Formation Bio Licenses miR-124 Activator for Autoimmune Diseases from CTFH

Acquisition adds a differentiated, oral, IND-stage asset with multi-indication potential to Formation Bio's rapidly growing portfolio

NEW YORK, Jan. 29, 2026 /PRNewswire/ -- Formation Bio and Jiangsu Chia Tai Feng Hai Pharmaceutical Co., LTD. (CTFH) today announced Formation Bio's acquisition of worldwide rights, excluding Greater China, to FHND5032, an oral, small-molecule miR-124 activator being developed for the treatment of  autoimmune diseases.

The asset will be housed within Formation's newly formed subsidiary Kenmare Bio, with plans to enter the clinic in 2026.

FHND5032 is designed to activate miR-124, an anti-inflammatory microRNA whose levels are reduced in multiple inflammatory diseases. By activating miR-124, FHND5032 targets key immune drivers of inflammation, with the potential to provide durable control of chronic autoimmune diseases, an area of substantial unmet medical need. Its oral formulation may offer patients a more convenient approach to long-term disease management.

"FHND5032 is exactly the type of high-potential program we built Formation Bio to accelerate," said David Steinberg, Chief Business Officer of Formation Bio. "The miR-124 mechanism has been clinically derisked through Phase 3 data in IBD, and holds broad potential across several chronic inflammatory diseases as a safe, oral therapy. With few miR-124 activators in development globally, we see an exciting opportunity to bring a differentiated treatment to patients who need better options. We are looking forward to partnering with CTFH to make that happen."

Formation Bio is utilizing its proprietary AI-driven clinical development platform, Forge, to fast-track and optimize the development of FHND5032 in a range of autoimmune diseases. Forge analyzes precedent data and regulatory guidance to inform indication selection and biomarker identification, outlining the optimal development strategy. "Many patients with autoimmune diseases face significant challenges in obtaining safe, efficacious and convenient medicines," said Benjamine Liu, co-founder and CEO of Formation Bio. "FHND5032 offers a promising new approach by addressing multiple pathophysiological pathways driving autoimmune disease. We are excited about using our AI enabled trial design and implementation capabilities to unlock the broad potential of the miR-124 mechanism in a range of autoimmune indications".

"We are pleased to partner with Formation Bio on the continued development of FHND5032," said Junyi Wang, Head of Global Business Development of CTFH. "FHND5032 is a well-characterized molecule with a compelling preclinical profile and strong translational rationale. Formation's US-based clinical development capabilities, advanced AI tools, and team with deep drug development expertise make them an ideal partner to realize the full potential of FHND5032 for patients around the world."

Under the terms of the agreement, CTFH will receive a minority equity stake in Kenmare Bio, plus an upfront payment and additional development, regulatory, and commercial milestones totaling up to $500 million US dollars, as well as royalties on potential future sales. The acquisition adds to Formation Bio's growing pipeline of assets.

About Formation Bio
Formation Bio is an AI-native pharma company differentiated by radically more efficient drug development. Formation Bio has built technology and AI platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies and biotechs to develop programs past clinical proof of concept and beyond, leveraging their proprietary tech and AI capabilities, ultimately helping to bring new medicines to patients.

About CTFH
Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. (CTFH) is an integrated pharmaceutical company with capabilities in R&D, manufacturing, and commercialization. CTFH's innovation-driven R&D focuses on oncology, autoimmune and neurology. The company has established a growing pipeline of differentiated small molecules spanning both first-in-class (FIC) and best-in-class (BIC) programs, supported by advanced AI-based R&D technologies and experienced drug development team, with the goal of delivering meaningful therapies to patients worldwide.

Contact Info
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SOURCE Formation Bio