CSPC’s SYH2059 Inhalation Powder Wins FDA IND Approval – PDE4B Inhibitor Targets Pulmonary Fibrosis with Enhanced Delivery
CSPC Pharmaceutical Group Ltd (HKG: 1093) announced FDA clearance to initiate a clinical study for...
Clinical trial approval / initiation
CF PharmTech Wins NMPA Approval for Olopatadine Mometasone Combo Trial – Fixed-Dose Nasal Spray Targets Moderate-to-Severe Allergic Rhinitis
CF PharmTech Inc. (HKG: 2652) announced NMPA clearance to initiate a clinical study for its...
Dongcheng Pharma Doses First Patient in 225Ac-LNC1011 Phase I/II Trial – PSMA-Targeted Alpha Radiotherapy for Metastatic Prostate Cancer
Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) announced first subject enrollment in a Phase...
Bio-Thera Wins NMPA Approval for BAT8008 BAT1006 Trastuzumab Combo Trial – Dual HER2 Trop2 Targeting in Advanced Solid Tumors
Bio-Thera Solutions Ltd (SHA: 688177) announced NMPA clearance to initiate a clinical study evaluating BAT8008...
Fosun Pharma’s HLX97 Wins NMPA Phase I Approval – First-in-Class KAT6A/B Inhibitor Targets Advanced Solid Tumors
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma, SHA: 600196, HKG: 2196) announced that HLX97,...
Insilico Medicine’s AI-Driven ISM4808 Hits Phase I Milestone – TaiGen Doses First Subject in CKD Anemia Trial
Insilico Medicine (HKG: 3696) announced that ISM4808, an AI-driven PHD inhibitor for chronic kidney disease...
HutchMed Initiates Phase I/IIa Trial for HMPL-A580 – Second Antibody-Targeted Triggered Conjugate Targets EGFR+ Solid Tumors
HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced the initiation of a Phase I/IIa clinical...
Ab&B Bio-Tech Wins FDA IND Approval for mRNA Mpox Vaccine – China’s First U.S.-Cleared Candidate Targets Immunocompromised Populations
Ab&B Bio-Tech CO., LTD. JS (HKG: 2627) announced that the U.S. Food and Drug Administration...
Eli Lilly’s Eloralintide Wins CDE Approval for Phase III Trials in China – Weekly Amylin Agonist Targets Weight Management Market
Eli Lilly and Company (NYSE: LLY) announced that China’s Center for Drug Evaluation (CDE) under...
Pyrotech Therapeutics’ PTT-936 Wins NMPA Approval – Novel ALPK1 Agonist Targets Bladder Cancer
Pyrotech (Beijing) Biotechnology Co., Ltd. (“Pyrotech Therapeutics”) announced that its internally developed small‑molecule innate immune...
Konruns Pharma’s KC1036 Wins NMPA Approval – Dual‑Target VEGFR2/AXL Inhibitor Enters IO Combination Trials
Beijing Konruns Pharmaceutical Co., Ltd (SHA: 603590) announced that China’s National Medical Products Administration (NMPA) has...
Sichuan Biokin’s CD33 ADC BL-M11D1 Wins NMPA Approval – Expands into Myelodysplastic Syndromes
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) announced that China’s National Medical Products Administration (NMPA) has...
CMS’s CMS-D008 Wins NMPA Approval – INHBE siRNA Targets Fat‑Selective Weight Loss
China Medical System Holdings Limited (CMS, HKG: 0867) announced clinical study approval from China’s National Medical...
ImmuneOnco’s IMM0306S Wins NMPA Approval – Subcutaneous CD47×CD20 Bispecific for Lupus Enters Clinic
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) announced clinical approval from China’s National Medical Products Administration...
Huadong Medicine’s DR30206 Wins NMPA Approval – Triple‑Target Fusion Protein for NSCLC Enters Phase II
Huadong Medicine Co., Ltd (SHE: 000963) announced that China’s National Medical Products Administration (NMPA) has approved...
Lepu Medical’s siRNA MWX401 Wins NMPA Approval – RNAi Therapy Targets Primary Hypertension
Lepu Medical Technology (SHE: 300003), a cardiovascular disease solutions provider, announced clinical approval from China’s National...
Xellsmart’s iPSC Neural Therapy Cleared by NMPA and FDA – First “Off‑the‑Shelf” Cell Therapy for MSA‑P Enters Clinic
Xellsmart, a Suzhou‑based stem‑cell startup, announced regulatory clearance from both China’s NMPA and the US...
ReviR Therapeutics Doses First Patient in RTX-117 Trial – China’s First “AI + RNA” Small Molecule Enters Clinic
ReviR Therapeutics, a clinical‑stage biotech incubated by XtalPi (HKG: 2228), announced first subject dosing in a...
CSPC Pharma’s SYHX2011G1 Wins FDA IND Approval – Instant‑Release Albumin‑Bound Paclitaxel for Metastatic Breast Cancer
CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that the U.S. Food and Drug Administration (FDA) has...
Gan & Lee’s AR PROTAC GLR2037 Wins NMPA Approval – First‑in‑Class Prostate Cancer Therapy Enters Clinic
Gan & Lee Pharmaceuticals (SHA: 603087) announced that China’s National Medical Products Administration (NMPA) has approved...