(Hong Kong, 24 November 2015) Uni-Bio Science Group Limited ("Uni-Bio" or the "Group"; HKEx code: 690) today announced that it will acquire exclusive global rights to manufacture and commercialise mitiglinide, a new oral antidiabetic agent, from Jiangsu Hansoh Pharmaceutical Co. Ltd ("Hansoh").
Mitiglinide is a new, oral antidiabetic agent which belongs to the glinides class of blood glucose lowering compounds. It is known to improve postprandial hyperglycemia in patients with Type 2 diabetes and has received New Drug Approval as a first and/or second line of treatment for the disease from the China Food and Drug Administration. In clinical studies, mitiglinide demonstrated a fast onset of action and was shown to be safe and effective with reduced gastrointestinal and cardiovascular side effects compared to other treatments in the same class. It is the market leader of the glinides class of Type 2 diabetes treatments in Japan, generating RMB900 million in revenue in 2014.
Hansoh has developed its own version of mitiglinide; it is currently being marketed and sold in China and Hansoh has successfully won a number of provincial tenders to date. Under the terms of agreement, Uni-Bio will acquire exclusive rights to distribute and commercialise Hansoh's mitiglinide globally and will manufacture the drug in its CGMP-certified plant in Beijing. Hansoh will continue to provide the active pharmaceutical ingredient to Uni-Bio.
Uni-Bio will begin to commercialise mitiglinide with immediate effect and will focus on building mitiglinide's market share across China, leveraging the strength of the Company's expanding sales team. In other markets Uni-Bio will seek distribution partners.
Worldwide, there are 387 million people living with diabetesi. China has the largest number of people with diabetes in the world and national diabetes prevalence currently stands at almost 100 million (approximately 8% of the population)i. If current trends continue, it is expected that 143 million people in China will have diabetes by 2035i. It is estimated that more than 50 million patients go undiagnosed, spurring the growth of the overall diabetes pharmaceutical markets in China to RMB20 billion in 2016ii.
Mr. Kingsley Leung, Executive Director of Uni-Bio, said: "With the prevalence rate of diabetes reaching epidemic levels in China and across the world, there is a pressing need for a broad range of treatment options to manage this long-term chronic condition. Mitiglinide has been shown to be a safe and effective treatment of Type 2 diabetes with the potential to be best-in-class amongst glinides; it will be an important addition to our growing diabetes portfolio, enabling us to build upon our relationships with key stakeholders as we prepare for the commercial launch of Uni-E4."
"Our agreement with Hansoh supports our growth strategy and focus on in-licensing products which complement and enhance our current portfolio whilst also making an important contribution to revenue. Uni-Bio is increasingly recognised as a leading provider of high-quality healthcare treatments in China and we are excited to continue to build upon our success."
Uni-E4 is Uni-Bio's proprietary recombinant GLP-1 receptor agonist for the treatment of Type 2 diabetes which effectively regulates blood glucose level through stimulating insulin secretion and inhibiting glucagon release. Earlier this year, the Company released positive phase III results for Uni-E4, and plans to submit a New Drug Application to the China Food and Drug Administration in early 2016.
Dr. Lv Aifeng, Executive Vice President of Hansoh Pharmaceutical, said: "I am delighted that Hansoh Pharmaceutical has entered into this strategic agreement with Uni-Bio Science Group."
"Mitiglinide possesses unique therapeutic advantages, and China's diabetes market has immense opportunities with tremendous room for growth; we are confident that Uni-Bio has the capabilities to tap into and capture those opportunities to expand mitiglinides' market share in the country. This collaboration is a win-win for both companies."