Analysis report of CDE drug review in June 2019

Highlight: this month, the total number of drug examination centers accepted is 627 (excluding reexamination) This month, 18 new chemical drugs of category 1 were accepted by CDE This month, 51 new acceptance numbers were applied according to the quality and efficacy consistency evaluation varieties of generic drugs According to the latest statistics of drug intelligence data, in June 2019, CDE undertook 627 new drug registration applications with acceptance number (excluding reexamination, the same below) Figure 1: the total acceptance of CDE drugs in January June 2019 increased by 3.29% compared with that in May Among them, 514 are chemical drugs, 32 are traditional Chinese medicine and 81 are biological products Let's take a look at the registration, acceptance and evaluation of chemical drugs, traditional Chinese medicine and biological products In June, CDE undertook 514 new chemical registration applications with acceptance number Figure 2 acceptance of CDE chemical drugs in various application types from January to June 2019 From the application of chemical drugs, the undertaking data of this month is higher than that of May, with different degrees of rise in new drugs, supplementary applications and one-off imports 1 The CDE has accepted a total of 30 acceptance numbers of domestic class 1 new drugs of chemical drugs this month, involving 12 varieties and 9 enterprises The following table shows the new class 1 drugs in June Table 1 new chemical class 1 drugs newly undertaken in June 2019 note: the queue number is up to June 30, 2019 Icp-022 tablets: icp-022, an innovative chemical medicine, is a highly effective and specific Btk inhibitor with excellent target selectivity Shr1459 tablet: shr1459 can inhibit the activation, proliferation and survival of B cell by selectively inhibiting Btk kinase, and then inhibit the growth of B cell lymphoma At the same time, inhibition of BTK can inhibit the activation of transcription factors, reduce the release of inflammatory factors, and then alleviate rheumatoid arthritis It is proposed to be developed for the treatment of B-cell lymphoma and rheumatoid arthritis Shr2554 is an EZH2 inhibitor EZH2 inhibits target gene expression by catalyzing trimethylation of the 27th amino terminal lysine of histone H3 The abnormality of EZH2 is closely related to the occurrence and development of lymphoma and multiple myeloma As a small molecule non peptide thrombopoietin receptor (tpor) agonist absorbed orally, hetrapa is mainly used in the treatment of chronic idiopathic immune thrombocytopenia (ITP) with poor therapeutic effect on glucocorticoids, immunoglobulins or splenectomy Ramtazolam mesylate for injection is a short acting agonist for GABAA receptor, which is suitable for general anesthesia in selective surgery Methoxyetomidate hydrochloride is an improved drug of etomidate, which has the advantage of safety and has a good market prospect in anesthesia operation Jack TiNi hydrochloride cream may be an effective drug for the treatment of skin diseases related to autoimmune diseases such as alopecia areata and atopic dermatitis After applying Jack TiNi hydrochloride cream, Jack TiNi is mainly distributed in the epidermis and dermis, less in subcutaneous tissues and muscles, and little drug enters the systemic circulation through the skin barrier, suggesting that the local The application of jaketinib hydrochloride cream can reduce the risk of systemic side effects caused by oral administration 2 The declaration of imported chemical drugs of category 1 was undertaken this month with 11 acceptance numbers of imported chemical drugs of category 1 Table II notes to newly undertaken imported chemical drugs of category 1 in June 2019: the queue number is up to June 30, 2019 02 evaluation of traditional Chinese medicine in June, CDE undertook 32 new applications for registration of traditional Chinese medicine, one of which was a new drug Figure 3 acceptance of CDE traditional Chinese medicine from January to June 2019 03 review of biological products in June CDE undertook 81 new biological product registration application acceptance numbers, 12 new drugs, 28 supplementary applications and 15 imports Figure 4 acceptance of CDE biological products from January to June 2019 10 biological products for treatment of category 1 were accepted this month, and now they have entered the corresponding queue for approval Table 3 new class 1 drugs of therapeutic biological products newly undertaken in June 2019 note: the queue number is up to June 30, 2019 04 the number of acceptance numbers declared according to conformity assessment in this month decreased by 32.89% compared with 76 in May, and 51 acceptance numbers declared according to conformity assessment were added Figure V acceptance quantity of consistency assessment from January to June 2019 Table IV acceptance number of new consistency assessment in June 2019 data source: drug intelligence data