Lynk Pharmaceuticals' Partner Formation Bio Doses First Participant in Phase 1 Trial of BLKR201 (originally designated as LNK01006), a CNS-Penetrant TYK2 Inhibitor

HANGZHOU, China, SHANGHAI and BOSTON, June 9, 2026 /PRNewswire/ -- Lynk Pharmaceuticals Co., Ltd. ("Lynk Pharmaceuticals"), a clinical-stage innovative drug development company focused on autoimmune and inflammatory diseases, today announced a significant clinical milestone achieved by its global partner, Formation Bio. 

Formation Bio announced the dosing of the first participant in a Phase 1, first-in-human clinical trial (BLKR201-101-HV) evaluating BLKR201 (originally designated as LNK01006). The study is a single ascending dose (SAD) and multiple ascending dose (MAD) trial conducted in healthy volunteers, with data readout expected in early 2027.

BLKR201 / LNK01006 is a novel, selective CNS-penetrant allosteric TYK2 inhibitor designed to regulate immune signaling within the central nervous system. TYK2 is a validated target, and the CNS exposure and high target selectivity of this compound may open up opportunities in a range of neural, autoimmune, and inflammatory conditions. This compound reflects Lynk Pharmaceuticals' medicinal chemistry expertise, incorporating a highly optimized scaffold engineered for target selectivity, metabolic stability, and CNS penetration.

Dr. Zhao-Kui (ZK) Wan, Founder, Chairman and Chief Executive Officer of Lynk Pharmaceuticals, said, "This milestone marks an important step forward in the global development of BLKR201. This swift progression is an important step in evaluating the clinical potential of our discovery and underscores the power of Formation Bio's accelerated development model. We look forward to their continued progress as they advance this promising asset, expand the therapeutic opportunities, and address unmet needs across broad patient populations."

In December 2025, Lynk Pharmaceuticals entered into an exclusive development and licensing agreement with Formation Bio's subsidiary Bleecker Bio for LNK01006 outside Greater China. Under the terms of the agreement, Lynk Pharmaceuticals received a minority equity stake in Bleecker Bio, an upfront payment, and is eligible for additional development, regulatory, and commercial milestones totaling up to $605 million, plus tiered royalties on potential future sales.

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 Lynk Pharmaceuticals

Lynk Pharmaceuticals is a clinical-stage innovative drug company focused on autoimmune and inflammatory diseases, committed to addressing unmet clinical needs through first-in-class innovation, developing differentiated small-molecule therapies, and providing superior oral alternatives to biologics. The company was founded by senior R&D leaders from Pfizer, MSD, and Johnson & Johnson, focusing on the JAK-STAT and expanding to TYK2 signaling pathways, and mastering targeted protein degradation.

The company combines AI-assisted drug design, comprehensive biological evaluation, and protein degradation technologies into an integrated innovative R&D platform spanning target discovery, molecular design, translational research, and clinical development to advance differentiated therapies for patients worldwide. To date, Lynk Pharmaceuticals has successfully developed and progressed multiple Class 1 new drug candidates and advanced multiple pipeline programs through internal research and development as well as global partnerships.

Forward-Looking Statements

This press release contains forward-looking statements regarding the BLKR201-101-HV Phase 1 trial, the anticipated data readout, and Lynk Pharmaceuticals' partnerships, which are subject to risks and uncertainties relating to clinical trial conduct and results, regulatory approvals, and partner performance. Actual results may differ, and Lynk Pharmaceuticals undertakes no obligation to update these statements except as required by law.

SOURCE Lynk Pharmaceuticals Co., Ltd.