Dizal’s Sunvozertinib NDA Accepted for Review by China’s NMPA
China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that its New Drug Application (NDA)...
Drug
HighTide Therapeutics Doses First Patient in Phase IIb Study for HTD1801 in NASH
Shenzhen-based HighTide Therapeutics Inc. has announced that the first patient has been dosed in a...
MSD Submits Initial Quotation for Molnupiravir in China Amid New COVID-19 Rules
Under new rules specifically for the launch of COVID-19 therapeutics in China, US-based Merck Sharp...
Treadwell Therapeutics’ CFI-402257 Granted Fast-Track Status by FDA
China-based clinical-stage biotech Treadwell Therapeutics has announced receiving fast-track status from the US Food and...
Jiangsu Kanion’s KYS202002A Greenlit for Clinical Study in Multiple Myeloma
China-based Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced receiving approval from the National...
Yiling Pharmaceutical’s BIO-008 Accepted for Review by China’s NMPA
China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced that its clinical trial filing for...
Luye Pharma Launches Named Patient Program for Lurbinectedin in Hong Kong
China-based Luye Pharma Group (HKG: 2186) has announced the launch of a Named Patient Program...
Innovent Biologics Doses First Patient in Phase III Study for Mazdutide
China-based Innovent Biologics, Inc. (HKG: 1801) has announced that the first patient has been dosed...
Cosunter’s COVID-19 Drug GST-HG171 Shows Superior Efficacy in Trial
China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced positive results from an investigator-initiated...
Fosun Foundation Donates COVID-19 Therapy Azvudine to Rural China
The Fosun Foundation, Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), and Henan...
Roche’s Glofitamab and Dizal’s Sunvozertinib Enter Priority Review
The Center for Drug Evaluation (CDE) website indicates that Swiss giant Roche’s (SWX: ROG) glofitamab...
Adagene’s ADG126 Shows Promise in Combination with Anti-PD-1 Therapy
China-based biotech Adagene Inc. (NASDAQ: ADAG), which also operates out of San Diego, California, has...
Jiangxi Jemincare’s JMKX003142 Gets FDA Nod for Clinical Study
China-based Jiangxi Jemincare Group has announced receiving approval from the US Food and Drug Administration...
Pfizer’s Paxlovid Excluded from China’s NRDL Amid Price Dispute
The National Reimbursement Drug List (NRDL) negotiations have concluded, with Pfizer’s (NYSE: PFE) COVID-19 therapy...
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...
Suzhou Thery’s Generic Nilotinib Approved by China’s NMPA
China-based Suzhou Thery Pharmaceutical Inc. has announced that the National Medical Products Administration (NMPA) has...
Zhifei Biological Products’ BCG Vaccine Filing Accepted by China’s NMPA
China-based Chongqing Zhifei Biological Products Co., Ltd (SHE: 300122) has announced that its clinical trial...
Yantai Dongcheng Pharma Gets FDA Go-Ahead for 177Lu-LNC1004 Clinical Trial
China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced receiving approval from the...
Hainan Poly Pharm’s Generic Ganciclovir Approved in Denmark
China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced receiving marketing approval from the...
Jacobio Pharma Doses First Patient in US Phase I/IIa Study for JAB-2485
China-based Jacobio Pharma (HKG: 1167) has announced that the first patient has been dosed in...