Hengrui medicine vonolazan fumarate preparation approved for clinical use

On November 19, Jiangsu Hengrui Pharmaceutical Co., Ltd officially announced that its subsidiaries Chengdu Shengdi Pharmaceutical Co., Ltd and Chengdu Xinyue Pharmaceutical Co., Ltd recently received the notice of approval opinions approved and issued by CFDA and agreed to carry out clinical trials on vonolazan fumarate preparation In addition, Chengdu Shengdi Pharmaceutical Co., Ltd., a subsidiary, received the approval for clinical trial of drugs issued by CFDA and agreed to the clinical trial application of vonolazan fumarate tablets According to the announcement, on July 15, 2015, Chengdu Shengdi Pharmaceutical Co., Ltd and Chengdu Xinyue Pharmaceutical Co., Ltd submitted drug registration applications to Sichuan food and Drug Administration and were accepted Vonolazan fumarate tablets have strong alkalinity, and remain in the acid production site of gastric parietal cells for a long time, inhibiting the generation of gastric acid The main indications of this product are gastric ulcer and duodenal ulcer Vonolazan fumarate is a potassium competitive acid blocker The original R & D company is Takeda Pharmaceutical Co., Ltd., which was approved by PMDA to be listed in Japan in December 2014 The product name is takecab ®, the dosage form is tablet, and the specification is 10mg, 20mg for the treatment of acid related diseases, including Helicobacter pylori infection, gastroesophageal reflux, peptic ulcer, duodenal ulcer, gastric ulcer and esophagitis As of the announcement date, the company has invested about 2.43 million yuan in R & D projects of vonolazan fumarate and tablets Attached basic information of drugs 1 Drug name: vonolazan fumarate dosage form: API application matters: domestic drug registration classification: original chemical class 3.1 application stage: clinical applicant: Chengdu Shengdi Pharmaceutical Co., Ltd and Chengdu Xinyue Pharmaceutical Co., Ltd acceptance No.: cxhl1501633 Sichuan approval No.: 2016l09700 Review conclusion: according to the drug administration law of the people's Republic of China and relevant regulations, after examination, this product meets the relevant requirements of drug registration, and agrees to carry out clinical trials of this product 2 Drug name: vorolazan fumarate tablets dosage form: tablet application matters: domestic drug registration classification: original chemical class 3.1 application stage: clinical applicant: Chengdu Shengdi Pharmaceutical Co., Ltd Review conclusion: according to the drug administration law of the people's Republic of China and relevant regulations, after examination, this product meets the relevant requirements of drug registration and agrees to the clinical trial application of this product.