The layout of Class 1 new drugs is heating up: clinical applications account for the largest proportion! 3 applications for production in the first half of the year

The reform of registration and classification of chemical drugs will undoubtedly have a profound impact on the development of the industry More than a year has passed since the work plan for the reform of chemical drug registration and classification was issued in March 2016 to classify chemical drug registration How does the status quo of industry project approval change? For this reason, the author analyzes the relevant data of the declaration of chemical drug production in the first half of 2017 In the first half of 2017, the application for production and administration was still mainly based on the application for chemical drugs, and there was no production report for proprietary Chinese medicine or new class 2 chemical drugs New class 1: two new class 1 tinidazine (chemical medicine class 1 new drug) have been reported for production, two of which are tinidazine They are respectively the androtinib hydrochloride capsules declared by Zhengda Tianqing Pharmaceutical Group Co., Ltd and Nanjing edcheng Ningxin pharmaceutical research and Development Co., Ltd and the furaquinidine capsules declared by Hutchison Huangpu Pharmaceutical (Shanghai) Co., Ltd In addition, there is a new class 1 new drug for biological medicine, which is a recombinant Ebola virus vaccine jointly declared by kangxinuo biological Co., Ltd and the Institute of bioengineering, Military Medical Academy of the people's Liberation Army The indications of the clinical projects that have been initiated before by the capsule include advanced non-small cell lung cancer, small cell lung cancer, advanced medullary thyroid cancer, differentiated thyroid cancer, advanced soft tissue sarcoma, colorectal cancer, advanced renal cell carcinoma, soft tissue sarcoma, advanced gastric cancer, advanced gastric esophageal junction adenocarcinoma and esophageal squamous cell carcinoma Enrotinib hydrochloride capsule was included in the list of priority review varieties because of its obvious treatment advantages and major special projects compared with the existing treatment methods The recombinant Ebola virus vaccine was also included in the list of priority evaluation varieties with innovative drug registration application and major special projects There is no application for priority review of fqtinib capsule The indications of clinical projects started by fqtinib capsule include colorectal cancer (CRC), solid cancer, non-small cell lung cancer and advanced gastric cancer New 3 categories: injection based chemical drugs new 3 categories: API and injection declaration based Paclitaxel for injection (albumin binding type) is a relatively hot product in recent years After 2016, the manufacturers applying for production include Ouyi Pharmaceutical Co., Ltd of Petrochemicals Group, Jiangsu Kanghe biopharmaceutical Co., Ltd and Jiangsu Hengrui Pharmaceutical Co., Ltd In 2017, Jiangsu Hengrui Pharmaceutical Co., Ltd reported the production of the old 6 categories Ouyi Pharmaceutical Co., Ltd of Shiyao group and Jiangsu Hengrui Pharmaceutical Co., Ltd all obtained the qualification of priority review Jiangsu Kanghe biopharmaceutical Co., Ltd reported production in 2017 with new 3 categories, and it is expected to report specifications that are not listed in China The indications of temozolomide for injection reported by Hengrui were the newly diagnosed adult patients with glioblastoma multiforme, and the adult patients with anaplastic astrocytoma recurred or progressed after routine treatment with nitrosourea and methylbenzylhydrazine In 2015, Hengrui applied for production according to the old chemical medicine classification of 3.3, and stopped in the first batch of bed self inspection and verification This time, it applied for production again according to the new 3 categories Jiangsu aosaikang Pharmaceutical Co., Ltd has completed clinical application of temozolomide for injection In 2016, the sample hospital market of temozolomide oral medicine was 480 million yuan The first flurbiprofen axetil injection of Wuhan Da'an Pharmaceutical Co., Ltd., which was originally the first one to be reported for production, stopped in the first batch of bed self inspection and re production, is now ranked second by Chongqing Yaoyou Pharmaceutical Co., Ltd "overtaking" declaration in 2016 In 2016, the sample hospital market of flurbiprofen axetil injection reached 620 million yuan If the products of Wuhan Da'an Pharmaceutical Co., Ltd can be listed, it will change the exclusive pattern of Beijing Taide New 4, old 6: the first imitation is still hot new 4 and old 6 are mainly oral drugs There are some first-class imitations, such as apixaban tablets, dasatinib tablets, viagliptin tablets and lenalidomide capsules, Zhengda Tianqing Pharmaceutical Group Co., Ltd., Sichuan Kelun Pharmaceutical Co., Ltd and Jiangsu Haosen Pharmaceutical Co., Ltd competing for apixaban tablets, Jiangsu Haosen Pharmaceutical Co., Ltd and Qilu Pharmaceutical Co., Ltd competing for viagliptin tablets and dasatinib tablets In 2017, only Sinopharm group Ouyi Pharmaceutical Co., Ltd applied, and the only applicant of lenalidomide capsule was Zhengda Tianqing Pharmaceutical Group Co., Ltd In 2016, CFDA approved the first generic product, and in 2017, many manufacturers joined the competition, such as tenofovir dipivoxil fumarate tablets, Anhui Baker biopharmaceutical Co., Ltd and Suzhou Terry Pharmaceutical Co., Ltd Imported drugs (new category 5.1): 13 new imported drugs were reported for production in 2017, a total of 13 unlisted new imported drugs were reported for production (new chemical drug category 5.1) Among them, the fastest approved one was oxotinib mesylate tablets of AstraZeneca, which was approved in February and March The reported production of imported generic drugs (new chemical drug category 5.2) is mainly based on APIs, and the only preparation declaration is ambroxol hydrochloride solution for inhalation from Korea and the United States, which is also the first batch of "re pot meat" after withdrawal of clinical self inspection and verification Currently, only Korea and the United States have reported production in China Ambroxol hydrochloride solution for inhalation has started clinical practice in China, including Ruiyang Pharmaceutical Co., Ltd., Yunnan Longhai natural plant Pharmaceutical Co., Ltd and Jilin Sihuan Pharmaceutical Co., Ltd There is a new acceptance number mode for the production reporting of pharmaceutical excipients The first three letters of import are "JFS", and the first three letters of domestic are "CFS" In the first half of 2017, a total of five pharmaceutical excipients were reported for production In the clinical application, the proportion of class 1 new drugs is the largest, the proportion of class 1 chemical drugs is the largest, and there is basically no class 3 drug application In terms of the application of new chemical drugs of category 1, Guangdong dongyangguang Pharmaceutical Co., Ltd ranked first in the 20 application acceptance numbers in 2017, namely hec30654acoh and capsule, hec68498 sodium salt and capsule, hec74647pa and capsule, kangdariwei sodium and tablet, ritapiren and tablet Novartis ranked second with 10 application numbers, including cnp520, lik066 and inc280 Jiangsu Hengrui acceptance No 9 ranked third, shr7280 and tablets, shr8554 and injection, shr9146 and tablets Summary < from the trend of application in 2017, it can be seen that the popularity of new drug projects in China has increased According to Xianda data v3.2, Guangdong Dongguang, Jiangsu Hengrui, Shiyao group, Nanjing Shenghe, Shandong LVYE, Guangdong Zhongsheng, Shanghai Jingfeng, Sichuan Kelun, Zhengda Tianqing and other new drugs are actively distributed in Category 1 In the aspect of production report, the first imitation of chemical drugs is still a hot spot in the near future In addition, the approval speed of class I clinical application is relatively fast, and there will be approval results within half a year of application in 2017.