VCBeat Pharma Weekly | Novo Nordisk wins approval, Pfizer reports clinical progress, Hansoh and Harbour Bio each sign major licensing deals
Clinical & Approval Progress
China's first and only cardiovascular risk-reducing weight-loss drug, Semaglutide Injection, approved, cutting cardiovascular event risk by 20%
On December 22, semaglutide injection (brand name: Wegovy®) received approval from the National Medical Products Administration (NMPA) for its cardiovascular indication, making it China's first and currently only weight management medication with dual benefits of weight loss and reduction of major adverse cardiovascular events. The drug is indicated for adult patients with established cardiovascular disease and a body mass index (BMI) ≥27 kg/m², demonstrating a significant 20% reduction in the risk of cardiovascular death, myocardial infarction, and stroke. Studies indicate that its cardioprotective effect is independent of weight reduction and may represent a unique advantage of the semaglutide molecule.
Eli Lilly announces latest results for Imlunestrant
On December 12, Eli Lilly released updated results from the Phase 3 EMBER-3 clinical trial of imlunestrant, an oral estrogen receptor antagonist. The study enrolled patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2–) advanced or metastatic breast cancer (MBC) who had previously received treatment with an aromatase inhibitor (AI) with or without a CDK4/6 inhibitor and experienced disease progression. Compared with endocrine therapy, imlunestrant monotherapy showed a clinically meaningful 38% reduction in the risk of disease progression or death in patients harboring ESR1 mutations.
Pfizer's PADCEV combined with Keytruda shows positive Phase III results in bladder cancer
On December 17, Pfizer and Astellas announced positive topline results from an interim analysis of the Phase III EV-304 trial evaluating the combination of PADCEV™ (enfortumab vedotin) and Keytruda in muscle-invasive bladder cancer (MIBC). The study demonstrated that the regimen, used as neoadjuvant/adjuvant therapy, achieved significant improvements in both event-free survival and overall survival compared to standard neoadjuvant chemotherapy. This marks the first "chemotherapy-free" perioperative regimen proven to be an alternative to traditional chemotherapy in cisplatin-eligible patients.
Johnson & Johnson's neurointerventional embolization system approved for new indication in chronic subdural hematoma
On December 18, Johnson & Johnson MedTech announced that its TRUFILL n-BCA liquid embolic system received expanded FDA approval for embolization of the middle meningeal artery (MMA) as a surgical adjunct in the treatment of symptomatic subacute and chronic subdural hematoma (cSDH). The approval was based on results from the randomized controlled MEMBRANE trial, which confirmed that the therapy outperformed standard care in both efficacy and safety. Having been used in the neurointerventional field for over 25 years, this approval extends its application to a common neurosurgical condition.
Transaction Trends
BioNTech completes acquisition of CureVac, consolidates leadership in mRNA field
On December 18, BioNTech announced the completion of its acquisition of CureVac, having obtained approximately 86.75% of the latter's shares. This transaction integrates the mRNA technologies and production capabilities of both companies, which will strongly support BioNTech's oncology-focused strategic expansion, particularly in the development of mRNA-based cancer immunotherapies and bispecific antibody candidates. CureVac will continue its existing operations, with subsequent integration plans expected to be finalized by January 2026.
Clinical Progress
Walvax Biotechnology's lyophilized zoster mRNA vaccine approved for clinical trials
On December 17, Walvax Biotechnology's lyophilized zoster mRNA vaccine received clinical trial approval from China's National Medical Products Administration. Developed by Walvax in collaboration with Fudan University and RNACure based on an independent mRNA platform, the vaccine is expected to provide a new technological option for zoster prevention in China.
HutchMed initiates global clinical trial for novel anticancer drug HMPL‑A251
On December 17, HutchMed announced the initiation of a global Phase I clinical trial for its first‑in‑class novel antibody‑targeted conjugate (ATTC) HMPL‑A251. The drug is intended for the treatment of HER2‑expressing advanced solid tumors, with the first patient already dosed in China. HMPL‑A251 is the first clinical candidate from HutchMed's next‑generation ATTC platform, designed to more precisely kill tumor cells by conjugating a potent PI3K/PIKK inhibitor with a targeting antibody, potentially improving the safety profile of traditional therapies.
Everest Medicines' introduced drug Lerodalcibep approved by FDA, plans China submission in first half of next year
On December 17, Everest Medicines announced that Lerodalcibep, a novel cardiovascular drug for which it holds exclusive rights in Greater China from Hasten Biopharmaceutical, has been approved by the U.S. FDA for lowering low‑density lipoprotein cholesterol (LDL‑C) in patients with hypercholesterolemia. As a third‑generation PCSK9 inhibitor administered once monthly via subcutaneous injection, the drug offers convenient dosing. Its pivotal Phase III trial in China has met its primary endpoint, and Everest Medicines plans to submit a Biologics License Application (BLA) to Chinese regulatory authorities in the first half of 2026, with potential approval in China as early as 2027.
CSPC Pharma's SYH2085 tablets approved for clinical trial in China
On December 19, CSPC Pharma announced that its self‑developed SYH2085 tablets have received approval from China's National Medical Products Administration to proceed with clinical trials in China. The product is an independently developed Category 1 innovative chemical drug, a novel oral small‑molecule candidate that inhibits the RNA polymerase acidic protein (PA) endonuclease activity of influenza viruses. The approved clinical indication is for the treatment of uncomplicated influenza A and B in adults and adolescents aged 12 years and above.
