Dianthus Therapeutics Inks $1 Billion Deal with China's Leads Biolabs for Autoimmune Asset

Dianthus Therapeutics has entered into a licensing agreement with Nanjing Leads Biolabs, offering up to $1 billion for the rights to a novel bispecific antibody targeting autoimmune disorders. The deal marks a significant move in the autoimmune disease space and underscores the growing importance of international collaborations in drug development.

Deal Structure and Financial Terms

Under the terms of the agreement, Dianthus will pay Leads Biolabs an initial $30 million in upfront cash and near-term milestones. An additional $8 million milestone payment is tied to the initiation of a Dianthus-led phase 1 study. The deal structure includes the potential for Leads Biolabs to earn up to $962 million in development, regulatory, and sales-based milestones across multiple indications, as well as tiered royalties.

In exchange, Dianthus gains exclusive rights to develop and commercialize the asset, now known as DNTH212 (formerly LBL-047), in all territories except Greater China. The U.S. biotech views this as a strategic acquisition, with CEO Marino Garcia stating, "We look forward to leveraging the pipeline-in-a-product potential of DNTH212."

DNTH212: A Novel Approach to Autoimmune Disorders

DNTH212 is described as a first-in-class bifunctional BDCA2 and BAFF/APRIL inhibitor with best-in-class potential. The candidate is designed to block two clinically validated pathways known to drive several autoimmune diseases. Dianthus and Leads Biolabs are optimistic that this dual mechanism of action will improve clinical benefits while offering the convenience of subcutaneous self-administration with infrequent dosing.

The companies have identified multiple potential indications for DNTH212, including Sjögren's syndrome, systemic lupus erythematosus (SLE), dermatomyositis, hidradenitis suppurativa, scleroderma, and pemphigus vulgaris. A two-part phase 1 study in China, set to begin by the end of 2025, will recruit both healthy participants and patients with SLE. Topline results from the healthy volunteer portion are expected in the second half of 2026.

Strategic Implications and Market Outlook

This deal significantly bolsters Dianthus's position in the competitive autoimmune landscape. Analysts at William Blair noted, "Overall, we view the deal, albeit early, as bolstering Dianthus's emerging best-in-class positioning among the competitive autoimmune landscape for minimal impact to the balance sheet."

The acquisition of DNTH212 complements Dianthus's existing pipeline, which includes claseprubart, an antibody targeting generalized myasthenia gravis. Claseprubart recently demonstrated positive results in a phase 2 trial, meeting its primary endpoint for safety and tolerability while also showing efficacy.

For Leads Biolabs, this partnership comes on the heels of their successful Hong Kong stock exchange debut, where they raised $189 million through an initial public offering. The Nanjing-based biotech, founded in 2012, has built a diverse pipeline of 14 candidates, with six currently in clinical trials.

As the pharmaceutical industry continues to seek innovative solutions for autoimmune disorders, collaborations like this between Dianthus and Leads Biolabs highlight the global nature of drug development and the potential for synergistic partnerships to accelerate the path to new treatments.