Zebutini, developed by Baiji Shenzhou, is listed in China today!

On June 3, The Baiji Shenzhou BTK inhibitor, The ® of Bacbane Zeitini ( generic name: Zebutini Capsules), was approved by the State Drug Administration to treat two adaptations in patients with adult cell lymphoma (MCL) who have previously received at least one therapy, and adult chronic lymphocytic leukemia (CLL)/small lymphocyte lymphoma (SLL) patients who have previously received at least one therapyPreviously, both applications for indications were prioritized by the NMPA Drug Review Centre (CDE)The ® received accelerated approval from the U.SFood and Drug Administration (FDA) in November 2019 to treat adult MCL patients who have received at least one treatment in the pastJohn VOyler, co-founder, CHIEF executive and chairman of baiji Shenzhou, said: "The approval of the Baiyue Ze ® for the treatment of Both R/R CLL/SLL and R/R MCL patients is a recognition of the professional competence and hard work of the Baiji Shenzhou teamIn just 7 months, our two in-house research and development products have been approved, covering four indications in China and one in the United StatesWe will continue to build on our broad product portfolio"
President of Baiji Shenzhou and General Manager of Baiji Shenzhou, DrWu Xiaobin, said, "Bai Yueze ® is the second independent research and development drug approved by Baiji Shenzhou in China following the Reilly Pearl monotonicresistance, which is another important expansion of our fast-growing commercial ization portfolioThe success of the Bai Yueze ® is approved without the strong support of many doctors and patients at home and abroad who have participated in our clinical trials, as well as the relevant government departmentsWe look forward to the listing of the ® in China, which has the potential to become one of the best-in-class BTK inhibitors, and it has accumulated a wealth of data from nine global Phase 3 or prospective clinical studies, including a recent head-to-head clinical trial data presented at the annual meeting of the American Society of Clinical Oncology (ASCO)"
approved by NMPA for the treatment of R/R CLL/SLLthis ® was approved by the Bai Yueze for the treatment of R/R CLL/SLL patients, based on a single-arm, critical Results of Phase 2 clinical trials (NCT03206918; BGB-3111-205) included 91 patients (82 of whom were R/R CLL patients and 9 were R/R SLL patients)The outcome of the outcome assessment of tumor remission in CLL patients and SLL patients by the Independent Review Committee (IRC) in accordance with the revised iwCLL Guidelines (2008) and Lugano (2014) criteria showed that the total remission rate (ORR) of Zebutinib treatment was 62.6%, including 3.3% total remission (CR) and 59.3% partial remission (PR) with an additional 22% of patients with increased lymphatic cells (PR)The most common adverse reactions (more than 10%) ®were neutrophilocytic reduction (68.1%), platelet reduction (40.7%), hematuria (35.2%), cyanosis (34.1%), anemia (23.1%), leukocyte reduction (18.7%), infectious pneumonia (18.7%), upper respiratory tract infection (15.4%), hemorrhage (14.3%) and rash (12.1%)The most common serious adverse reaction was pneumonia (11.0%)"Chronic lymphocytic leukemia is a kind of lymphoma with a high incidence and relatively slow progress in the elderly, so the safety and tolerance of the treatment is an important consideration for us," said Professor Li Jianyong, M.D., director of the First Hospital affiliated with Nanjing Medical University,The approval of The ® will provide an important treatment option for R/R CLL patients in China, with a total remission rate of over 60% in R/R CLL patients, while also achieving good safety and tolerance"
obtained NMPA approval for the treatment of R/R MCLthis ® was approved by the National Drug Administration of China (NMPA) for the treatment of R/R MCL patients, based on the results of a single-arm, critical phase 2 clinical trial in 86 patients in China (NCT03206970; BGB-3111106)The results of the outcome of the Independent Review Committee (IRC) based on the Lugano (2014) classification criteria showed that the total remission rate after treatment ® was 83.7%, of which the total mitigation rate was 68.6% and the partial mitigation rate was 15.1%the most common adverse reactions (more than 10%) of the ® included neutrophilocytosis (47.7%), rashes (32.6%), leukocyte reduction (31.4%), platelet reduction (30.2%) and anemia (11.6%)The most common serious adverse reactions (more than 2%) were infectious pneumonia (8.1%), bleeding (2.3%) and platelet reduction (2.3%) Professor Zhu Jun, Director of Lymphoma Department, Director of Major Surgery and M.D., , said: "Bai Yueze ® has a good prospect for the treatment of a variety of blood system malignancies, including set cell lymphoma, which has shown strong results in clinical trials, with a total remission rate of 68.6%, and we are optimistic and excited about the clinical effect simply for patients ®." The recommended dose of the the ® of Budue Ze is 160 mg, taken orally twice daily, before or after meals The dose of the drug can be adjusted appropriately according to adverse reactions and reduced in patients with severe liver damage and in specific drug reactions prior to the approval, the two new drug listing applications for R/R MCL and R/R CLL or SLL ® were included in the priority review by the Drug Review Center (CDE) of the State Drug Administration of China about chronic lymphocytic leukemia/small lymphocyte lymphoma
