China’s NMPA Unveils Comprehensive Regulatory Framework for Cell and Gene Therapy Products with Streamlined Review Pathways
China’s National Medical Products Administration (NMPA) has issued two landmark regulatory guidelines—the Guideline on the...
Changchun High & New Tech Secures NMPA Clinical Approval for GenSci164 PTH1R Agonist in Hypoparathyroidism Treatment
Changchun High & New Tech (SHE: 000661) announced it has received clinical trial approval from...
Hua Medicine Partners with GemVCare on Real-World Clinical Study for Dorzagliatin in Precision Diabetes Management
Hua Medicine (HKG: 2552) announced a research collaboration agreement with GemVCare (GVC), a Hong Kong-based...
Hengrui Pharmaceuticals Secures NMPA Priority Review for Trastuzumab Rezetecan in HER2-Low Breast Cancer, Expanding Third Indication in China
Hengrui Pharmaceuticals (SHA: 600276; HKG: 1276) announced that China’s National Medical Products Administration (NMPA) has...
Edding Genor’s Trispecific Antibody GB268 Secures NMPA IND Approval for Phase Ib/II Breast Cancer Trial, Targeting TNBC and HR+/HER2- Subtypes
Edding Genor Group Holdings Limited (HKG: 6998) announced that China’s National Medical Products Administration (NMPA)...
Hengrui Pharmaceuticals Secures NMPA Priority Review for Trastuzumab Rezetecan in HER2-Low Breast Cancer, Expanding Third Indication in China
Hengrui Pharmaceuticals (SHA: 600276; HKG: 1276) announced that China’s National Medical Products Administration (NMPA) has...
Shandong Boan Biotechnology Secures NMPA Approval for Phase II Trial of BA1106/BA1104 Combination in NSCLC, China’s First Non-IL-2-Blocking Anti-CD25 Antibody
Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced that China’s National Medical Products Administration (NMPA)...
CSPC Pharmaceutical’s Megalith Subsidiary Enters $1.77 Billion siRNA Collaboration with AstraZeneca for Novel RNAi Therapeutics
CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that its subsidiary Megalith has entered into a...
Bio-sincerity Secures NMPA Clinical Trial Approval for BIOS0629-109, Novel XPO1 Inhibitor for Advanced Malignant Tumors
Bio-sincerity (SHE: 301096) announced that China’s National Medical Products Administration (NMPA) has approved its investigational...
Novartis Secures EU Approval for Itvisma, First Gene Replacement Therapy for Broad SMA Population Including Patients Two Years and Older
Novartis AG (NYSE: NVS) announced that the European Commission (EC) has granted marketing authorization for...
Ocumension Therapeutics Secures NMPA Approval for OT-502, China’s First Single-Dose Sustained-Release Intraocular Steroid for Postoperative Inflammation
Ocumension Therapeutics (HKG: 1477) announced that China’s National Medical Products Administration (NMPA) has approved the...
Hotgen Biotech Launches AI Subsidiary to Transform Small Nucleic Acid Drug Discovery
Hotgen Biotech (SHA: 688068) has officially registered Beijing Shangjing Zhiyao Technology Co., Ltd., a wholly-owned...
Hangzhou Adamerck’s Aom0498 Receives NMPA Approval as China’s First Homegrown Neuromuscular Blockade Reversal Agent – Completing Decade-Long National Innovation Program
Hangzhou Adamerck Pharmlabs Inc. announced that its independently developed Class 1 innovative drug Aom0498 has...
Junshi Biosciences Licenses Anti-IL-17A Antibody Roconkibart to Fosun Wanbang for Greater China – $1.34B Deal Secures Commercialization of Phase III-Ready Psoriasis Therapy
Junshi Biosciences (HKG: 1877, SHA: 688180) announced a licensing agreement with Fosun Wanbang Pharma Group,...
Jingxin Pharmaceutical Secures NMPA Approval for China’s First Generic Cariprazine in Schizophrenia – Capturing Market Opportunity as Reference Product Remains Unlaunched
Jingxin Pharmaceutical (SHE: 002020) announced that China’s National Medical Products Administration (NMPA) has approved the...
TransThera Completes Patient Enrollment in Global Phase III Trial of Tinengotinib for Advanced Cholangiocarcinoma – Multi-Kinase Inhibitor Backed by Multiple Regulatory Designations
TransThera (Nanjing) Technology Co., Ltd. (HKG: 2617) announced the completion of patient enrollment in the...
TransThera Advances Phase II Trial of Selective BTK Inhibitor TT-01488 with Anti-CD20 Antibodies for Mantle Cell Lymphoma – Novel Non-Covalent Approach Shows Enhanced Safety Profile
TransThera (Nanjing) Technology Co., Ltd. (HKG: 2617) announced that China’s National Medical Products Administration (NMPA)...
Insilico Medicine and Takeda Launch $600M Strategic AI Drug Discovery Collaboration – Pharma.AI Platform to Drive Candidate Identification for High-Potential Therapeutic Targets
Insilico Medicine (HKG: 3696) announced a strategic collaboration agreement with Takeda Pharmaceutical Company Limited (TYO:...
Nona Biosciences and Lonza Forge Strategic Alliance to Develop Best-in-Class Blood-Brain Barrier Penetration Technology for CNS Therapeutics
Nona Biosciences and Lonza Group Ltd. (SWX: LONN) announced a strategic collaboration to jointly develop...
Juventas Cell Therapy’s CAR-T Therapy Yuanruida Receives HSA Filing Acceptance for r/r B-ALL – Expanding Global Regulatory Footprint Following NMPA Approval
Juventas Cell Therapy Ltd. announced that the New Drug Application (NDA) for Yuanruida (inaticabtagene autoleucel),...