Hansoh Pharma presents data on Resencatinib (HS‑10365 Capsules) for RET fusion‑positive locally advanced or metastatic NSCLC
On December 18, Hansoh Pharma presented data on its self‑developed highly selective RET inhibitor Resencatinib (HS‑10365 capsules, a receptor tyrosine kinase inhibitor) for the treatment of RET fusion‑positive locally advanced or metastatic non‑small cell lung cancer (NSCLC) in a poster presentation at the 2025 European Society for Medical Oncology Asia Congress (ESMO ASIA).
BeOne Medicines' BGB‑B2033 granted FDA Fast Track designation for hepatocellular carcinoma
On December 18, BeOne Medicines announced that its self‑developed GPC3×4‑1BB bispecific antibody BGB‑B2033 has been granted Fast Track designation by the U.S. FDA for the treatment of adult patients with hepatocellular carcinoma (HCC) who have progressed after prior therapy. The drug is currently being evaluated in a global Phase I trial assessing its safety and antitumor activity both as monotherapy and in combination with the PD‑1 inhibitor tislelizumab.
Innovent Biologics publishes back‑to‑back Phase III results for Mazdutide injection
On December 18, Innovent Biologics announced that the results of two pivotal Phase III studies (DREAMS‑1 and DREAMS‑2) for its first‑in‑class GCG/GLP‑1 dual‑receptor agonist Mazdutide injection have been published back‑to‑back online in Nature. The studies confirmed that in patients with type 2 diabetes, the drug was superior to the comparator in both glycemic control and weight reduction, while also improving multiple cardiometabolic, liver, and kidney‑related parameters.
Innocare Pharma announces CDE approval of Phase II/III trial for novel TYK2 inhibitor Soficitinib
On December 18, Innocare Pharma announced that its self‑developed novel oral TYK2 inhibitor Soficitinib (ICP‑332) has received approval from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration to initiate a Phase II/III clinical trial for the treatment of chronic spontaneous urticaria (CSU). By blocking key cytokine signaling pathways such as IL‑4 and IL‑13, the drug is designed to alleviate itching and wheals and improve CSU symptoms.
Transaction Trends
Fosun Pharma announces controlling stake acquisition of Green Valley Pharmaceuticals to strengthen innovative pipeline in central nervous system
On December 15, Fosun Pharma announced that its controlled subsidiary, Fosun Pharma Industrial, has entered into a related investment agreement with Green Valley Pharmaceuticals and its existing relevant shareholders, proposing to acquire a controlling stake in Green Valley Pharmaceuticals with an investment of approximately RMB 1.412 billion. Upon completion of the acquisition, Green Valley Pharmaceuticals will become a controlled subsidiary of Fosun Pharma, and its core product, Sodium Oligomannate Capsules, will be integrated into Fosun Pharma's innovative drug pipeline, primarily indicated for the treatment of mild to moderate Alzheimer's disease.
Fosun Pharma and Clavis Bio enter strategic collaboration to co-develop innovative therapies targeting source innovation
On December 18, Fosun Pharma announced that its controlled subsidiary, Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd., has entered into a strategic collaboration with biotechnology company Clavis Bio, Inc. The two parties will jointly develop innovative therapies based on cutting-edge targets nominated by Clavis Bio. Clavis Bio is a wholly-owned subsidiary established by an Aditum Bio fund specifically for this collaboration.
Under the agreement, within the designated five-year collaboration period, the parties will jointly select and advance preclinical development of compounds targeting selected nominees (up to four per year) based on targets proposed by Clavis Bio.
Harbour BioMed and Bristol Myers Squibb enter global strategic collaboration and licensing agreement
On December 17, Harbour BioMed announced a long-term global strategic collaboration with Bristol Myers Squibb to jointly develop next-generation multispecific antibody therapies. Under the agreement, Harbour BioMed will receive a total upfront payment of $90 million and is eligible for milestone payments of up to $1.035 billion, as well as tiered royalties on future product sales.
Hansoh Pharma grants Glenmark multi-region exclusive rights to Almonertinib
On December 16, Hansoh Pharma announced an exclusive licensing, collaboration, and distribution agreement with Glenmark Specialty S.A. for the third-generation EGFR-TKI Almonertinib. Under the agreement, Glenmark obtains exclusive development and commercialization rights for the drug in multiple regions, including the Middle East and Africa, Southeast and South Asia, and Australia. Hansoh Pharma will receive an upfront payment, along with cumulative potential milestone payments exceeding $1 billion and tiered sales royalties.
Executive Moves
BeOne Medicines announces executive moves
On December 19, BeOne Medicines (formerly known as BeiGene) announced the appointment of Dr. Lai Wang, the company's Global Head of R&D, as President and Global Head of R&D, effective immediately. He will continue to oversee BeOne Medicines' R&D, business development, and alliance management functions. The roles and responsibilities of John V. Oyler, Founder, Chairman, and CEO of BeOne Medicines, and Dr. Xiaobin Wu remain unchanged.