[exclusive] analysis report on CDE drug review in September 2018

According to the latest statistics of drug intelligence database, in September 2018, CDE undertook 630 new drug registration applications with acceptance number (except for reexamination, as of September 28, 2018, the same below) The total acceptance amount of this month is slightly higher than that of August, mainly due to the obvious increase of pharmaceutical excipients Among them, 496 are accepted for chemical medicine, 25 for traditional Chinese medicine, 64 for biological products, 13 for medical packaging materials, 25 for medical auxiliary materials and 6 for raw materials Let's analyze the registration, acceptance and evaluation of chemical drugs, traditional Chinese medicine and biological products In September 2018, CDE undertook 496 new chemical registration applications with acceptance number From the perspective of chemical drug declaration, the decrease in the number of accepted drugs is mainly in the import, import re registration and generic drugs, with a small increase in new drugs and a significant increase in supplementary applications In this month, CDE accepted 28 acceptance numbers of class 1 chemical drugs, involving 9 varieties and 8 enterprises The figure below shows the new class 1 new drugs in September (Table 1) new chemical class 1 drugs newly undertaken in September 2018 note: 1 Queue No until September 28, 2018 Chengdu Haichuang Pharmaceutical Co., Ltd has applied for hp501 and its sustained-release tablets, which have been accepted by CDE Hp501 is used to treat hyperuricemia and gout According to the results of preclinical studies, hp501 has better bioactivity than other drugs of the same kind, showing excellent PK and toxicological properties, and its bioactivity is higher than that of known products of the same target At present, there is no independent and innovative gout treatment drug in China The listing of hp501 will break the monopoly of foreign pharmaceutical enterprises in China's gout new drug market and provide safe, effective and reasonably priced treatment drugs for Chinese patients The first class new drug hzb1006 and its preparation applied by Harbin Zhenbao Pharmaceutical Co., Ltd are the first class innovative drugs jointly researched and developed by Harbin Zhenbao Pharmaceutical Co., Ltd and Shanghai yaomingkant new drug development Co., Ltd according to the "pan-fgfr inhibitor treatment of liver cancer class 1 new drug project technology development contract" signed by both parties Harbin Zhenbao Pharmaceutical Co., Ltd has its own independent Intellectual property Hzb1006 capsule is a multi kinase inhibitor mainly composed of FGFR and VEGFR It has dual effects of cell inhibition and anti angiogenesis The mechanism of action of the drug is clear, and the target selectivity of efficacy is high It is evaluated in preclinical liver cancer model, showing that the in vivo efficacy is better than that of the same listed control drug, with better safety, drug-forming and clinical development value The target drug on the market is sorafenib toluenesulfonate tablets produced by Bayer company of Germany, and erdafitinib of Janssen biotechnology company is under research, and phase II clinical research is under way (from its listing announcement) Jiangsu Hengrui Pharmaceutical Co., Ltd declared two varieties of new chemical drugs of category 1 this month, namely shr0302 tablets and shr2285 tablets Shr0302 is a small molecule JAK kinase selective inhibitor independently developed by Hengrui and with intellectual property rights Tofetinib developed by Pfizer was approved to be listed in the United States in November 2012, and imported tofetinib was approved to be listed in China in March 2017 It is the only JAK kinase inhibitor listed for the treatment of rheumatoid arthritis at present Because of its strong inhibition on Jak1 / 2 / 3, it is found that there are adverse reactions of anemia on the bed Based on this, Hengrui developed a more secure Jak1 selective kinase inhibitor shr0302 Heptenofovir fumarate and its preparation, a class 1 new drug jointly declared by Xi'an Xintong Pharmaceutical Research Co., Ltd and Guangdong Qifang Pharmaceutical Co., Ltd., have been accepted by CDE This product is an antiviral drug Dano Pharmaceutical (Suzhou) Co., Ltd is an innovative enterprise in the clinical stage, specializing in the research and development of the first and best antibacterial new drugs of the same kind, committed to solving the major medical needs in the field of antibacterial Tnp-2198 capsule is also a kind of double target molecular drug for bacterial vaginitis This month, 8 acceptance numbers of imported class 1 drugs were undertaken (Table 2) notes to newly undertaken imported chemical drugs of category 1 in September 2018: 1 Queue No until September 28, 2018 In September, CDE undertook a total of 25 new TCM registration application acceptance numbers, including 1 new drug and 24 supplementary applications In September, CDE undertook 64 applications for registration of new biological products, 14 new drugs, 23 supplementary applications and 15 imports Since May 2018, the acceptance numbers declared according to the conformity assessment have increased significantly, reaching a new high in September, adding 71 acceptance numbers declared according to the conformity assessment requirements Statement: this opinion only represents the author, not the position of yaozhi.com, 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.