Phase III clinical trial application of the first full biological expression new drug of Liankang group was accepted by the State Food and Drug Administration

November 26, 2018 / Meitong news agency / -- Liankang Biotechnology Group Co., Ltd ("Liankang group" or "the group", stock code: 690), an integrated biopharmaceutical manufacturer with R & D, production and sales, is pleased to announce that the phase III clinical trial application of recombinant insulin stimulating hormone injection liquid ("the second generation uni-e4") submitted by the company was awarded the national food on November 20, 2018 The review center of the State Administration of Drug Administration ("SFDA") accepted the acceptance and received the acceptance notice with acceptance no of cxsb1800011 and cxsb1800012 In view of this, the board of directors is optimistic about the listing process of the second generation uni-e4, and will successfully complete the review and carry out the test, which is expected to be put on the market in 2022 Uni-e4 is an innovative biological preparation independently developed by the group It is a kind of antidiabetic drug called GLP-1 inducer It is an optional non insulin hypoglycemic drug that can be treated by stimulating the incretin channel These drugs have been proved effective and recognized in the treatment of type 2 diabetes, and are the only diabetes drugs that can reduce weight, reduce the risk of hypoglycemia and promote β cell regeneration On August 3, 2015, the group published the positive phase III clinical test results of the first generation of uni-e4 At present, the water injection type declared by the group is the second generation of uni-e4, which has been developed by the group since the beginning of 2017 As a new liquid formula, the effective component is the fully biologically expressed exenatide molecule, which can be combined with a safe and efficient injection pen, allowing multiple injections, increasing the convenience of operation Uni-e4 water injection is designed to be injected once every two days The patient can give it by himself, effectively aiming at the problem of postprandial blood sugar, and at the same time, it can ensure that there will be no hypoglycemia before meals It is more suitable for Asian patients who prefer low-dose clinical drugs and are prone to postprandial blood sugar rise According to the data of China Business Industry Research Institute, China is currently the country with the largest number of patients with type 2 diabetes, with 120 million patients in 2017 It is expected to increase to 160 million by 2028 Based on the large number of patients, the industry forecasts that the market size of type 2 diabetes will reach US $3.2 billion Based on the positioning of experts in endocrine and metabolic Biopharmaceutics, Liankang group has a complete product line in the field of endocrine, especially diabetes Uni-e4 and oral Acarbose Tablets are used to treat type 2 diabetes The latter has started to recruit patients to enter the clinical trials of human bioequivalence research in June 2018, and officially put on the Internet in July (Registration No.: ctr20181019), At present, tests are being carried out in an orderly manner With the integrated business platform of Beijing Yongtai, a subsidiary of the group, and its strong marketing strength, it is expected that the two kinds of diabetes drugs will quickly open the competition situation of the hospital terminal after they come into the market due to their superior curative effect and reasonable price, connect with the patient terminal, and provide the safe and efficient optimal drug treatment scheme for them To this end, Mr Liang Guolong, chairman and executive director of Liankang Biotechnology Group Co., Ltd., said: "Liankang group's in-process product reserve is the top priority of the group's long-term development Among them, the second generation of uni-e4, as the trump brand new drug independently developed by the group, we have high hopes for its listing, which can fully meet the market demand and further expand the group's product supply In addition, compared with the first generation of uni-e4, the new products will increase pricing and reduce raw material costs, bringing higher returns to the group At this time, we obtained the acceptance of the second generation uni-e4 phase III clinical trial application from the drug administration, which is in line with the schedule set by the group While giving us full confidence and encouragement, it also indicates that the group has made a further step towards China's highly competitive comprehensive innovative biopharmaceutical company " About Liankang Biotechnology Group Co., Ltd Liankang Biotechnology Group Co., Ltd is mainly engaged in drug research and development, manufacturing and distribution business The R & D center of the group has a complete set of systems for the research and development of genetically engineered drugs, and a testing base for the experimental plant meeting the requirements of the State Food and drug administration The group also has a production base in Beijing and a production base in Shenzhen that conforms to the latest cGMP The group focuses on developing new treatments for diabetes, ophthalmology and dermatology.