生产企业：Lupeng Pharmaceutical Ltd, Guangzhou Lupeng Pharmaceutical Co., Ltd.，另有 1 家
Rocbrutinib (LP-168) is a fourth-generation, orally available Bruton's tyrosine kinase (BTK) inhibitor with a dual covalent and non-covalent binding mechanism, developed by Lupeng Pharmaceutical. It was granted accelerated approval by China's NMPA in June 2026 for relapsed/refractory mantle cell lymphoma (R/R MCL) in patients who have received at least two prior systemic therapies including BTK inhibitors. It is engineered to overcome resistance mutations including C481X, T474X, and L528W. In a Phase II trial in drug-resistant lymphoma patients, rocbrutinib demonstrated an ORR of 63.9%, a CR of 23%, and a median DOR of 16.5 months. A global Phase 3 head-to-head trial (ROCKET-CLL) against pirtobrutinib in R/R CLL/SLL is underway.
Rocbrutinib (LP-168) is a fourth-generation, orally available Bruton's tyrosine kinase (BTK) inhibitor with a dual covalent and non-covalent binding mechanism, developed by Lupeng Pharmaceutical. It was granted accelerated approval by China's NMPA in June 2026 for relapsed/refractory mantle cell lymphoma (R/R MCL) in patients who have received at least two prior systemic therapies including BTK inhibitors. It is engineered to overcome resistance mutations including C481X, T474X, and L528W. In a Phase II trial in drug-resistant lymphoma patients, rocbrutinib demonstrated an ORR of 63.9%, a CR of 23%, and a median DOR of 16.5 months. A global Phase 3 head-to-head trial (ROCKET-CLL) against pirtobrutinib in R/R CLL/SLL is underway.
Rocbrutinib (LP-168) is a novel, orally available, highly selective fourth-generation Bruton's tyrosine kinase (BTK) inhibitor. It is engineered to combine covalent (irreversible) and non-covalent (reversible) binding, enabling inhibition of both wild-type and C481-mutant BTK and overcoming multiple resistance mutations, including C481X, T474X, and L528W. This dual mechanism was developed on Lupeng's proprietary BeyondX Oral MedChem Platform.
In China, rocbrutinib received accelerated approval from the NMPA for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (R/R MCL) who have received at least two prior systemic therapies, including BTK inhibitors. Additionally, rocbrutinib has received Breakthrough Therapy Designation (BTD) in China for adult patients with relapsed or refractory non-germinal center B-cell-like diffuse large B-cell lymphoma (R/R non-GCB DLBCL) who have received at least two prior lines of therapy. Clinical development is also ongoing for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
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