HONG KONG, Jan. 5, 2019 /PRNewswire/ -- A fully integrated biopharmaceutical company – Uni-Bio Science Group Limited (the "Company", together with its subsidiaries, the "Group, Stock code: 0690.HK), is pleased to announce that the bioequivalence study ("BE Study") and its clinical materials on Acarbose tablets jointly developed by Beijing Genetech Pharmaceutical Co., Limited (a wholly-owned subsidiary of the Company) and Beijing Baiao Pharmaceutical Co., Ltd. has been formally accepted by the National Medical Products Administration ("NMPA") with reference number of CYHS1900008GUO and CYHS1900007GUO, corresponding to the oral tablets under two specifications of 50mg and 100mg for this submission respectively. This submission, if approved, means that the Company will be qualified for batch production of such product, which will be produced and launched to the Mainland China market as newly approved generic drugs.
Acarbose tablet is an oral anti-diabetic drug which belongs to the Alpha-Glucosidase Inhibitors class. It is used to treat Type 2 diabetes and is reimbursed under the National Reimbursement Drug List. It targets patients with pre-diabetes condition who need to be treated in early stage, and those with post prandial hyperglycemia under control.
Acarbose tablet, with a market value as high as US$3.2 billion, is effective for Asian people with a carbohydrate-rich diet. As a small-molecule drug for Type 2 diabetes, Acarbose tablet has limited competitors in China. At present, the main manufacturers of Acarbose tablet are Bayer and Huadong Pharmaceutical Co., Ltd. Due to less competition in the variety, plus the implementation of procurement policies of large varieties drugs with target quantity, the market will be reconstructed with lower competition density, from which the enterprises that pass consistency evaluation will be fully benefitted.
At present, the Group completed the BE study of Acarbose tablet and is in the view that BE results are robust. The Group is taking the lead on the research progress among other ongoing projects of the same category and it is expected that the Group could be in the first batch of manufacturers to apply for the production approvals and it is anticipated to be officially granted in the first half of 2019. In view of the fact that the progress of developing Acarbose tablets is 3 months ahead of original schedule and the management is optimistic about the official launch of the product within the year of 2019. In the meantime, the Company is actively exploring long-term collaboration with raw material suppliers on Acarbose tablets and other generic drug production to improve cost control and secure a stable supply of active pharmaceutical ingredients.
Webpage of The National Medical Products Administration
Website：http://samr.sfda.gov.cn/WS01/CL0135/
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About Uni-Bio Science Group Limited
Uni-Bio Science Group Limited is principally engaged in the research and development, manufacture and distribution of pharmaceutical products. The research and development center is fully equipped with a complete system for the development of genetically-engineered products with a pilot plant test base which is in line with CFDA requirements. The Group also has two GMP manufacturing bases in Beijing and Shenzhen. The Group is focused on the development of novel treatments and innovative drugs addressing the therapeutic areas of diabetes, ophthalmology and dermatology.
Uni-Bio Science Group Limited was listed on the Main Board of the Hong Kong Stock Exchange on November 12, 2001. Stock code: 0690.
This press release is issued by DLK Advisory Limited for and on behalf of Uni-Bio Science Group Limited.
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Tel: +85228577101
Fax: +85228577103
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