China's first global anti-cancer drug, Bai Yueze, ® approved at home

Yesterday, Baiji Shenzhou announced that the company's self-developed next-generation BTK inhibitor, Bai Yueze ® (Zebutini Capsules), has been approved by China's State Drug Administration (NMPA) for the treatment of adult suite cell lymphoma (MCL) patients who have received at least one treatment in the past, and adult chronic lymphoblastic leukemia (CLL)/small lymphocytic lymphoma (SLL) who has received at least one treatment in the past.This marks Bai Yueze becoming the first domestic BTK inhibitor to be listed in China, which will bring a new treatment option with high remission rate for patients with lymphoma in China. At the same time, this is another important milestone in the process of local and global commercialization of Baiji Shenzhou following the successful approval of Baiyue Ze in the United States.Dr. Wu Xiaobin, General Manager and President of Baiji Shenzhou China, said: "Bai Yueze has welcomed the first approval of two major adaptive disorders in China, which makes us very excited, this is the first new anti-cancer drug in china's history to go to sea in developed markets, finally landed in the mainland, can bring new treatment options for more patients with lymphoma in China." Bai Yueze has been successfully listed at home and abroad, is in recent years the rise of China's innovative pharmaceutical industry, representing China's pharmaceutical enterprises have full strength for local patients to develop international first-class quality, accessability and affordability of better innovative good drugs, to help China's cancer patients improve drug treatment problems.helps to improve the five-year survival rate and bring new hope to more patients with lymphomalymphoma is a group of malignant tumors originating from the lymphatic hematosis system, which is one of the ten most common malignant tumors in China and one of the fastest growing malignant tumors in China and the world. According to epidemiological statistics, non-Hodgkin's lymphoma (NHL) accounts for about 91%2% of all lymphomas in china each year, including 66% of B-cell non-Hodgkin's lymphoma. Of these, sleeve lymphoma (MCL) accounts for about 5%2 of all B-cell non-Hodgkin's lymphoma, while chronic lymphocyte lymphoma (CLL)/small lymphocyte lymphoma (SLL) accounts for about 6.4%2 of all B-cell non-Hodgkin's lymphoma.Bai Yueze is a new powerful BTK inhibitor, which is optimized for molecular structure to form a complete and long-lasting precise inhibition of BTK targets. In a series of clinical trials, it shows good efficacy and safety in MCL, CLL and other B-cell lymphomas. In November 2019, Bai Yueze (Zebutini capsule) was approved by the FDA for the treatment of patients with once-treated set of cell lymphoma, becoming the first local research and development of anti-cancer drugs approved in the United States, and achieving a "zero breakthrough" in the development of new local drugs.This time, Bai Yueze obtained two adaptation approvals in China, mainly based on data from two key clinical studies. Data from a key Phase 2 multi-center clinical trial in China, BGB-3111-206, show that the total mitigation rate of R/R MCL in the single-drug treatment of Banyanze is 84%, and the total remission rate is 69%. In another study of BGB-3111-205, a key phase 2 multi-center clinical trial in China for R/R CLL/SLL, the total mitigation rate of Baiyueze therapy reached 62.6%, the total remission rate reached 3.3%, the partial remission rate reached 59.3%, and another 22.0% of patients received partial remission with increased lymphocytes.Professor Li Jianyong, director of the haematology department of the First Affiliated Hospital of Nanjing Medical University and director of the Pukou Slow Gonorrhea Center, led the 205 clinical studies in CLL, professor Li said: "Lymphoma is a disease that is high in the elderly, especially chronic lymphocytic leukemia, such as the relatively slow progress of subtypes, many patients may have a survival of more than ten years, so whether the treatment plan is safe, sustainable, is an important consideration for us." I am pleased to be able to witness the excellent results demonstrated by the next generation of BTK inhibitors in clinical studies, with good tolerance and a very low risk of atrial fibrillation, bleeding, etc. It is believed that its approval in China, can bring patients better efficacy, less side effects of treatment options, help patients improve the prognosis, further improve the quality of life, as clinicians, our treatment confidence will be more adequate.Professor Zhu Jun, Director of Lymphoma Department and Director of Department of Internal Medicine, Peking University Cancer Hospital, said: "In the past, due to the lack of effective treatment programs, lymphoma patients have long faced difficulties in medication, expensive medication, treatment effectiveness and quality of life need to be improved." Today, China has made breakthroughs in clinical research and research and development of new drugs, inging new hope for our patients. As a clinician and researcher, I am pleased to witness our local research and development of a new generation of oral targeted drug Bai Yueze can bring better survival for patients, won the praise of experts at home and abroad, I