[Yao Kejun] important news in September: "enterprises" stop looking at Whampoa, Hengrui, Fosun, Zhengda Tianqing, "Yao" also looks at tinib, PD-1, CD47 mAb

September is coming to an end, and the Mid Autumn Festival just after the National Day is coming Is it exciting to have a little long holiday plus a big one? I wish all my friends a happy holiday here In this week's "drug gajun" column, let's take a look at some important domestic drug trends in September Production of new drug report: the first self-developed new anticancer drug furaquitinib, the first approved flutamizole cream in China By the end of this month (September 21), 5 new drugs have been approved in total among the new drugs reported for production, among which fquinotinib capsule, a new chemical medicine of category 3.1, two traditional Chinese medicines of category 8, and one vaccine have been approved In addition, one drug has not been approved, and two drugs have been approved The details are as follows: Data source: China's first self-developed new anticancer drug "fuquinotinib" was registered and accepted in the database of pharmaceutical intelligence On September 13, the fuquinotinib capsule declared by Hutchison Whampoa pharmaceutical was approved for production Fuquinotinib capsule is an innovative drug not listed at home and abroad, and it is a new anticancer drug for the treatment of advanced colorectal cancer It was born in Zhangjiang laboratory in Shanghai It was completely developed by domestic researchers It took 12 years and invested more than 1.5 billion yuan Fiquitinib is a quinazoline type small molecule angiogenesis inhibitor, whose main target is VEGFR kinase family (VEGFR1, 2 and 3) By inhibiting the phosphorylation and downstream signal transduction of VEGFR on the surface of vascular endothelial cells, inhibiting the proliferation, migration and lumen formation of vascular endothelial cells, thus inhibiting the formation of tumor neovascularization, and finally playing the role of tumor growth inhibition Fuquinotinib capsule provides a new therapeutic approach for patients with metastatic colorectal cancer, which can significantly prolong the survival of patients with advanced colorectal cancer who have received at least two chemotherapy regimens but still have disease progression On September 13, Jiangsu Yuanheng Pharmaceutical Co., Ltd approved the first approved flutramazole cream in China At present, only one of the first approved flutramazole cream in China has obtained the approval Flutemazol cream is used for the treatment of tinea (Trichophyton rubrum, Trichophyton mentagrophyte), dermatophyton (Trichophyton flocculus), Candida (Candida albicans, Candida near smooth, Candida tropicalis), trichosporum (trichosporidium assassi, trichosporidium mucilaginosum), Trichoderma and other sensitive disease control fungi caused by adult tinea pedis, tinea corporis, tinea cruris, cutaneous candidiasis, and tinea versicolor Ringworm At present, the sales situation of antifungal drugs in China is good Yuanheng pharmaceutical's flutramazole cream has been approved, or it is expected to seize billions of market shares of antifungal drugs Report the clinical situation of Fosun PD-1 monoclonal antibody, Xinda biological CD47 monoclonal antibody, SAR of special and heavy products reported to clinical new drugs, 7 drugs were approved this month, 1 drug was not approved, and 11 drugs showed "issued" The details are as follows: data source: Fosun PD-1 McAb in the registration and acceptance database of smart drugs was approved in the clinical trial of recombinant anti PD-1 humanized McAb injection applied by Fosun Pharmaceutical holding subsidiary Shanghai Fuhong Hanlin Biotechnology Co., Ltd on September 3 The new drug is an innovative therapeutic biological product independently developed by Fosun Pharmaceutical Group, which is mainly used for solid tumor treatment At present, the new drug has also been approved for solid tumor treatment in the United States and Taiwan: in September 2017, the Western time of the United States, the solid tumor treatment was approved by the U.S Food and Drug Administration for clinical trials; in December 2017, the solid tumor treatment was approved by the clinical trials of Taiwan's "health and Welfare Department" Up to now, the recombinant anti-PD-1 humanized monoclonal antibody injections on the global market include opdivo and keytruda There are no similar drugs with the same target in China (excluding Hong Kong, Macao and Taiwan) According to the latest data of iqviamid ASTM, in 2017, the global sales volume of recombinant anti PD-1 humanized monoclonal antibody injection was about 8.8 billion US dollars Xinda biological anti-CD47 monoclonal antibody obtained clinical approval on September 3, and Xinda biological recombinant all human anti-CD47 monoclonal antibody (R & D Code: ibi188) obtained clinical approval, which is intended to be used in the treatment of a variety of blood tumors and solid tumors, including non Hodgkin's lymphoma and ovarian cancer As one of the hot targets in the field of anti-tumor immunotherapy, CD47 has been hailed as the next "Star" in the field of tumor immunity after PD1 / PDL1 antibody This time, ibi188 obtained the approval document of clinical research, which means that Cinda biological's research on the target of CD47 has entered the stage of clinical research from early research and development, and is in a leading position in China On September 3, sar107375e injection, a dual inhibitor of XA and IIA factors, was applied for clinical application of sar107375e injection, a major special and specially approved drug, which was declared by Beijing kelibe Pharmaceutical Development Co., Ltd and showed "issued document" Sar107375e (SAR for short) is a direct dual inhibitor of XA and IIA factors (thrombin), which is intended to prevent and treat thromboembolic diseases SAR was first discovered by Sanofi Aventis in France, and some preclinical pharmacy and pharmacology and toxicology research were carried out in France In 2012, Beijing Kleiber Pharmaceutical Development Co., Ltd obtained the exclusive authorization to develop SAR in China It plans to complete preclinical pharmacy, pharmacology and toxicology research and clinical research in China, and finally promote its listing in China In September, three imported drugs were approved for import, and one drug showed "issued" The following is the specific situation: data source: drug intellectual drug registration and acceptance database, heavyweight