Formation Bio, a US-based AI-native biopharmaceutical company, signed up with China’s Jiangsu Chia Tai Feng Hai Pharmaceutical Co., Ltd (CTFH) for a license to worldwide rights (excluding Greater China) to FHND5032, an oral, small-molecule miR-124 activator. The molecule, under development for chronic autoimmune diseases, will be housed in a new Formation subsidiary, Kenmare Bio, with plans to initiate clinical development in 2026.

Under the agreement, CTFH will receive an upfront payment, a minority equity stake in Kenmare Bio, and development, regulatory, and commercial milestones totaling up to USD 500 million, as well as royalties on future sales. Financial specifics beyond aggregate milestones and equity interest were not disclosed.

Research context

FHND5032 is designed to activate miR-124, an anti-inflammatory microRNA whose endogenous levels are reduced in multiple inflammatory states. By upregulating this microRNA, the molecule targets key immune drivers of inflammation implicated in chronic autoimmune pathophysiology. The oral, small-molecule nature of FHND5032 may offer convenience advantages over injectable biologics in long-term disease management. The molecule is IND-stage, expected to enter the clinic later this year, with multi-indication potential.

The miR-124 target class has gained some attention in autoimmune inflammatory disease contexts. Notably Abivax’s obefazimod (ABX464), an oral small molecule, reportedly upregulates miR-124 and has produced good efficacy and safety data in Phase III trials in ulcerative colitis; maintenance data and regulatory filings are anticipated.

Formation’s AI-driven business model

Formation is applying an in-licensing model to build an immunology and inflammation portfolio with differentiated mechanisms. The firm applies various AI models and tools to clinical development, from identifying “dark assets” – promising clinical-stage drugs deprioritized by large pharma companies for non-scientific reasons – to applying its proprietary Muse flagship AI agent to eliminate manual bottlenecks of trial setup such as patient recruitment, and automating routine paperwork such as adverse event notifications.

The firm has struck a series of license deals, including with China’s Lynk Pharmaceuticals in 2025 for a CNS-penetrant TYK2 inhibitor, as well as picking up molecules from IMIDomics, Asana BioSciences, and Merck KGaA.