Application for clinical trial of bromocriptine mesylate, a new diabetes drug of Hanyu pharmaceutical, was accepted

According to reports, bromocriptine mesylate tablet (bromoergocin tablet) is a new type II diabetes treatment drug approved by FDA in May 2009 The new drug is the first diabetes drug to pass the risk assessment after FDA released the guidelines for risk assessment of new hypoglycemic drugs and cardiovascular diseases The indication product has not been put on the market in China Announcement of Shenzhen Hanyu Pharmaceutical Co., Ltd on the acceptance of clinical trial application of bromocriptine mesylate tablets the company and all members of the board of directors guarantee that the content of information disclosure is true, accurate and complete without false records, misleading statements or major omissions Shenzhen Hanyu Pharmaceutical Co., Ltd (hereinafter referred to as "the company" or "Hanyu pharmaceutical") received the acceptance of the application for clinical trials of imported chemicals of bromocriptine mesylate tablets (bromoergometrine tablets) from the State Food and drug administration On September 26, 2014, the company obtained the acceptance notice with the acceptance number of "jxhl1400320 countries" Bromocriptine mesylate is a new type II diabetes drug approved by FDA in May 2009 The new drug is the first diabetes drug to pass the risk assessment after FDA released the guidelines for risk assessment of new hypoglycemic drugs and cardiovascular diseases The indication product has not been put on the market in China In 2012, Hanyu Pharmaceutical (Hong Kong) Co., Ltd., a wholly-owned subsidiary of the company, was established in Hong Kong As one of the main businesses of Hanyu in Hong Kong, the project of cycloset is the first time for the company to standardize the introduction of new drugs into the market It is a brand-new attempt for the company in drug variety screening, international registration and application, new drug market development, in-depth academic education, international business cooperation and many other aspects, and it is also a rapid improvement of organizational learning ability and comprehensive competitiveness Important practice The company's application for the clinical trial of bromocriptine mesylate tablets (bromoergocin tablets) has been accepted, which will not affect the company's recent business performance According to relevant national drug registration laws and regulations, after the clinical research application of the product is accepted, CFDA will conduct quality inspection and quality standard review on the applied samples, and the drug review center of State Food and Drug Administration will conduct technical review; after passing the review and approval of State Food and Drug Administration and obtaining the clinical test approval documents, the company will In order to carry out clinical research, the results and time of examination, review and approval are uncertain The company will timely perform the information disclosure obligation for the follow-up progress of the project Please make careful decisions and pay attention to investment risks It is hereby announced Board of directors of Shenzhen Hanyu Pharmaceutical Co., Ltd September 26, 2014