European Commission Approves Bristol Myers Squibb’s Sotyktu for Psoriatic Arthritis Following FDA Clearance
The European Commission (EC) granted marketing authorization this week for Bristol-Myers Squibb‘s (BMS, NYSE: BMY)...
Drug
Keymed Biosciences Secures NMPA Breakthrough Therapy Designation for CM336 in AL Amyloidosis
Keymed Biosciences Inc. (HKG: 2162) announced that its BCMA×CD3 T cell engager (TCE), CM336 (OM336),...
Innovent Biologics Secures Third Breakthrough Therapy Designation for IBI363 in MSS/pMMR Colorectal Cancer
Innovent Biologics, Inc. (HKG: 1801) announced that its first-in-class PD-1/IL-2α-bias bispecific antibody (BsAb) fusion protein,...
Hengrui Pharmaceuticals Secures NMPA Clinical Approval for KRAS G12D Inhibitor HRS-6093 and Multiple Combination Regimens in Advanced Solid Tumors
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced it has received clinical trial...
Kelun-Biotech Submits New NMPA Filing for Jaitailai in First-Line NSCLC Combination Therapy with Keytruda
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced it has submitted a new indication approval...
Ab&B Bio-Tech Secures NMPA Clinical Approval for mRNA RSV Vaccine, Addressing Critical Unmet Need in China
Ab&B Bio-Tech Co., Ltd. (HKG: 2627) announced it has received clinical trial approval from China’s...
Mabwell Bioscience Secures FDA Clearance for 9MW5211 in IBD, Advances Multi-Indication Autoimmune Pipeline
Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062, HKG: 2493) announced it has received clinical clearance...
Harbour BioMed Receives FDA Clearance for Phase I Trial of Novel B7H4xCD3 Bispecific Antibody HBM7004
Harbour BioMed (HKG: 2142) announced it has received clearance from the U.S. Food and Drug...
Johnson & Johnson Terminates Two CAR-T Development Programs Amid Portfolio Prioritization
Johnson & Johnson (J&J, NYSE: JNJ) announced the termination of development programs for JNJ-9530, a...
Huadong Medicine’s Asthma Drug CXG87 Receives NMPA Filing Acceptance Following Successful Phase III Trial Against Symbicort
Huadong Medicine Co., Ltd. (SHE: 000963) announced that the National Medical Products Administration (NMPA) has...
Wuhan YZY Biopharma’s Bispecific Antibody M701 Receives NMPA Acceptance for Review in Malignant Ascites Treatment
Wuhan YZY Biopharma Co., Ltd. (HKG: 2496) announced that the National Medical Products Administration (NMPA)...
Guangdong Zhongsheng Pharma Reports Positive Phase IIb Results for First-in-Class ZSP1601 in Metabolic Dysfunction-Associated Steatohepatitis with Fibrosis Reversal Potential
Guangdong Zhongsheng Pharmaceutical Co., Ltd. (SHE: 002317) announced positive top-line results from its Phase IIb...
Suzhou Zelgen Biopharmaceuticals Achieves Primary Endpoint in Phase III Trial for Zesuning in Thyroid Cancer Ablation Therapy
Suzhou Zelgen Biopharmaceuticals Co., Ltd. (SHA: 688266) announced that its Phase III clinical trial of...
Jiangsu Lianhuan Pharma Reports Positive Phase III Results for LH-1801 SGLT-2 Inhibitor in Type 2 Diabetes Treatment
Jiangsu Lianhuan Pharmaceutical Co., Ltd. (SHA: 600513) announced successful unblinding of two pivotal Phase III...
Sino Biopharmaceutical’s Subsidiary Tianqing Secures Expanded NMPA Approval for Saitanxin – First-in-Class CDK2/4/6 Inhibitor Moves to First-Line Breast Cancer
Chia Tai Tianqing Pharmaceutical Group, a wholly owned subsidiary of Sino Biopharmaceutical Ltd. (HKG: 1177),...
Cutia Therapeutics Secures NMPA Approval for CU-30101 Topical Anesthetic Cream – Dermatology Specialist Expands Commercial Portfolio
Cutia Therapeutics (HKG: 2487), a dermatology-focused specialty pharmaceutical company, announced that China’s National Medical Products...
Changchun High-Tech’s Subsidiary GeneScience Advances GenSci155 – Long-Acting IGF-1 Analog for Preterm Infants and Stroke Patients
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that the National Medical...
Joincare Pharma Secures NMPA Clinical Trial Approval for JKN2501 – China’s First Broad-Spectrum β-Lactamase Inhibitor for Drug-Resistant Pneumonia
Joincare Pharmaceutical Group Industry Co., Ltd. (SHA: 600380) announced that China’s National Medical Products Administration...
Amgen Secures NMPA Approval for Evenity (Romosozumab) – Novel Osteoporosis Treatment for High-Risk Postmenopausal Women in China
Amgen Inc. (NASDAQ: AMGN) announced that China’s National Medical Products Administration (NMPA) has granted marketing...
NMPA Approves Hangzhou Biosunpharma’s Bewintinib as First-Line JAK2 Inhibitor for Myelofibrosis with 62.8% Spleen Volume Response Rate
China’s National Medical Products Administration (NMPA) has granted approval to Hangzhou Biosunpharma Co., Ltd. for...