Simcere Pharmaceutical is paying Connect Biopharma $21 million upfront and offering up to $120 million in biobucks for the right to develop and commercialize Connect’s monoclonal antibody (mAb) to treat certain inflammatory diseases in Greater China.
The exclusive licensing deal gives China-based Simcere rights to rademikibart—a mAb that targets IL-4Rα for the treatment of Th2-driven inflammatory diseases—in all indications in mainland China, Hong Kong, Macau and Taiwan.
Under the agreement, California-based Connect will wrap up rademikibart’s ongoing China clinical trials in atopic dermatitis (eczema). Simcere will then be responsible for submitting a new drug application in China, a move expected by the end of the first quarter of 2024, according to a Nov. 21 news release.
In a separate release, Connect shared long-term data from the pivotal trial being conducted in China for patients with moderate to severe eczema. The 52-week follow-up built on initial 16-week results, which met the primary efficacy and safety goals of the trial, and showed that the majority of initial responders to the mAb maintained their response, according to Connect.
Simcere will now be responsible for all future clinical studies in any additional disease indications for rademikibart in Greater China, while Connect will keep the right to develop and commercialize the antibody in all other markets.
Connect, and now partner Simcere, hope rademikibart can provide patients with eczema a treatment that has convenient dosing and improved sustained efficacy.