Huahai Pharmaceutical Co., Ltd.'s withdrawal of 8 drug applications

A notice issued by the General Administration of drugs on the 26th once again pushed Huahai Pharmaceutical (600521) to the forefront of the wave Huahai pharmaceutical shares fell 4.41% on the 27th In response to the announcement on the evening of the 29th, 38 million yuan was invested in R & D expenses Withdrawal of drug applications only delayed the domestic listing of drugs Recently, the State Food and Drug Administration issued the announcement on 90 enterprises withdrawing 164 drug registration applications (2015 No 255) Huahai Pharmaceutical Co., Ltd is one of the enterprises with the largest number of applications for withdrawal of drugs Eight drugs of the company have applied for registration withdrawal Huahai pharmaceutical announced on the evening of November 29 that the company's voluntary withdrawal of the above eight drug registration applications is based on the current situation and problems of the domestic clinical institutions, as well as the suggestions of the clinical research institutions and the contract research organizations, and at the same time, in combination with the latest review and approval policies of the State Food and drug administration "Six of the above-mentioned products have been approved in Europe and the United States and have been marketed on a large scale The clinical research of non Brest tablets in the United States has been completed and are applying for registration and approval According to Huahai pharmaceutical, the accumulated R & D cost of the above eight drugs is about 38 million yuan (including the R & D cost of European and American registration of some varieties) The withdrawal of the registration application will not affect the company's current business performance, but will delay the domestic listing of relevant varieties and affect the company's domestic market sales in the short term In July, the State Food and Drug Administration required 1622 varieties of drugs from hundreds of pharmaceutical enterprises to carry out self-examination in clinical trials Before August 25, the applicant shall submit the electronic self inspection report and the authenticity commitment signed by the legal representative for the varieties listed in the annex and the food and drug audit and inspection center The false applicants, clinical trial institutions, contract research organizations and relevant responsible personnel shall be blacklisted The clinical trial data of the person directly responsible for fraud participating in the research or organizing the research shall not be accepted within ten years It is reported that 509 varieties have withdrawn drug registration applications, accounting for 31.4% of the 1622 verified varieties There are 530 varieties, accounting for 32.67% of the varieties examined So far, one third of the 1622 self inspection varieties have been withdrawn or not approved However, 90 pharmaceutical companies voluntarily withdrew this time, which had nothing to do with the fake "blacklist" of clinical trial data released by the General Administration on November 11 Zhejiang Huahai Pharmaceutical Co., Ltd in the "blacklist" voluntarily withdrew 17 varieties, and 90 pharmaceutical companies withdrew the most varieties Other enterprises with a large number of applications for registration withdrawal this time include: Shaanxi quantum high tech Pharmaceutical Co., Ltd 6 varieties, Hainan Lingkang Pharmaceutical Co., Ltd 5 varieties, Shandong Jingwei Pharmaceutical Co., Ltd 4 varieties.