Hualing medicine announces the first global satisfactory result of phase II clinical trial of single drug treatment of new diabetes medicine

October 17, 2016, Shanghai, China, San Francisco, California, USA Hualing pharmaceutical, a leading innovative pharmaceutical R & D enterprise, today announced that the phase II clinical trial of "new glucokinase agonist (GKA) H ms5552", an innovative diabetes drug, has obtained the first positive results of similar new drugs in the world Hms5552 is the fourth generation of oral glucokinase activator It works by regulating the target of glucokinase as "glucose sensor" and controlling the steady-state balance of blood glucose metabolism The data of phase II clinical trial is very satisfactory, and the statistical results show that the curative effect is significant In addition, the test results also showed that hms5552 had excellent tolerance and safety, lower risk of hypoglycemia, and lower risk of common side effects of most diabetes treatment in this study The 12 week clinical trial was led by Professor Zhu Dalong, chairman designate of diabetes credit association of Chinese Medical Association, and was carried out in 22 leading clinical centers nationwide The phase II clinical trial of hms5552 is a multicenter, randomized, double-blind, placebo-controlled, 5-dose group parallel study with 258 patients with type 2 diabetes The patients were divided into placebo group, 75mg QD (once a day), 100mg QD group, 50mg bid (twice a day) group and 75mg bid dose group After a 4-week placebo induction period, patients were randomly assigned to any of the above groups for 12 weeks of double-blind treatment The inclusion criteria of HbA1c were 7.5% - 10.5% at baseline, and the average HbA1c baseline before treatment was 8.37% At the end of the 12 week treatment period, HbA1c of each group corrected by the least partial multiplication was - 0.3% in the placebo group, - 0.5% in the 75mg QD group, - 0.7% in the 100mg QD group, - 0.8% in the 50mg bid group and - 1.1% in the 75mg Bid Group Except for the lowest dose of 75mg QD group, all other dose groups had statistically significant differences compared with placebo Compared with the baseline, fasting blood glucose, postprandial blood glucose and HbA1c levels all showed significant dose-dependent decrease, indicating a continuous downward trend after 12 weeks, and no other early GKA drug efficacy rebound or failure was observed as early as 4 weeks In addition, hms5552 also showed excellent tolerance and safety, as well as a relatively low risk of hypoglycemia There was no drug-related serious adverse event (SAE) or severe hypoglycemia The overall incidence of adverse events (AE) was similar to that of placebo The incidence of hypoglycemia (5.4%) was similar to that of FDA approved low-risk diabetes drugs such as DPP IV inhibitors (2-6%) There were no significant changes in liver enzymes, blood lipids or other laboratory parameters compared with placebo, and no significant findings of physical examination, vital signs, or ECG abnormalities
"We sincerely thank the researchers, cros and SMOs of all 22 clinical research centers participating in the phase II clinical trial, especially all diabetic patients participating in the study, who worked together with the Hualing team to achieve the success of the trial," said Dr Zhang Yi, vice president of Hualing medical clinical research center "The excellent results of the clinical research prove that our team insists on Follow the highest international quality control standards and always make the patient's health and safety the primary goal " "With the approval of relevant departments, we plan to launch the clinical phase 3 key study of hms5552 in the first half of 2017 The company will also continue to explore the clinical mechanism of hms5552 and will conduct joint drug research in the United States and Europe, "said Dr Chen Li, CEO of Hualing pharmaceutical." the phase II clinical trial of hms5552 is the first global clinical study of innovative drugs launched in China by the Chinese clinical research and development team, and also in the field of major diseases (non tumors) " Completed the first phase II clinical study of new class 1 original new drug in the world The successful completion of this phase II clinical trial is an important milestone in the development process of innovative drugs in China, and also breaks the original first in Class new drug basically completes phase II clinical trials in foreign countries, which represents that the independent clinical research and development of innovative drugs in China is close to or up to the international advanced level We are honored to participate in the continuous major new drug innovation reform and innovation in China " About Hualing medicine, Hualing medicine is a leading enterprise in the research and development of new drugs in China At present, it focuses on the personalized treatment of type 2 diabetes and neurodegenerative diseases The company, founded by the top international pharmaceutical R & D experts and investment team, currently has two international development rights for innovative drugs Among them, the most advanced is the world's first oral drug for the treatment of type 2 diabetes, which has completed phase II clinical trials in China The company also has two other early-stage compounds for metabolic diseases and central nervous system disorders The strategy of Hualing pharmaceutical is to introduce overseas advanced technology and product resources by virtue of the company's internal strong drug R & D ability and management ability, and develop, produce and sell innovative products and services in the field of major diseases in the operation mode of "combination of Chinese and western, joint innovation" The company is committed to becoming an important driving force for China to move forward to the global drug R & D innovation center.