Pfizer to Acquire Metsera for Up to $7.3 Billion; Genfleet Biosciences Lists on HKEX; Frontier Biotech and Johnson & Johnson Release Clinical Data | Arterial Weekly

Li Jiaying Author: Interns Chen Chuan, Zheng Ao, He Duo

New Drug EntryExpand

Akeso's Dual-Target Antibody Fusion Protein AK130 CombinationHeywoxiFirst Patient Enrolled in the Treatment of Advanced Pancreatic Cancer

On September 22, Akeso announced that the registration-directed Phase II clinical study (AK130-202) of its fully self-developed TIGIT/TGF-β dual-target antibody fusion protein AK130, in combination with the PD-1/VEGF bispecific antibody new drug Evecima (AK112), for the treatment of locally advanced or metastatic pancreatic cancer that has progressed after prior systemic therapy (not exceeding second-line treatment), has completed the enrollment of the first patient.

Hengrui Pharma's Adebrelimab Adult Non-Small Cell Lung Cancer New Indication Marketing Application Accepted

Recently, Shanghai Hengrui Shengdi Pharmaceutical Co., Ltd., a subsidiary of Hengrui Pharma, received the "Acceptance Notice" issued by the National Medical Products Administration (NMPA). The marketing authorization application for the company’s self-developed Class 1 new drug, Adebrelimab (brand name: Aireli®), has been accepted. The indication is as follows: This product, in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by continued use of this product as monotherapy for adjuvant treatment post-surgery, is intended for the treatment of adult patients with resectable stage II, IIIA, and IIIB non-small cell lung cancer (NSCLC) who have no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

Another subsidiary, Guangdong Hengrui Pharmaceutical Co., Ltd., received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration, approving the clinical trial of the Class 1 new drug SHR-1139 injection for patients with ulcerative colitis. In addition, Guangdong Hengrui Pharmaceutical Co., Ltd. and Shanghai Hengrui Pharmaceutical Co., Ltd. received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration, approving the clinical trial of the Class 1 new drug SHR-3045 injection for patients with rheumatoid arthritis.

Walvax's Herpes Zoster mRNA Vaccine Clinical Trial Application Accepted

Recently, the clinical trial application for the freeze-dried shingles virus mRNA vaccine jointly developed by Walvax, Fudan University, and Bluebird Biotech has been accepted by the National Medical Products Administration. Shingles has a high incidence rate among middle-aged and elderly people and may cause long-term neuropathic pain. Currently, there are limited types of vaccines globally, and they are relatively expensive. If successfully marketed, this vaccine will provide more accessible immune protection for middle-aged and elderly populations and will be of great significance to the innovative development of China's vaccine industry.

WuXi Biologics Launches a Cell Line Development Platform

On September 25, WuXi Biologics announced the launch of TrueSite TI™, an industry-leading site-specific integration CHO cell line development platform. The platform offers a more competitive solution for innovative biopharmaceutical development by significantly optimizing the quality of cell lines for antibodies and complex drug molecules, demonstrating excellent stability in process scale-up, and substantially shortening the R&D cycle. Unlike traditional random integration or transposase-mediated integration technologies, site-specific integration greatly simplifies the development process, requiring only the screening of dozens of cell clones to identify high-performance candidate cell lines. This not only ensures stable long-term expression of the target protein but also significantly reduces the preparation time for new drug clinical trial applications (IND).

Frontage Biopharma Announces Preclinical Data of FB7011, a First-in-Class Dual-Target siRNA Drug

At the 18th International IgA Nephropathy Symposium in 2025, Frontier Biotech unveiled for the first time preclinical data of FB7011, its globally pioneering dual-target siRNA drug. The data showed that FB7011 achieved potent and long-lasting inhibition of target proteins in primate models, with a single dose effect lasting over 12 weeks, suggesting the potential for once every 4-6 months dosing in humans, which would significantly improve patient compliance. Additionally, the drug demonstrated significant therapeutic effects and favorable safety.

