Ibio Inc. has received clinical trial notification (CTN) acknowledgement from Australia’s Therapeutic Goods Administration (TGA), as well as Human Research Ethics Committee approval, for IBIO-600, enabling the initiation of a first-in-human trial in Australia.
Kalohexis LLC has launched as a spin-out from Endevica Bio Inc. with the goal of advancing the clinical development of a portfolio of drug candidates harnessing the melanocortin system for the treatment of metabolic disorders such as obesity and cancer cachexia.
The GLP-1 fight has moved from injectables to pills, and Structure Therapeutics Inc. is in the ring with phase III-ready aleniglipron. According to the Bay Area biotech, its oral once-daily glucagon-like peptide-1 (GLP-1) drug candidate, aleniglipron, demonstrated an absolute weight loss of “up to 39 pounds” in the 44-week Access II trial.
China Medical System Holdings Ltd. has received clinical trial approval from China’s National Medical Products Administration (NMPA) for CMS-D008 injection for overweight or obese individuals.
China’s National Medical Products Administration has accepted for review Jiuyuan Genetic Biopharmaceutical Co. Ltd.’s drug application for Jikeqin, a biosimilar product to Novo Nordisk A/S’s Wegovy (semaglutide) for obesity.
Gubra A/S has announced the submission in Germany of a clinical trial application (CTA) for a first-in-human study of GUB-UCN2, the company’s lead asset for weight loss. The planned phase I/IIa trial will enroll both healthy volunteers and individuals with obesity, with and without related co-morbidities. GUB-UCN2 is expected to enter clinical development in the first half of this year.
China’s National Medical Products Administration has accepted for review Jiuyuan Genetic Biopharmaceutical Co. Ltd.’s drug application for Jikeqin, a biosimilar product to Novo Nordisk A/S’s Wegovy (semaglutide) for obesity.
The U.S. FDA approved Allurion Technologies Inc.’s premarket application for its swallowable gastric balloon system, which features its Smart Capsule, for weight loss. The clearance is boon for the company as GLP-1 agonists gets increasingly adopted to treat obesity. The approval also brings to the market a new non-invasive option to patients looking for alternative ways to lose weight.
CSPC Pharmaceutical Group Ltd. has obtained IND approval from the FDA for SYH-2082 injection, a GLP-1/GIP receptor dual-biased agonist polypeptide long-acting injection for weight management for individuals with obesity or overweight and at least one weight-related comorbidity.
