Dianthus Therapeutics Inc. has joined the recent trend of companies licensing therapies in development from China. The company will pay as much as $1 billion to Nanjing Leads Biolabs Co. Ltd. for DNTH-212, a bifunctional BDCA2 and BAFF/APRIL inhibitor to treat autoimmune disorders.
The payment comprises $30 million up front and some near-term milestones, plus an $8 million milestone for getting a phase I study underway. Leads Biolabs is in line to bring in another $962 million in milestones and royalties.
In return, Waltham, Mass., and New York-based Dianthus gets the exclusive development and commercialization rights outside of greater China.
Chinese biotechs are reshaping the U.S. biopharma landscape as in-licensing assets from China offers ways to lower spending. China's cost advantages extend to labor, the supply chain and clinical trials.
Asia contributed nearly 25% of licensing deals to the global market in 2024. While raising money was tough in Asia in 2024, the deal flow was enormous as many Chinese companies out-licensed China rights to multinational companies to keep their pipelines afloat.
In China, Leads Biolabs is developing DNTH-212 as LBL-047. The extended half-life bifunctional fusion protein targets plasmacytoid dendritic cell BDCA2 to lower production of type 1 interferon as it inhibits BAFF/APRIL to suppress B-cell function.
A phase I trial in China, composed of healthy volunteers and also those with systemic lupus erythematosus, is anticipated by the companies to begin before year-end. Top-line data from the healthy volunteers portion is expected sometime in the second half of 2026.
Marino Garcia, CEO, Dianthus Dianthus said it ultimately expects to administer the drug from a prefilled syringe but ideally an auto-injector will allow patients to self-administer, CEO Marino Garcia told investors on an Oct. 16 conference call.
“And our goal is at a minimum every four weeks and potentially less frequent than that,” Garcia said. “That's the goal we have set for our team, and the goal I fully expect we'll achieve.”
He hinted that the treatment targets may include IGA nephropathy and Sjogren's disease. As for keeping the exact indications broad and relatively vague, Garcia said, “there are so many indications and we could have added quite a few more to that list.” Dianthus has a prioritized list of indications in mind, he added, “but for competitive reasons we just don't want to reveal them just now.”
Founded in 2012, Leads’ lead product is LBL-024, a registrational-stage PD-L1/4-1BB dual-targeting bispecific antibody being developed for treating advanced extrapulmonary neuroendocrine carcinoma as a third-line-plus monotherapy or first-line combination therapy. Thirteen other candidates are in the pipeline, including five clinical candidates and eight preclinical-stage candidates. Its anti-GPRC53/CD3 bispecific antibody, LBL-034, for advanced multiple myeloma has IND clearance in both the U.S. and China.
Dianthus – the name is associated with the Greek god Zeus – refers to a genus of flowering plants, which includes carnations. The company was founded in 2019 by seed investors Tellus Bioventures and Fairmount.
Dianthus’ $100 million series A funding in May 2022 was led by 5AM Ventures, Avidity Partners and Fidelity Management & Research Co. Other participants included Wedbush Healthcare Partners, as well as founding investors Fairmount, Tellus and Venrock Healthcare Capital Partners.
Chairman Lonnie Moulder, of Tellus, and board director Tomas Kiselak, of Fairmount, reviewed the broad field of complement modulation and consulted with key experts as they developed the ideas that underpin the young company.
Dianthus stock (NASDAQ:DNTH) popped about 10% upward before the market opened but settled to a loss of a half of a percentage point on Oct. 16, with shares closing at $36 each.
Leads Biolabs stock (HKEX:9887) also was quiet on the day, closing 1.1% downward at HK$66.25 on Oct. 16.
