China's first successful anti-cancer drug Baiyueze was approved locally

　　my country's first successful anti-cancer drug Baiyueze was approved

　　Science and Technology Daily News (Reporter Fu Lili) Recently, the reporter learned from BeiGene (Beijing) Biological Technology Co., Ltd. (hereinafter referred to as BeiGene) that the new generation of Bruton's tyrosine kinase independently developed by the company ( BTK inhibitor Baiyueze (Zebutinib capsule) was approved by the State Drug Administration on June 3, becoming the first domestic BTK inhibitor to be marketed in China, and it is expected that Chinese patients will be able to use it within a few weeks. This is another important milestone in the local and global commercialization process of Baekje China after its successful listing in the United States.

　　Dr. Wang Lai, senior vice president of BeiGene and head of global research and Asia-Pacific clinical development, introduced that Baiyueze is a new powerful inhibitor targeting BTK, which is mainly used to treat at least one treatment in the past Adult mantle cell lymphoma (MCL) and adult chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma patients. Compared with the first-generation BTK inhibitor, after the optimization of molecular structure, it is more "specific", that is, better target selectivity and better safety; at the same time, it is also more "long-term", complete and lasting The BTK inhibitory effect has better efficacy. In November 2019, Baiyueze was approved by the US Food and Drug Administration (FDA), becoming my country's first domestically approved anti-cancer drug to be developed in the United States, and achieved a breakthrough in the localization of new drugs.

　　It is understood that Baiyueze's approval for two indications in China is mainly based on data from two key clinical studies. Li Jianyong, director of the Department of Hematology of the First Affiliated Hospital of Nanjing Medical University and director of the Pukou Slow Lymphatic Center, who led one of the clinical studies, said that chronic lymphocytic leukemia is a type of lymphoma that is highly prevalent and relatively slow in the elderly. Safety and tolerance are important considerations. The approval of Baiyueze will provide an important treatment plan for patients with chronic lymphocytic leukemia in China. It also achieves good safety and tolerability, and the risk of atrial fibrillation and bleeding is very low.

　　In the past, due to the lack of effective treatment options, patients with lymphoma have long faced the dilemma of difficult and expensive medication. In this regard, Dr. Wu Xiaobin, general manager and president of Beiji China, said that as a local research and development and an internationally recognized high-quality new drug, I believe it will help patients in China with higher accessibility and affordability. . Next, I hope to promote Baiyueze to be included in my country's medical insurance catalogue as soon as possible, so as to bring well-being to domestic patients.