Baiji Shenzhou baize'an has been approved for listing, and there are 4 domestic PD-1 competitors

[industry trends of pharmaceutical network] on December 28, Baiji Shenzhou announced that the anti-PD-1 antibody drug baizean (general name: tirelizumab injection) had been approved by the State Food and Drug Administration on December 27 for the treatment of relapsed or refractory classic Hodgkin's lymphoma (R / R CHL) patients who had undergone at least second-line system chemotherapy Before that, the new drug application for listing had been included in the priority review by nmpa After the BTK inhibitor brukinsa (zebutinib) independently developed by Baiji Shenzhou was approved by the US FDA, baize'an is the first self-developed new anti-cancer drug approved in China It is worth noting that this is also the sixth PD-1 drug on the market in China Previously, the drugs on the market included Bristol Myers Squibb (BMS) drug o, mosadong drug K, AstraZeneca drug I, Kingdee's tuoyi and Cinda's Dabusu The industry believes that with the approval of this PD-1, the "4 + 2" situation of domestic PD-1 competition has been formed, and there are four domestic PD-1 competitors In recent years, PD-1 market is extremely hot According to IMS database, the global sales of PD-1 antibody in 2017 was about 8.83 billion US dollars In 2018, the global sales volume has reached US $14.178 billion, and the domestic sales volume is about US $6.4375 million Among them, PD-1 single drug sales performance is outstanding In the ranking of global drug sales revenue in 2018, the annual sales of drugs O and K exceeded 7 billion US dollars The huge market prospect of PD-1 makes the market competition more and more fierce According to the sales data in the first half of 2019, in the first half of the year, drug O and drug K achieved sales of 430 million yuan and 1 billion yuan respectively; tuoyi sales revenue of monarch bio was 308 million yuan; dabushu sales revenue of Cinda bio was 331 million yuan The approved baize'an is a humanized IgG4 anti-PD-1 monoclonal antibody designed to avoid binding with FC γ r receptor on macrophage surface and activate phagocytosis of macrophage, so as to reduce its negative effect on T-effector cells Baize'an is the first candidate drug developed by Baiji Shenzhou's immune tumor biological platform At present, a series of single drug and combined therapy clinical trials are being carried out to develop a series of extensive indications for solid tumors and blood tumors In addition, another application for new indications for patients with locally advanced or metastatic urothelial carcinoma (UC) who have previously received treatment has been accepted and included in the priority review Dr Wu Xiaobin, general manager and President of Baiji China, said that baize'an has achieved gratifying clinical efficacy and safety in the treatment of relapsed or refractory classic Hodgkin's lymphoma It is reported that baizean will be produced by Boehringer Ingelheim biopharmaceutical industry after listing In September this year, the baiji Shenzhou Guangzhou bio pharmaceutical production base, with a total investment of more than 2.3 billion yuan, covering an area of 100000 square meters and focusing on the development and production of large molecular bio pharmaceutical technology on a commercial scale, has completed the first phase of project construction After passing the relevant qualification verification and approval, it will provide additional commercial supply for the subsequent large-scale application of baize'an to ensure sufficient Capacity According to the data, Baiji Shenzhou is a global, commercial stage, R & D-based biotechnology company, focusing on the research and development of molecular targeting and immunotumor therapy At present, the product line under research includes new oral small molecule and monoclonal antibody anticancer drugs At present, Baiji Shenzhou is also building a drug combination program for anti-cancer treatment, aiming to bring lasting and far-reaching impact on the life of cancer patients Bringer Ingelheim has more than 35 years of experience in biopharmaceutical production At present, it has more than 3600 employees around the world to provide biopharmaceutical production OEM business, which has helped more than 30 drugs to market around the world.