[weight] analysis report on CDE drug review in November 2018

Highlight: 10 innovative drugs of category 1 of variegated drugs have been accepted by CDE this month, among which 3 innovative drugs of category 1 of variegated drugs have applied for listing This month, 81 acceptance numbers were added according to the quality and efficacy consistency evaluation varieties of generic drugs According to the latest statistics of drug intelligence database, in November 2018, CDE undertook 629 new drug registration applications with acceptance number (except for reexamination, as of November 30, 2018, the same below) Figure 1 the acceptance of CDE drugs from January to November 2018 the total acceptance of CDE drugs in this month increased compared with that in October Among them, 507 were accepted for chemical medicine, 33 for traditional Chinese medicine, 87 for biological products and 2 for in vitro diagnostic reagents Let's analyze the registration, acceptance and evaluation of chemical drugs, traditional Chinese medicine and biological products Review of monochemical drugs in November 2018, CDE undertook 507 new chemical registration applications with acceptance number Figure 2 acceptance of CDE chemical drugs from January to November 2018 from the perspective of chemical drug declaration, compared with October, the number of new drugs, supplementary applications and import re registration increased significantly, while the number of imports, imitations and one-time imports decreased, but on the whole, it increased slightly compared with October 1 Application of chemical medicine class 1 new drugs CDE accepted 27 acceptance numbers of chemical medicine class 1 new drugs this month, involving 10 varieties and 10 enterprises The figure below shows the new class 1 new drugs in November Table I new chemical class 1 drugs newly undertaken in November 2018 note: 1 Queue No up to December 4, 2018 The clinical trial application for the third generation EGFR inhibitor drugs c-005 and c-005 tablets jointly submitted by Nanjing Yinhe Biotechnology Co., Ltd and Wuxi Shuangliang Biotechnology Co., Ltd has been undertaken by CDE The third generation EGFR inhibitor clinical trial application jointly submitted includes one API and two specifications of tablets, and its clinical indication is non-small cell lung cancer It is understood that lung cancer is the first malignant tumor in China The incidence rate of EGFR gene mutation is nearly 50% in the lung cancer patients in China The third generation EGFR inhibitor has a huge market prospect Nanjing Xiansheng Dongyuan Pharmaceutical Co., Ltd has applied for the listing of a new class 1 drug, d-camphenol and edaravone d-camphenol injection, which has been undertaken by CDE This product is composed of Edaravone and (+ - 2-camphenol (4:1) It is the best combination of Edaravone and (+ - 2-camphenol It can clear the free radicals (· Oh, no · and ONOO ~ - ions) after stroke, inhibit the expression of inflammatory cytokines (TNF - α, IL-1 β, COX-2 and iNOS), block the interaction of free radicals and inflammatory circulation, and play a multi mechanism synergistic effect A large number of studies have confirmed that the efficacy of compound edaravone is 38% higher than that of edaravone, the dose is reduced to 1 / 10, and the therapeutic time window is prolonged by one time It is a new mechanism drug for stroke Edaravone is a kind of brain protective agent, which can remove free radicals and inhibit lipid peroxidation, thus inhibiting the oxidative damage of brain cells, vascular endothelial cells and nerve cells Edaravone can prevent the development of brain edema and cerebral infarction, relieve the accompanying neurological symptoms and inhibit the delayed neuronal death However, it was found that it had some side effects, such as acute renal failure with unknown degree, abnormal liver function, less platelet splashing and disseminated intravascular coagulation Yichang humanwell Pharmaceutical Co., Ltd has applied for the listing of class 1 new drug rimazolum besylate and rimazolum besylate for injection, which has been undertaken by CDE Remazolam besylate is a new type of super short effect sedative / anesthetic drug, which has the characteristics of water solubility and short half-life Compared with the same kind of products, rimazolom benzenesulfonate has faster onset, faster metabolism and lower activity of metabolites, which can reduce the interaction between drugs and has good effectiveness and safety The application for listing of Lvgu pharmaceutical's class 1 new drug, mannan oligosaccharide diacid and mannan oligosaccharide diacid capsule, has been undertaken by CDE Mannan oligosaccharide diacid (gv-971) is a kind of marine oligosaccharide drug, which can play an anti Alzheimer's disease role by inhibiting the aggregation of β - amyloid protein, regulating the imbalance of intestinal flora, reducing the neuroinflammation and other multi-target characteristics The results of phase III clinical study show that gv-971 can significantly improve the cognitive dysfunction of Alzheimer's disease after 36 weeks of treatment, and the incidence of adverse events is very similar to placebo, with good safety It is expected to become the world's first multi-target anti Alzheimer's drugs 2 The declaration of class 1 imported chemicals 8 acceptance numbers of class 1 imported chemicals were undertaken this month Table II notes to newly undertaken imported chemical drugs of category 1 in November 2018: 1 Queue No up to December 4, 2018 2 Evaluation of traditional Chinese medicine in November, CDE undertook 33 new applications for registration of traditional Chinese medicine, including 2 new drugs and 31 supplementary applications Figure 3 acceptance of CDE traditional Chinese medicine from January to November 2018 three review of biological products in November CDE undertook a total of 87 new biological product registration application acceptance numbers, 18 new drugs, 52 supplementary applications, 12 imports and 5 re imports Figure 4 acceptance of CDE biological products from January to November 2018 (4) information form of new drugs approved for clinical application / listing in this month (3) new drugs approved for clinical application / listing in November 2018 (5) application and approved varieties according to conformity assessment From May 2018, the acceptance number declared according to the conformity assessment has increased significantly, and it has been basically flat by September In November, 81 acceptance numbers declared according to the conformity assessment requirements were added Figure 5 data source of consistency evaluation varieties undertaken from January to November 2018: Yaozhi data statement: this point of view 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.