CSPC Pharmaceutical Secures Second Breakthrough Therapy Designation for EGFR-Targeting ADC SYS 6010 in Esophageal Cancer
CSPC Pharmaceutical Group Ltd. (HKG: 1093) announced it has received a second Breakthrough Therapy Designation...
Drug
AmoyDx PCR11 Companion Diagnostic Approved in Japan for Johnson & Johnson’s Rybrevant in NSCLC with EGFR Exon 20 Insertions
Amoy Diagnostics Co., Ltd. (SHE: 300685) announced in collaboration with Japanese partners Riken Genesis Co.,...
CanSino Biologics’ Five-Component Pertussis Vaccine Enters NMPA Priority Review for Ages 6+
CanSino Biologics Inc. (HKG: 6185) announced that China’s National Medical Products Administration (NMPA) has included...
Henlius Biotech Expands European Footprint with Two Additional EC Approvals for HanSiZhuang PD-1 Inhibitor
Shanghai Henlius Biotech Inc. (HKG: 2696) announced it has secured two additional indication approvals from...
Henlius Biotech Receives FDA Clearance for Phase I Trial of HLX05-N Cetuximab Biosimilar in Metastatic Colorectal Cancer
Shanghai Henlius Biotech Inc. (HKG: 2696) announced it has received Investigational New Drug (IND) clearance...
Hansoh Pharmaceutical’s B7-H3 ADC HS-20093 Receives Fifth NMPA Breakthrough Therapy Designation for Esophageal Cancer
Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that its B7-H3-targeted antibody-drug conjugate (ADC) HS-20093...
CStone Pharmaceuticals Launches First Commercial Batch of Gavreto in China Following NRDL Inclusion
CStone Pharmaceuticals (HKG: 2616) announced the first batch manufacturing and release of its Gavreto (pralsetinib...
Wenda Pharmaceutical Secures NMPA Breakthrough Therapy Designation for NHWD-870 in Rare NUT Carcinoma
Zhejiang Wenda Pharmaceutical Technology Co., Ltd. announced it has received Breakthrough Therapy Designation (BTD) from...
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)...
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...