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...
Drug
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...
Junshi Biosciences Gets NMPA Go-Ahead for TAB009/JS009 Cancer Study
Junshi Biosciences (HKG: 1877, SHA: 688180) has received approval from the National Medical Products Administration...
Clover Biopharmaceuticals’ SCB-2019 Vaccine Proves Effective in Teenagers
China-based Clover Biopharmaceuticals Ltd (HKG: 2197) announced positive results from a global Phase II/III trial...
Alpha Biopharma Completes EVEREST Trial for Zorifertinib in EGFR+ NSCLC with CNS Metastases
Shanghai-based Alpha Biopharma announced the completion of the last patient visit in the Phase II/III...
Sorrento Therapeutics’ Abivertinib Shows Positive Long-Term Data in NSCLC Trial
Sorrento Therapeutics Inc. (OTCMKTS: SRNE) announced positive long-term results for its third-generation EGFR inhibitor abivertinib...