CDE drug review analysis: PARP, FAK, BTK hot target new drug pile acceptance

Point of view
The total number of drug trial centers received this month was 485 (excluding review)this month 17 chemical drugs 1 class of new drug varieties were accepted by CDEthis month added 55 new acceptance numbers for the declaration of varieties evaluated by the consistency of quality and efficacy of generic drugsaccording to the latest statistics of the, in October 2019, CDE undertook a total of 485 new drug registration applications (except for review, the same below)Figure 1 January-October 2019 CDE drug acceptance
the total number of acceptances this month affected by the National Day holiday decreased by 25.04 percent compared to SeptemberAmong them, 403 were chemical drugs, 22 were Chinese medicine, and 60 were biological productsThe following and look at the registration of chemical drugs, traditional Chinese medicine, biological products acceptance and review of the analysisIThe review of chemical drugsin October CDE a total of 403 applications for the registration of new chemical drugs to accept the numberFigure 2 June-October 2019 CDE drug application types of acceptance (due to space limitations only show data in the last May)from the declaration of chemical drugs, this month's acceptance data compared to September, each application type of import re-registration, one-time import and supplementary applications have decreased to varying degrees1Chemical drug 1 domestic declaration CDE this month to accept the chemical drug domestic class 1 new drug a total of 17 acceptance numbers, involving 8 varieties of 8 enterprises The following table shows the new class 1 new medicines for October Table 1, October 2019 new drug 1 new drug note: the queue serial number until October 31, 2019 Zebutini capsules are auto-developed Luton's tyrosine kinase (BTK) inhibitors developed by BeiGene The drug design of this new BTK inhibitor is designed to maximize specific binding rates to BTK targets while minimizing off-target effects fluorofluorine pari is a PARP inhibitor and is one of the top 10 popular new drug targets in the world Currently, there are four PARP inhibitors listed worldwide, and in August 2018, Olapari was approved for listing in China, becoming the first small molecule-targeted PARP inhibitor in China The global market is around $1 billion in 2018, with Olapari accounting for more than half of the market HSK21542 Injection ("HSK21542") is a new, proprietary-intellectually available analgesic developed by Hesco For the treatment of acute and chronic pain According to the classification of new chemicals in China, the registration of drugs is classified as a class 1 of chemical drugs According to preclinical studies, HSK21542 is a selective agonist of peripheral kappa opioid receptors, with strong and long-lasting analgesic effect, this product is not easy to pass through the blood-brain barrier, in the play of peripheral analgesia at the same time, can avoid central opioid-related side effects, such as addiction, hallucinations, respiratory suppression and so on SH2442 (Bennotta) is a small molecular inhibitor of acetyl coenzyme A pyridine enzyme (ACC) developed independently by Nanjing San he pharmaceutical industry for the treatment of non-alcoholic fatty hepatitis (NASH) and its resulting liver fibrosis IN10018 is an FAK inhibitor developed by Bollinger Ingelheim and is now home to global development and commercialization rights to the drug FAK plays a role in many cellular functions that are critical to tumor development, such as adhesion, migration, proliferation, and immune escape, and FAK inhibitors can inhibit tumor growth and metastasis through cancer cells or immunomediated systos 2 Declaration of 1 imported drugs this month a total of 20 imported chemical drugs 1 category acceptance number was accepted to undertake Table II October 2019 new class 1 imported medicine note: the queue serial number as of October 31, 2019 II, The review of Chinese medicine in October CDE to undertake a total of 22 acceptance numbers for the registration of new Chinese medicine applications, of which 1 is a one-time import, 2 is a new drug, one is imitation, the other is a supplementary application Figure III January-October 2019 CDE Chinese medicine acceptance , biological products review October CDE to undertake a new biological products registration application acceptance number of a total of 60, 13 new drugs, supplementary applications 30, import 9, import re-registration 3, one-time import 5 Figure 4 January-October 2019 CDE biological products acceptance situation
this month there are 9 1 class of therapeutic biological products acceptance number to be accepted, are now in the corresponding sequence queue pending trial Table III In October 2019, the new treatment biologics 1 new drug note: the queue serial number as of October 31, 2019 IV, according to the consistency evaluation of the declaration of varieties this month according to the consistency evaluation of the number of acceptance numbers also affected by the National Day holiday compared with 91 in September decreased by 39.56 percent, the addition of 55 according to the consistency evaluation requirements of the acceptance number Figure I January-October 2019 CDE Drug Acceptance Form 1 October 2019 New Drug 1 New Drug Data Source: Drug Registration and Acceptance Database