new liver cancer drug "revatinib" On September 5, the market application of lovatinib mesylate capsule applied by Weicai for the treatment of HCC was approved Lovatinib is a multi-target kinase inhibitor, which can block a series of regulatory factors including vegfr1-3, fgfr1-4, PDGFR α, kit and RET in tumor cells On February 13, 2015, it was approved by FDA as a priority review and orphan drug for the treatment of high-risk differentiated thyroid cancer that is difficult to treat with radioiodine On May 13, 2016, it was approved by FDA and afinitor to treat advanced renal cell carcinoma that had previously received anti VEGF therapy On September 5, ekuzumab, a rare disease drug, was approved for import by Hangzhou tag pharmaceutical It is used for the treatment of paroxysmal sleep hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) in adults and children These two diseases are rare in the world Ekuzumab injection can control the above two diseases Ekuzumab is developed by alexion company of Switzerland and registered as an import agent by Hangzhou tiger Pharmaceutical Technology Co., Ltd The drug evaluation center of the State Food and drug administration has included the product into the priority evaluation procedure for evaluation because it is a clinically urgent product It is also exempted from the registration of clinical trials, but the applicant is required to supplement the effectiveness and safety information of the product after marketing, continue the clinical trials as planned, and dynamically revise the risk management plan It is reported that ekuzumab is very expensive, which costs about half a million dollars per person per year (US), which is the most expensive drug in the Guinness world record history According to relevant media reports, the price of the drug is higher in Canada, with an average annual drug cost of 700000 US dollars Among the generic drugs reported for production in September, 8 drugs were approved for production, 1 drug was not approved, 1 drug was approved for clinical use, and 7 drugs were "issued" The details are as follows: data source: drug registration and acceptance database Hengrui paclitaxel for injection (albumin binding type) On September 3, the paclitaxel for injection (albumin binding type) declared by Jiangsu Hengrui pharmaceutical was approved with the approval number of "gyzz h20183378" At the same time, after inquiry, the drug was recently recorded in the catalogue of Chinese listed drugs, which was deemed to have passed the consistency evaluation At present, there are also the first imitations of Eucalyptus in China, and they are also included in the list of drugs on the market Paclitaxel for injection (albumin binding type) is an anti microtubule drug, which is used to treat metastatic breast cancer or breast cancer relapsed within 6 months after adjuvant chemotherapy Data source: Taxol for injection (albumin binding type), a drug catalogue set listed in China, was developed by albolis life science company of the United States It was approved by the food and Drug Administration of the United States as early as 2005 Its English trade name is Abraxane It has been listed in the United States, the European Union, Japan and other countries and regions In September, according to the consistency evaluation varieties declared in the supplementary application, 2 drugs were approved, and 2 drugs showed "issued", as shown in the figure below: data source: drug intellectual drug registration and acceptance database Hengrui tansulosin hydrochloride sustained release capsule passed the first time On September 3, Jiangsu Hengrui's tamsulosin hydrochloride sustained release capsule was approved and passed the quality and efficacy evaluation of generic drugs Tamsulosin hydrochloride sustained release capsule is a selective adrenergic α - 1A receptor antagonist, which can be used to treat the abnormal urination symptoms caused by prostatic hyperplasia Developed by shannei Pharmaceutical Co., Ltd., it was first approved for marketing in Japan in 1993 On September 3, Harbin Sanlian mirtazapine tablet was first approved by Harbin Sanlian Pharmaceutical Co., Ltd about mirtazapine tablet (15mg), and passed the consistency evaluation of quality and efficacy of generic drugs Mirtazapine belongs to piperazine - azone compound, which is used in the treatment of depression It was developed by ojianong pharmaceutical in the Netherlands, approved to be listed in the Netherlands in 1994, and imported domestically in 2004 On September 3, the two drugs of Zhengda Tianqing showed "delivered products" Two varieties of Zhengda Tianqing, docetaxel injection and levofloxacin calcium for injection, showed "delivered products" Docetaxel is a semi synthetic taxol derivative, which has been widely used in the treatment of a variety of malignant tumors in recent years It is considered to be one of the most effective anticancer drugs Docetaxel has achieved good curative effect in the clinical treatment of breast cancer, ovarian cancer, non-small cell lung cancer and other malignant tumors It is also one of the most active drugs in the treatment of advanced breast cancer It is reported that the sales volume of docetaxel injection in the U.S market in 2015 was $154 million, while that in China was $318 million Levofloxacin calcium is mainly used in the treatment of osteosarcoma after high-dose methotrexate treatment, with clear clinical location and obvious advantages Combined with 5-fluorouracil, it plays an important role in the treatment of advanced gastric cancer and colorectal cancer The safety of levofloxacin calcium for injection is good, the incidence of adverse reactions is low, it has significant biological metabolism and clinical advantages, and has a broad application prospect In addition, at the end of August and the beginning of September, some other enterprises claimed that their products had entered the catalogue of Chinese drugs on the market and passed the consistency evaluation Specifically, there are moxifloxacin hydrochloride tablets and clarithromycin sustained-release tablets of dongyangguang, zuoxiracetam oral solution of Chongqing shenghuaxi Pharmaceutical Co., Ltd., and montelukast sodium granules of Changchun Haiyue Pharmaceutical Co., Ltd Data source: drug intelligence database information source: Announcement statement of relevant enterprises: the viewpoint of this article only represents the author, not the position of drug intelligence network, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.