Market Dynamics

GenFleet Therapeutics Listed on the Main Board of the Hong Kong Stock Exchange

On September 19, GenFleet Therapeutics was officially listed on the Main Board of the Hong Kong Stock Exchange. The issuance size before the exercise of the over-allotment option was 2.33 billion US dollars, and will reach 2.68 billion US dollars after the exercise of the over-allotment option.

WuXi AppTec Implements First Interim Dividend Plan, Distributing Cash Dividends of 1.03 Billion Yuan

On September 22, WuXi AppTec implemented its first interim dividend plan, distributing a total cash dividend of 1.03 billion yuan. WuXi AppTec stated that the total amount of cash dividends, share repurchases, and cancellations implemented this year has reached 6.88 billion yuan, accounting for more than 70% of the company's 2024 net profit attributable to shareholders.

New Drug Development

Tezspire Recommended for Approval by EMA's CHMP for the Treatment of Chronic Rhinosinusitis with Nasal Polyps

Tezspire (Tezepelumab), jointly developed by AstraZeneca and Amgen, has been recommended for approval by the European Union (EU) for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. This positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) is based on the results of the Phase III clinical study, WAYPOINT. The study data were presented at the 2025 joint annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) and the World Allergy Organization (WAO), and simultaneously published in The New England Journal of Medicine.

Johnson & Johnson's Seltorexant Phase III MDD3005 Results Did Not Meet Primary Endpoint

On September 22, Johnson & Johnson announced the Phase III clinical trial results of Seltorexant in combination with Quetiapine XR as an adjunctive treatment for adult and elderly patients with Major Depressive Disorder (MDD) accompanied by insomnia symptoms. Seltorexant demonstrated efficacy comparable to Quetiapine XR, with a somnolence rate (6%) four times lower than that of Quetiapine XR (24%). Additionally, weight gain caused by Seltorexant was significantly reduced. According to reports, this study did not meet its primary endpoint, but researchers believe that Seltorexant has a potential first-in-class mechanism of action and holds great promise for treating MDD with insomnia symptoms.

AbbVie's CD3/CD20 Bispecific Antibody New Indication Submitted for Marketing Approval in China

On September 23, the CDE website showed that AbbVie's CD3/CD20 bispecific antibody Epcoritamab Injection (Epcoritamab) marketing application has been accepted. This drug had already been included in the priority review, with an indication for use in combination with Rituximab and Lenalidomide for the treatment of adult patients with relapsed or refractory Follicular Lymphoma (FL). Currently, this drug has been approved for marketing in the United States, the European Union, and Japan, with indications covering Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, and Primary Mediastinal Large B-Cell Lymphoma.

Roche Presents OCREVUS Treatment Data Preventing Different Multiple Sclerosis (MS) Patient Populations

On September 24, Roche's official website announced that it presented new data on OCREVUS® and the investigational Bruton's tyrosine kinase (BTK) inhibitor fenebrutinib at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The data showed that OCREVUS treatment demonstrated significant benefits in preventing disability progression across different populations of multiple sclerosis (MS) patients, including children with relapsing-remitting multiple sclerosis (RRMS), women with MS during pregnancy or breastfeeding, and adult patients with late primary progressive multiple sclerosis (PPMS).

Transaction Trends

Pfizer Plans Up to $7.3 Billion Acquisition of Metsera to Strengthen Weight-Loss Drug Pipeline

On September 22, Pfizer's official website announced that it would acquire Metsera for an upfront payment of $4.9 billion, with subsequent milestone payments of approximately $2.4 billion, bringing the total valuation of the deal to up to $7.3 billion. Metsera is a pharmaceutical R&D company focused on advancing treatments for obesity and cardiometabolic diseases. Metsera’s core pipeline includes: MET-097i, a long-acting GLP-1 receptor agonist (RA) currently in Phase II clinical trials; MET-233i, an amylin analog currently being evaluated as a monotherapy or in combination with MET-097i in Phase I clinical trials; two oral GLP-1 RA candidates expected to enter clinical trials soon; and multiple preclinical-stage nutrient-stimulated hormone therapies.