Lynk Pharmaceuticals Co., Ltd

The freshly inked deal follows another Formation pact worth more than $600 million biobucks for ex-China rights to an immunology asset.\n AI-fueled Formation Bio has inked another licensing deal for a China asset, this time picking up an oral small molecule designed to treat autoimmune disease in a deal worth up to $500 million biobucks.The deal is between Formation Bio’s freshly created subsidiary Kenmare Bio and Jiangsu Chia Tai Feng Hai Pharmaceutical, according to a Jan. 29 release.Under the terms of the agreement, Formation’s subsidiary will gain global rights—excluding Greater China—to a miR-124 activator, FHND5032, for the treatment of autoimmune conditions. While the deal didn’t disclose indication specifics, the asset has been studied in preclinical models for ulcerative colitis.In exchange, Chia Tai Feng Hai is collecting a minority equity stake in Kenmare. The pharmaceutical also will receive an undisclosed upfront payment and has the chance to collect milestone payments in a deal worth up to $500 million US dollars, plus royalties.Under Formation’s wing, the small molecule is set to enter in-human trials this year. The company will use its AI-driven clinical development platform, dubbed Forge, to speed up the process “in a range of autoimmune diseases,” according to the company.FHND5032 is designed to switch on miR-124, an anti-inflammatory microRNA that is found at lower levels in several inflammatory diseases. The asset could possibly be used for durable control of chronic autoimmune diseases, according to the two companies, while the candidate’s oral administration is designed to boost convenience for patients.  “FHND5032 is exactly the type of high-potential program we built Formation Bio to accelerate,” Formation’s Chief Business Officer David Steinberg said in a statement. “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,” the CBO added.Formation is a member of the Fierce 15 class of 2025, honored for its use of AI to clear up the clinical trial bottleneck and make studies more affordable. The company’s model is to license candidates that range from clinic-ready to having proof-of-concept data.Since raising a Sanofi-backed $372 million series D in 2024, Formation has been on the hunt for new assets worth licensing and spinning out new companies to carry forward development. Just last month, the AI company penned a deal worth more than $600 million biobucks for ex-China rights to a next-gen immunology asset from Lynk Pharmaceuticals. The program is now being developed by Formation’s new subsidiary, Bleecker Bio.In a deal extremely similar to today’s, China-based Lynk also gained a minority equity stake in the Formation subsidiary.As for Chia Tai Feng Hai, the company is owned by parent company Sino Biopharmaceutical, a large Chinese pharma based in Hong Kong. In July, Sino inked a deal worth up to $951 million to acquire Chinese compatriot LaNova Medicines to get in on the PD-1xVEGF action.  

Formation Bio on Thursday snagged ex-China rights to an autoimmune disease asset from Jiangsu Chia Tai Feng Hai Pharmaceutical (CTFH), its third licensing deal in six months, and its second sourced from China. The company uses AI to identify promising assets, design an efficient development strategy for each candidate, and speed them through clinical testing. Its latest find, FHND5032, is an oral small molecule activator of miR-124, an anti-inflammatory microRNA that's suppressed in several inflammatory diseases. By activating the target, FHND5032 is designed to "provide durable control" over chronic autoimmune diseases."FHND5032 is exactly the type of high-potential programme we built Formation Bio to accelerate," said David Steinberg, Formation's chief business officer. "With few miR-124 activators in development globally, we see an exciting opportunity to bring a differentiated treatment to patients who need better options."FHND5032, slated to enter the clinic this year, will be housed in a subsidiary of Formation dubbed Kenmare Bio. CTFH will receive a minority equity stake in Kenmare, along with an upfront payment plus development, regulatory and commercial milestones worth in total up to $500 million dollars; it's also eligible for royalties.Thursday's agreement marks a rapid dealmaking pace for Formation. In December, the company licensed LNK01006, a TYK2 inhibitor, from Chinese firm Lynk Pharmaceuticals; it expects to start a Phase I autoimmune disease study this half. The biotech also gained rights to anti-CD226 mAb RVW101 from IMIDomics last July, with plans to study the asset in ulcerative colitis.China heats upFormation's latest tie-up backs the prediction made by many of the pharma execs and investors FirstWord spoke with at the JP Morgan Healthcare Conference (JPM) — that China would continue to be a hotbed for deal activity in 2026 (see – Today at JPM: China's continuing biotech boom).Given the comparative absence of regulatory roadblocks and cost-savings of conducting clinical research in China — last year, the country surpassed the US in new clinical trial starts and drug approvals — the region is quickly becoming one that industry "cannot ignore." And data suggest that pharma certainly isn't ignorant to the opportunities in China. A recent FirstWord analysis found that in 2025, nearly a quarter of significant licensing deals by major pharma targeted assets from China, up from about 16% the year prior (see – Vital Signs: Charting China's course westward into 2026).Chinese firms also stole the dealmaking spotlight at JPM. A pair of rumoured takeouts for Western biotechs Revolution Medicines and Abivax did not come to fruition; instead, 2026's conference saw AbbVie license RemeGen's PD-1/VEGF-targeted bispecific antibody for $650 million upfront, while Roche paid $570 million upfront for rights to an antibody-drug conjugate from MediLink Therapeutics.Notably, Abivax holds the most advanced miR-124–targeting programme in the clinic. Last year, its oral miR-124 enhancer obefazimod met the primary endpoint in a pair of pivotal Phase III ulcerative colitis studies. While Formation's miR-124 asset is much further behind in development, it also gained FHND5032 for far less than the €15 billion ($17.5 billion) Eli Lilly was reportedly contemplating spending to buy Abivax.

