Zebtini officially approved for listing in China!

On June 3, the State Drug Administration announced that it had approved the listing of the class 1 innovative drug Zebutinib (zanubrutinib) for adult set cell lymphoma (MCL) patients who have previously received at least one treatment and patients with chronic lymphoma (CLL)/small lymphocytic leukemia (SLL) who have previously received at least one treatmentZebutinib, a small molecule inhibitor developed by Baiji Shenzhou to maximize Bruton tyrosine kinase (BTK) and minimize off-target effects, was approved by the U.SFDA in November 2019 to treat MCL adult patients who have previously received at least one treatment, becoming the first locally developed anti-cancer drug to be approved for sale in the U.SUnfortunately, Zebbutini did not perform as well as expected after listing in the U.S., with sales of just $720,000 in the first quarter of 2020BTK is one of the most prominent frontier targets in the field of blood tumor research, with a market size of more than US$8 billionA total of four BTK inhibitors have been approved worldwide, with Ibtinib as the world's first approved BTK inhibitor to almost take market shareIn August 2017, Ibtini was approved in China and then negotiated into the 2017 health care catalogThe approval of Zebtini, the second BTK inhibitor approved in the country, will compete head-on with IbtiniIn addition to approved indications, Baiji Shenzhou is also developing Zebutinib for the treatment of other B-cell malignancies, such as Fahrenheit cytoproteinemia (WM)Baiji Shenzhou said it will submit sNDA in China in 2020 for the treatment of WM patientsAt the just-concluded ASCO 2020 meeting, Baiji Shenzhou published follow-up data from the ASPEN Phase 3 clinical trial for the treatment of WM patients, and the long-term follow-up data of the Phase 1/2 clinical trial of Zebutinib as a single drug for the treatment of patients with primary or recurrent/refractive (R) WMASPEN Phase 3 Clinical Trial Strial Data: Phase 1/2 Clinical Trial Data: Source: Although ASPEN Clinical Trials failed to achieve statistically significant efficacy at the primary endpoint (CR and very good VGPR rates), Zebutinib's treatment produced a higher numerical VGPR rate than ibtinib, as well as a significant improvement in safety and toleranceThe new 5-month follow-up data in the overall patient population further reinforces the trend of Zebutinib's ability to increase VGPR rates and have security advantagesIt is worth mentioning that on May 23, the 2020 edition of the Chinese Society of Clinical Oncology (CSCO) Lymphoma Diagnosis and Treatment Guide will be released through a televisual conference to officially release the updated version of the guideAmong them, China's first local research and development of anti-cancer new drug Zebutinib as a new generation of BTK inhibitors were officially included, listed as set cell lymphoma (MCL), chronic lymphoblastic leukemia (CLL) recommended programIt also marks the first locally developed new anti-cancer drug to be recommended by China's CSCO guidelines and the National Comprehensive Cancer Network (NCCN) guidelines.