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

Dianthus Therapeutics has entered into a licensing agreement with Nanjing Leads Biolabs for DNTH212, a novel bispecific antibody targeting autoimmune disorders. The deal, potentially worth up to $1 billion, marks a significant development in the pursuit of innovative treatments for conditions such as Sjögren's syndrome and systemic lupus erythematosus (SLE).

Deal Structure and Financial Terms

Under the terms of the agreement, Dianthus will pay Leads Biolabs $30 million upfront, with an additional $8 million milestone payment tied to the initiation of a Dianthus-led phase 1 study. The Chinese biotech stands to receive 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 DNTH212 outside of Greater China. The U.S. biotech expects to maintain a strong financial position following the deal, with a projected cash runway of $525 million extending into 2028.

DNTH212: A "Pipeline in a Product"

DNTH212, previously known as LBL-047, is described as a first-in-class bifunctional BDCA2 and BAFF/APRIL inhibitor. The asset is designed to block two clinically validated pathways implicated in various autoimmune diseases, potentially offering improved clinical benefits and convenience through subcutaneous self-administration with infrequent dosing.

Dianthus CEO Marino Garcia highlighted the "pipeline-in-a-product potential" of DNTH212, emphasizing its role in the company's vision to become a leading autoimmune-focused biopharmaceutical entity. The candidate shows promise in treating conditions such as Sjögren's syndrome, SLE, dermatomyositis, hidradenitis suppurativa, scleroderma, and pemphigus vulgaris.

Clinical Development and Future Outlook

A two-part phase 1 study for DNTH212 is scheduled to commence in China by the end of 2025, enrolling both healthy volunteers and SLE patients. Topline results from the healthy volunteer cohort are anticipated in the second half of 2026.

Analysts at William Blair view the deal positively, noting that it strengthens Dianthus's position in the competitive autoimmune landscape. They emphasize the unique dual mechanism of DNTH212, which targets both innate and acquired immune inhibition, while highlighting that safety data from the phase 1 trial will be crucial in evaluating the asset's potential.

This licensing agreement adds to Dianthus's growing portfolio, which includes claseprubart, an antibody targeting generalized myasthenia gravis that recently demonstrated positive results in a phase 2 trial. As both companies look to advance their respective pipelines, this collaboration represents a significant step forward in the development of novel autoimmune therapies.