HELP Therapeutics Secures NMPA Approval for HiCM388, China’s First Cell‑Based Therapy for STEMI
HELP Therapeutics Corp., a pioneer in cell‑based therapeutics, announced that the National Medical Products Administration...
Clinical trial approval / initiation
Mabwell Bioscience Receives NMPA IND Approval for 7MW4911 CDH17‑Targeting ADC in Advanced Solid Tumors
Mabwell Bioscience (SHA: 688062) announced today that the National Medical Products Administration (NMPA) has granted...
Everest Medicines Commences Global Phase I Trial of Universal mRNA Cancer Vaccine EVM14
Everest Medicines Limited (HKG: 1952) announced today that the first patient has been successfully dosed...
Everest Medicines Receives NMPA Approval for Universal Oncology Vaccine EVM14
Everest Medicines Limited (HKG: 1952) announced today that the National Medical Products Administration (NMPA) has...
Beihai Biotech Secures FDA IND Approval for First‑In‑Class Peptide‑Drug Conjugate BH1621
China‑based Zhuhai Beihai Biotech Co., Ltd. announced today that its Category 1 innovative drug BH1621 has...
Xingqi Pharma Secures NMPA Approval for SQ‑129, a Novel Treatment for Diabetic Macular Edema
China‑based Shenyang Xingqi Pharmaceutical Co., Ltd. (SHE: 300573) announced today that the China National Medical...
Huadong Medicine Secures NMPA Trial Approval for HDM2017, a CDH17‑Targeting ADC
China‑based Huadong Medicine Co., Ltd. (SHE: 000963) announced that its novel antibody‑drug conjugate (ADC), HDM2017...
Northeast Pharma Secures NMPA Approval for DCTY0801 Injection Targeting EGFRvIII‑Positive Brain Gliomas
China‑based Northeast Pharmaceutical Group Co., Ltd. (SHE: 000597) has announced that its chimeric antigen receptor...
Hengrui, SHR‑4298, RAS: China Approves Two Novel Anti‑Tumor Drugs for Clinical Trials
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the National Medical Products Administration...
Shanghai Fosun Secures NMPA Approval for HLX43 + HLX07 Combination in Advanced Solid Tumors
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196) announced that the National Medical Products Administration...
Simnova Secures FDA IND for CAR‑NK Therapy in SLE
Shanghai Simnova Biotech Co., Ltd. (Simnova) announced that its CD19‑targeted chimeric antigen receptor gene‑modified natural...
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...
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...