Lupeng：Rocbrutinib received marketing approval

Lupeng Pharmaceutical’s BTK inhibitor Rocbrutinib granted priority review and conditional approval.

Rocbrutinib is the world’s first fourth-generation BTK inhibitor with a dual covalent and non-covalent binding mechanism. It was developed by Lupeng Pharmaceutical using its proprietary BeyondX® platform and is specifically designed to overcome resistance to BTK inhibitors. It has the potential to become a best-in-class (BIC) therapy.

Compared with first-generation BTK inhibitors, Rocbrutinib achieves a mechanism upgrade: it binds covalently to wild-type BTK and reversibly to resistance mutations such as C481S/F/R, while also irreversibly targeting the T474I gatekeeper mutation. This comprehensively overcomes drug resistance, with higher potency and greater selectivity. The currently approved indication is for adult patients with relapsed or refractory mantle cell lymphoma (R/R MCL) who have previously received BTK inhibitor therapy.

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