Sangpi capsule, a new Chinese medicine for diabetes mellitus of Jiaying pharmaceutical, has entered the phase Ⅱ clinical supplement stage

Jiaying pharmaceutical announced in the evening of May 28 that Hunan Jinsha Pharmaceutical Co., Ltd., a wholly-owned subsidiary of the company, recently submitted to the board of directors a report on the new drug sangpi Su capsule (traditional Chinese Medicine) for the treatment of type II diabetes entering the phase II clinical supplement stage Sangpi Su capsule is one of the five kinds of new Chinese medicine developed by Jinsha pharmaceutical industry since 2000 It is also the only five kinds of new Chinese medicine in Hunan Province At present, the drug has completed phase I and phase II clinical research The results show that its curative effect on diabetes is significantly better than that of traditional Chinese patent medicine, comparable with the first-line chemical medicine, and it is a rare innovative Chinese medicine Jiaying pharmaceutical said that at present, sangpi capsule has entered the phase II clinical supplement stage, and it will carry out phase III (the last phase) clinical research and apply for drug production approval This means that in the future, the company will have its own innovative traditional Chinese medicine to treat diabetes, develop new leading drug varieties, enrich the product structure of the company, and enhance the company's development potential, so as to improve the company's core competitiveness and independent innovation ability, and form a new profit growth point, which is in line with the company's future development strategy Jiaying Pharmaceutical Co., Ltd.: announcement date of announcement on new drugs of wholly-owned subsidiary entering phase II clinical supplement stage 2014-05-29 Guangdong Jiaying Pharmaceutical Co., Ltd announcement on new drugs of wholly-owned subsidiary entering phase II clinical supplement stage Securities code: 002198 securities abbreviation: Jiaying pharmaceutical Announcement No.: 2014-028 announcement of Guangdong Jiaying Pharmaceutical Co., Ltd on new drugs entering phase II clinical supplementary stage of wholly-owned subsidiary The company and its directors, supervisors and senior managers guarantee that the contents of the announcement are true, accurate and complete, and that there are no false records, misleading statements or major omissions in the announcement Hunan Jinsha Pharmaceutical Co., Ltd (hereinafter referred to as "Jinsha pharmaceutical"), a wholly-owned subsidiary of Guangdong Jiaying Pharmaceutical Co., Ltd (hereinafter referred to as "the company"), recently submitted a report to the board of directors of the company that the new drug sangpi Su capsule (traditional Chinese Medicine) for the treatment of type II diabetes has entered the phase II clinical supplement stage Sangpi Su capsule is one of the five kinds of new Chinese medicine developed by Jinsha pharmaceutical industry since 2000 It is also the only five kinds of new Chinese medicine in Hunan Province At present, the drug has completed phase I and phase II clinical research The results show that its curative effect on diabetes is significantly better than that of traditional Chinese patent medicine, comparable with the first-line chemical medicine, and it is a rare innovative Chinese medicine 1 Drug characteristics and advantages 1 Significant efficacy: pharmacodynamic test shows that sangpi capsule can significantly reduce blood glucose, reduce glycosylated hemoglobin, and improve insulin level; phase I and phase II clinical results show that it has the same efficacy as Bayer's chemical α - glucosidase inhibitor - betacanthine, which can be used as a first-line diabetes drug The characteristics of sangpi capsule (traditional Chinese Medicine) compared with Baitangping (acarbose): the main chemical components of sangpi capsule, deoxynojirimycin (DNJ) and acarbose, are strong α - glucosidase inhibitors, acarbose is amylase inhibitor, DNJ is the downstream disaccharidase inhibitor, The side effects of sangpi capsule were much lower than acarbose In addition, Fagomine, another main component of sangpi capsule, has a significant effect on insulin secretion, and plays a multi-target hypoglycemic role together with the main component 2 Low side effects: sangpi capsule is from the common non-toxic traditional Chinese medicine Sangbaipi No obvious side effects were found in its general pharmacology, acute toxicity, long-term toxicity test and phase I and phase II clinical trials 3 High content of active ingredients: sangpi capsule contains 80% of the preparations with effective hypoglycemic parts, which is more than 50% of the requirements of class V of new drugs announced by Guangdong Jiaying Pharmaceutical Co., Ltd that new drugs of wholly-owned subsidiaries enter the phase II clinical supplement stage 4 Clear ingredients: the active and effective parts of sangpi capsule are confirmed as nitrogen-containing heterocyclic sugars 5 The mechanism of hypoglycemic action is clear: sangpi capsule can reduce postprandial blood glucose by multiple targets, mainly with the function of α - glucosidase inhibitor, in addition to improving the sensitivity of body cells to insulin and improving the insulin level of body 2 The clinical trials have been carried out Jinsha pharmaceutical research center has researched and developed the sangpi capsule for more than ten years It has been in four clinical trial bases: the Second Affiliated Hospital of Liaoning University of traditional Chinese medicine, the Oriental Hospital of Beijing University of traditional Chinese medicine, the Affiliated Hospital of Changchun University of traditional Chinese medicine and the First Affiliated Hospital of Tianjin University of traditional Chinese medicine, The phase I and phase II clinical studies (clinical research approval No.: 2005l01424) were successfully completed The control drug was acarbose, a German chemical α - glycosidase inhibitor The results show that sangpi capsule can significantly reduce the three evaluation indexes of diabetic patients (glycosylated hemoglobin, fasting blood glucose, postprandial blood glucose), and has no abnormal effect on the ECG, blood, urine, liver and kidney functions of the patients, and has no significant toxic and side effects 3 Impact on the company diabetes is one of the most common endocrine and metabolic diseases, with genetic susceptibility, which is easily triggered by environmental factors With the development of social economy and the change of people's life style (energy intake and exercise decrease) and the aging of population, the incidence rate of diabetes has increased year by year Now it has become the third non communicable disease threatening people's health and life after cardiovascular disease and tumor Type 2 diabetes, also known as adult onset diabetes, usually occurs after the age of 35-40, accounting for more than 90% of diabetic patients Sangpi Su capsule is mainly used in the treatment of type II diabetes Compared with the chemical drugs, it has no toxic side effects and has the same efficacy - Safety and effectiveness Compared with the traditional Chinese medicine compound preparation, it has a clear material basis and mechanism of action, a clear mechanism and controllable quality It also has the advantages of chemical medicine and traditional Chinese medicine products It is in line with the overall strategy and planning of the development of component traditional Chinese medicine in China At present, sangpi Su capsule has entered the stage of phase II clinical supplement In the future, phase III (the last phase) clinical research and application for drug production approval will be carried out This means that in the future, the company will have its own innovative traditional Chinese medicine to treat diabetes, develop new leading drug varieties, enrich the product structure of the company, and enhance the company's development potential, so as to improve the company's core competitiveness and independent innovation ability, and form a new profit growth point, which is in line with the company's future development strategy IV Risk Reminder: Guangdong Jiaying Pharmaceutical Co., Ltd announced that new drugs of wholly-owned subsidiary entered the phase II clinical supplement stage Sangpi capsule is a self-developed project of Jinsha Pharmaceutical Co., Ltd., which is currently in the phase II clinical supplement stage, In the development process, there may be risks such as the effect is not as expected, and there may be risks such as new drug approval and sales 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 that the board of directors of Guangdong Jiaying Pharmaceutical Co., Ltd May 28, 2014