Shanghai Pharmaceutical Group 1.1 chemical drug "sph3127 API and its tablets" obtained clinical approval

Shanghai Pharmaceutical announced on the evening of May 11 that the class 1.1 chemical drug "sph3127 API and its tablet" declared by the company and its wholly-owned subsidiary Shanghai Pharmaceutical Group (Benxi) north pharmaceutical Co., Ltd has obtained the approval document for drug clinical trials issued by the State Food and drug administration According to the announcement, the drug has the effect of lowering blood pressure The preclinical pharmacological and toxicological studies showed that the drug was superior to the similar products in efficacy, bioavailability, animal accumulation, safety window, etc The drug is jointly developed by Shanghai Pharmaceutical Co., Ltd and Japan's tambian Mitsubishi Pharmaceutical Co., Ltd., both of which have intellectual property rights Shanghai Pharmaceutical has submitted patent applications for the product to the United States, Japan, Europe, Australia, South Korea, the Philippines, China and other countries and regions, and has obtained authorization in China, the United States, Japan, Australia Shanghai Pharmaceutical is about to carry out clinical research work In the follow-up, the drug must pass the review and approval of the State Food and Drug Administration and obtain the production approval before it can be put on the market for industrialized production Up to now, the accumulated R & D cost of the drug has been about 81.826 million yuan Sph3127 is an antihypertensive drug with a large market demand According to ims-chpa data, the total sales volume of prescription antihypertensive drugs in Chinese hospitals in 2015 was 18.6 billion yuan.