[Yao Kejun] the first MS rare disease drug in China was approved, the second PD-1 drug keytruda was approved, and Qilu, Shiyao Ouyi and xinlitai have applied for listing of heavy-duty generic drugs

Domestic medicine news this week (July 21 - July 27) among the new drugs CDE undertook to apply for listing, there are 1 new drug, 1 imported drug and 8 generic drugs In addition, several blockbuster drugs have been approved for marketing, such as the first MS rare disease drug telifloxane tablets, the second PD-1 star drug keytruda, and the two first generic drugs of colen The details are as follows: 1 on July 25, the listing application of class 2.1 new drugs of Shijiazhuang No.4 Pharmaceutical Co., Ltd was undertaken, and the application of class 2.1 new drugs of l-ornidazole and sodium chloride injection applied by Shijiazhuang No.4 Pharmaceutical Co., Ltd was undertaken According to the pharmaceutical intelligence data, at present, only Nanjing Shenghe Pharmaceutical Co., Ltd has the approval document of levononazole sodium chloride injection in the market, which dominates the market of levononazole injection It also comes from the fact that the drug is a kind of new drug developed by Nanjing Shenghe in 10 years and hundreds of millions of yuan L-ornidazole is the left-handed body of the third generation of the anti anaerobic and antigenic drug ornidazole Clinical trials show that the clinical efficacy of l-ornidazole is equivalent to that of ornidazole, and the incidence of clinical adverse reactions is significantly reduced, only 1 / 15 of ornidazole, which is safer in clinical application Shijiazhuang No.4 Pharmaceutical Co., Ltd is the second company to apply for listing of levornidazole sodium chloride injection in many years If it is approved, the market share will be divided 2 on July 25, the application for listing BMS abamipo injection was accepted, and the application for listing BMS abamipo injection was accepted Abamipo has been listed in the United States, Europe and Japan The drug is a selective T-cell costimulatory modulator, mainly used in one or more anti rheumatic drugs (DMARD), such as methotrexate, tumor necrosis factor (TNF) blocker treatment but insufficient response in adult patients with moderate or severe active rheumatoid arthritis As one of the best-selling products of Bristol Myers Squibb, abacept is also one of the top 10 best-selling rheumatic drugs in the world, with a revenue of 2.48 billion US dollars in 2017 3 Multiple generic drug listing applications are undertaken Among the eight generic drugs applying for listing this week, pemetrexed disodium for injection applied by Qilu pharmaceutical is of great concern At present, there are many domestic manufacturers of this drug, only Sichuan Huiyu and Jiangsu Haosen apply for consistency evaluation, and Sichuan Huiyu has entered the catalogue of Chinese listed drugs This time, Qilu will apply for listing according to the four categories of new chemical drugs, which is likely to be approved Take the lead in the assessment of consistency In addition, the generic drug of epsilon tablet applied by Ouyi has been listed According to the data of pharmaceutical intelligence, only two enterprises have applied for listing, and the other one is Jiangsu Haosen However, Haosen has withdrawn from the clinical self examination in 2016 If Ouyi is approved, it will become the first generic enterprise Finally, the tegrilol tablet applied by Shenzhen xinlitai is also worthy of attention At present, tegrilol tablet has not been listed domestically, but there are many enterprises applying for listing, including Zhengda Tianqing, Zhejiang Haizheng, Beijing Sihuan pharmaceutical, etc xinlitai's application has been undertaken, and the competition is intensified 4 on July 23, the first MS rare disease drug in China was approved, and telifloxamide tablet was approved for import for the treatment of recurrent multiple sclerosis (MS) This drug is the first approved oral disease correction treatment drug for multiple sclerosis in China In May 2018, multiple sclerosis was included in the first list of rare diseases in China According to the clinical research results, the drug significantly reduced the annual recurrence rate of patients and delayed the progress of disability The second PD-1 drug, keytruda, was approved On July 26, MSD announced that its PD-1 inhibitor, keytruda pabolizumab, was officially approved by the State Drug Administration for the treatment of unresectable or metastatic melanoma that failed in the first-line treatment It is the only PD-1 inhibitor approved for the treatment of advanced melanoma in China On June 15, CFDA officially approved the launch of the first PD-1 inhibitor in China, the Bristol Myers Squibb drug, opdivo, nevolumab injection, to treat some adult patients with non-small cell lung cancer (NSCLC) It took about seven months for opdivo to be listed and approved, while keytruda took more than five months and the listing speed was accelerating 6 on July 25, two first imitations of Kelun were approved for listing Sichuan Kelun Pharmaceutical Co., Ltd (hereinafter referred to as "Kelun") issued two successive announcements on the first imitations The two products are respectively "amino acid glucose injection" and "fat emulsion (10%) / amino acid (15) / glucose (20%) injection" The specification of amino acid glucose injection approved by Kelun pharmaceutical is 1000ml This product is the first amino acid glucose ready to use parenteral nutrition dual cavity bag