effective treatment option for patients with advanced gastric cancer."

About gastric/gastroesophageal junction adenocarcinoma

Gastric cancer is one of the most common malignant tumors in the world and is one of the leading causes of death due to cancer worldwide. The 5-year survival rate of patients with metastatic gastric cancer is less than 5%¹. China and Japan are high-incidence areas for gastric cancer². Currently, chemotherapy and immune checkpoint inhibitor therapy combined with fluoropyrimidine and platinum are the standard treatment for patients with advanced metastatic gastric cancer. Systemic therapy has limited efficacy for advanced gastric cancer, especially for third-line and above gastric cancer, the prognosis is usually poor, with few treatment options and short expected survival. The median survival is about half a year³.

CLDN18.2, a tight junction protein specifically expressed in normal gastric mucosa and abnormally highly expressed in gastric cancer and gastroesophageal junction adenocarcinoma (positivity rate up to approx. 80% of cases), is a promising star target for precision treatment of gastric cancer.

About IBI343 (Arcotatug tavatecan)

IBI343 (Arcotatug tavatecan) is a recombinant human anti-CLDN18.2 monoclonal antibody-drug conjugate (ADC) developed by Innovent Biologics. It specifically binds to the tumor cells expressing CLDN18.2, triggering CLDN18.2-dependent internalization of the ADC. Once inside the cell, the cytotoxic payload is released, resulting in DNA damage and ultimately apoptosis of the tumor cells. The released drug can also diffuse across the plasma membrane to reach and kill neighboring cells, resulting in a "bystander killing effect".

Arcotatug tavatecan is currently under NMPA's review and being explored in solid tumor types such as gastric cancer and pancreatic cancer, including:

• Arcotatug tavatecan is under NMPA's priority review for previously treated locally advanced unresectable or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma, based on the positive first interim analysis results from the international multi-center Phase 3 clinical study G-HOPE-001;
• Arcotatug tavatecan is under a Phase 3 clinical study in China for patients with CLDN18.2-positive advanced pancreatic cancer;
• Arcotatug tavatecan is also being explored in Phase 1 clinical studies such as the first-line treatment for patients with gastric cancer and patients with pancreatic cancer.

In October 2025, Innovent Biologics entered into a global strategic partnership with Takeda Pharmaceuticals, which includes granting Takeda exclusive rights for IBI343 (Takeda's R&D code: TAK-921) outside Greater China.

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 1 asset under NMPA review, 4 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 Eli Lilly, Roche, Takeda, 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.

Forward-Looking Statements

The information in this press release may contain certain forward-looking statements. These statements carry considerable risk and uncertainty in nature. The use of the words "anticipate," "believe," "predict," "expect," "intend," and other similar expressions in connection with the Company is intended to identify forward-looking statements. The Company is under no obligation to update these forward-looking statements on a continuing basis.

These forward-looking statements are based on the Company's management's existing views, assumptions, expectations, estimates, forecasts, and understandings of the future affairs at the time of the statements. These statements are not guarantees for future development and are subject to risks, uncertainties, and other factors, some of which are beyond the control of the Company and are difficult to predict. As a result, actual results may differ materially from those contained in the forward-looking statements as a result of future changes and developments in our business, competitive environment, political, economic, legal, and social conditions.

References

1. Lasithiotakis K, Antoniou SA, Antoniou GA, Kaklamanos I, Zoras O. Gastrectomy for stage IV gastric cancer.  a systematic review and meta-analysis. Anticancer Res. May 2014;34(5):2079-85.
2. Xu B, Wang JM. Epidemiological study of gastric cancer[J]. Chin J Cancer Prev Treat, 2006,13(1): 81-87.
3. Chan WL, Lam KO, So TH, et al. Third-line systemic treatment in advanced/metastatic gastric cancer: a comprehensive review. Ther Adv Med Oncol. 2019;11:1758835919859990.