RemeGen Secures China CDE Approval for Telitacicept in Sjögren’s Syndrome, First Biologic of Its Kind
China‑based pharmaceutical company RemeGen (HKG: 9995) announced that the Center for Drug Evaluation (CDE) of...
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...
Grand Pharma Secures CE Mark for SIR‑Spheres Y‑90, Expanding Liver‑Cancer Treatment Portfolio
Grand Pharmaceutical Group Limited (HKG: 0512) announced that SIR‑Spheres Y‑90 resin microsphere injection (brand name:...
Chongqing Genrix Bio Secures NMPA Approval for GR2303, a Novel TL1A‑Targeting Antibody in IBD
China‑based Chongqing Genrix Biopharmaceutical Co., Ltd. (SHA: 688443) announced that its Class 1 biological product GR2303...
Fosun Pharma Secures Foritinib Approval for ALK‑NSCLC Trials, Paving Way for Targeted Therapy
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (HKG: 2196, SHA: 600196) announced that its Class 1 chemical...
Duality Biotherapeutics Hits PFS Milestone with DB‑1303/BNT323 in HER2‑Positive Breast Cancer
China‑based Duality Biotherapeutics, Inc. (HKG: 9606) announced that its Phase III study of the HER2‑targeting antibody‑drug...
Innovent Biologics Announces Strong Phase II Results for Tigulixostat in Chinese Gout Patients
China-based Innovent Biologics Inc. (HKG: 1801) revealed that its next‑generation xanthine oxidase inhibitor (XOI), tigulixostat...
XWPharma Secures $205 M Valiloxybate Deal with Avadel
China‑based XWPharma Ltd. announced today that it has entered into an exclusive licensing agreement with...
FDA Launches “Green List” to Shield U.S. Markets from Unsafe GLP‑1 APIs
The U.S. Food and Drug Administration (FDA) today announced a new “green list” import alert...
InnoCare Pharma Secures Singapore HSA Approval for Orelabrutinib in Relapsed MZL
Shanghai‑based InnoCare Pharma (HKG: 9969, SHA: 688428) announced on September 8, 2025 that its Bruton’s tyrosine kinase...
Regenelead Secures NMPA Approval for RGL‑305 Cell Therapy in Advanced Malignant Tumors
On September 2, 2025, Shanghai‑based Regenelead announced that its internally developed cell‑therapy product RGL‑305 Injection received...
Takeda Secures FDA Approval for VONVENDI’s Expanded Use in Adult and Pediatric VWD
Japan-based Takeda Pharmaceutical (TYO: 4502, NYSE: TAK) today confirmed that the U.S. Food and Drug...
QuantumPharm XtalPi Secures Phase I Approval for PEP08, a Next‑Generation PRMT5 Inhibitor
Shenzhen-based QuantumPharm Inc., known as Xtalpi Inc. (HKG: 2228) announced a pivotal clinical milestone for...
Escugen and Huahui Health Form Exclusive Partnership to Develop First‑in‑Class ADC for Solid Tumors
Shanghai‑based Escugen and Beijing‑headquartered Huahui Health have announced a global, exclusive cooperation agreement to develop...
NHSA Releases Draft Regulations to Tighten Medical Insurance Funds Oversight
On September 7, 2025, China’s National Healthcare Security Administration (NHSA) issued the Draft Implementation Rules for the...
Gilead Terminates $2.3 B Collaboration With Kite Pharma Over Off‑the‑Shelf Cell Therapies
US-based Gilead Sciences’ (NASDAQ: GILD) subsidiary Kite Pharma has officially ended its $2.3 billion collaboration with Shoreline...
Junshi Biosciences’ JS005 IL‑17A Antibody Shows Promise in Phase III Psoriasis Trial
Shanghai Junshi Biosciences Co., Ltd. (HKG: 1877, SHA: 688180) announced that its proprietary recombinant humanized...
Hengrui’s RSS0393 PDE4 Inhibitor Approved for Atopic Dermatitis Clinical Trial
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that its proprietary topical RSS0393...
Hengrui’s HRS‑4729 GLP‑1 Triple Agonist Receives NMPA Approval for MASLD & MASH
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that its investigational drug HRS‑4729...