in China It is the only series of dual cavity bag products that can be used for children's patients in the world The fat emulsion (10%) / amino acid (15) / glucose (20%) injection is 1000ml and 1500ml, which is the first industrial "all in one" three cavity bag product in the world It is used for the nutritional support of children and adults over 2 years old who cannot or have incomplete function or are contraindicated to take nutrition through the mouth / gut At present, the "all in one" nutrient solution infusion mode realized by the industrial three chamber bag is the development trend and recognized best form of parenteral nutrition treatment Zhejiang Huahai Pharmaceutical Co., Ltd announced that it has recently received the approval for drug registration of rocuronium injection issued by the State Food and drug administration It indicates that Huahai has the qualification to sell the drug in the domestic market Rocuronium injection is an auxiliary drug for general anesthesia It is used for tracheal intubation during routine induction anesthesia and for maintaining neuromuscular block of skeletal muscle during operation The drug was developed by organon and approved for marketing in the United States, the United Kingdom and the Netherlands in 1994 At present, the main domestic manufacturers of rocuronium injection include North China Pharmaceutical Co., Ltd., Zhejiang Xianju Pharmaceutical Co., Ltd., Fuan Pharmaceutical Group qingyutang Pharmaceutical Co., Ltd., etc According to the query, in 2017, the global market sales of rocuronium injection was about US $209.6 million (data source: IMS database), of which the domestic market sales was about RMB 340 million (data source: PDB database) Hot information of international pharmaceutical 1 Accession A new breakthrough in the past 10 years has been achieved On July 25, the approval of the heavyweight new drug of albway was granted On July 25, abbvie and neuroscience announced that the US FDA approved orilissa through the priority review Gamma Elagolix, the only oral gonadotropin releasing hormone (GnRH) antagonist, is used to treat women with moderate to severe endometriosis pain It is worth mentioning that orilissa Gamma It is the first oral therapy approved by FDA for this indication in ten years Accession For the first time in 60 years, GSK and medicines for Malaria Venture announced that the US FDA has approved the listing of their krintafel (tafenoquine) for the treatment of P vivax malaria It is worth mentioning that this is the first new drug that can prevent Plasmodium vivax malaria in a single dose, the first new treatment approved for treatment of Plasmodium vivax malaria in 60 years, and the 23rd new drug approved by the US FDA this year Accession The first IDH1 inhibitor was approved to treat specific leukemia On July 21, Agios pharmaceuticals announced that tibsovo ® (ivosedenib) was approved by the US FDA to treat adult patients with relapsed or refractory acute myeloid leukemia (R / R AML), whose susceptible isocitrate dehydrogenase-1 (IDH1) mutations were detected by FDA approved tests Tibsovo ® is an oral targeting inhibitor of IDH1 enzyme It is the only R / R AML therapy approved by FDA for IDH1 mutation 2 cutting edge development Accession Takeda new drug arrives at the end of phase 3, which is expected to become the first-line treatment for lung cancer on July 26th, Takeda Pharmaceutical (Takeda) Co., Ltd Pharmaceutical) announced that its global randomized phase 3 clinical trial alta-1l reached the primary end point in the first pre-determined mid-term analysis, confirming that in adult patients with local advanced or metastatic non-small cell lung cancer (NSCLC) who are ALK positive and have not received ALK inhibitors, Alibaba (brigatinib) can significantly improve the progression free survival (PFS) Arunbridge ® is a cancer targeting drug discovered by ariad pharmaceuticals and was acquired by Takeda in February 2017 In April 2017, Alibaba ® was approved by the US FDA to treat patients with ALK positive metastatic NSCLC who were in progress of disease or intolerant to clozatinib Accession Keytruda phase 3 clinical data is excellent, significantly prolonging head and neck cancer OS on July 26, MSD announced that its heavy-duty immunotherapy keytruda (pembrolizumab) in a phase 3 clinical trial, as the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma, significantly prolonging the total survival of patients, reaching the main clinical end point It is worth mentioning that this is also the first anti-PD-1 therapy with excellent overall survival in the first-line treatment of the disease Accession On July 25, GSK's VIV healthcare company announced that the dual drug treatment program composed of dolutegravir (DTG) and lamivudine (3TC) reached the main end point in the clinical phase 3 trial of treating patients with HIV infection After 48 weeks of treatment, the efficacy of the dual drug regimen was compared with that of DTG + tenofovir (TDF) / emtricitabine (FTC), which reached the non inferiority standard, and did not cause the generation of virus resistance Accession Recently, celgene company announced that the combination therapy (R2 therapy) of revivid (lenalidomide) and rituximab (rituximab) in the treatment of recurrent or refractory follicular lymphoma (FL) and marginal zone lymphoma In the clinical trial of lymphama, MZL), the main end point of the trial was reached Content source: Yaozhi data, yaozhi.com, yaomingkant, Sina pharmaceutical, China securities.com