March: 2 NDA, 11 ind

In March, 11 products were involved in the clinical application for new drugs, and another two applications for new drugs were rimazolum of Hengrui medicine and utidelon injection of Huahao Zhongtian According to the trend, there are still nine applications for antineoplastic drugs in an explosive state (the applications for Zhengda Tianqing are temporarily included); one for cardiovascular drugs; two for infectious drugs, but they belong to different dosage forms; one for anesthesia Some new drugs worthy of attention are commented as follows S086 tablet: This product is the first heart failure drug sacubatralisartan sodium tablet declared by xinlitai The eutectic compound has applied for patent (patent cn105963296a) S086 uses technical advantages to make patent barrier Its indication is chronic heart failure, which is the eutectic compound of sacubaqu and exp3174 (active molecule of xinlitan) Previously, xinlitai thought that s086 was more effective than entresto at the Chengdu exchange meeting Yl-90148 tablets: Shanghai Yingli Pharmaceutical Co., Ltd is a wise chemical related company Two new drugs, PI3K inhibitor and SGLT2 inhibitor, have been declared before The former is in clinical phase 1, and the latter is jointly declared with Shanghai Medical Engineering Institute (it is said to be transferred to modern pharmaceutical) Other new drug target applications can see Ido / TDO inhibitors, ALK5 inhibitors and URAT1 inhibitors The author speculates that this product may be the current hot Ido inhibitors Zsp1241 tablet zsp1241 is an innovative drug with clear mechanism of action and independent intellectual property rights jointly developed by Zhongsheng pharmaceutical and yaomingkant It is mainly used to treat liver cancer, gastric cancer and other malignant tumors Related compounds have applied for domestic patents and international PCT patents The results of preclinical study showed that zsp1241 was effective in vitro and in vivo, and showed significant antitumor effect on various liver cancer, gastric cancer CDX or PDX models This product is the fifth innovative drug with independent intellectual property rights submitted by Zhongsheng Pharmaceutical Co., Ltd for clinical trial registration, and the fourth innovative drug for tumor treatment developed by the company and accepted by CFDA for clinical trial registration I guess this product may be SMO inhibitor Tsl-1502 capsule the author speculates that this product may be a PARP inhibitor, the original code is hd-199 The drug may be purchased by Tianshili from Henderson Pharmaceutical Co., Ltd in Suzhou, with a total R & D cost of 19.58 million yuan, supported by the 12th Five Year Plan of "major new drug" development The applications for registration and listing of rimazolom toluene sulfonate and rimazolom toluene sulfonate for injection submitted by Hengrui Pharmaceutical Co., Ltd and its subsidiaries Shanghai Hengrui and Jiangsu Shengdi have been undertaken by CFDA According to the inquiry, at present, only Hengrui medicine has submitted the listing application of rimazolum toluenesulfonate and its preparation in China, and another rimazolum toluenesulfonate and its injection developed by Renfu Pharmaceutical Co., Ltd are in clinical trials Up to now, Hengrui pharmaceutical has invested about 41.9 million yuan in the R & D project Zl-2401 zl-2401 (omadacycline) is a drug licensed from paratek pharmaceuticals in April 2017, with a down payment of $7.5 million and a milestone payment of $54.5 million The drug is a tetracycline derivative, which can inhibit the protein synthesis of bacteria and play an anti infection effect This declaration reflects the superiority of MAH system API is provided by kailaiying, injection is manufactured by Hangzhou AoYa, and tablet is manufactured by xuantai Haimen pharmaceutical The indication of qhrd107, a class 1 new drug of qhrd107 capsule Qianhong pharmaceutical, is acute myeloid leukemia (AML) Its target is CDK9 It can inhibit the growth of tumor cells by inhibiting the phosphorylation of RNA polymerase Ⅱ at the transcription level Qhrd107 is one of the most active CDK9 inhibitors It is also the only CDK9 inhibitor that has been declared clinically in China It is expected to be the first new type of CDK9 inhibitor that can effectively treat AML In addition to qhrd107, which has been applied for clinical application, ls009 project is also in pre clinical research stage, and it is expected to apply for clinical application next year At present, Qianhong pharmaceutical has established a new drug innovation platform that combines the research and development of macromolecular drugs with the research and development of micromolecule drugs, and its R & D strength has been greatly improved At the same time, it has jointly built a Sino Australian new drug research and development joint laboratory with Nan'ao University, which is expected to continue to introduce high-quality innovative drug projects, and drive long-term development through innovation transformation The project was developed by the holding subsidiary, Innolux As early as 2015, Qianhong pharmaceutical purchased 55% equity of Changzhou Innolux, an innovative anti-cancer drug R & D enterprise, with 16.5 million yuan, to enhance the R & D strength of the company Legubicin for injection is an anti-tumor drug developed by Dr Liu Chen, which should be the platform of prodrug technology The patent shows that the derivative improves the metabolism of doxorubicin in vivo, improves the half-life and greatly reduces the toxicity in tumor site activation In addition The company has also developed taxol At present, budweitini capsule Hangzhou Derun Yucheng biology Co., Ltd should be a subsidiary of Suzhou Taolue biology Co., Ltd established in Hangzhou, and the patent of the drug should be the BTK inhibitor related patent of the company Utidelone (utd1) is a genetically engineered epolmycin analogue 26 hospitals across the country have carried out phase III clinical studies to compare the efficacy and safety of utd1 combined with capecitabine and capecitabine alone in patients with advanced breast cancer who failed to receive anthracycline and taxol based regimens The results showed that the median PFS, OS, objective remission rate and clinical benefit rate of utd1 and capecitabine groups were significantly better than those of capecitabine group In terms of safety, there was no significant difference between the other groups except for the peripheral neuropathy in utd1 + capecitabine group New drug application in 2018 is expected to exceed 70% of anti-tumor drugs Does China's tumor drug market really need so many new drugs? We are not seeing the improvement of new drug research and development in China, but rather the over concentration of bubbles, but some companies are making great arrangements in the development of new targets.