Walvax’s Third‑Generation COVID‑19 mRNA Vaccine Wins NMPA Approval – JN.1‑Based Shot Clears Regulatory Bar for Adults in China
Walvax Biotechnology Co., Ltd. (SHE: 300142) announced that its COVID‑19 mRNA vaccine has been approved...
Product approvals
Allergan Aesthetics’ JUVÉDERM VOLBELLA Wins NMPA Approval for Infraorbital Hollowing – Hyaluronic Acid Filler Expands China Label Beyond Lips
Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced that JUVÉDERM VOLBELLA WITH LIDOCAINE has received...
GSK’s Shingrix Wins Japan Approval for Prefilled Syringe Presentation – Recombinant Zoster Vaccine Gains Administration Flexibility
GlaxoSmithKline Plc (GSK; NYSE: GSK) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW)...
Novo Nordisk’s Sogroya (Somapacitan) Wins NMPA Approval for Three New Pediatric Indications – Now China’s Broadest‑Label Long‑Acting Growth Hormone
Novo Nordisk A/S (NYSE: NVO) announced that its innovative, long‑acting human growth hormone Sogroya (generic...
Novo Nordisk’s Wegovy Wins NMPA Approval for MASH in China – First and Only GLP‑1 Receptor Agonist Indicated for Metabolic Dysfunction‑Associated Steatohepatitis with F2–F3 Fibrosis
Novo Nordisk A/S (NYSE: NVO) announced that semaglutide injection (brand name: Wegovy) has received approval...
Guangzhou Baiyunshan Pharma Wins Registration and Marketing Approval in Macau for Its Freeze‑Dried Rabies Vaccine (Vero Cells) – Joining a Highly Concentrated Supplier Landscape
Guangzhou Baiyunshan Pharmaceutical Co., Ltd. (SHA: 600332) announced that its freeze‑dried rabies vaccine (Vero cells)...
Jenscare’s LuX‑Valve Plus Wins Hong Kong Approval, Expanding Global Footprint of Transcatheter Tricuspid Valve Replacement System
Ningbo Jenscare Scientific Co., Ltd. (HKG: 9877) announced that its transcatheter tricuspid valve replacement system,...
MSD’s KEYTRUDA Wins NMPA Approval for Perioperative Treatment of Resectable Locally Advanced HNSCC in China
Merck & Co., Inc. (MSD; NYSE: MRK) announced that its PD-1 inhibitor KEYTRUDA (pembrolizumab) has...
Trinomab’s Retavibart Wins NMPA Priority Approval as RSV Prevention Monoclonal Antibody Xinduotuo
Zhuhai Trinomab Pharmaceutical Co., Ltd. (SHA: 688806) announced that its Category 1 pediatric innovative drug,...
Betta’s Ensartinib Wins NMPA Approval for Third Indication as Adjuvant Therapy in ALK-Positive NSCLC
Betta Pharmaceuticals (SHE: 300558) announced that ensartinib (trade name: Ensacove) has been approved by China’s...
NMPA Approves Eisai’s Lecanemab Subcutaneous Autoinjector for Early Alzheimer’s Disease in China
Eisai Co., Ltd. (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) announced that China’s National Medical...
Kanghong’s Conbercept Wins NMPA Approval for Fifth Indication in Retinopathy of Prematurity (ROP)
Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) announced that China’s National Medical Products Administration...
Simcere’s Culevibart Wins NMPA Approval as China’s RSV Prevention Monoclonal Antibody Yingmule
Simcere Pharmaceutical Group (HKG: 2096) announced that Culevibart Injection (trade name: Yingmule), a domestic Category...
Fosun Pharma’s luvometinib Wins NMPA Approval for NF1-Associated Plexiform Neurofibromas in Adults
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that its drug luvometinib...
Everest Medicines Wins NMPA Approval for Etripamil Nasal Spray Cardamyst in PSVT, Bringing ER‑Free Arrhythmia Care to Greater China
Everest Medicines (HKG: 1985) announced today that its etripamil nasal spray has received marketing approval...
Allergan Aesthetics’ SKINVIVE by Juvéderm Wins NMPA Approval for Perioral Wrinkles, Backed by 93.4% POLSS Responder Rate
Allergan Aesthetics, an AbbVie (NYSE: ABBV) company, announced that its SKINVIVE by Juvéderm, an injectable...
Eli Lilly Wins FDA Approval for Mounjaro Cardiovascular Risk Reduction in Type 2 Diabetes
Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA)...
Takeda Wins FDA Approval for MIMRYLO, First‑in‑Class Hepcidin Mimetic for Polycythemia Vera
Takeda Pharmaceutical Company Limited (TYO: 4502; NYSE: TAK) announced that the U.S. Food and Drug...
Fosun Pharma’s Velinotamig Wins NMPA Conditional Approval for Relapsed or Refractory Multiple Myeloma
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that velinotamig (project code:...
HutchMed’s Fanregratinib Wins NMPA Conditional Approval for FGFR2-Rearranged Intrahepatic Cholangiocarcinoma
HutchMed (China) Limited (NASDAQ: HCM, HKG: 0013) announced that the New Drug Application (NDA) for...