High density alarm! Three trends of clinical trials in pharmaceutical enterprises

As the cost of clinical projects rises again and again, enterprises choose to start clinical projects more and more cautiously Therefore, by analyzing which projects start clinical and which projects do not start clinical, we can judge the project orientation and preference of enterprises, and find out the existing problems As of June 15, 2017, there were 410 registration numbers publicized by CDE drug clinical trial registration and information publicity platform in 2017 Oral dosage forms are the main dosage forms, 181 tablets (including sustained-release tablets, orally disintegrating tablets, etc.), 65 capsules (including soft capsules, sustained-release capsules, etc.) and 88 injections In terms of injection, the products have been re evaluated, such as cinepazide maleate injection and enoxaparin sodium injection Trend 1: the most popular generic drugs in 2017 are tenofovir fumarate dipivoxil tablets according to the clinical registration number Chongqing Yaoyou Pharmaceutical Co., Ltd., Shandong new era Pharmaceutical Co., Ltd., Jiangxi Qingfeng Pharmaceutical Co., Ltd., Zhejiang Nanyang Pharmaceutical Co., Ltd., Hunan qianjinxiangjiang Pharmaceutical Co., Ltd., Shanghai huilun Jiangsu Pharmaceutical Co., Ltd and Sichuan hisic Pharmaceutical Co., Ltd., which launched clinical trials in 2017, plus the manufacturers Sichuan Kelun pharmaceutical Co., Ltd., Shijiazhuang Longze Pharmaceutical Co., Ltd., and Shenzhou Pharmaceutical Co., Ltd., which started clinical trials in 2016 but did not appear on the market, not mentioned above Wei Pharmaceutical Co., Ltd., Suzhou Teri Pharmaceutical Co., Ltd., Anhui Baker biopharmaceutical Co., Ltd., Anhui Anke Hengyi Pharmaceutical Co., Ltd and Jiangsu Zhengda Tianqing Pharmaceutical Co., Ltd It can be seen that since 2015, the CFDA quality consistency evaluation reform and clinical data self-examination and verification policy have had an impact on the cluster declaration of generic drugs The number of declaration manufacturers has decreased from more than 20 to about 10, but the competition is still fierce Since the second half of 2015, many products have been approved for clinical use in batches Xianda data v3.2 reviewed the start-up of clinical generic drugs approved in batches after 2016, and found that Jiangsu Hengrui and Zhengda Tianqing are the enterprises with the largest number of start-up projects among popular generic drugs In view of the rising cost of the project, the products with large market scale and market potential still have the phenomenon of starting clinical practice, such as tadalafil tablets and ibuprofen injection Tadalafil tablets started clinical acceptance in 2017, next to tenofovir fumarate dipivoxil tablets For the products with more competitors, limited product potential and relatively large number of listed manufacturers (such as repaglinide tablets), no enterprise has started clinical practice Clopidogrel bisulfate tablets are the only popular generic drugs in the 289 product catalog that must complete the consistency evaluation in 2018 At present, only Shenzhen xinlitai Pharmaceutical Co., Ltd is fighting for product protection Good products will never lack competitive manufacturers At present, four unlisted manufacturers have launched clinical trials Although atorvastatin calcium tablets are not included in the 289 product catalog, two listed manufacturers, Zhejiang xindonggang Pharmaceutical Co., Ltd and Beijing Jialin Pharmaceutical Co., Ltd., have started product protection war Table 1 clinical status of hot generic drugs with more approved clinical approvals (data source: Xianda data v3.2) trend 2: PPI inhibitor optical isomers cluster in 2016, after adjusting the chemical registration classification, the two categories were adjusted to "new improved drugs not listed at home and abroad" Among them, 2.1 category includes "APIs and preparations containing optical isomers of known active ingredients prepared by resolution or synthesis and having obvious clinical advantages" Dextran Lansoprazole for injection is in line with the standard of improved new drugs Jiangsu aosaikang Pharmaceutical Co., Ltd officially launched clinical practice in April 2017 In addition to dextran Lansoprazole for injection, many optical isomers of PPI inhibitors that are not listed in the domestic generic drugs also started clinical trials in 2017: Jiangsu aosaikang Pharmaceutical Co., Ltd started the clinical application of dextrorebellazole sodium for injection, Zhengda Tianqing Pharmaceutical Co., Ltd started the clinical application of dextroresolazole sustained-release capsules, and Hunan Mingrui Pharmaceutical Co., Ltd started the clinical application of dextrorebellazole sodium for injection and dextrorebellazole sodium enteric coated tablets Esmoloprazole in PPI inhibitor is the left-handed body of omeprazole The author presumes that the above project of PPI inhibitor optical isomer will go for the success of replicating esomeprazole In 2017, the international multicenter test of vorolazan fumarate tablets (tak-438) in Wutian, Tianjin continued Tak-438 is a new PPI inhibitor belonging to potassium competitive acid blocker (p-cab) It can stop the secretion of gastric acid in advance by inhibiting the binding of K + to H + - K + - ATPase (proton pump) in the last step of gastric acid secretion of gastric parietal cells It has a strong and lasting inhibition of gastric acid secretion It is expected to be listed in China in 2018 Trend 3: tumor is still hot In terms of clinical classification, anti-tumor drugs are still the hot field of clinical trials in China, no matter generic drugs or innovative drugs In 2017, nearly one quarter of clinical registration numbers correspond to cancer Among them, lung cancer, especially non-small cell lung cancer (NSCLC), is a hot spot In 2017, nearly half of the clinical registration numbers of anti-tumor drugs correspond to the indications of non-small cell lung cancer 90% of clinical trials of NSCLC are innovative drugs Table 2 drugs that started clinical trials of lung cancer in 2017 (data source: Xianda data v3.2) diabetes drugs are the second largest heat classification, 60% of clinical trials are bioequivalence trials, The corresponding products are Acarbose Tablets, agliptin benzoate tablets, fenofibrate tablets (Ⅲ), glimepiride tablets, cigliptin phosphate tablets, regglinide metformin tablets, wiggliptin tablets, metformin hydrochloride sustained-release tablets and metformin hydrochloride tablets Summary < from the data of clinical trials in 2017, the author thinks that "clustering" can be used as a key word summary: innovation is mainly clustered in anti-tumor drugs, and mainly clustered in non-small cell lung cancer; generic drugs start to cluster again, and the optical isomers of PPI inhibitors are also clustered clinically.