[Yao Kejun] the approval of PD-1 tirizumab in Baiji Shenzhou is on the way; this product has many competitors, and Hengrui wins the first imitation

This week's highlights: Baiji Shenzhou PD-1 is "in the process of approval" for the listing application of rilizumab; Hengrui celecoxib is the first to prevent the attack; Tonghua Dongbao, the domestic insulin leader, is about to launch the first three generations of insulin This week, 34 acceptance numbers (29 varieties) of nmpa approval were reported to update the production processing status, including 5 new drugs, 4 imported drugs and 20 generic drugs Details are shown in the following table: some products of great concern are as follows: tirelizumab injection Tirelizumab (bgb-a317) is a PD-1 receptor inhibitor of human IgG4 monoclonal antibody independently developed by Baiji Shenzhou, a domestic innovative enterprise Tirelizumab is specially designed to minimize the binding with FC γ r on macrophages, thus eliminating antibody dependent phagocytosis (ADCP effect), which may be a potential mechanism for reducing T-cell depletion and resistance to anti-PD-1 therapy Baiji Shenzhou PD-1 for one of the ralizumab application for listing status shows "in approval" At present, China has 4 domestic PD-1 products, plus o, K drugs, a total of 6 PD-1 inhibitors, which are suitable for the treatment of non-small cell lung cancer, lymphoma, melanoma, etc It is no surprise that bleuzumab will be the 10th PD-1 / PD-L1 product in the world, the 4th in China and the 6th in China In addition, according to drug intelligence data, one of the indications of tirelizumab injection of bringer Ingelheim biopharmaceutical (China) Co., Ltd is also under approval In the past health care negotiations, Cinda bioxin dilimab injection has become the only PD-1 that has successfully entered the medical insurance negotiations; now, Baiji Shenzhou has been approved, and with the gradual negotiation and access of medical insurance, hundreds of billions of anti-tumor market doors have been opened Celecoxib (general name: celecoxib, trade name: Celebrex / Celebrex) is a COX-2 specific inhibitor developed by Pfizer and the first selective non steroidal anti-inflammatory and analgesic drug (NSAIDs) in the world It has successfully solved the problem of gastrointestinal injury of traditional non steroidal anti-inflammatory and analgesic drugs, and is known as a "milestone breakthrough" The drug was first approved by FDA in 1998, and its global sales once reached US $3 billion Since entering China in 2012, the market has been tightly held by Pfizer Data source: in November 2017, Pharma intelligence data reported that Hengrui's celecoxib capsule was listed in four new registration categories and included in the priority review to start the listing process of domestic generic drugs Subsequently, the application for listing of three enterprises was also included in the priority review: Jiangsu Zhengda Qingjiang, Qingdao Baiyang pharmaceutical, and Sinopharm Europe Italy In addition, Tianjin Jinyao Pharmaceutical Co., Ltd., Qilu Pharmaceutical (Hainan), Sichuan Guowei Pharmaceutical Co., Ltd., Beijing Fuyuan Pharmaceutical Co., Ltd., Beijing Yabao biopharmaceutical Co., Ltd and Nanjing Xiansheng Dongyuan Pharmaceutical Co., Ltd also apply for listing in the new 4 categories There are 7 enterprises that apply for 5.2 categories of imports, including alanbik pharmaceutical According to drug intelligence data, on November 29, the listing application of Hengrui generic celecoxib (acceptance No.: cyhs1700234) has been changed to "approved - pending certification", which is expected to be approved for listing in the near future About to win the first imitation in China! Source: the listing application of insulin glargine Tonghua Dongbao third generation insulin glargine has been changed to "under approval", which is expected to be approved for listing this month and take the bus at the end of 2019 Data source: Ganjing insulin injection is a new type of insulin analogue, which has the effect of long-term effect, no peak value of blood concentration and stable lowering of blood glucose Insulin glargine (trade name: Laishi / Lantus), originally developed as Sanofi, was approved by the U.S Food and Drug Administration (FDA) and the European medical product review committee in April and June 2000 respectively for the treatment of type 1 and type 2 diabetes Listed in China in 2004 Since its launch, the product has become the most dazzling star of insulin and its analogues in the world with its good curative effect, ranking first in the list of similar products for many years in a row At present, two domestic companies, Ganli Pharmaceutical Co., Ltd and Zhuhai federal Pharmaceutical Co., Ltd., have obtained the listing license of insulin glargine in 2005 and 2017 respectively There are 5 domestic third-generation insulin manufacturers, 3 foreign enterprises and 2 domestic ones The competition pattern is relatively stable Both insulin glargine and recombinant insulin glargine have been included in class B of national medical insurance catalog 2019 After the approval of Tonghua Dongbao's insulin glargine, it will further accelerate the domestic substitution and bring more drug choices for the majority of diabetic patients Review and approval of new acceptance: this week, CDE added 26 production acceptance numbers (18 varieties), including 1 new drug, 4 imported drugs and 13 generic drugs Details are as follows: how to break through the market of naduramine capsule in Baiji Shenzhou! Lenalidomide, one of the three new magic drugs, is an immunomodulator and antitumor drug Developed by celgene It belongs to TNF - α inhibitor and has the characteristics of immunoregulation, anti angiogenesis and anti-tumor The drug was approved by FDA on December 27, 2005, and then marketed in Europe (June 14, 2007), Japan (June 25, 2010) and China (January 23, 2013), respectively, for the treatment of myelodysplastic / dysplastic syndrome, mantle cell lymphoma and multiple myeloma On February 17 and 20, 2015, the US FDA and the EU EMA extended the indications of lenalidomide to treat multiple myeloma combined with dexamethasone In recent years, in the international market, naduramine has gradually become a popular single product in the field of medicine Data source: at present, there are 4 enterprises in the domestic market, namely Xinji, Beijing Shuanglu pharmaceutical, Zhengda Tianqing pharmaceutical and Qilu pharmaceutical The price competition of lenadelamine capsules from Beijing Shuanglu, Zhengda Tianqing and Qilu pharmaceutical is extremely fierce, with the biggest drop of 76% According to the data of pharmaceutical intelligence, the lenalidomide capsule of Baiji Shenzhou has applied for listing on December 2 Facing the big market and price war, how can Baiji Shenzhou break through? 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