[yaokejun] big move! Zhengda Tianqing takes the lead. In the past 10 years, it has made a blank and heavy-duty "TiNi" copy of the first production report. In the competition of 12 enterprises, it has made the first copy of the future by European medicine. The PD-1 of Baiji Shenzhou is brilliant again

New developments of review and approval this week (May 31 - June 6), 4 drugs reported for production enter the "in approval" status It is worth noting that europeane, the first group of three generic drugs for Parkinson's disease, is the first one to be applied for marketing, and the antifungal drug of Zhengda Tianqing is kapofungin acetate for injection On June 3, the Anda application of itrotofylline tablet declared by the company showed that it was "under approval" Itrotofylline was developed by Kyowa Hakko Kirin, Japan It was approved for listing by PMDA on March 25, 2013, and the commodity name is nouriast According to the sales database of smart drugs, the sales volume of the drug in 2018 reached 9.4 billion yen, equivalent to 563 million yuan Itrotofylline is the first adenosine A2A receptor antagonist in the world Adenosine A2A receptor is a kind of G-protein-coupled receptor (GPCR), which is widely distributed in human body In the brain, adenosine A2A receptors are thought to be particularly distributed in the basal ganglia, and degeneration or abnormality of the basal ganglia is common in Parkinson's disease The drug is used in combination with drugs containing levodopa to improve the end of dose phenomenon in Parkinson's patients According to the data of Yaozhi, no itracophylline tablets have been approved for listing in China 12 enterprises have applied for the clinical application of class 3.1 new drugs of the drug, all of which have been approved for clinical application successively, including Nanjing Huawei Pharmaceutical Co., Ltd., Shijiazhuang No.4 Pharmaceutical Co., Ltd., Chengdu Shengdi Pharmaceutical Co., Ltd The only one that applies for listing is Sinopharm Europe Italy pharmaceutical Now it has entered the stage of "approval", and will become the first listed company to imitate On June 3, tropisetron hydrochloride injection of Tianheng Pharmaceutical Co., Ltd in Ningbo showed "under approval" Tropisetron is the third 5-HT3 receptor antagonist after ondansetron and granisetron It is mainly used to prevent and treat nausea and vomiting caused by cancer chemotherapy and postoperative nausea and vomiting Chemotherapeutic drugs can stimulate the release of 5-HT in vivo, and transmit the signal to the vomiting center through the mediation of 5-HT3 receptor, leading to vomiting Therefore, the inhibition of 5-HT3 receptor antagonists on chemotherapy-induced vomiting is of great clinical significance Tropisetron hydrochloride injection belongs to the class B medicine of national medical insurance, which has certain market potential According to the domestic medicine database of pharmaceutical intelligence, at present, there are 31 production approvals of the medicine in China, involving 24 production enterprises If Tianheng pharmaceutical industry is approved this time, one more enterprise will compete However, because it is an old class 6 application, it still needs to pass the consistency evaluation to have an advantage in the market competition In addition, it is worth noting that in recent years, the drug control has become stricter In 2016, the drug was included in the key monitoring drugs of some tertiary medical institutions in Qinghai Province, and in 2018, it was included in the key monitoring drugs catalog of Ankang City On June 3, the generic application of caspofungin acetate for injection of Zhengda Tianqing showed "under approval" Caspofungin acetate was developed by Merck sharp Dohme (MDS) It was first approved by the US Food and Drug Administration (FDA) on January 26, 2001, and then approved by the European Drug Administration (EMA) on October 24, 2001 It entered China in 2002 under the trade name of Cancidas Kapofungin acetate is a new systemic antifungal drug It is suitable for the treatment of invasive aspergillosis which is ineffective or intolerant to other treatments At present, the global market sales of the drug is declining In 2017 and 2018, the decline rate is fast In 2018, the sales volume is only 326 million US dollars, almost half of that in 2009 However, the growth in the Chinese market is still considerable It is a heavy product in the domestic antibiotic market, which has been included in the national health insurance category B in 2015, the sales volume in the Chinese market exceeded 70 million US dollars But at present, in addition to the original research, only Jiangsu Hengrui has been approved for the first time At present, Hengrui has applied for consistency evaluation If Zhengda Tianqing is approved and applied for consistency evaluation in the same period, it is still possible to win a large market share In addition, it is worth noting that the acceptance number declared by Hainan Jinrui Pharmaceutical Co., Ltd was on August 18, 2017, and the review and approval status was updated to "certificate preparation completed - issued approval document", but nmpa has not updated the results In addition, Sichuan pharmaceutical preparation Co., Ltd was also on August 15, 2017, and the status showed "approval in progress", and there is no following, of which the reason is unknown New acceptance of review and approval: 31 production acceptance numbers were accepted this week, including 2 new drug acceptance numbers, 7 imported drug acceptance numbers and 22 generic drug acceptance numbers On June 3, 2019, the