Dianthus Therapeutics Licenses DNTH212 for Autoimmune Diseases from Nanjing Leads Biolabs

NEW YORK and WALTHAM, Mass. — October 16, 2025 — Leads & Copy — Dianthus Therapeutics, Inc. (Nasdaq: DNTH) has entered into an exclusive licensing agreement with Nanjing Leads Biolabs Co., Ltd. (“Leads” (9887.HK) for DNTH212 (being developed in China by Leads Biolabs as LBL-047), a first and potentially best-in-class bifunctional BDCA2 and BAFF/APRIL inhibitor.

DNTH212 is a bifunctional fusion protein targeting plasmacytoid dendritic cell (pDC) BDCA2 to reduce Type 1 interferon production, while simultaneously inhibiting BAFF/APRIL to suppress B cell function. The FDA cleared the IND in September 2025 and is expected to clear in China in Q4’25. The Phase 1 study of DNTH212 is expected to initiate in Q4’25 with top-line results in healthy volunteers in 2H’26.

“We are excited to partner with Leads Biolabs and build upon our vision of becoming a leading autoimmune-focused biopharmaceutical company with the addition of DNTH212 to our pipeline,” said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics.

Under the terms of the agreement, Dianthus will pay Leads Biolabs up to $38 million, comprised of $30 million in upfront and near-term milestone payments plus an additional $8 million milestone upon the initiation of a Dianthus-led Phase 1 study, for exclusive rights to develop and commercialize DNTH212 globally outside of Greater China.

Dianthus will have an estimated pro forma cash balance of approximately $525 million following the in-licensing of DNTH212 and reaffirms runway into 2028.

Investor conference call and webcast to be held today at 8:00 a.m. ET.

Contact: Jennifer Davis Ruff, Dianthus Therapeutics, jdavisruff@dianthustx.com

Source: Dianthus Therapeutics, Inc.

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