Access Pharmaceuticals Inc., a biopharm company focused on the development of treatments in the areas of oncology, diabetes, and RNAi, today announced that its MuGard partner in China, Rhei Pharmaceuticals HK Ltd., has received regulatory approval from the State Food and Drug Administration (SFDA) to market MuGard in China.
China's regulatory agency approved MuGard to treat cancer patients afflicted with oral mucositis a debilitating side effect of many anticancer treatments. The approval provides Access the opportunity to tap into an expansive market with a largely unmet medical need. Access will soon begin manufacturing MuGard in the United States to meet demand created by Jian An Ltd., Rhei's sales and marketing partner in China.
"Receiving final marketing approval from the SFDA of China is a transformative milestone for our global MuGard program. China represents a key target market with its large and increasingly affluent population and its desire for improved oncology care," Jeffrey B. Davis, president and CEO of Access stated in the press release. "With the approval process now complete, we look forward to moving as quickly as we can to complete manufacturing so Rhei and Jian An can launch MuGard through their well-established sales and marketing infrastructure in China."
"China is one of the fastest growing oncology markets and cancer supportive care has been improving throughout recent years," said Sven De Backer, CEO of Rhei. "Rhei and Jian An are proud to bring MuGard to patients and physicians as we believe it is a critical and valuable product that addresses a significant unmet need for a large and growing patient population."
Access and Rhei last year signed a supply agreement for MuGard, which ensured manufacturing capacity of up to a minimum of $30 million of product in the licensed territories. Access also approved a sub-license agreement between Rhei and Jian designed to leverage Jian An's sales, marketing, and regulatory infrastructure for the launch of MuGard in China and Taiwan.
For more information visit accesspharma.com
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