application of PD-1 mAb for blepharizumab injection by Baiji Shenzhou and bolingyingehan was accepted with new indications On September 6, 2018, CDE accepted the listing application of the drug for the first time The application indication is Hodgkin's lymphoma, and it has been included in the special approval and priority review, following the domestic pattern closely At present, the application has been reviewed and will enter the approval stage Although Baiji Shenzhou did not catch up with other enterprises in the time of listing in China (at present, five PD-1 monoclonal antibodies have been approved in China: pabolizumab (coreda) from mosadong, nevulizumab (odevo) from Bristol Myers Squibb, Cinda bio pharmaceutical sindelimab, Junshi bio trepril monoclonal antibody, Jiangsu Hengrui injection carrelizumab), this time, Baiji God The new indications of state code increase application, review and approval are also in the process of acceleration, and behind them are bringer Ingelheim and Bristol Myers Squibb, the US giant The market competition potential cannot be underestimated Note: 1 In September 2017, Xinji and Baiji Shenzhou carried out global strategic cooperation in the field of cancer The new base has obtained the exclusive authorization for the development and commercialization of tirelizumab bgb-a317 in the United States, Europe, Japan and other countries and regions outside Asia for the treatment of solid tumors, while the state reserves the solid tumor rights of tirelizumab bgb-a317 in Asia except Japan, as well as the global rights in the field of hematoma and internal drug combination In January 2019, Bristol Myers Squibb, an American pharmaceutical giant, agreed to purchase its competitor Xinji pharmaceutical at a price of US $74 billion, which did not affect the marketization of tirelizumab injection 2 In January 2018, Boehringer Ingelheim signed a long-term supply agreement for commercial products with Baiji As a part of the exploration and practice of "drug marketing license holder system" by Baiji Shenzhou and bringer Ingelheim, tirizumab will be produced in the world-class biological pharmaceutical production base in Shanghai The following are the clinical trials of tirelizumab injection declared in China at present, among which the indications for three phases of clinical trials are: localized esophageal squamous cell carcinoma, recurrent or metastatic NPC, HCC, esophageal squamous cell carcinoma, squamous non-small cell lung cancer, non squamous non-small cell lung cancer On June 3, CDE accepted the listing application of ulinuzumab injection and ulinuzumab injection (intravenous infusion) that Janssen applied for again Before that, in February of 19 years, the State Drug Administration approved the drug to be listed in China for the first time As the world's first all human "double target" interleukin-12 (IL-12) and interleukin-23 (IL-23) inhibitors, the drug is a biological preparation injected subcutaneously every three months for the treatment of unresponsive, contraindicated or intolerable adult plaque psoriasis with other systems such as cyclosporine, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) Patient Ustekinumab was developed by Janssen (a subsidiary of Johnson & Johnson), approved by EMA on January 16, 2009, FDA on September 25, 2009, approved by PMDA on January 21, 2011, and sold by Janssen in Europe, the United States and Japan The product name is stellara Since its launch, the sales volume of the drug has grown steadily, becoming one of the top ten best-selling rheumatic drugs in the world, with sales volume reaching US $5.156 billion in 2018 On June 3, the application for listing of lunvatinib mesylate capsule declared by Zhengda Tianqing Pharmaceutical Co., Ltd was accepted Zhengda Tianqing is also the first company to apply for the generic listing of the drug In addition, six enterprises have applied for the clinical trials of class 3.1 new drugs of the drug, including Jiangsu Hengrui, Jiangsu aosaikang Pharmaceutical Co., Ltd., Shiyao group, etc., while Jiangsu aosaikang Pharmaceutical Co., Ltd has also applied for class 1.6 new drugs Lovatinib mesylate, independently developed by Weicai, is an oral tyrosine kinase inhibitor with a new receptor binding mode In addition to other pathway related RTKs (including PDGF receptor PDGFR α; kit and RET) involved in tumor angiogenesis, tumor progression and improvement of tumor immunity, it also selectively inhibits vascular endothelial growth factor (V EGF receptor (VEGFR1, VEGFR2 and VEGFR3) and fibroblast growth factor (FGF) receptor (FGFR1, FGFR2, FGFR3 and FGFR4) In September 2018, the drug was approved for the first time in China for single drug treatment of unresectable HCC patients who have not received systemic treatment before It has become the first new systemic therapy for unresectable liver cancer in China in about 10 years, and has finally broken the ice for 10 years In addition to domestic, the drug has also been approved as a treatment for HCC in Japan, the United States, Europe and other countries In addition, the drug has other indications on the market Weicai has been approved in more than 50 countries, including the United States, Japan, Europe and Asia, to use lumbrotinib mesylate for the treatment of refractory thyroid cancer In more than 45 countries, including the United States and Europe, the drug was approved to be combined with everolimus for second-line treatment of renal cell carcinoma In Europe, the drug was approved for the treatment of renal cell carcinoma Data source: Pharmaceutical 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