Tokyo-headquartered Otsuka Pharmaceutical Co. Ltd. said Aug. 1 that it will acquire Boston-based Jnana Therapeutics Inc. through a potential $1.125 billion M&A deal. Under the terms, Otsuka will work to close the transaction by the third quarter of 2024, with $800 million paid out to Jnana shareholders, along with up to $325 million in additional development and regulatory milestones payments.
Three Chinese biopharmaceuticals have filed for IPOs on the Hong Kong exchange in July alone, highlighting a potential “newfound positivity” to strengthen the HKEX IPO market in the second half of 2024.
Gan & Lee Pharmaceuticals’ long-acting GLP-1 receptor agonist (GLP-1 RA), GZR-18, achieved as much as 17.29% weight loss in a phase IIb trial in obese and overweight Chinese patients. Developed independently by Shanghai-based Gan & Lee, GZR-18 is a once-weekly or potentially biweekly GLP-1 RA being developed to treat adults with type 2 diabetes and for weight management for obese or overweight patients.
Innovent Biologics Inc.’s glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, mazdutide, met the primary endpoint and all key secondary endpoints in a phase III type 2 diabetes trial in Chinese adults. “Mazdutide is the first and fastest-developed GLP-1R/GCGR dual agonist in the world, and we are actively promoting the development of mazdutide for weight loss, T2D and other indications,” Lei Qian, Innovent’s vice president of clinical development, said.
Renalys Pharma Inc. completed a ¥6 billion (US$38.199 million) series A round that will enable it to complete a phase III trial for sparsentan for immunoglobulin A nephropathy (IgAN) in Japan. Tokyo-based Renalys in-licensed rights to sparsentan in January 2024 from Travere Therapeutics Inc. to develop the compound in Japan and 13 Asian countries to treat IgAN, a rare kidney disease.
Nonalcoholic steatohepatitis was renamed, for the first time in 34 years, to metabolic dysfunction associated steatohepatitis (MASH), but a name change is far from being the biggest development in the field, according to experts at Bioplus Interphex (BIX) Korea 2024.
Biocity Biopharmaceutics Co. Ltd.’s selective endothelin receptor type A antagonist, SC-0062, met the primary endpoint of reducing proteinuria in a phase II chronic kidney disease trial. The candidate showed a clinically meaningful and statistically significant reduction in proteinuria, with a clear dose-response relationship and good safety profile.
The U.S. FDA has approved the NDA for Sofdra (sofpironium) for treating excessive underarm sweating from Botanix Pharmaceuticals Ltd. The approval was based on two pivotal phase III studies and is approved for those ages 9 and older.
Innovent Biologics Inc.’s glucagon-like peptide-1 receptor and glucagon receptor dual agonist, mazdutide, saw 80% reduction in liver fat content in patients with more than 10% liver fat content in the phase III Glory-1 obesity trial.
Celltrion Inc., of Incheon, South Korea, gained MFDS clearance of Eydenzelt (CT-P42) as a biosimilar referencing Regeneron Pharmaceuticals Inc./Bayer AG’s Eylea (aflibercept) on May 30. The news comes on the heels of the U.S. FDA approving the first Eylea interchangeable biosimilars on May 20.
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