Domestic PD-1 therapy! Baiji Shenzhou Baizean ® first-line treatment of advanced squamous lung cancer (NSCLC) new indications application by the State Drug Administration to accept!

April 21, 2020 / Biovalley BIOON / -- BeiGene announced recently that the National Drug Administration (NMPA) Drug Review Center (CDE) has accepted its anti-PD The -1 antibody drug Perze®zumab (tillizumab, Terellizumab, Terelli zumab) is used in a combination of two chemotherapy regimens for the first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) with new indications (NDA) this NDA is based on the results of a Phase III clinical trial (clinicaltrial.gov registration number: NCT03594747) The trial was conducted in patients with untreated phase IIIB or IV scaly NSCLC in mainland China, and was evaluated in baccaynon ® and caplonol, or abrasin esothalol (ABRAXANE ®) and caplonium, and compared with a programme that uses only yew alcohol and caplonium In the trial, a total of 360 patients were randomly grouped with a ratio of 1:1 to 1, receiving either a combination of chemotherapy regimens ® or chemotherapy only As reported in January 2020, the trial reached a statistically significant lye end in the program's mid-term analysis, assessed by the Independent Review Board (IRC) as a statistically significant increase The security data of the two groups of Baczean ® test groups matched the known risks of each group, with no new security alerts The full trial data will be released at the of the academic conference in the near future "The recent approval of Baize an ® for the treatment of urinary skin cancer in China marks the first approval in the field of solid tumor indications, and we have just announced a second study on NSCLC, the results of a positive clinical trial for the treatment of first-line non-scaly NSCLC patients," said Dr Wu Xiaobin, General Manager and President of Baiji Shenzhou China, This new indication son-in-market application was followed by another important milestone in the history of the ® Urgent patients, we moved quickly, from the launch of the clinical trial to the submission of a market ingress application, which took only 20 months We look forward to working closely with the Drug Review Centre on this application to bring a new treatment to the vast number of patients with advanced squamous NSCLC in China who are expected to benefit from immunotherapy "
contrast swords against the declining lung cancer mortality rate in most Western countries, and the incidence of lung cancer in China continues to rise In 2018, China added about 770,000 lung cancer cases and 690,500 deaths Lung cancer is the leading cause of cancer-related death in both men and women Non-small cell lung cancer (NSCLC) is the most common type of lung cancer in China Baczean ® (Treli-Jumono) is a human-derived lgG4 anti-procedural death receptor-1 (PD-1) monoclonal antibody designed to minimize binding to fc-R receptors in macrophages Preclinical data show that the binding of the Fc'r receptor in macrophages activates antibody-dependent cell-mediated killer T cells, thereby reducing the antitumor activity of PD-1 antibodies Tireli Zumat is the first drug candidate developed by Baiji Shenzhou's immuno-oncology bioplatform, and is currently conducting clinical trials of single-drug and co-therapies worldwide developing a range of awiderange of adaptations to solid tumors and blood tumor Bazean ® has been approved by the State Drug Administration (NMPA) for the treatment of patients with recurrent or incurable classic Hodgkin's lymphoma with at least second-line system chemotherapy, as well as for patients with topical late or metastatic urinal skin cancer whose failure to treat PD-L1 high expression, including new or auxiliary chemotherapy, within 12 months of progress currently, there are 15 registered clinical trials in The ® in China and worldwide, including 11 Phase 3 clinical trials and four critical Phase 2 clinical trials So far, 10 PD-(L)1 tumor immunotherapy series have been approved worldwide: Keytruda (Korida, Target PD-1, Mersadon), Opdivo (Odivo, Target PD-1, Time Mese Treasure), Tecentriq (Tesanqi, generic name: atezolizumab, Ateju monofight, target PD-L1, Roche), Imfinzi (Infyige, generic name: durvalumab, Duvalliu monofight, target P D-L1, AstraZeneca), Bavencio (avelumab, target PD-L1, Pfizer/Merck), Libtayo (cemiplimab, Sanofi/Regeneration), Towie (Triplin, Target PD) -1, Junshi Bio), Daboshu (Sindili Mono, Target PD-1, Sinda Bio), Erika (Carrelli Pearl Single Resistance, Target PD-1, Hengrui Pharmaceuticals), Baczean (Treli Zhu Mono, Target PD-1, Baiji Shenzhou) eight of the 10 PD-(L) treatments have been approved in China , namely Keytruda (Korida), Opdivo (Odivo), Imfinzi (Infyfan), Tecentriq (Tesci), Baczean (Treli-Single), Tuyi (Treprii Single Resistance), Daboschu (Sindili Anti-Single), Andery (Carico) six of the 10 treatments have been approved for URric disease (UC) indications It is worth mentioning that Bacheran ® is the first anti-PD-(L)1 treatment approved for UC treatment in China April 10, this year, Baiji Shenzhou announced that the State Drug Administration (NMPA) approved Bazean ® a new indication for the treatment of patients with advanced partial or metastatic pD-L1 hyperexpression of urinary disease (UC) who received platinum-containing chemotherapy failures within 12 months of progression of new or auxiliary chemotherapy (biovalleybioon.com) original origin: Baiji Shenzhou, BioValley