believe that in the near future, there will be more new drugs from Chinese biopharmaceutical companies will be approved around the world, China's patients will be more and more treatment options.a new generation of BTK inhibitorsThe new generation of BTK inhibitors, was born at baiji Shenzhou's research and development center in Changping, Beijing. In June 2012, the research team officially launched the BTK development project, after a series of screening and testing, and finally in more than 500 compounds, selected the final candidate molecule, for its number BGB-3111, meaning the establishment of Baiji Shenzhou made the 3111th compound.Dr. Wang Zhiwei, one of the main inventors of Baiyue Zebtini capsule and head of chemical research and development in Baiji Shenzhou, said, "When we first started the project, our goal was very clear, to be a highly selective compound that inhibits very specific targets." By optimizing the molecular structure of the drug, we hope to maximize the specific binding rate of BTK targets and minimize off-targeting to reduce the occurrence of adverse reactions and help patients achieve better efficacy and safety in the clinic. In2013, Baiji Shenzhou filed a patent application. This is a global patent originating from the Chinese Patent Office, and also makes Bai Yueze a true chinese research and development of new anti-cancer drugs. In 2014, Bai Yueze (Zebutini capsule) officially entered the clinical stage in Australia, and in August of the same year, the world's first patient was given the drug.From the laboratory project to today's successful listing in China and the United States, Bai Yueze's research and development spans 8 years. At present, Bai Yueze has launched nearly 25 clinical trials worldwide, covering more than 20 countries, more than 500 international clinical experts participated in or presided over its related clinical trials, including more than 70 clinical experts from China. Globally, more than 1,700 patients were treated with Zebutini capsules.“ From the beginning of clinical initiated, Bai Yueze has been practicing the global development strategy, in China and overseas countries to carry out clinical research simultaneously, which also put forward higher requirements for the design and quality of our clinical trials. Dr. Wang Li, Senior Vice President, Global Research, Clinical Operations and Biostatization and Asia Pacific Clinical Development, one of the leading leaders in research and development of Baiyue Zebutini Capsules, said, "In this process, it is their trust and support for many clinicians and patients in China and overseas that make it possible for its clinical research at home and abroad to advance smoothly and bring practical help to more patients." At, Baiji Shenzhou is conducting 16 clinical studies worldwide, including 9 registered or promising clinical trials. At the same time, Bai Yueze is conducting 2 global clinical phase 3 head-to-head studies against Ibtinib for Fahrenheit globulinemia (WM) and CLL, which is the first local new drug to carry out direct head-to-head research with foreign pharmaceutical companies. Clinical data for phase 3 of the first phase, which has been published in WM, show that Zebutini has achieved higher remission rates and higher safety and tolerance advantages than Ibdini.The globalization process has accelerated, benefiting more patientsBai Yueze since entering the clinical trial stage, has been in the international and domestic access to a number of recognition, has been China's NMPA priority review certification, including the FDA priority review of the four Grand Slams, and has been included in the U.S.-China clinical guidelines for lymphoma treatment experts recommended.Following China and the United States, Bai Yueze has also recently submitted applications for the listing of new drugs in Israel, which have been accepted. Under the previously announced plan, the company will also communicate with the European Medicines Agency (EMA) this year to accelerate the worldwide listing of Park Yueze."Thanks to the excellent data from clinical trials, we have been in close communication with drug regulators in several countries in the hope of bringing this new drug of world-class quality to patients in more countries," said Ms. Ni Xiaojun, Senior Vice President of Baiji Shenzhou and Head of Global Pharmaceutical Affairs. In this process, we are very grateful to the Chinese and U.S. drug regulatory departments for the recognition of Bai Yueze, in China and the United States have been approved, for us to accumulate a wealth of experience and foundation, will help us better promote the declaration work in other countries. DrXiaobin, President of Baiji Shenzhou, said, "At present, Baiji Shenzhou has been fully prepared in all aspects of the industrial chain to ensure the first time after approval of production and supply." As a local research and development, internationally recognized high-quality new drugs, I believe it will be more accessable, affordability to help our patients, at the same time, we look forward to communicating with the national health care sector, to promote the early inclusion of Bai Yueze into the health care directory, to bring well-being to domestic patients, promote the healthy operation of the health insurance fund. The
(arterial network)