The availability of other JAK1 inhibitors means zemprocitinib will face tough competition if the drug makes it to market.\n A phase 3 rheumatoid arthritis trial of Lynk Pharmaceuticals’ JAK1 inhibitor in China has hit its primary endpoint, boosting the prospects of a candidate designed to avoid the adverse events caused by existing drugs.JAK1 inhibitors such as AbbVie’s Rinvoq have improved outcomes in rheumatoid arthritis and a range of other indications, racking up blockbuster sales in the process. But the drug mechanism is associated with safety and tolerability problems—including increased risk of infection, cardiovascular events and death—that have led the FDA to slap boxed warnings on product labels.Lynk designed zemprocitinib, also called LNK01001, to have higher selectivity and better safety than the existing options. The biotech put its hypothesis to the test in a phase 3 trial that compared zemprocitinib to placebo in patients with moderate to severe active rheumatoid arthritis in China. After 24 weeks of twice-daily oral dosing, 79.1% of people taking zemprocitinib met the ACR20 criteria, indicating they had at least a 20% improvement on a composite measure of disease severity. With 39.7% of people on placebo meeting the criteria, the study achieved its primary endpoint.  Lynk reported a significant difference in ACR20 at Week 12, and in ACR50—which requires at least a 50% improvement on the composite measure—at weeks 12 and 24. Significant improvements in DAS28, a measure of disease severity, rounded out the dataset.The availability of other JAK1 inhibitors means zemprocitinib will face tougher competitors than placebo when physicians evaluate whether to use the molecule in the real world. With the study lacking an active control arm, and cross-trial comparisons being potentially unreliable, it is unclear exactly how Lynk’s candidate is shaping up versus the competition. But the available data suggest the asset has promise. Lynk enrolled patients on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (DMARDs). An inadequate response or intolerance to biologic DMARDs was an enrollment requirement. AbbVie reported (PDF) an ACR20 of 65% for Rinvoq at Week 12 in a phase 3 trial that gave background DMARDs to patients failed by biologics. In Lynk\'s trial, most treatment-emergent adverse events were mild to moderate in severity, and the incidence of serious adverse events was comparable between the zemprocitinib and placebo groups. The biotech saw no new safety signals. Earlier trials reported no major adverse cardiovascular events, blood clots, serious infections or formations of malignant tumors, a set of safety issues linked to Rinvoq. Simcere partnered with Lynk to commercialize zemprocitinib in greater China in 2022. When Lynk filed (PDF) to go public in Hong Kong last November, the company said it planned to file for approval in rheumatoid arthritis in the second half of 2026. A filing for approval in atopic dermatitis, an indication not covered by the deal with Simcere, is planned for the first half of the year. Lynk has the rights to all indications outside China. The biotech offloaded the ex-China rights to another asset, an allosteric TYK2 inhibitor, to Formation Bio last month in a deal worth more than $600 million in biobucks.