CARsgen Therapeutics Launches GMP Manufacturing for CAR-T Cell Therapies in North Carolina
China’s CARsgen Therapeutics Holdings Ltd (HKG: 2171), a chimeric antigen receptor (CAR)-T cell specialist, has...
Drug
Hengrui Medicine’s HRG2101 Inhaler Wins NMPA Approval for IPF Clinical Trial
China’s Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has received approval from the National Medical...
RedCloud Bio Doses First Patient in H002 EGFR TKI Phase I/IIa Trial for NSCLC
Shanghai-based RedCloud Bio announced that the first patient has been dosed in a Phase I/IIa...
Lepu Biopharma’s MRG002 Earns FDA Orphan Drug Status for Gastric Cancer
China’s Lepu Biopharma Co., Ltd (HKG: 2157) announced that the U.S. FDA has granted orphan...
CDE Releases 62nd Batch of Chemical Generic References, Updates 39 Specifications
The Center for Drug Evaluation (CDE) has released the 62nd batch of chemical generic reference...
Jacobio Pharmaceuticals Doses First Patient in JAB-21822 Phase IIa Trial for KRAS G12C NSCLC
China’s Jacobio Pharmaceuticals Group Co., Ltd (HKG: 1167) announced the first patient dosed in a...
Akeso Bio’s AK112 Wins Breakthrough Designation for First-Line NSCLC
China’s Akeso Bio has secured a breakthrough therapy designation (BTD) from the Center for Drug...
Connect Biopharma Completes Phase I Trial of CBP-174 for Itch in Skin Diseases
Sino-US biotech Connect Biopharma Holdings Ltd (NASDAQ: CNTB), headquartered in San Diego, California, and Taicang,...
Boehringer, Eli Lilly’s Jardiance Wins NMPA Approval for Heart Failure with Preserved Ejection Fraction
Boehringer Ingelheim and Eli Lilly (NYSE: LLY) announced that China’s National Medical Products Administration (NMPA)...
Merck’s Gardasil 9-Valent HPV Vaccine Approved for Expanded Age Range in China
US-based Merck Sharp & Dohme (MSD; NYSE: MRK) announced that China’s National Medical Products Administration...
Sinocelltech’s Ripertamab Wins NMPA Approval for DLBCL Treatment
China-based Sinocelltech Group Ltd (SHA: 688520) has received New Drug Application (NDA) approval from the...
Clover Biopharma’s SCB-2019 Vaccine Shows Strong Immune Response to Omicron BA.5
China-based Clover Biopharmaceuticals, Ltd (HKG: 2197) announced positive Phase II/III trial results for its COVID-19...
Staidson and J&J’s Teclistamab Gain Breakthrough Designation for Hemophilia and Myeloma
The Center for Drug Evaluation (CDE) has indicated that Staidson (Beijing) Pharmaceutical Co., Ltd’s (SHE:...
InnoCare Pharma and CStone Pharmaceuticals’ Drugs Receive Prioritized CDE Review
The Center for Drug Evaluation (CDE) has granted prioritized review status to InnoCare Pharma’s (HKG:...
Biocytogen and Tracon Pharmaceuticals Gain FDA IND Approval for Sarcoma Trial
China-based Biocytogen (Beijing) Co., Ltd and US-based Tracon Pharmaceuticals Inc. (Nasdaq: TCON) announced that the...
Hengrui Medicine’s Dalpiciclib Hits Superiority Criteria in Phase III Study
China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that its Phase III SHR6390-III-302 study...
ImmuneOnco’s IMM40H Receives NMPA Clinical Trial Approval for CD70 Antibody
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd announced that it has received clinical trial approval from the...
Sirnaomics’ STP705 Achieves 100% Complete Remission in Basal Cell Carcinoma Study
Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) announced positive results from a Phase II...
Henlius Biotech’s PD-1 Inhibitor Serplulimab Secures NMPA Review for Esophageal Cancer
Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the National Medical Products Administration (NMPA) has...
Junshi Biosciences’ TAB009/JS009 and JS110 Advance in Cancer Trials
Junshi Biosciences (HKG: 1877, SHA: 688180) has received approval from the National Medical Products Administration...