Simcere Receives FDA Clearance for Clinical Study of SIM0237
China-based Simcere Pharmaceutical Group (HKG: 2096) announced that it has received clearance from the US...
PD-1/L1
Shanghai Henlius’ PD-1 Inhibitor Serplulimab Gains Australian Clearance for Phase III Study
Shanghai Henlius Pharmaceutical Co., Ltd (HKG: 2696) has announced receiving regulatory clearance in Australia to...
Hengrui Medicine Gains Approval for Phase Ib/II Study of SHR-A1811 and SHR-1701 in HER2-Positive Gastric Cancer
China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced receiving approval to initiate a...
Hengrui’s Camrelizumab and Akeso’s AK112 Set to Receive Breakthrough Designation in China
The Center for Drug Evaluation (CDE) website indicates that China-based Jiangsu Hengrui Medicine Co., Ltd’s...
Akeso Biopharma Gains NMPA Approval for AK112 and AK119 Clinical Study
China-based Akeso Biopharma (HKG: 9926) has announced receiving approval from the National Medical Products Administration...
Hengrui Medicine’s Deputy GM Tao Weikang Resigns, Joins Qilu Pharma
China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its deputy general manager...
BeiGene Partners with Immune-Onc for Clinical Development of Myeloid Checkpoint Inhibitors
China-based biotech BeiGene (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has entered into a clinical study...
Merck’s Keytruda Gains 9th Indication Approval in China for Hepatocellular Carcinoma
US major Merck Sharp & Dohme’s (MSD, NYSE: MRK) programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab)...
Junshi Biosciences Launches PD-1 Inhibitor Tuoyi for Advanced NSCLC in China
Junshi Biosciences (HKG: 1877, SHA: 688180), a China-based biopharmaceutical company, has held a national market...
Lepu Biotechnology’s PD-1 Inhibitor HX008 Gains New Indication Approval
China-based Lepu Biotechnology Co., Ltd (HKG: 2157) has announced that it has received another indication...
Abbisko Therapeutics Doses First Patient in Phase I Study of ABSK043
Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that the first patient has...
Junshi Biosciences’ Tuoyi Approved for First-Line NSCLC Treatment in China
China’s Center for Drug Evaluation (CDE) has approved Junshi Biosciences’ (HKG: 1877, SHA: 688180) Tuoyi...
Antengene’s ATG-101 Receives Orphan Drug Designation for Pancreatic Cancer
China-based biotech Antengene Corp., Ltd (HKG: 6996) has announced that its pipeline candidate ATG-101, a...
Ascletis Completes Enrollment for HIV Functional Cure Study with PD-L1 Antibody ASC22
China-based Ascletis Pharma Inc. (HKG: 1672) announced that the clinical study of PD-L1 antibody ASC22...
Alphamab/3DMed’s Envafolimab Gains FDA Fast-Track Status for Sarcoma Treatment
Alphamab Oncology (HKG: 9966) and 3D Medicines’ envafolimab (KN035) has obtained fast-track status from the...
BeiGene’s Tislelizumab Meets Primary Endpoint in HCC Study at ESMO
BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) presented the latest results of the global Phase...
Innovent’s Tyvyt Combo Shows PFS Benefit in EGFR-Mutant NSCLC
China-based Innovent Biologics Inc. (HKG: 1801) announced positive results from the Phase III ORIENT-31 study...
Innovent’s Tyvyt Shows PFS Benefit in EGFR-Mutant NSCLC at ESMO
China-based Innovent Biologics, Inc. (HKG: 1801) presented results of the ORIENT-31 study for its PD-1...
Alphamab Oncology Highlights KN046, KN026 Advances at ESMO 2022
China’s Alphamab Oncology (HKG: 9966) will present updated clinical data for its bispecific antibody candidates...
Henlius Biotech Plans US Bridging Study for Serplulimab in ES-SCLC
Shanghai Henlius Biotech (HKG: 2696) is advancing its checkpoint inhibitor serplulimab toward the U.S. market,...