Novartis’ LNP023 and Janssen’s Tremfya on Track for Breakthrough Designations
The Center for Drug Evaluation (CDE) website indicates that Swiss major Novartis’ (NYSE: NVS) LNP023...
Breakthrough therapy
Kelun’s SKB264 Receives Breakthrough Therapy Designation for Lung Cancer
Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has announced that its antibody-drug conjugate (ADC) SKB264,...
Abbisko’s ABSK021 Receives FDA Breakthrough Therapy Designation for TGCT
Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving breakthrough therapy designation (BTD)...
Hengrui’s EZH2 Inhibitor SHR2554 Nears Breakthrough Therapy Designation
China-based Jiangsu Hengrui Pharmamceuticals (SHA: 600276) has announced that its enhancer for the zeste homolog...
Eli Lilly’s Donanemab Set to Gain Breakthrough Therapy Designation in China
The Center for Drug Evaluation (CDE) website indicates that US-based Eli Lilly’s (NYSE: LLY) injectable...
Innovent Biologics’ GFH925 Receives Breakthrough Therapy Designation
China’s Center for Drug Evaluation (CDE) website indicates that China-based Innovent Biologics (HKG: 1801) has...
Jacobio’s KRAS G12C Inhibitor JAB-21822 Receives Breakthrough Therapy Designation
The Center for Drug Evaluation (CDE) website indicates that China-based Jacobio Pharmaceuticals Group Co., Ltd’s...
Akeso Biopharma’s AK112 Receives Two New Breakthrough Therapy Designations
The Center for Drug Evaluation (CDE) website indicates that China-based Akeso Biopharma (HKG: 9926) has...
RemeGen’s Telitacicept Set for Breakthrough Therapy Designation in Myasthenia Gravis
The Center for Drug Evaluation (CDE) website indicates that China-based RemeGen Co., Ltd’s (HKG: 9995,...
Hengrui’s Pyrotinib Granted Breakthrough Therapy Designation by CDE
The Center for Drug Evaluation (CDE) website indicates that China-based Hengrui Medicine Co., Ltd’s (SHA:...
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...
Ark Biosciences’ Ziresovir Shows Positive Results in Phase III AIRFLO Study for RSV Infection
China-headquartered Ark Biosciences has announced positive results from the Phase III AIRFLO study for its...
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 MRG003 Receives Orphan Drug Designation from FDA
China-based Lepu Biotechnology Co., Ltd (HKG: 2157) has announced that it has received orphan drug...
Keymed and Lepu’s CMG901 Receives Breakthrough Therapy Designation for Gastric Cancer
The Center for Drug Evaluation (CDE) website indicates that CMG901, a Claudin 18.2 (CLDN18.2)-targeted antibody...
Hainan Yuekang’s YK-029A Biosimilar Set for BTD in EGFR ex20ins NSCLC
The Center for Drug Evaluation (CDE) website indicates that China-based Hainan Yuekang Biological Medicine Co.,...
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...
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:...
Belief-Delivery BioMed’s BBM-H901 Granted BTD for Hemophilia B Prevention
The Center for Drug Evaluation (CDE) website indicates that Shanghai Belief-Delivery BioMed Co., Ltd’s injectable...
Neurophth’s NR082 Gene Therapy Receives BTD for Leber Hereditary Optic Neuropathy
China’s Center for Drug Evaluation (CDE) has awarded breakthrough therapy designation (BTD) to Wuhan Neurophth...