In a crowded thyroid eye disease (TED) space, Innovent Biologics Inc. reported positive late-stage findings for its TED therapy, IBI-311, spurring the Suzhou, China-based biopharma to file for regulatory approval in China.
Innovent Biologics Inc. said its glucagon-like peptide-1 receptor and glucagon receptor dual agonist, mazdutide, met the primary endpoints and all key secondary endpoints in its first phase III trial in Chinese adults who were overweight or obese. The company plans to submit the first mazdutide NDA for weight management to China's NMPA shortly.
Innovent Biologics Inc. and Sanegene Bio USA Inc. (Sanegenebio) have announced they have entered into a collaboration agreement to co-develop SGB-3908, an siRNA drug candidate targeting angiotensinogen (AGT) for the treatment of hypertension.
In less than one week, Innovent Biologics Inc. has seen two NDAs for non-small-cell lung cancer accepted for review by China’s National Medical Products Administration, and both are firsts for China. The NDA for IBI-351 under priority review marks China’s first NDA for a KRAS G12C inhibitor, and the NDA for taletrectinib is the first global submission for the ROS1 inhibitor.
In less than one week, Innovent Biologics Inc. has seen two NDAs for non-small-cell lung cancer accepted for review by China’s National Medical Products Administration, and both are firsts for China. The NDA for IBI-351 under priority review marks China’s first NDA for a KRAS G12C inhibitor, and the NDA for taletrectinib is the first global submission for the ROS1 inhibitor.
“Why do the top 10 pharmaceutical companies remain in the top 10?” asked Li Chen, founder and CEO of Hua Medicine, to audience members at the Chinabio Partnering Forum in Shanghai on Sept. 20. “[It comes down to] their ability to innovate themselves, but also the capability to acquire technology from partnerships, [to] manufacture and sell in countries like the U.S."
“Why do the top 10 pharmaceutical companies remain in the top 10?” asked Li Chen, founder and CEO of Hua Medicine, to audience members at the Chinabio Partnering Forum in Shanghai on Sept. 20. “[It comes down to] their ability to innovate themselves, but also the capability to acquire technology from partnerships, [to] manufacture and sell in countries like the U.S."
Innovent Biologics Inc. announced a HKD$2.37 billion (US$306 million) placement on the Hong Kong Stock Exchange (HKEX) to advance its late-stage pipeline, including mazdutide, a GLP-1R/GCGR dual agonist for diabetes and obesity. The company plans to offer 68 million new shares priced at HKD$34.92, which represents an 8.8% discount to the previous closing price of HKD$38.30 per share, the company said in a filing on the HKEX. Morgan Stanley is the sole placing agent.
China’s National Medical Products Administration has approved Innovent Biologics Inc.’s proprotein convertase subtilisin/kexin-type 9 (PCSK9) inhibitor, Sintbilo (tafolecimab), making it the first first locally developed PCSK9 monoclonal antibody to be approved in China.
China’s National Medical Products Administration has approved Innovent Biologics Inc.’s proprotein convertase subtilisin/kexin-type 9 (PCSK9) inhibitor, Sintbilo (tafolecimab), making it the first first locally developed PCSK9 monoclonal antibody to be approved in China. The approval is for treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia (abnormal lipid levels). Tafolecimab marks Innovent's first cardiovascular drug as well as the company’s 10th approval.