On November 9,2022, according to the NMPA's official website, the National Drug Administration conditionally approved the first class of innovative drug tablet (trade name: Intaari) declared by Shanghai Yingli Pharmaceutical Co., Ltd. through the priority review and approval process. This drug is an innovative drug independently developed in China and with independent intellectual property rights. It is suitable for adult patients with relapsed or refractory follicular lymphoma who have received at least two previous systemic treatments.
The approval was mainly based on the positive results of a clinical study called YY-20394-002. This study (NCT04370405) is a single-arm, open-label, multi-center phase II clinical trial designed to evaluate the safety, tolerability, and efficacy of limprixer in patients with relapsed and / or refractory follicular lymphoma. A total of 93 patients with relapsed and / or refractory follicular lymphoma who had progressed after second or above systemic systemic therapy (with meruvarab and at least one alkylating agent) were included in this study.
The results showed that the objective response rate (ORR) (DCR) and 95% in 89 patients (evaluable cases), and that oral administration was safe, controllable and well tolerated. The incidence of common gastrointestinal adverse reactions such as nausea and similar drugs, such as diarrhea and hepatotoxicity, is lower than that reported in the literature for the same target drugs.
