[yaocajun] it is the best-selling generic medicine in China that has passed Hengrui, zhengdaqingjiang and Shiyao in the speed priority review. It is the first one that will be sold in China. It has a large number of imported drugs, including Novartis, GSK, UCB and Weicai

Highlights: 1 Novartis 20 billion market power MS drug will be in the future; 1 The first drug approved by FDA in 56 years, the heavy-duty lupus erythematosus monoclonal antibody will be listed in China; 2 Yushi bieselizumab will be approved soon; 3 This enterprise may be the first in China after passing the priority review of Hengrui, Zhengda Qingjiang, Shiyao Ouyi and Baiyang pharmaceutical; 4 FDA approved another "only" orphan drug On July 5, the State Drug Administration issued a notice saying that it is conditional to approve the application for import registration of daratonumab injection for the single drug treatment of relapsed and refractory multiple myeloma in adult patients, including those who have previously received an egg white body inhibitor and an immunomodulator and who had disease progression during the last treatment Daretozumab is a humanized, anti-cd38igg1 monoclonal antibody, which binds to CD38 expressed in tumor cells, and induces apoptosis of tumor cells through various immune related mechanisms such as complement dependent cytotoxicity (CDC), antibody dependent cell-mediated cytotoxicity (ADCC), antibody dependent cell phagocytosis (ADCP), and FC γ receptor In addition to the official announcement of the State Food and Drug Administration on the listing of heavyweight drugs, this week (June 28 July 5), there are still some important developments in the domestic review and approval 01 new trends of domestic production reporting drugs Among the drugs reported for production, there are mainly 15 acceptance drugs in this week (except the drugs updated last week, for details, please refer to the previous issue [drug Kajun]) for status update Among them, fengomod hydrochloride capsule of Novartis, berylumab for injection of GlaxoSmithKline, peserizumab injection of ucbpharmasa and celecoxib capsule of Jinyao pharmaceutical are worthy of attention Fengomod hydrochloride capsule of Novartis Fengomod, developed by Novartis, was approved by the US FDA in September 2010 The indication is multiple sclerosis (MS); in March 2011, it was approved by the European Union; in September 2011, it was approved in Japan, and it was launched in Japan in November for the treatment of MS; in July 2014, it was approved by the European Union for the treatment of relapsing remitting multiple sclerosis (RRMS) patients who do not respond to the treatment of interferon β injection For gilenya ® According to the pharmaceutical sales database, since its launch, its sales have continued to grow In 2018, Novartis' sales reached US $3341 million, and Mitsubishi Tanabe Pharma's sales reached JPY 57.4 billion, a total of 24.59 billion yuan Beleyuzumab for injection of GlaxoSmithKline was jointly developed by British pharmaceutical giant GSK and American human genome science company (HGS, purchased by GSK in August 2012) It was approved by FDA as early as March 9, 2011, and used for adult SLE patients with positive autoantibody It was the first new drug for SLE in 56 years at that time On July 20, 2017, the subcutaneous injection type of baileyuzumab was approved by FDA for use in adult patients with active, autoantibody positive systemic lupus erythematosus (SLE) undergoing standard treatment On April 27, 2019, beryluzumab was approved by FDA for use in pediatric SLE patients over 5 years old It is the first drug approved for use in children's SLE in the United States The drug is the first inhibitor of B lymphocyte stimulating factor (BLyS) protein and the first monoclonal antibody for the treatment of lupus erythematosus In the market, sales growth of the drug remained stable, reaching 473 million pounds in 2018, equivalent to 4.153 billion yuan Ucbpharma SA peserizumab injection Peserizumab, developed by UCB, was approved by FDA on April 22, 2008, EMA on May 21, 2008, and approved by PMDA on December 25, 2012 Its indications are Crohn's disease, rheumatoid arthritis and psoriasis Arthritis and ankylosing spondylitis Elibrin mesylate injection elibrin mesylate injection, developed by Weicai, is the first single drug chemotherapy drug used to improve the overall survival of patients with metastatic breast cancer It was approved by FDA as early as November 2010 The drug is intended to be used in the treatment of local recurrence or metastasis of female breast cancer in China The domestic application for listing experienced more twists and turns It was accepted on August 15, 2016, but withdrawn on June 21, 2017 It was reapplied in December of that year Now it has entered the "in approval" stage and is expected to be approved this time Jinyao pharmaceutical celecoxib capsule was jointly developed by Pfizer and Astellas It was first approved by FDA on December 31, 1998, approved by EMA on October 17, 2003, and approved by PMDA on January 26, 2007 Pfizer is responsible for its listing in the United States and Europe, with the commodity names of Celebrex and onsenal respectively; Ansteel is responsible for its listing in Japan, with the commodity name of celecox Celecoxib is a cyclooxygenase (COX-2) inhibitor for the treatment of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis (as), acute pain (AP), primary dysmenorrhea (PD), and rheumatoid arthritis (JRA) in children over 2 years old Pfizer's sales reached $686 million in 2018 At present, there are only imported celecoxib capsules in China There are 64 acceptance numbers of domestic imitations, 51 of which are declared according to the old 6 categories and 13 of which are declared according to the new 4 categories, involving 7 pharmaceutical enterprises including Jiangsu Hengrui, Jiangsu Zhengda Qingjiang, Qingdao Baiyang pharmaceutical, Shiyao Ouyi, Tianjin Jinyao pharmaceutical, Qilu (Hainan), Sichuan, among which Jiangsu Hengrui, Jiangsu Zhengda Qingjiang Qingdao Baiyang Pharmaceutical Co., Ltd and Sinopharm Ouyi 4 enterprise application acceptance number were included in the priority review Jinyao Pharmaceutical Co., Ltd took the lead in entering the "in approval" stage this time and is expected to become the first approved enterprise in China 02 FDA approved NDA within this week, FDA approved 20 NDA applications, including one newly approved new molecular entity drug, xpovio of karyopharmtherapeutics Inc 6, and orphan drug Karyopharmtherapeuticsinc6 product xpovio On July 3, FDA approved karyopharmtherapeutics's xpovio (selinexor) to be listed in combination with dexamethasone for the treatment of patients with relapsed / refractory multiple myeloma These patients have received at least four kinds of pre-treatment, and are resistant to a variety of therapies, including at least two proteasome inhibitors, at least two immunomodulators and one anti-C D38 monoclonal antibody therapy In 2018, xpovio obtained the orphan drug qualification and priority approval qualification granted by FDA Xpovio is the first and only nuclear export inhibitor approved by FDA, and the only prescription drug that can be used to treat multiple myeloma that is not sensitive to proteasome inhibitors, immunomodulators and anti-CD38 monoclonal antibodies Statement: this opinion only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; 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