China’s CDE has told drugmakers to communicate more with them and will offer guidance for breakthrough therapy applications.
Suzhou biotech MediLink Therapeutics has closed a $70 million Series B round to support the clinical development of new-generation ADCs. More news from Nutshell Therapeutics, Yuesai Bio, Hansoh Pharma, Sobi, CStone, the NMPA and the CDE.
The CDE issued a new batch of guidelines that covers the subjects, primary endpoints and design of clinical trials for COVID-19 drugs. The move came six days after the NMPA granted conditional approval for Pfizer's Paxlovid.
Vaccine developer Hualan Biological Bacterin raised RMB 2.28 billion ($400 million) on the ChiNext market on the Shenzhen Stock Exchange on Feb. 18. More news from Kexing, Starmab, Jigene, Haihe Pharma, Carsgen Therapeutics, Immune-Onc Therapeutics, Dizal Pharmaceutical, CDE and NHC.
Innovent Biologics said its IBI306, a recombinant full-human anti-PCSK-9 monoclonal antibody, met primary endpoint in two Chinese registration studies in non-familiar hypercholesterolemia (non-FH) patients at high or very high cardiovascular risk as well as in patients with hypercholesterolemia. More news from RemeGen and the CDE.
Clover Biopharmaceuticals is conducting trials to evaluate its COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum), as a universal COVID-19 booster vaccine.
Leap Therapeutics' anti-DKK1 antibody in combination with BeiGene's anti-PD-1 antibody demonstrated clinical activity in both first- and second-line advanced gastric or gastroesophageal junction cancer patients. More news from Eluminex Bio, CTTQ, Neurophth, BeiGene and the CDE.
Incubated by Legend Capital, Binhu Biotech said it has raised nearly RMB200 million to develop universal cell and gene therapies for oncology, autoimmune diseases, and genetic diseases, and more news from Xellsmart, Youcare, BeiGene, CANbridge, Eli Lilly, JW Therapeutics and Chinese regulators.