[Yao Kejun] Zhengda Tianqing TAF has applied for listing! Howson's first lung cancer drug is coming

Highlights: 1 Xinlitai 60mg tegrilol tablet shows "hair piece"; 2 Haosen's first lung cancer drug, alfatinib maleate tablet, shows "hair piece"; 3 The gospel of hepatitis B patients, Zhengda Tianqing phosphorenofovir tablet (TAF) is reported for production This week (October 20-26), in the review and approval of drugs reported for production, 4 new Chinese medicines were approved, 1 generic Chinese medicine was approved, and 3 generic drugs showed "issued documents"; in addition, 1 new drug, 6 generic drugs and 2 imported drugs were applied for listing Let's take a look at each of them Among the new drugs reported for production in the new trends of drug handling, 142 acceptance numbers have changed this week, including 4 approval numbers for production (as shown in the figure below), and 131 acceptance numbers for new Chinese medicine, indicating "issued" Data source: among the generic drugs reported by the registration and acceptance database of pharmaceutical smart drugs, there are 4 acceptance numbers changed this week, of which, the important generic products of xinlitai, Jiangsu Haosen and Zhejiang Huahai all show "issued documents", as follows: data source: registration and acceptance database of pharmaceutical smart drugs On October 22, the acceptance number of tegrilol tablet, the first potential generic drug of xinlitai, was cyhs1800179, indicating "sent" According to the information of drug administration, its EMS mail No was 1090651128030 It is reported that the acceptance number corresponds to 60 mg tegrilol tablets Previously, xinlitai's 90mg specification was approved on August 7, becoming the first domestic model Tegrerolol is a direct acting, reversible combination of P2Y12 platelet inhibitor, which is used in patients with acute coronary syndrome (unstable angina, non ST elevation myocardial infarction or ST elevation myocardial infarction), including patients receiving drug treatment and PCI treatment, to reduce the incidence of thrombotic cardiovascular events It is reported that the industry is more optimistic about the prospect of the drug, and it is predicted that the market may exceed that of clopidogrel bisulfate tablets On October 22, the first alfatinib maleate imitation tablet in Haosen, Jiangsu Province, showed "sent pieces" According to the intelligence data of medicine, Haosen declared three acceptance numbers of the generic drug, which is one of the acceptance numbers this time Data source: alfatinib maleate was developed by Boehringer Ingelheim, which was approved by the US Food and Drug Administration (FDA) on July 12, 2013 The drug is used in the first-line treatment of metastatic non-small cell lung cancer (NSCLC), that is, when FDA approved clinical tests confirm the absence of exon 19 of tumor epidermal growth factor receptor (EGFR) or the substitution of exon 21 (L858R) for mutation On October 22, Zhejiang Huahai sailuodoxin capsule showed "delivered pieces" The drug was produced in the same production line and passed the FDA production site inspection as it was included in the priority review of 29 batches on June 5 The medicine is used to treat the symptoms and signs caused by benign prostatic hyperplasia (BPH) At present, only the first pharmaceutical (Beijing) has been approved in China Data source: registration and acceptance database of smart drugs new trends of drug undertaking new drugs this week, a new new drug reported for production is zanbutinib capsule of Baiji Shenzhou Data source: zanbutinib is a powerful and highly selective small molecule Btk (Bruton tyrosine kinase) inhibitor developed by Baiji Shenzhou As a single preparation and combination therapy drug, zanbutinib has been developed for the treatment of various lymphoma, and clinical trials have been carried out in many countries and regions And zambutinib has been approved by FDA for clinical research, and has also been awarded three orphan drug qualification certification by FDA, respectively for the treatment of mantle cell lymphoma, Fahrenheit megaglobulinemia and chronic lymphocytic leukemia In July of this year, the drug also received FDA's fast track qualification to treat patients with Fahrenheit megaglobulinemia (WM) It is reported that the main competitors of zambutinib in the global market are the first generation of BTK targeting drug imbruvica (erutinia) approved in 2013 and the second generation of BTK targeting drug calsequence (acalabrutinib) approved by FDA in 2017 It can be seen that the potential of the drug is unlimited, if approved, it may play a brilliant role in the domestic tumor industry In fact, Baiji Shenzhou has applied for the first acceptance number of the drug in August 2018, and it has also been listed in the list of special approved drugs, as shown in the figure below Data source: this week, the database of registration and acceptance of pharmaceutical and intellectual drugs newly undertook new drugs, and also undertook six new generic drugs reported for production, among which dongyangguang's xigliptin phosphate tablets, Nantong Lianya pharmaceutical's quetiapine fumarate sustained release tablets, Zhengda Tianqing's fospronofovir tablets are worth looking forward to The details are as follows: data source: drug intelligence drug registration and acceptance database Zhengda Tianqing fospronovoid tablets (TAF) on October 22, Zhengda Tianqing's fospronovoid tablet listing application was undertaken, at present, the original drug of Gilead's vemlidy is also listed in China TAF is a drug developed by Gilead for the treatment of patients with chronic hepatitis B (HBV) infection with compensatory liver disease The domestic hepatitis B market is huge, TAF as a new generation of hepatitis B antiviral drugs, its potential is self-evident, and if Zhengda Tianqing becomes the first company to develop the drug in the domestic market, its prospects are promising On October 22, the listing application of acerbitine phosphate tablets declared by dongyangguang Pharmaceutical Co., Ltd was accepted, which was used to treat type 2 diabetes At present, there are only imported drugs in China, and no enterprises have imitated and listed them However, a number of domestic enterprises have applied for listing, including 22 Acceptance numbers according to the six categories of chemical drugs, all of which have been approved for clinical use According to the new registration classification, 4 categories of application are Sichuan Kelun, Zhejiang medicine, Shiyao Ouyi and dongyangguang pharmaceutical Who's the first to imitate flowers? We're looking forward to it On October 22, quetiapine fumarate sustained-release tablet of Nantong Lianya Pharmaceutical Co., Ltd was accepted as the undertaker It is a non classical antipsychotic drug It is mainly used to treat schizophrenia At present, there are 3 domestic enterprises holding quetiapine fumarate tablets, and there is no production approval for sustained-release tablets This week, the company also undertook two new imported drugs reported for production, including the acceptance number of keytruda (pabolizumab), the star of Merck, which had been approved in July Data source: pharmaceutical registration and acceptance database information source: enterprise announcement and network information data source: pharmaceutical data statement: this point of view only represents the author, not the position of pharmaceutical 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.