Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as "Lynk Pharmaceuticals") and Formation Bio announced Formation Bio's acquisition of worldwide rights, excluding Greater China, to LNK01006, a next generation central nervous system (CNS)–penetrant highly selective TYK2 inhibitor. The asset will be developed within Formation Bio's newly formed subsidiary Bleecker Bio.

LNK01006 recently received IND clearance from the FDA to initiate first-in-human studies in the US. Formation Bio plans to initiate a Phase 1 study in the first half of 2026, reflecting the company's growing momentum in building a diverse portfolio of high-potential, clinical-stage assets.

LNK01006 is a next-generation, CNS-penetrant allosteric TYK2 inhibitor that combines potent, selective inhibition of TYK2-mediated cytokine signaling with a pharmacologic profile optimized for central immune modulation. Its potential best-in-class selectivity and CNS exposure are designed to regulate immune signaling within the central nervous system, potentially modulating the immune responses implicated in a range of autoimmune and inflammatory diseases. Its unique pharmacologic profile offers optionality to explore indications where central or compartmentalized immune pathways are believed to play a key role.

"This asset represents a prime example of what we call our 'Known In New' strategy of applying validated mechanisms to novel areas of high unmet need," said David Steinberg, Chief Business Officer at Formation Bio. "Leveraging world class human expertise, robust clinical data sets, and homegrown, state-of the-art AI tools, we've developed deeply grounded hypotheses around novel therapeutic applications of clinically derisked asset classes."

Founded by veteran drug hunters from Johnson & Johnson, Merck, and Pfizer, Lynk Pharmaceuticals has established a broad discovery platform in immunology and inflammation. LNK01006 reflects Lynk Pharmaceuticals' medicinal chemistry expertise, incorporating a highly optimized scaffold engineered for target selectivity, metabolic stability, and CNS penetration.

"We are excited to partner with Formation Bio to advance LNK01006 into the clinic," said Zhao-Kui (ZK) Wan, CEO of Lynk Pharmaceuticals. "Formation Bio's experienced clinical development team and AI-enabled capabilities provide the ideal environment to translate this compound's scientific potential into meaningful patient impact."

Under the terms of the agreement, Lynk Pharmaceuticals will receive a minority equity stake in Bleecker Bio, an upfront payment and additional development, regulatory, and commercial milestones totaling up to $605 million US dollars and tiered royalties on potential future sales. Pacific Bridge NY, a New York-based investment fund specializing in supporting companies through late preclinical and clinical development, is a minority co-investor in Bleecker Bio.

Formation Bio acquires and advances high-potential assets, bringing the capital, technology, and development infrastructure needed to move promising programs forward in-house. Its model combines deep therapeutic expertise, dedicated operating teams, and a proprietary AI platform that streamlines everything from asset sourcing to clinical execution – with the ultimate goal of improving development speed, efficiency, and probability of success.