ImmuneOnco’s IMM2902 Receives FDA Fast-Track Designation for CD47/HER2 Targeting
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd announced that the U.S. Food and Drug Administration (FDA) has...
Cancer
Luye Pharma’s Lurbinectedin Receives Hainan Approval for SCLC Treatment
China-based Luye Pharma Group (HKG: 2186) announced approval from the Hainan Medical Products Administration for...
CStone Pharmaceuticals’ Gavreto Wins Hong Kong Approval for RET Fusion NSCLC
CStone Pharmaceuticals (HKG: 2616) announced that its RET inhibitor Gavreto (pralsetinib) has received marketing approval...
Kelun Pharma’s SKB264 ADC Receives NMPA Green Light for Phase II Solid Tumor Study
China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) announced that its antibody drug conjugate (ADC)...
BeiGene’s Tislelizumab Faces FDA Delay Due to Inspection Hurdles
BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) announced a delay in the U.S. FDA’s decision...
Orion Holdings to Build Jining Vaccine Plant in China’s Shandong Province
South Korea-based conglomerate Orion Holdings Corp. will enter China’s vaccine market by constructing a manufacturing...
Simcere’s Trilaciclib Wins NMPA Approval for Chemotherapy Myeloprotection
Jiangsu Simcere Pharmaceutical Co., Ltd’s trilaciclib has received marketing approval from the National Medical Products...
GenScript ProBio Partners with ACT Therapeutics on CAR-T Cell Therapy Development
GenScript ProBio, a global Contract Development and Manufacturing Organization (CDMO), announced a memorandum of understanding...
Abbisko Therapeutics’ ABSK021 Receives BTD for Giant Cell Tumor Treatment
Shanghai-based Abbisko Therapeutics Co., Ltd (HKG: 2256) announced that its Category 1 drug ABSK021 has...
HutchMed’s Orpathys-Tagrisso Combo Shows Promise in NSCLC at WCLC
China-based HutchMed (NASDAQ: HCM, HKG: 0013) announced the publication of an abstract detailing the SAVANNAH...
Junshi Biosciences’ JS203 Bispecific Antibody Receives NMPA Green Light for NHL Study
China-based Junshi Biosciences (HKG: 1877, SHA: 688180) announced that the National Medical Products Administration (NMPA)...
CDE Grants Priority Review to Ascentage’s Olerembatinib and Roche’s Crovalimab
The Center for Drug Evaluation (CDE) has granted priority review status to two drugs: Suzhou...
Hengrui Medicine’s SHR-1701 + Ameile Combo Greenlit for EGFR-Mutated NSCLC Trial
China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that the National Medical Products Administration...
Eucure Biopharma Doses First Patient in YH003 + Keytruda Trial for Mucosal Melanoma
Eucure Biopharma, a subsidiary of Sino-US contract research organization Biocytogen, announced that the first patient...
Overland ADCT BioPharma Launches Global Phase III Trial for Zynlonta in DLBCL
Overland ADCT BioPharma, a joint venture between China’s Overland Pharmaceuticals and Switzerland’s ADC Therapeutics SA...
Bio-Thera Solutions Doses First Patient in BAT8006 Phase I Study for Solid Tumors
Guangzhou-based Bio-Thera Solutions (SHA: 688177) announced that the first patient has been dosed in a...
OBI Pharma Halts OBI 888 Trial Over Manufacturing Costs, Shifts Focus to Globo H ADC
Taiwan-based OBI Pharma (TPEx: 4174) announced the discontinuation of a Phase I/II trial for its...
CSPC Pharmaceutical’s JMT103 Anti-RANKL Antibody Prioritized for CDE Review
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that its market filing for JMT103, an...
Innovent Biologics’ Pemazyre Becomes First FGFR2 Inhibitor Approved in China
China-based Innovent Biologics Inc. (HKG: 1801) announced that the first prescription has been filled in...
Dizal Pharma’s DZD1516 Receives NMPA Green Light for HER2+ Breast Cancer Trial
China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192), spun out from AstraZeneca’s China drug discovery unit...