Ibrutinib tablets receiving drug registration certificate is considered equivalent to passing the consistency evaluation

August 4, 2026  Source: drugdu 23

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China Securities Intelligent Finance Huabang Health(002004) announced on the evening of July 31 that its wholly-owned subsidiary, Chongqing Huabang Pharmaceutical Co., Ltd., recently received the Drug Registration Certificate for Ibrutinib tablets issued by the National Medical Products Administration. The specifications are 0.14g and 420mg, and the registration category is Class 3 chemical drug, which is regarded as passing the consistency evaluation of generic drug quality and efficacy.
The announcement indicates that this drug is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy; patients with chronic lymphocytic leukemia/small lymphocytic lymphoma; patients with Waldenström macroglobulinemia who have received at least one prior therapy, or those who are unsuitable for chemoimmunotherapy .This product is a first-line treatment for patients with Waldenström macroglobulinemia; when used in combination with rituximab, it is suitable for the treatment of patients with Waldenström macroglobulinemia.
The company stated that the official approval of this product will further enrich its product pipeline in the anti-tumor field, providing clinical patients with more high-quality medication options. The company noted that it will resume production and sales as soon as possible after the patent for ibrutinib tablets expires.

https://finance.eastmoney.com/a/202607313828719169.html

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