Novartis Expands Iptacopan Approval to IgA Nephropathy in China
Swiss pharmaceutical giant Novartis (NYSE: NVS) announced that its first‑in‑class oral inhibitor Iptacopan (Fabhalta) has...
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...
DaAn Gene Secures NMPA Approval for First HIVDNA Diagnostic Kit
China‑based DaAn Gene Co., Ltd. (SHE: 002030), a research arm of Sun Yat‑sen University, announced that...
NMPA Releases Online Prescription Compliance Guidelines to Tighten Drug Retail Oversight
The National Medical Products Administration (NMPA) issued a draft of its Compliance Guidelines for Online...
Sirnaomics Secures HK$138 M Investment from Bloomage Biotech, Expanding Oncology and Aesthetic Pipelines
Sirnaomics Ltd. (HKG: 2257) announced a strategic investment agreement with Bloomage Biotech (Hong Kong) Limited, a...
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...