China Resources Double-Crane Gets NMPA Approval for Semaglutide Biosimilar Clinical Trial
China Resources Double-Crane Pharmaceutical Co., Ltd (SHA: 600062) has announced that it has received clinical...
Drug
J&J Submits sBLA to FDA for Subcutaneous Tremfya Regimen in Ulcerative Colitis
Johnson & Johnson (J&J; NYSE: JNJ) has submitted a supplemental Biologics License Application (sBLA) to...
Servier’s Vorasidenib Approved in Boao Lecheng Medical Zone for Diffuse Gliomas
French pharmaceutical company Servier’s Voranigo (vorasidenib), an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor,...
Leads Biolabs’ LBL-024 Earns FDA Orphan Drug Designation for Neuroendocrine Cancer
China-based Leads Biolabs Inc. has announced that it has obtained Orphan Drug Designation (ODD) from...
Signet Therapeutics’ SIGX1094 Earns Orphan Drug Designation for Gastric Cancer from FDA
China-based Signet Therapeutics has announced that it has received Orphan Drug Designation (ODD) from the...
MSD Partners with Cancer Foundation of China for HPV Vaccine Donation Program
Merck, Sharp & Dohme (MSD; NYSE: MRK) has entered into a donation agreement with the...
Sciwind Biosciences’ Ecnoglutide Accepted for Review by China’s NMPA for Type 2 Diabetes
China-based Sciwind Biosciences Co., Ltd has announced that the National Medical Products Administration (NMPA) has...
HutchMed Anticipates Milestone Payment as Takeda Launches Fruzaqla in Japan for CRC
China-based HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) is poised to receive a milestone payment...
First Patient Dosed in Abbisko’s Phase II Trial of ABSK061 and ABSK043 in FGFR2/3 Altered Tumors
Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced the first patient dosing in...
Bayer’s Nubeqa Files for FDA Approval in mHSPC
German pharmaceutical company Bayer AG (ETR: BAYN) has announced that the US Food and Drug...
China Grants Marketing Approval for MSD’s Welireg for von Hippel-Lindau Disease Tumors
China’s National Medical Products Administration has issued marketing approval for Merck, Sharp & Dohme’s (MSD;...
Easton Pharmaceutical Secures NMPA Approval for Generic Jakavi and Urocit-K
Chengdu-based Easton Pharmaceutical Co., Ltd (SHA: 688513) has announced that it has received separate marketing...
Innorna’s mRNA Drug IN015 Earns Orphan Drug Designation for PFIC Treatment
Shenzhen-based Innorna Co., Ltd, a leading platform company specializing in mRNA technology and LNP (lipid...
Jiangsu Hengrui Receives NMPA Approval for HRS-6208 Solid Tumor Clinical Study
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from...
InxMed’s Ifebemtinib Earns Breakthrough Therapy Designation for NSCLC Treatment in China
China-based InxMed (Nanjing) Co., Ltd has announced that the Center for Drug Evaluation of the...
Hua Medicine and Bayer AG Terminate Co-promotion Agreement for HuaTangNing
China-based Hua Medicine (HKG: 2552) has announced the termination of its co-promotion agreement with German...
Sino Biopharmaceutical Submits NDA for Anlotinib and Penpulimab Combo in HCC to NMPA
China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced the submission of a New Drug Application...
Innovent Biologics’ IBI354 Earns Breakthrough Therapy Designation for Ovarian Cancer Treatment
The Center for Drug Evaluation (CDE) website has indicated that China-based Innovent Biologics, Inc. (HKG:...
CDE Includes Double-Crane’s Hydroxocobalamine and Sanofi Genzyme’s Fitusiran in Rare Disease Care Plan
China’s Center for Drug Evaluation (CDE) has announced the inclusion of China Resources Double-Crane Pharmaceutical...
Apeiron Therapeutics Initiates Phase Ia/B Study for GTA182 in Solid Tumors with MTAP Deficiency
Apeiron Therapeutics, a biomarker-driven cancer therapy developer with operations in Shanghai, China, and San Francisco,...