Xinhua Pharma Wins China Trial Approval for Dual‑Mechanism PAH Drug LXH‑1211
Shandong Xinhua Pharmaceutical Co., Ltd. (HKG: 0719) announced that its pulmonary arterial hypertension (PAH) candidate...
Clinical trial approval / initiation
Simcere Secures FDA Approval for ADC SIM0609 in Advanced Solid Tumors
Simcere Pharmaceutical Group Limited (HKG: 2096) announced that the U.S. Food and Drug Administration (FDA)...
CMS Wins NMPA Green Light for Phase‑3 Trial of MG‑K10 Anti‑IL‑4Rα in Chronic Urticaria
China Medical System Holdings Limited (CMS, HKG: 0867) announced that the National Medical Products Administration...
HanX Biopharmaceuticals Secures NMPA Approval for HX044‑HX008 PD‑1 Therapy Combination in Advanced Solid Tumors
HanX Biopharmaceuticals (Wuhan) Co., Ltd., a fast‑growing Chinese biotech, announced that the National Medical Products...
CSPC Pharma Secures NMPA Approval for Lecanemab Biosimilar, First of Its Kind in China
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that the National Medical Products Administration (NMPA) has...
Mabwell Bioscience Hits Phase II Milestone with First‑Patient Dose of 9MW3011, the Only Anti‑TMPRSS6 Monoclonal Antibody for Polycythemia Vera
Shanghai‑listed Mabwell Bioscience (SHA: 688062) announced today that its anti‑TMPRSS6 monoclonal antibody 9MW3011 (R&D code 9MW3011/DISC‑3405)...
FibroGen Launches Phase 2 Dose‑Optimization Trial for CD46‑Targeted ADC FG‑3246 in Metastatic Castration‑Resistant Prostate Cancer
FibroGen, Inc. (NASDAQ: FGEN) announced today the start of a randomized, open‑label Phase 2 monotherapy trial...
DualityBio Initiates Global Phase Ia/Ib Study of ADAM9‑Targeting ADC DB‑1317
Hong Kong‑listed Duality Biologics (DoalityBio, HKG: 9606) announced that the first patient has been dosed...
RM Bio‑Tech Secures CDE Approval for HF001 Stem‑Cell Therapy in Type 2 Diabetes
Beijing RM Bio‑Tech Co., Ltd. announced that the Center for Drug Evaluation (CDE) under the...
Yantai Dongcheng Secures NMPA Approval for 225Ac‑LNC1011 Alpha‑Particle Radiopharmaceutical to Target Prostate Cancer
China‑based Yantai Dongcheng Pharmaceutical Group Co., Ltd. (SHE: 002675) announced that its investigational 225Ac‑LNC1011 injection...
Sino Biopharmaceutical Reports First‑Patient Enrollment for LM‑2417 Phase I Trial
China‑based Sino Biopharmaceutical (HKG: 1177) announced today that its internally‑developed Class 1 innovative drug LM‑2417 has...
Youcare Pharma Secures FDA Approval for YKYY013, a Novel siRNA Therapy for Chronic Hepatitis B
Youcare Pharmaceutical Group (SHA: 688658) announced that the U.S. Food and Drug Administration (FDA) has...
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...
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...