Ascent Pharma's third-generation BCR-ABL inhibitor plans to be included in breakthrough treatment products

Source: Guanlan Pharmaceutical

According to the latest announcement by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China, Yasheng Pharmaceutical's wholly-owned subsidiary, Shunjian Biologics, a new class 1 drug, nectinib tablets (HQP1351, also known as oribatinib), will be included in the breakthrough treatment Variety, the proposed indication is: for the treatment of chronic myelogenous leukemia (CML) patients who are resistant and/or intolerant to first- and second-generation tyrosine kinase inhibitors.

Screenshot source: CDE official website

CML is a rare hematological malignant disease.

Mutations in the kinase region of BCR-ABL are one of the important mechanisms of acquired drug resistance.

According to the announcement issued by Yasheng Pharmaceutical earlier, HQP1351 is China's first three-generation BCR-ABL targeted drug-resistant CML therapy, and has the potential to become a "best-in-class" drug for drug-resistant CML therapy.

According to the Phase 1 clinical progress data released by Ascent Pharmaceuticals at the American Society of Hematology (ASH) annual meeting in 2019, HQP1351 is well tolerated and performed in TKI-resistant CML patients (including patients with T315I mutations) Significant and long-lasting anti-tumor activity.

In October 2020, HQP1351 was included in the priority review and approval program by the CDE as a drug that meets the conditions for approval.

Screenshot source: CDE official website

This time HQP1351 is planned to be included in the CDE breakthrough treatment product, which means that the product is expected to receive another special review channel of NMPA.