BeiGene Zebutinib was approved by the FDA! Will it be listed simultaneously in China? !

Today, the first domestic anti-cancer drug approved by FDA is born! This morning, zanubrutinib, a Btk inhibitor in Baiji, was approved by the US FDA as a "breakthrough therapy"! It is used in the treatment of adult mantle cell lymphoma (MCL) It is the only FDA approved Btk inhibitor that can reach a median of 100% in peripheral blood cells; it is also the only Btk inhibitor that can be taken once or twice a day At the same time, this is the first time that the anti-cancer therapy developed in China has been approved by FDA, achieving "zero breakthrough" Zanubrutinib's FDA approval is based on the validity data of two clinical trials, which show that brukinsa produces a total remission rate of 84% in patients participating in both clinical trials (complete and partial remission synthesis; ORR) Brukinsa is a small molecule inhibitor of Burton's tyrosine kinase (Btk) independently developed by scientists in Baiji, China At present, it is carrying out a wide range of key clinical trials in the world, as a single drug and combined with other therapies to treat a variety of B-cell malignant tumors At the same time, it is expected to be approved in China this month According to the data of drug intelligence, in August and October 2018, Baiji Shenzhou successively submitted the listing application of zanubrutinib treatment kit cell lymphoma and chronic lymphocytic leukemia / small lymphocytic lymphoma, and obtained the qualification of priority evaluation and special evaluation by China drug administration, which is expected to be listed in China quickly It is particularly noteworthy that according to the timeline of drug registration of drug intelligence data, the review of domestic Baiji Shenzhou's application for listing has been completed in September On the premise that today's FDA accelerates the approval of its listing, it is no surprise that the approval timeline is completed according to the forecast The domestic listing is expected to be approved this month, and the innovation breakthrough will be synchronized internationally On November 13, Baiji Shenzhou released the 2019 Q3 performance report The revenue of Baiji Q3 was US $50.14 million, a year-on-year decrease of 7.49%; the net profit was US $307 million, a year-on-year increase of 113.4%; the R & D investment was US $237 million, a year-on-year increase of 60.6% At the same time, CEO and chairman Ou Lei Qiang announced that the cooperation between Baiji and Amgen is expected to be completed by the beginning of 2020, when the commercialization and development plan for three Amgen commercial stage drugs and 20 candidate drugs in China will be implemented In addition, on November 13, the drug evaluation center (CDE) of the State Food and Drug Administration (SFDA) has completed the technical evaluation of the registration application of Baiji Shenzhou PD-1 for leilizumab, and the recommended conclusion of the technical evaluation is "production approval" In other words, it's only a step away from the official approval of the baiji Shenzhou PD-1 monoclonal antibody for Lei Lizhu Zanubrutinib and tirelizumab have been approved and listed one after another The innovation and R & D of Baiji Shenzhou has gradually entered the harvest period, and the era of huge profits may come Baiji Shenzhou R & D pipeline (photo source: Baiji Shenzhou official website) is the first one The patient welfare comes to Mr ou leiqiang, founder, CEO and chairman of Baiji Shenzhou, who said: "we are committed to improving the treatment of cancer patients around the world This approval makes us closer to the mission of bringing the highest quality drugs to patients around the world Following the previous breakthrough treatment in this indication, brukinsa's FDA approval today proves its importance as a treatment plan for recurrent or refractory MCL We will continue to develop brukinsa in other blood tumors, and hope that this approval will be the first for many subsequent marketing approvals " Yan Xiaojun, senior vice president of Baiji Shenzhou and head of global drug administration, commented: "brukinsa, as a Btk inhibitor, is designed to maximize the targeted share while avoiding the Miss target effect Since brukinsa launched a wide range of clinical projects in 2014, it has enrolled more than 1600 patients Today's accelerated approval is the result of many years of efforts by the baiji Shenzhou team and clinical trial researchers, but more importantly, thanks to every patient participating in the clinical trial We are honored to have the opportunity to participate in the development of this therapy, making it the first anti-cancer drug independently developed by Baiji and approved by FDA " Professor Zhu Jun, director of Department of general medicine, Department of lymphoma and doctor of medicine of Peking University Cancer Hospital, said: "as a Chinese cancer clinician, I am very excited to witness the historical breakthrough that the innovative anticancer drugs independently developed by local biomedical companies have been approved by FDA for the first time This breakthrough is an important milestone in China's local biomedical industry and clinical tumor research, marking that we can not only develop new drugs for Chinese patients, but also benefit patients from more countries, provide China's programs for the world, and contribute China's wisdom " Meghan Gutierrez, chief executive of the American Foundation for lymphoma research, commented: "the approval of zebutini as a second-line therapy for MCL is a significant progress in the treatment of this indication The broadening of treatment options can help improve patient experience and provide hope for patients diagnosed with MCL " Attachment: about the clinical project of zebotinib, zebotinib was compared with ibotinib (the only Btk inhibitor approved for the treatment of this indication) in Aspen phase 3 clinical trial (clinical trials.gov Registration No.: nct03053440; at present, the patients have been enrolled); Zebutinib in combination with rituximab in the treatment of primary (TN) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) patients in the seuoia 3 phase clinical trial (clinical trials Gov Registration No.: nct03336333); Zebotinib compared with ibotinib in the alpine phase 3 clinical trial (clinical trials Gov Registration No.: nct03734016) for the treatment of relapsed / refractory (R / R) CLL or SLL patients, and zebotinib combined with gazyva ® obitazumab in the phase 2 clinical trial (clinical trials Gov Registration No.: nct03332017) for the treatment of R / R follicular lymphoma (FL) patients; The third phase clinical trial (clinical trials Gov registration number: nct04002297) of the combination of zebutinib and rituximab in the treatment of mantle cell lymphoma (MCL) patients, and the second phase clinical trial (clinical trials Gov registration number: nct03846427) of Magnolia in the treatment of R / R marginal zone lymphoma (MZL) patients; Phase 2 clinical trial of rosewood in the treatment of R / RFL patients (clinical trials Gov Registration No.: nct03332017) by zebutinib combined with obituzumab compared with obituzumab; Two phase clinical trials (clinical trials Gov registration number: nct03206970; completed) of zebutinil for the treatment of R / rmcl patients and two phase clinical trials (clinical trials Gov registration number: nct03206918; completed) for the treatment of R / RCLL or SLL patients; Zebotinib was used in phase 2 clinical trials of WM patients (clinical trials.gov registration number: nct03332173; patient enrollment completed) 37 statement: This article is the integration content, the viewpoint only represents the author, does not represent the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.