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.