"Drug Curry Jun" Johnson 20 billion varieties were accepted; CAR-T again welcome new players; Collon catch the last bus collection; international drug dynamics sad and happy ...

Guide: The latest, the week's drug review dynamics!this week to look at theinternational drug dynamics, sad and happythird domestic Tofatini was approved for listingthe car-T therapy of the drug MingJuno, China is the first to report productionthe second domestic, domestic HPV vaccine ushered in a new spoilerJohnson and Johnson's heavy target CD38 anticancer drug in China submitted two new listing applicationsthe current issue (June 29 to July 3) international and domestic drug approvals are proceeding in an orderly mannerInternational drug dynamics: Johnson and Johnson Ebola vaccine program, Pfizer's leukemia drug Daurismo are approved for listing in the European Union; Ono's new Parkinson's drug is also on the market in Japan; PD-1/-L1 products are in intensive harvest: Merck/Pfizer PD-L1 fda approval for first-line maintenance treatment of urethra cancer; Mercadong K.Kkeytruda FDA approved to treat skin-thyclusal cancerHowever, the treatment of OBAcholic acid NASH was rejected by the FDA, and the first NASH drug failed, and the Eljiann AMD drug abicipar pegol was also rejected by the FDAin the country, The first imitation of Ziru's lesaquilan tablets has been issued, and Parkinson's disease is the second most common neurodegenerative disease after Alzheimer's diseaseData show that China's Parkinson's disease patients about 3.1 million, with the aging problem is becoming more serious, it is expected that by 2030, China will reach about 5 million people, the market potential is huge, Qilu first approved, seize the market opportunityThe third domestic-made Tofatini, from Collum Pharmaceuticals, has been approved for saleThere are also a number of heavy-duty drugs declared for listingMore dynamics in this issue are as follows:the new dynamics of domestic review and approval
this week CDE has 32 acceptance numbers (27 varieties) reported production status updates, of which 15 status updates "issued" and 17 status updates "in approval", the specific dynamics are as follows: this issue focuses on the acetate In the recently announced third batch of the national drug collection regulations, the drug is one of the important varieties, Collum Pharmaceuticals as the third generic drug was approved for the market, the opportunity to ride the third batch of collection of the last bus, there is more room for price reduction Tofacitinib, an oral small molecule inhibitor developed by Pfizer's JAK1/JAK3, was approved by the FDA in November 2012 for the treatment of moderate to severe rheumatoid arthritis (RA), the world's first JAK inhibitor approved for the treatment of rheumatoid arthritis Entering our country in 2017 and entering the National Health Insurance Category B directory through negotiations in 2019 Tofatib's global sales reached $2.24 billion in 2019, up 26% year-on-year at present, in addition to Zhengda Qing, Qilu and this approved Colum, there are 11 enterprises to submit listing applications, in the context of the collection of large enterprises to open the race for generic drugs the new acceptance of the domestic review and approval this week CDE new report acceptance number 21 (18 varieties), the middle east sunshine phosphoric acid oseltamido dry suspension agent declared for listing, this is the third domestic declaration of this dosage form of enterprises; The application selling applications for the domestic divalent HPV vaccine of Johnson and Johnson Injection, Johnson and Johnson's Daretoyu mono-anti-monotonica injection, and the simple drug analysis are as follows: Johnson-Darattouyu monoimmune injection (daratumumum injection) Daretouu mono-injection is a human-derived, anti-CD38 IgG1 monoclonal antibody Approved in the United States in 2015, it is the world's first target CD38 monoclonal antibody At present, there have been many approvals in the United States to extend the scope of treatment of MM patients In July last year, it was conditionally marketed in China for single-drug treatment for recurrent and refractable multiple myeloma (MM) adult patients According to the drug clinical trial registration and information publicity platform, so far, the product has registered 5 clinical studies in China, the indications in addition to MM, there are recurrent or refractive nasal natural killing /T cell lymphoma , according to Johnson and Johnson's annual report, the product has sales of $2,998 million in 2019 and is a veritable heavy-duty drug At present, the domestic submission of 2 applications for indications, also means that and Johnson and Johnson quickly seize the Chinese market determination Xi Zerun Biological - Divalent HPV vaccine Xi Zerun biorecombined human papillomavirus (type 16/18) vaccine (yeast) is the second declared production of the dicvalent HPV vaccine in China At present, a total of four HPV vaccines have been approved for market, namely GlaxoSmithKline's dual-price vaccine, Mercado's quadrine and nine-valent vaccine, and Xiamen Wantai's domestic dual-price vaccine, the details are as follows: price alone, domestic HPV vaccine still occupies a certain advantage The report of the Zerrun bio-divalent cervical cancer vaccine is expected to further intensify the competition between domestic and imported HPV vaccines in the future but in terms of sales, the number of divalent HPV vaccines issued in China from 2017 to 2019 was 1107,150, 2112,000, and 2007,470 In 2019, the number of tetravalent HPV vaccines was 4622,152, and the number of ninth-price HPV vaccines was 2865551 Data show that the current domestic HPV vaccine market is still the dominant price of four and nine prices, look forward to with more domestic divalent HPV vaccine market, divalent HPV vaccine market can usher in new growth space drug Mingjuno- Ruikilensay injection Riquilensay injection (tentative) is based on the U.S giant company JCAR017, developed by the drug MingJuno independently developed a targeted CD19 CAR-T therapy It is also the second domestic CAR-T treatment to be declared listed after Fosun Kate Yikirillon In early June, the company completed a $100 million round B financing Rekirunsay injections were submitted to THE IND Application (Clinical Trial Application for New Drugs) through Mingju Bio in December 2017 to conduct clinical studies on the treatment of relapsed refractively difficult-to-treat lymphoma and leukemia, which was accepted in January 2018 There are currently two CAR-T treatments available worldwide, namely Gilead/Fosun Kate's Yescarta and Novartis's Kymriah, all of which are CD19 In 2019, Yescarta and Kymriah generated global sales of approximately $456 million and $278 million, respectively finally, Baiji Shenzhou PD-1 for the application of the 5th new indication, according to the announcement, this indication is for the treatment of previously treated non-removable hepatocellular carcinoma (HCC) patients data sources: drug intelligence data, enterprise announcements and other network public data
information sources: drug intelligence network, enterprise announcements and other network public information