Analysis report on CDE drug review in April

Highlights: Qilu pharmaceutical took the lead in applying for trelagriptin and was accepted by CDE Triagliptin is the world's first weekly oral antidiabetic drug, which was recently approved for marketing in Japan (trade name zafatek), developed by Takeda pharmaceutical, known as the heavyweight bomb in the field of diabetes The second generation of targeted antitumor drugs, beta CDE, was the core of the essence medicine in April 21, 2015 The new drug of 1.1 class of Weikeli medicine was approved for clinical use, including the drug substance of Weikeli, the tablets of Weikeli (2.5mg), the tablets of Weikeli (10mg), and the tablets of Weikeli (25mg) The new quarter has begun again According to the latest statistics of drug intelligence registration and acceptance database, in April 2015, CDE undertook 837 new drug registration applications with acceptance number (excluding reexamination, the same below) Among them, 720 are chemical drugs, 38 are traditional Chinese medicine, 69 are biological products and 10 are pharmaceutical excipients Let's analyze the registration acceptance and evaluation of chemical drugs, traditional Chinese medicine and biological products Figure 1 acceptance of CDE drugs from January to April 2015 in April 2015, the increase of acceptance quantity of chemical drugs and biological products led to a significant change in the total acceptance amount The total acceptance amount of this year exceeded 800 for the first time, with a 16.9% month on month increase and a 28.2% year-on-year increase 1、 In April, CDE undertook 720 new chemical registration applications with acceptance number, up 17.1% month on month Figure 2: the acceptance of CDE chemicals from February to April 2015: after the acceptance of new chemicals reached a low value in March, it showed a significant increase in April, with an increase of 71.7% Import, import re registration, and supplementary applications have all decreased, while the acceptance of generic drugs continues to rise The following is a detailed analysis of the acceptance of CDE chemicals in April 2015 1 New drug Figure 3: registration and distribution of new chemical drugs in April 2015 the number of new chemical drug applications in April was 309, accounting for 42.9% of the total number of chemical drug applications 68.0% of them were new drugs of class 3.1 1 7.4% of class 1 new drugs The proportion of five kinds of new drugs increased, accounting for 5.2% of the new drug application, only next to 3.1 and 1.1 new drugs Note: chemical drug registration and classification 2 Change the way of administration and have not been marketed at home and abroad 4 Change the drug substance and its preparation that have been sold on the market, including acid radical, base (or metal element), but do not change its pharmacological effect 5 Change the dosage form of the drugs that have been marketed in China, but do not change the way of administration 1) There are 23 acceptance numbers in 1.1 class of new drugs accepted by CDE this month, involving 8 varieties The figure below shows the new class 1.1 drugs in April Table I tnp-2092, a new class 1.1 new drug declared by Dano medicine in April 2015, entered the evaluation center on April 10 It is a drug for Helicobacter pylori, Clostridium difficile infection and other important gastrointestinal pathogenic bacteria infection The first phase of clinical trial has been completed in the United States As the second generation of targeted antitumor drugs, the essence of the pharmaceutical industry is a new structural compound It is screened by the Aspedia LLC company from its patent medicine targeting antitumor drugs that has the potential to cure lung cancer The essence pharmaceuticals get the exclusive right to use patatinib in China and Hong Kong and Macao Among them, Asia LLC is a research and development institution specialized in drug design and prospective drug screening in the United States In April 2015, a total of 9 new chemical drugs of category 1.1 were approved 2 in April 2015, artemisinine maleate, a new chemical drug of category 1.1, was approved as a water-soluble artemisinin derivative with a new structure It is a candidate new drug of category 1.1 for the treatment of systemic lupus erythematosus Shanghai Institute of medicine, Chinese Academy of Sciences reported to CFDA in October 2013 Applying for clinical research, according to the drug intelligence registration and acceptance database, the clinical approval has been obtained Systemic lupus erythematosus (SLE) is a typical systemic, refractory and lethal autoimmune disease In the past half century, there has not been a new chemical drug for systemic lupus erythematosus treatment in FDA in the United States, nor a new chemical drug with independent intellectual property rights in China Although the first antibody drug was approved by FDA in 2011 for the treatment of systemic lupus erythematosus, it is only used for lupus with moderate incidence