NMPA Proposes Framework for Synchronized Development of Anti-Tumor Drugs and Companion Diagnostics
China’s National Medical Products Administration (NMPA) announced that the Center for Medical Device Evaluation and...
Drug
CSPC Pharmaceutical Launches Phase II Trial of Novel ADC SYS6041 for Recurrent Ovarian Cancer in China
CSPC Pharmaceutical Group (HKG: 1093) announced that a Phase II clinical trial evaluating its self-developed...
Qyuns Therapeutics Secures NMPA Approval for QX027N Clinical Trials in COPD and CRSwNP, Announces Global Partnership
Qyuns Therapeutics Co., Ltd. (HKG: 2509) announced that its self-developed long-acting bispecific antibody, QX027N Injection,...
Jinling Pharmaceutical’s Ferric Carboxymaltose Injection Receives NMPA Acceptance for Market Authorization
Jinling Pharmaceutical Co., Ltd. (SHE: 000919) announced that the marketing authorization application for its Ferric...
Mabwell (Shanghai) Bioscience Secures NMPA Approval for 9MW5211 Clinical Trials in Primary Biliary Cholangitis
Mabwell (Shanghai) Bioscience Co., Ltd. (HKG: 2493) announced that China’s National Medical Products Administration (NMPA)...
Nanjing Leads Biolabs Secures NMPA Approval for Opamtistomig (LBL-024) in Metastatic Colorectal Cancer Clinical Trial
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced that China’s National Medical Products Administration (NMPA)...
BrightGene’s Generic Tiotropium Bromide Inhalation Spray Gains NMPA Approval as China’s First Domestic COPD Treatment Alternative
BrightGene (Suzhou) Co., Ltd. (SHA: 688166) announced that its tiotropium bromide inhalation spray has received...
Insilico Medicine’s NLRP3 Inhibitor ISM8969 Secures NMPA IND Approval for Parkinson’s Disease with Global Clinical Trials Underway
Insilico Medicine (HKG: 3696) announced that ISM8969/HT-001, an innovative oral NLRP3 inflammasome inhibitor co-developed with...
Henlius HLX43 PD-L1 ADC Gains NMPA Approval for Advanced Solid Tumor Trials with Bevacizumab
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196; HKG: 2196) announced that China’s National Medical...
Roche’s Vabysmo Wins NMPA Approval for Retinal Diseases in China Market Expansion
Roche Holding AG (SWX: ROP; OTCMKTS: RHHBY) announced that China’s National Medical Products Administration (NMPA)...
Buchang Pharmaceuticals Withdraws Efperepoetin Alfa Registration Application for CKD Anemia Due to Dossier Enhancement Requirements
Shandong Buchang Pharmaceuticals Co., Ltd. (SHA: 603858) announced the voluntary withdrawal of its drug registration...
Hengrui Pharmaceuticals’ HER3-Targeting ADC Ruzaltatug Rezetecan Receives NMPA Marketing Application Acceptance for EGFR-Mutant NSCLC Post-TKI Progression
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that the marketing authorization application...
Huahai Pharmaceutical’s Anti-IL-36R Antibody Huayijing Receives NMPA Priority Review Approval for Generalized Pustular Psoriasis Flares
Zhejiang Huahai Pharmaceutical Co., Ltd. (SHA: 600521) announced that its Category 1 therapeutic biologic HB0034...
CSPC Pharmaceutical’s Nectin-4 Targeting ADC CRB-701 Receives FDA Approval for Registrational Trial in Second-Line Oropharyngeal Squamous Cell Carcinoma
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that CRB-701 (SYS 6002), a next-generation antibody-drug conjugate...
Hengrui Pharmaceuticals Secures NMPA Approval for HRS5580 Long-Acting NK-1 Antagonist in Combination Therapy for Postoperative Nausea and Vomiting Prevention
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its novel selective neurokinin-1...
Akeso and Allink Biotherapeutics Launch Phase II Trial of PD-1/VEGF-FGFR2b ADC Combination for Squamous NSCLC Following NMPA IND Approval
Akeso, Inc. (HKG: 9926) and Shanghai Allink Biotherapeutics Inc. announced a clinical research collaboration to...
Guangzhou Innogen’s Ultra-Long-Acting GLP-1 Agonist Efsubaglutide Alfa Advances to Adolescent Obesity Phase Ib Trial Following NMPA Approval for Diabetes
Guangzhou Innogen Pharmaceutical Group Co., Ltd. (HKG: 2591) announced plans to initiate a Phase Ib...
Ribo Life Science’s siRNA Therapy Vortosiran Receives EMA Approval for Stroke Prevention Trial in Atrial Fibrillation Patients
Ribo Life Science (HKG: 6938) announced that its small interfering RNA (siRNA) therapy vortosiran (BD4059)...
Hansoh Pharmaceutical’s B7-H3 ADC Risvutatug Rezetecan Hits Primary Endpoint in Osteosarcoma Phase III Trial, Validating GSK Partnership
Hansoh Pharmaceutical (HKG: 3692) announced that its pivotal Phase III ARTEMIS-011 clinical trial of Risvutatug...
Shionogi Launches XOCOVA (Ensitrelvir) in US for COVID-19 Post-Exposure Prophylaxis Following 67% Risk Reduction in Global Trial
Shionogi & Co., Ltd. (TYO: 4507) announced the U.S. commercial availability of XOCOVA (ensitrelvir), an...