RemeGen Secures China CDE Approval for Telitacicept in Sjögren’s Syndrome, First Biologic of Its Kind
China‑based pharmaceutical company RemeGen (HKG: 9995) announced that the Center for Drug Evaluation (CDE) of...
Market approval filings
Hengrui’s HRS9531 Injection Clears NMPA Approval, Hits 19.2% Weight Loss in Phase 3
China‑based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) confirmed that China’s National Medical Products...
Simcere Secures NMPA Approval for Deunoxavir Marboxil, First Pediatric Influenza Drug
Simcere Pharmaceutical Group Limited (HKG: 2096) today announced that the National Medical Products Administration (NMPA)...
Sino Biopharmaceutical’s Benmelstobart‑Anlotinib Combo Secures NMPA NDA for Advanced ASPS
Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd. (CTTQ), a wholly‑owned subsidiary of Sino Biopharmaceutical Ltd...
Daiichi Sankyo’s Enhertu Submitted for Priority Review in China for HER2-Positive Breast Cancer
On August 22, 2025, Daiichi Sankyo (TYO: 4568) submitted a marketing authorization application for Enhertu...
Haihe Biopharma Seeks Japan Approval for Risovalisib in PIK3CA-Mutated Ovarian Cancer
Haihe Biopharma Co., Ltd. has filed a market application with Japan’s Ministry of Health, Labour...
Hengrui Pharma’s Hetrombopag Olamine Accepted by NMPA for Chemotherapy-Induced Thrombocytopenia
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) announced that the National Medical Products...
Livzon Announces NMPA Acceptance of JP-1366 Tablets Application for Reflux Esophagitis
Livzon Pharmaceutical Group Inc. (HKG: 1513) announced that the drug registration application for its JP-1366...
Everest Medicines’ Velsipity NDA Accepted for Review in Taiwan
China-based Everest Medicines (HKG: 1952) announced that the New Drug Application (NDA) for its Velsipity...
Hengrui Pharmaceuticals Expands Hetrombopag Olamine’s Indication for ITP Patients
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) announced that the indication expansion for...
Arvinas and Pfizer’s Vepdegestrant NDA Accepted by FDA for ER+/HER2- Breast Cancer
Arvinas, Inc. (NASDAQ: ARVN) and its partner Pfizer (NYSE: PFE) announced on August 8, 2025,...
Junshi Biosciences’ Toripalimab Receives NMPA Acceptance for HER2-expressing UC Treatment
China’s Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) announced that it has received...
Haisco’s Ciprofol NDA Accepted by FDA: A Milestone for Chinese Anesthesia Innovation
China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced that the New Drug Application (NDA)...
Biogen’s Zurzuvae Receives Positive CHMP Opinion for Postpartum Depression Treatment
US-based Biogen (NASDAQ: BIIB) announced that the Committee for Medicinal Products for Human Use (CHMP)...
Yifan Pharma’s Generic Glycerol Phenylbutyrate Accepted for NMPA Review
China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) announced that the National Medical Products Administration (NMPA)...
Daiichi Sankyo and AstraZeneca Submit Enhertu Application for HER2-Positive Gastric Cancer in China
Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) have submitted a supplemental new-drug application...
SinoMab BioScience Voluntarily Withdraws BLA for Suciraslimab in China Citing Need for Additional Data
SinoMab BioScience Ltd (HKG: 3681) announced the voluntary withdrawal of its Biologics License Application (BLA)...
GSK’s Arexvy RSV Vaccine Expansion for Adults 18-49 Receives FDA Review
UK-based GlaxoSmithKline (GSK; NYSE: GSK) announced that the U.S. Food and Drug Administration (FDA) has...
MSD’s Once-Daily HIV-1 Therapy Doravirine/Islatravir NDA Accepted by FDA for Review
Merck, Sharp & Dohme (MSD, NYSE: MRK) announced that the U.S. Food and Drug Administration...
Jiangsu Chia Tai Tianqing’s Culmerciclib Receives NMPA Review for Expanded Breast Cancer Indication
Subsidiary of China based Sino Biopharmaceutical Ltd (HKG: 1177) Jiangsu Chia Tai Tianqing Pharmaceutical Co.,...