Huadong Medicine Secures FDA IND Approval for HDM2017 ADC
Huadong Medicine Co., Ltd. (SHE: 000963) announced today that the U.S. Food and Drug Administration...
Clinical trial approval / initiation
Stone Pharmaceuticals Launches CS2009 Phase II Trial in Australia
CStone Pharmaceuticals (HKG: 2616) announced today that the first patient has been dosed in Australia...
Nanjing Leads Biolabs Secures FDA IND for LBL‑047, a First‑In‑Class Bispecific Fusion Protein
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced today that the U.S. Food and Drug...
Hengrui Pharma Secures NMPA Approval for Two Novel Immune‑Inflammatory Drugs
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that China’s National Medical Products...
Chongqing Genrix Secures NMPA Trial Approval for GR2301 IL‑15 Antibody in Vitiligo
Chongqing Genrix Biopharmaceutical Co., Ltd. (SHA: 688443) announced that the National Medical Products Administration (NMPA)...
Suzhou Zelgen Secures NMPA Approval for ZGGS34 TriTEs Targeting MUC17‑Positive Solid Tumors
Suzhou Zelgen Biopharmaceuticals Co., Ltd. (SHA: 688266) announced that the National Medical Products Administration (NMPA)...
CSPC’s ALMB-0166 Approved for Phase II Trials in Parkinson’s Disease
CSPC Pharmaceutical Group Limited (HKG: 1093), a China-based company, announced on September 15, 2025, that...
Nanjing Leads Biolabs Doses First Patient in Opamtistomig Melanoma Trial
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced today that the first patient has been...
Guangzhou Baiyunshan Pharmaceutical Launches Phase I/II Trial for RET‑Targeted BYS10
Guangzhou Baiyunshan Pharmaceutical Co., Ltd. (SHA: 600332) announced that the Center for Drug Evaluation (CDE)...
CSPC Pharmaceutical Group Secures NMPA Approval for SYH2066 in RSV Trials
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that its novel oral small‑molecule, SYH2066, has been...
FibroX Therapeutics Secures IND Approval for FibroCell in Lumbar Disc Degeneration
Shanghai‑based FibroX Therapeutics announced that its investigational new drug (IND) application for FibroCell, an allogeneic...
Genrix Bio Secures NMPA Approval for GR1803 Bispecific Antibody in Systemic Lupus Erythematosus
China‑based Genrix Biopharmaceutical Co., Ltd. (SHA: 688443) announced that the National Medical Products Administration (NMPA)...
TransThera Sciences Secures China Phase II Trial Approval for Tinengotinib‑Fulvestrant Combination
TransThera Sciences (Nanjing) Inc. (HKG: 2617) announced that the China National Medical Products Administration has...
Taiji Group Secures NMPA Approval to Begin Clinical Trials of Semaglutide Biosimilar
China‑based Chongqing Taiji Industry (Group) Co., Ltd. (Taiji Group, SHA: 600129) announced that its semaglutide...
Betta Pharmaceuticals Secures NMPA Approval for MCLA‑129/Ensartinib Combination in Advanced Solid Tumors
China-based Betta Pharmaceuticals (SHE: 300558) announced that China’s National Medical Products Administration (NMPA) has approved...
Qilu Pharmaceutical Commences Phase III Trial of QLS31905 for Advanced Pancreatic Cancer
China‑based Qilu Pharmaceutical Co., Ltd. announced that it has opened enrollment for its first‑in‑class QLS31905...
Sihuan Pharma Secures IND for Dual‑Target GLP‑1/GCGR Drug P052 Injection
China‑based Sihuan Pharmaceutical Holdings Group Ltd. (HKG: 0460) announced that the Investigational New Drug (IND)...
Simcere Secures NMPA Approval for CDH17‑Targeting ADC SIM0609 in Advanced Solid Tumors
Simcere Pharmaceutical Group Limited (HKG: 2096) announced that its internally developed SIM0609, a CDH17 antibody‑drug...
Shanghai Henlius Biotech Secures FDA IND Approval for HLX17, a Pembrolizumab Biosimilar
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the U.S. Food and Drug Administration (FDA)...
Kintor Pharmaceutical Completes KT‑939 Tyrosinase Inhibitor Safety Trial, Highlights Cosmetic Potential
Kintor Pharmaceutical Limited (HKG: 9939) announced that it has finished enrolling 130 subjects in the...