CDE Releases Draft Guidelines for Tumor Therapeutic Vaccine Clinical Trials
The Center for Drug Evaluation (CDE) has released the “Tumor Therapeutic Vaccines Clinical Trial Technical...
Cancer
Guangdong Zhongsheng Receives USPTO Patent for FGFR4 Inhibitor ZSP1241
China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced receiving a patent award from...
Simcere Completes Enrollment for Phase III Study of CDK4/6 Inhibitor in mTNBC
China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the completion of first-line enrollment for its...
Hengrui Medicine’s Pyrotinib Filing Accepted for Review by NMPA
China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its supplementary market filing...
Innovent’s Cyramza Gains NMPA Approval for Hepatocellular Carcinoma
Innovent Biologics Inc. (HKG: 1801) has announced that the supplementary Biologic License Application (sBLA) for...
Salubris Pharmaceuticals’ First-in-Class Anti-Tumor Drug SAL008 Accepted by NMPA
China’s Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has announced that a clinical trial filing...
Roche’s Subcutaneous Herceptin Approved in China for HER2-Positive Breast Cancer
Swiss pharmaceutical giant Roche’s (SWX: ROG) Herceptin (trastuzumab, subcutaneous injection) has been approved in China...
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)...
Convalife and Jointown Partner for Global Drug Development and Commercialization
Shanghai-based Convalife Pharmaceuticals has entered into a strategic partnership with fellow Chinese firm Jointown Pharmaceutical...
Eli Lilly’s Retevmo Wins First China Approvals for RET-Driven Cancers
Eli Lilly & Co (NYSE: LLY) has secured its first approvals in China for Retevmo...
China’s NMPA Proposes Reforms to Enhance Radiopharmaceutical Review and Approval
China’s National Medical Products Administration (NMPA) has released a draft proposal titled “Opinions on Reforming...
Pfizer’s Talzenna Shows Positive Results in Phase III TALAPRO-2 Study for mCRPC
US-based pharmaceutical giant Pfizer (NYSE: PFE) has announced positive results from the Phase III TALAPRO-2...
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...
WuXi Biologics Partners with neoX Biotech to Advance AI-Driven Drug Development
China-based Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has entered into...
Henlius Biotech Gets FDA Nod for HLX07 Clinical Study in CSCC
Shanghai Henlius Biotech (HKG: 2696) has announced that it has received approval from the US...
Lepu Biotechnology’s MRG003 Receives Breakthrough Therapy Designation for Nasopharyngeal Carcinoma
China-based Lepu Biotechnology Co., Ltd (HKG: 2157) has announced that it has received Breakthrough Therapy...
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...
3D Medicines Partners with Denfo Medical for Cancer Therapy Development
China-based 3D Medicines has entered into a strategic partnership with compatriot firm Denfo Medical Group,...
Zai Lab Licenses Seagen’s Tivdak for Greater China Development and Commercialization
Chinese firm Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has formed a collaboration with US-based...
Telix Pharmaceuticals Gains IND Approval for TLX250-CDx in China
Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) has announced that it has received Investigational New Drug...