Its efficacy needs to be confirmed by long-term clinical application, and tens of thousands of US dollars of treatment cost per year will also be excluded from the vast majority of patients Viagra, a new drug of category 1.1 of Weikeli medicine, has just been approved by Yatai, including Viagra bulk drug, Viagra tablets (2.5mg), Viagra tablets (10mg) and Viagra tablets (25mg) Wicagrel is an improvement of clopidogrel, which can inhibit platelet aggregation after two steps of metabolism activation in human body It is a platelet aggregation inhibitor for patients with acute coronary syndrome Clopidogrel, developed by Sanofi, was listed in China in 2001 In 2010, its global sales exceeded US $10 billion, accounting for more than 62% of the global market share of antithrombotic drugs It was the second largest drug in the world in 2010 According to the principle of medicine, compared with clopidogrel, the key metabolic activation step of wicagrel is carried out in the gut, which can avoid the CYP2C19 metabolic activation pathway of "clopidogrel" in the liver, and then prevent the "clopidogrel resistance" phenomenon of CYP2C19 weak metabolism patients and the resulting stent thrombosis The clinical dose of wicagrel will be much lower than that of clopidogrel, which can reduce the dose-related side effects caused by high dose 2) In April, the center accepted 210 applications for class 3.1 new drugs Among them, trilagliptin, which Qilu pharmaceutical first declared, is particularly noteworthy Triagliptin, the world's first weekly oral antidiabetic drug, was recently approved for marketing in Japan (trade name zafatek), developed by Takeda pharmaceutical, known as the heavyweight bomb in the field of diabetes Tregliptin is a weekly dipeptidyl peptidase IV (DPP-4) inhibitor It can selectively and continuously inhibit DPP-4 and control blood glucose level DPP-4 is an enzyme that can cause the inactivation of incretin (glucagon like peptide-1 (GLP-1) and Glucose dependent insulin-stimulating peptide (GIP)), and these two kinds of incretin play an important role in the regulation of blood glucose Inhibition of DPP-4 can increase blood glucose level dependent insulin secretion and control blood glucose level It is understood that DPP-4 inhibitor is the first new type 2 diabetes drug that can control blood glucose level by improving the body's own ability It can be used as a single drug or in combination with other oral hypoglycemic drugs Its mechanism of action is unique It has the unique advantages of no hypoglycemia, no weight gain, and small side effects The incidence of gastrointestinal adverse reactions is also very low At present, qugliptin is only listed in Japan and has not yet submitted clinical application in China Qilu pharmaceutical first applied and obtained CDE on April 24, 2015 The acceptance numbers are cxhl1500819, cxhl1500820 and cxhl1500821 respectively 2 Generics figure IV acceptance of generics from January 2015 to April 2015 from the last quarter to the beginning of this quarter, the number of chemical generics continued to rise, and the small editors are very "looking forward" to the performance of chemical generics in May 2、 In April, CDE undertook 38 new applications for registration of traditional Chinese medicine with the acceptance number 11 new drugs and 27 supplementary applications Figure 5: registration, classification and distribution of new traditional Chinese medicine in April 2015; the number of traditional Chinese medicine varieties accepted by CDE decreased in April Table 3: in April 2015, the varieties of new drugs of traditional Chinese medicine were reviewed from January 2015 to April 2015, even back to 2014, there were the same problems: the number of new drug R & D applications of traditional Chinese medicine was not large, and it remained in the compound preparation of traditional Chinese Medicine and natural medicine, i.e 6 kinds of drugs, especially 6.1 kinds of drugs, i.e compound preparation of traditional Chinese medicine How to break through this bottleneck is a key problem for Chinese medicine enterprises in China 3、 In April, CDE undertook 69 new applications for registration of biological products with acceptance number Figure 6 acceptance of CDE biological products in February April 2015: new drug acceptance increased by two acceptance numbers, but actually decreased by two varieties; supplement application increased by eight acceptance numbers Table 4 in April 2015, Tiantan biology, a new class 1 acceptance variety of biological products, started to apply for h7n9 influenza virus split vaccine and adjuvant in February 2014 and was accepted again in April 2015 As early as January this year, Hualan biological vaccine Co., Ltd has obtained the clinical approval of h7n9 influenza virus split vaccine Data source: drug intelligence registration and acceptance database note: the intellectual property rights of the above articles are owned by drug intelligence 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