NMPA Grants Marketing Authorisation to Hefei Amvite’s Memantine Hydrochloride ODT for Alzheimer’s Disease
The National Medical Products Administration (NMPA) has approved Memantine Hydrochloride Orally Disintegrating Tablets (ODT) produced...
Product approvals
Shanghai Henlius Biotech Secures UK MHRA Approval for Denosumab Biosimilars BILDYOS & BILPREVDA
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the United Kingdom’s Medicines and Healthcare Products...
Grand Pharmaceutical & Glenmark Specialty Secure China NMPA Approval for Ryaltris Nasal Spray
Grand Pharmaceutical Group Limited (HKG: 0512) together with Glenmark Specialty S.A. announced that the Ryaltris...
Novartis Wins FDA Approval for Remibrutinib Tablets – First BTK Inhibitor for Chronic Spontaneous Urticaria
Novartis AG (NYSE: NVS) announced that the U.S. Food and Drug Administration (FDA) has granted...
Gaush Meditech’s Subsidiary Secures China Registration for Integrated Ophthalmic Electrophysiology System
Gaush Meditech Ltd. (HKG: 2407) announced that its wholly‑owned subsidiary Gaush Tech Ltd. has been issued...
LifeTech Scientific Secures NMPA Approval for G‑Branch TAAA Stent‑Graft System
LifeTech Scientific Corporation (HKG: 1302) announced that China’s National Medical Products Administration (NMPA) has granted...
Siemens Shanghai Gains NMPA Clearance for Prostate‑Cancer AI Detection Software
Siemens Shanghai Medical Equipment Ltd. (SSME) announced that the National Medical Products Administration (NMPA) has...
UCB Wins FDA Approval for KYGEVVI in Rare Mitochondrial Disease TK2d
UCB (EBR: UCB) announced that KYGEVVI received FDA approval for the treatment of adult and...
Pluvicto Radioligand Therapy Receives Dual NMPA Approvals in China
Novartis (NYSE: NVS) has announced that its Lutetium‑177‑labelled therapy Pluvicto (lutetium ¹⁷⁷Lu‑vipivotide tetraxetan) now holds...
Zhejiang Acea Pharma Secures Conditional NMPA Approval for Olgotrelvir Sodium Capsules – First Dual‑Target COVID‑19 Oral Antiviral in China
Zhejiang Acea Pharmaceutical Co., Ltd. announced that China’s National Medical Products Administration (NMPA) has granted...
Amoy Diagnostics Announce NMPA Approval of China’s First KRAS G12C Companion Diagnostic
Amoy Diagnostics Co., Ltd. (“AmoyDx”) have secured approval from the China National Medical Products Administration...
Bayer Secures FDA Approval for Elinzanetant, First Dual NK Therapy for VMS
Bayer (ETR: BAYN) announced that the U.S. Food and Drug Administration had granted marketing approval...
Lepu Biopharma Secures Conditional NMPA Approval for Becotatug Vedotin (MGR003) in Recurrent Nasopharyngeal Carcinoma
Lepu Biopharma Co., Ltd. (HKG: 2157) today announced that its antibody‑drug conjugate (ADC) Becotatug Vedotin (MGR003)...
GSK Secures FDA Approval for Blenrep in Multiple Myeloma
GlaxoSmithKline (GSK, NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has...
Astellas China Secures GBA Approval for First‑in‑Class Fezolinetant (VEOZA)
Astellas (TYO: 4503) China announced that its global first‑in‑class, non‑hormonal, selective neurokinin‑3 (NK3) receptor antagonist...
Huadong’s Mefatinib Approved by NMPA for EGFR‑Driven NSCLC
Huadong Medicine (SHE: 000963) announced that its Class 1 innovative drug Mefatinib Tablets has received marketing...
Hengrui Launches Henagliflozin Triple‑Combination Metformin for Type 2 Diabetes
Hengrui Medicine (SHA: 600276, HKG: 1276) today announced the commercial launch of its first independently developed...
Boehringer Ingelheim’s Nerandomilast Approved by China NMPA for Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim announced that its oral selective phosphodiesterase‑4B (PDE4B) inhibitor Nerandomilast (JASCAYD®) has received formal...
Novo Nordisk Secures FDA Approval for Rybelsus to Reduce Cardiovascular Risk in Type 2 Diabetes
Novo Nordisk (NYSE: NVO) announced that the U.S. Food and Drug Administration (FDA) has granted...
Kelun-Biotech’s Trastuzumab Botidotin Approved by NMPA for HER2-Positive Breast Cancer
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced on October 17, 2025, that its Human...