chronic lymphocytic leukemia (CLL) and small lymphocyte lymphoma (SLL) are non-Hodgkin lymphomas originating from B lymphocytes and are a blood tumor In essence, CLL and SLL belong to the same disease, except where the tumor first occurs When most tumor cells are distributed in peripheral blood and bone marrow, they are called CLL, and tumor cell distribution is often found even in the lymph nodes and spleen When most tumor cells are distributed in the lymph nodes, the tumor is defined as SL In China, according to epidemiological statistics, non-Hodgkin lymphoma (NHL) accounts for about 91% of all lymphomas each year, of which about 66% is B-cell non-Hodgkin lymphoma, and CLL or SLL accounts for about 6.4% of all B-cell non-Hodgkin lymphoma, or about 3,390 new cases per year on cell lymphoma lymphoma is a group of malignant tumors containing multiple subtypes that originate from B cells, T cells, or NK cells Cell lymphoma (MCL) is usually a more invasive non-Hodgkin lymphoma (NHL) that originates in "set- B cells" According to epidemiological statistics, non-Hodgkin's lymphoma (NHL) accounts for about 91% of all lymphomas in China each year, of which about 66% is B-cell non-Hodgkin lymphoma, while MCL accounts for about 5% of all B-cell non-Hodgkin lymphoma, or about 2,600 new cases per year Patients with MCL generally have a poor prognosis, with a median survival of three to four years, and patients are usually in the late stages of the disease at the time of diagnosis about the ® of Beayouze
(Zebbutini) ® Zebbutinib, a bruton tyrosine kinase (BTK) small molecule inhibitor developed by scientists in Baiji Shenzhou, is currently undergoing a wide range of critical clinical trials around the world to treat a wide range of B-cell malignancies as a single drug and in combination with other therapies ® received accelerated approval from the U.S Food and Drug Administration (FDA) in November 2019 for the treatment of patients with cell lymphoma (MCL) who have previously received at least one treatment This accelerated approval is based on the Total Mitigation Rate (ORR) Continued approval of the indicationwill will depend on the validation and description of the clinical benefits in validation trials In June 2020, The ® was approved in China for the treatment of adult patients with at least one treatment, adult chronic lymphocytic leukemia (CLL)/small lymphocyte lymphoma (SLL) patients who have previously received at least one treatment Bai Yueze ® has not been approved in the United States and outside China on the clinical trial project on Zebbutini Zebbutini clinical trial sits on (BTK)(WM)ASPEN(clinicaltrials.gov:NCT03053440;); (TN)(CLL)(SLL)SEQUOIA(clinicaltrials.gov:NCT03336333); /(R/ R) Alpine Phase III Clinical Trials for Patients with CLL or SLL (clinicaltrials.gov registration number: NCT03734016); Zebbutini in conjunction with GAZYVA ® (Obbiter monosar) for treatment of patients with R/R glomerative lymphoma (FL) clinicaltrials.gov registration number: NCT033333 2017); Zebutinib combined lytuxicemau-phenydamytinini combined clinical trial for the treatment of untreated MCL patients (clinicaltrials.gov registration number: NCT04002297); zebutinib for the treatment of patients with R/R edge lymphoma (MZL) Phase 2 Clinical Trials (clinicaltrials.gov registration number: NCT03846427); Zebutini combined with obitodre monotorisa-opbitod monotorinsis for the treatment of r/R FLROSE patients in Phase 2 clinical trials (clinicaltrials.gov registration number: NCT03332017); Zebuti Nico-Combined Maintenance Therapy vs placebo combined maintenance therapy for the treatment of COVID-19 new coronary pneumonia and lung distress patients in the United States phase 2 clinical trial (clinicaltrials.gov registration number: NCT04382586); Zebutinib for the treatment of WM patients in China Phase 2 clinical trial (clinicalclinicals.gov registration number: NCT03332173) Zebutinib for the treatment of R/R MCL patients in China Phase 2 Clinical Trials (clinicaltrials.gov registration number: NCT03206970; completed) and China Phase 2 clinical trials for r/R CLL or SLL patients (clinicaltrials.gov registration number: NCT03206918; completed) Source: Baiji Shenzhou Baiji Shenzhou Source: Baiji Shenzhou