Ash | legend of Baiji Shenzhou, Yasheng and Nanjing released a number of key data

From December 1 to 4 local time, the 60th American Society of Hematology (ash) conference was held in San Diego In today's report, we will share with you some of the progress made by China's biomedical upstarts The complete remission rate was 61.4% Tislilizumab (bgb-a317), which was brought by Baiji Shenzhou, is a human monoclonal antibody in research It can bind to PD-1 receptor on cell surface with high affinity and specificity According to the preclinical data, the modification of the FC segment of tislilizumab can minimize the potential negative interaction with other immune cells, so it has potential differences with the currently approved PD-1 antibody The clinical data released today come from a single arm, open label, multicenter, critical phase 2 clinical trial In this trial, tislilizumab was used as a single drug therapy to treat Chinese patients with recurrent or refractory classical Hodgkin's lymphoma (R / rchl) As of May this year, data for a total of 70 patients were available for evaluation The analysis of the Independent Review Committee showed that 85.7% of the total remission rate (ORR) of the antibody was achieved, of which the complete remission rate (CR) was 61.4% and the partial remission rate was 24.4% 92.3% of the patients (12 / 13) who had received auto stem cell transplantation received objective remission, and the complete remission rate was 69.2% "The excellent results we report include a high rate of complete remission This is the first study to register a potentially different anti-PD-1 antibody, and we are excited about that " Dr Huang Weijuan, chief medical officer of Hematology in Baiji, said in a press release Two data of zanubrutinib clinical research published by Baiji Shenzhou, zanubrutinib is a small molecule inhibitor of Brunton's tyrosine kinase (Btk) under research Currently, it is conducting a wide range of key clinical trials around the world, as a single drug and combined with other therapies to treat multiple lymphoma At the ash conference, two clinical research data of zanubrutinib were released by Baiji Shenzhou In a key phase 2 clinical trial to treat recurrent or refractory mantle cell lymphoma (MCL), the researchers evaluated the potential of zanubrutinib as a single drug for Chinese patients The analysis of the Independent Review Committee showed that the overall response rate (ORR) of the drug was 83.5% (71 / 85), of which the complete response rate (CR) was 58.8% and the partial response rate (PR) was 24.7% In another phase 1 clinical trial conducted in many countries around the world, zanubrutinib was used as a single drug to treat multiple B-cell subtypes of lymphoma The results evaluated by the researchers showed that the orr of the drug was 88.9% (40 / 45), of which CR was 26.7% and PR was 62.2% "These two clinical studies provide encouraging data supporting zanubrutinib as a potential treatment for MCL "Dr Huang Weijuan, chief medical officer of Baiji Shenzhou hematology, mentioned in the press release At present, the NDA of zanubrutinib for the treatment of relapsed or refractory MCL and for the treatment of relapsed or refractory chronic lymphoblastic leukemia (CLL) / small cell lymphoma (SLL) has been accepted by China National Drug Administration (nmpa), and the NDA for MCL has been included in the priority review Baichi plans to deliver zanubrutinib's first NDA in the United States to the FDA in 2019 or early 2020 Yasheng medicine announced the latest progress of hqp1351 in the treatment of chronic myeloid leukemia Hqp1351 is an original class 1 new drug under the research of Yasheng medicine It is an effective third-generation bcr-abl inhibitor It can not only target wild-type bcr-abl, but also target T315I mutant bcr-abl It is expected to treat patients with resistant chronic myeloid leukemia (CML) ▲ partial data summary of hqp1351 (picture source: reference [4]) the latest data released at the ash conference showed that hqp1351 had good tolerance, and no patient withdrew from the clinical trial due to treatment-related side effects (RAE) In the evaluation of curative effect, 65 patients (93%) achieved complete remission of Hematology (CHr) in 3 treatment cycles Of the 47 patients who received three treatment cycles or more, 24 (51%) achieved major cytogenetic remission (mcyr) It is worth mentioning that hqp1351 is also highly active in patients with T315I mutation These preliminary results show that hqp1351, as a third generation TKI, is safe and effective in the targeted patient population Nanjing legend released the latest data of car-t therapy, and the dual specificity car-t therapy lcar-b38m brought by Nanjing legend has been a hot spot in the industry in recent period In 2017, the treatment was born out of nowhere and is considered one of the biggest black horses at ASCO last year At today's ash conference, Nanjing legend also updated the latest safety and efficacy data of the treatment ▲ partial data summary of lcar-b38m (picture source: reference [5]) as of June this year, a total of 57 patients have received treatment, with a total response rate (ORR) of 88% (95% CI: 76% - 95%) Among them, 42 patients achieved complete remission (CR), accounting for 74% (95% CI: 60% - 85%) In 42 patients with complete remission, up to 39 were negative for MRD There was no association between the dose of car-t and remission, and the expression of BCMA was not associated with clinical remission.