Hua Medicine Ltd. has received marketing approval from China's NMPA for its glucokinase activator (GKA), Huatangning (dorzagliatin tablets), for two indications: as a monotherapy to improve blood glucose control for drug-naïve type 2 diabetes patients and in combination with metformin in metformin-tolerated type 2 diabetes patients to control blood glucose level. It marks the first GKA drug to gain approval in any market, according to Hua.
Jilin Huisheng Biopharmaceutical Co. Ltd., a non-wholly owned subsidiary of Sihuan Pharmaceutical Holdings Group Ltd., has raised ¥500 million (US$70 million) in a series A round. Huisheng, which has developed a pipeline of programs addressing both diabetes and its complications, plans to use the new funds to speed up its clinical trials and purchase manufacturing equipment, according to Che Fengsheng, executive director and chairman of Sihuan Pharma.
Hua Medicine Ltd. presented findings from two phase III trials of its first-in-class dual-acting glucokinase activator dorzagliatin that show the drug significantly improved early phase insulin secretion and glucose sensitivity in patients with type 2 diabetes, thereby restoring glucose homeostasis to treat the underlying cause of diabetes.
Shenzhen Chipscreen Biosciences Co. Ltd.’s Bilessglu (chiglitazar), a peroxisome proliferator-activated receptor (PPAR) pan-agonist globally for the treatment of type 2 diabetes mellitus, has received marketing approval from the NMPA in China.
Ushering in a new era for the U.S. biosimilar marketplace, the FDA, on July 28, approved its first interchangeable biosimilar, which also will be the first to bring biosimilar competition to the U.S. insulin space. The honor went to Viatris Inc.’s Semglee, which the FDA recognized as both biosimilar to and interchangeable with Sanofi SA’s Lantus (insulin glargine).
Poxel SA and Sumitomo Dainippon Pharma Co. Ltd. said their first-in-class drug, Twymeeg (imeglimin hydrochloride), won its first approval in Japan, where it could change the treatment regimen for type 2 diabetes.
Scohia Pharma Inc. has secured an agreement with Huadong Medicine Co. Ltd., enabling the former to tap the greater China market for SCO-094, its GLP-1R and GIPR dual agonist.
PERTH, Australia – Australia’s Medical Technologies and Pharmaceuticals Industry Growth Center (MTPConnect) is boosting funding for the translation and commercialization of research in diabetes, cardiovascular disease and regenerative medicine.
HONG KONG – Sanofi SA has finally ended its clinical development of Hanmi Pharmaceutical Co. Ltd.’s efpeglenatide as a type 2 diabetes treatment, and the Korean firm is now considering how to move forward with developing the once-weekly GLP-1 receptor agonist, which employs Hanmi's Lapscovery delivery technology.
An Australian study led by University of Melbourne scientists has identified a previously unknown role for the hepatokine, sparc-related modular calcium-binding protein 1 (SMOC1), in suppressing hepatic glucose production.