Domestic PD-1 will usher in the "2 + 4" first echelon, Baiji, Shenzhou, a number of products under development, accelerate the "start"

According to the interface news report, at present, CDE has completed the technical review of the registration application of Baiji Shenzhou PD-1 for ralizumab, which has been sent to the State Drug Administration for approval on November 13, and the conclusion of the technical review of varieties is to approve the production However, the final approval result is subject to the official information of the enterprise In addition, industry media reported that at the recent (November 13) PD-1 product access medical insurance negotiation meeting, drug K was included in the medical insurance with a large price cut in exchange for a first-line lung cancer indication, while Xinda and Jun were included in the medical insurance with a small price cut, drug o was out of the game, and the final data still need to be subject to the official disclosure It can be imagined that if the PD-1 of Baiji Shenzhou is officially approved, the domestic competition pattern of 2 + 4 + (x) PD-1 McAb will officially open Since its listing, Baiji Shenzhou has become the focus of the whole industry If it's a medical topic, maybe no one is against it Today (November 14), I'd like to show you the rise of Baiji, the exclusive animal of medicine In February 2016, Baiji Shenzhou successfully landed in the NASDAQ capital market of the United States, becoming the first Chinese bio pharmaceutical company to IPO in the United States, and listed in Hong Kong in August 2018 In the past year, Baiji Shenzhou has received US $1.7 billion in financing around the world Baiji Shenzhou is a global biopharmaceutical company dedicated to the research and development of new molecular targeted drugs and tumor immunotherapy It is mainly engaged in the research and development of molecular targeted drugs, the creation of immunotumor therapy, and the optimization of joint drug use programs In 2018, the total R & D investment of Baiji Shenzhou reached 679 million US dollars As the most expensive domestic pharmaceutical enterprise in the year, the total R & D investment flowed to the external cost of clinical stage projects, internal R & D expenditure, in-process R & D expenditure and external cost of non clinical stage projects, which involved the later critical clinical research and late stage of continuous development and new start-up Registration and commercial release preparation of candidate drugs, pre commercial production and supply, and expansion of clinical phase projects "Cancer immunology is a research area that we have focused on in the past three years Whether in China or globally, we are at the forefront of immunooncology research." He also pointed out that the research in this field needs not only the innovation of biotechnology, but also the comprehensive strength and scale of drug development, while Baiji Shenzhou has not only both, but also other competitive advantages "In addition, most innovative biotech startups in the United States focus either on the development of small molecule drugs or on the development of large molecule drugs, and we have both experience in the development of these two drugs." Baiji Shenzhou CEO Lei ouqiang said in an interview The author thinks that the starting point of baiji is very high The starting point of baiji is high in many aspects, but the most important thing is the high level of its founders Wang Xiaodong's academic influence is needless to say As an academician of the American Academy of Sciences, he is the director of the Beijing Institute of Life Sciences (NIBS) In addition, his own research field is closely related to cancer and even anticancer drugs What most science net friends don't know is that before Wang founded Baiji Shenzhou, he also founded joyant pharmaceuticals (a tumor biotechnology company) in the United States Recently in the news, Wang Xiaodong, Shi Yigong and Rao Yi are called "three swordsmen" However, none of the three Niu people is a real "swordsman", but at least two (especially RAO) are "bloggers" The three of them have many things in common, but they also have their own characteristics: of the three, only Wang didn't open a blog on ScienceNet, Rao didn't have the experience of opening a company, and Shi had both involved In fact, PD-1 of Baiji Shenzhou is aimed at the whole world At present, clinical trials are carried out in more than 30 countries on five continents Whether from the pharmaceutical point of view or from the perspective of patients, it should be safe It should be supervised by many countries around the world The time of clinical research will be a little longer Since it is a global product, it must have its own characteristics In this process, it is difficult to achieve without years of deep immunology, pharmaceutical engineering and large-scale production capacity With the continuous optimization and upgrading of industrial policies, biopharmaceutics ushered in the spring of development Benign competition is conducive to the development of industry It can be seen that Baiji's PD-1 target layout is no less than that of Hengrui, a domestic pharmaceutical giant The development of PD-1 focuses more on the high incidence of tumors in Asian patients, including non-small cell lung cancer, liver cell cancer, esophageal cancer and gastric cancer At the same time, the clinical research on the indications of PD-1 monoclonal antibody combined with chemotherapy for gastric cancer, esophageal cancer, lung cancer, liver cancer and so on is advancing in an orderly manner Amgen, one of the world's largest biopharmaceutical companies (hereinafter referred to as "Amgen"), will spend 2.7 billion US dollars to acquire 20% of China's local biopharmaceutical enterprise Baiji Shenzhou In the early morning of November 1, 2019, Baiji Shenzhou issued a notice that Amgen purchased about $2.7 billion worth of Baiji Shenzhou common shares on the Nasdaq market at a price of $174.85 per share, accounting for about 20.5% of the total issued share capital of Baiji Shenzhou on the NASDAQ The acquisition is expected to be completed in the first quarter of 2020 Let's take a look at Baiji's R & D pipeline in drug research, which has made rapid progress in zanubrutinib (Btk small molecule inhibitor), tirelizumab (PD-1 inhibitor) and pamiparib (small molecule PARP inhibitor) Zanubrutinib is a Btk small molecule inhibitor, which is mainly used in the treatment of relapsed / refractory chronic lymphoblastic leukemia, Fahrenheit megaglobulinemia and other diseases Tirelizumab is now a popular PD-1 inhibitor in the market The indications of the company for listing are relapsed / refractory Hodgkin's lymphoma At the same time, there are several clinical products under development Finally, pamiparib is a small molecule PARP inhibitor, which is mainly used in the maintenance treatment of 2-line platinum sensitive recurrent ovarian cancer and 1-line platinum sensitive recurrent gastric cancer.