LEO Pharma Submits NDA for Anzupgo in China for Chronic Hand Eczema
LEO Pharma announced on October 17, 2025, that it has submitted a New Drug Application...
Market approval filings
Hansoh Pharmaceutical Submits HS‑10365 NDA to NMPA for RET‑Positive NSCLC
China‑based Hansoh Pharmaceutical Group Co., Ltd. (HKG: 3692) announced today that it has filed a New Drug Application...
Indetek Laboratory Secures NMPA Approval for IDT‑001 Gel, a Novel Film‑Forming Therapy for SSTIs
Indetek Laboratory announced that the National Medical Products Administration (NMPA) has formally accepted the New...
Summit Therapeutics Plans U.S. FDA BLA Submission for Ivonescimab + Chemotherapy in EGFR‑Mutated NSCLC
Summit Therapeutics, the former China partner of Akeso Inc. (HKG: 9926), announced today that it...
Maxvax Biotech Secures NMPA Acceptance for Its Recombinant Herpes Zoster Vaccine
Maxvax Biotech announced today that the China National Medical Products Administration (NMPA) has accepted the...
CSPC Pharmaceutical Group Announces NMPA Acceptance of Efmedaglutide Alfa Injection for Long‑Term Weight Management
CSPC Pharmaceutical Group Limited (HKG: 1093) today announced that the National Medical Products Administration (NMPA)...
Peijia Medical Secures NMPA Approval for GeminiOne TEER System
Peijia Medical Limited (HKG: 9996) announced today that the National Medical Products Administration (NMPA) of...
RemeGen & Santen Announce CDE Acceptance of RC28‑E for Diabetic Macular Edema
China‑based RemeGen Co., Ltd. (SHA: 688331, HKG: 9995) and Japan’s Santen Pharmaceutical Co., Ltd. confirmed...
Hua Medicine Secures Hong Kong NDA Acceptance for Dorzagliatin, First‑In‑Class Glucokinase Activator
China‑based Hua Medicine (HKG: 2552) announced that the Hong Kong Department of Health has accepted its...
AstraZeneca and Daiichi Sankyo Submit Priority‑Review sBLA for Enhertu as First‑Line Therapy for HER2‑Positive Breast Cancer
AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) have filed a supplemental Biologics License...
Fosun Kairos Secures NMPA Approval for Second CAR‑T Product, FKC889, Targeting Relapsed/Refractory B‑Cell ALL
Fosun Kairos, a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196),...
Jiangsu Hengrui Receives NMPA Acceptance for SHR7280 Oral GnRH Antagonist
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the National Medical Products...
Jiangsu Hengrui’s Adebrelimab New Indication Accepted by NMPA for Stage II‑IIIB NSCLC
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that the National Medical Products...
Sichuan Kelun‑Biotech’s A400 Receives NDA Acceptance in China
Sichuan Kelun‑Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced today that the Center for Drug Evaluation...
Shenzhen Salubris Submits NMPA NDA for SAL003, a Once‑Monthly Anti‑PCSK9 Biologic
Shenzhen Salubris Pharmaceuticals Co., Ltd. (SHE: 002294) announced that it has filed a New Drug...
Guangdong Taienkang Secures NMPA Approval for Safinamide Generic
Guangdong Taienkang Pharmaceutical Co., Ltd. (SHE: 301263) announced that the National Medical Products Administration (NMPA)...
Jiangsu Hengrui Secures Priority Review for Trastuzumab Rezetecan in HER2‑Positive Breast Cancer
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the National Medical Products...
Novo Nordisk to File US Approval for High‑Dose Wegovy, Aiming to Match Lilly’s Zepbound
Novo Nordisk A/S (NYSE: NVO) has announced plans to seek U.S. regulatory approval for a...
Genrix Succeeds with Telikibart Phase 3, Targets Atopic Dermatitis
China‑based Chongqing Genrix Biopharmaceutical Co., Ltd. (SHA: 688443) announced today that its telikibart (GR1802) injection...
CSPC Pharmaceutical Group Submits Anbenitamab for NMPA Approval in HER2‑Positive Gastric Cancer
CSPC Pharmaceutical Group (HKG: 1093) announced today that Anbenitamab Antibody Injection (KN026), co‑developed with Alphamab...