Burlington, Massachusetts-based Flexion Therapeutics, Inc. has signed an exclusive license agreement with Hong Kong Tainuo Pharma Ltd. (HK Tainuo) and Jiangsu Tainuo Pharmaceutical Co. Ltd. (Jiangsu Tainuo) for the development and commercialization of ZILRETTA® in greater China. The agreement covers mainland China, Hong Kong, Macau, and Taiwan.
Per the agreement terms, Flexion will receive an upfront payment of $10 million from HK Tainuo. In addition, Flexion will be eligible to receive up to $32.5 million in milestone payments.
Flexion will continue to manufacture and supply ZILRETTA and will be responsible for providing ZILETTA to HK Tainuo. A separate supply agreement will cover the terms related to ZILRETTA’s manufacturing and supply.
By the end of the year, HK Tainuo plans to file a Clinical Trial Application for ZILRETTA with the China National Medical Products Administration. As soon as possible after filing, HK Tainuo plans to begin clinical studies in China.
Biopharmaceutical company Flexion Therapeutics focuses on the development and commercialization of therapies for patients with musculoskeletal conditions, beginning with osteoarthritis (OA) knee pain. ZILRETTA is an extended-release corticosteroid approved by the U.S. Food and Drug Administration to manage OA knee pain.
Jiangsu Tainuo is one 30 subsidiaries of China Shijiazhuang Pharmaceutical Co, Ltd. (CSPC). CSPC is one of the largest pharmaceutical manufacturers in China. With six business segments, CSPC develops, manufactures, and markets a wide range of pharmaceuticals.
OTW spoke with Flexion Therapeutics President and Chief Executive Officer Mike Clayman, M.D., about the partnership. Dr. Clayman told OTW, “We couldn’t be happier to be partnering with CSPC on this venture. CSPC is one of the most prominent biopharmas in China—well-established, a terrific reputation, deep expertise in both commercial and drug development, and a pleasure to work with.”
Dr. Clayman continued, “CSPC did a deep dive to determine that this is a product that they want. We were able to do a deal that made sense for both of us.”
Dr. Clayman explained that “the imminent medical need in China is extraordinary. There are approximately 115 million symptomatic knee OA patients in China compared with 15 million in the U.S. with symptomatic [knee OA]—literally 100 million more patients in China. We are very excited about the potential to make a difference for millions of patients there. This partnership will allow us to help those Chinese patients while allowing us to maintain our company focus: getting ZILETTA to U.S. patients.”
For OTW’s coverage of ZILRETTA over the years, see “How Athletes Respond to Extended Release Corticosteroids,” “Flexion: Full ZILRETTA Launch,” “Flexion Submits NDA for ZILRETTA,” “Flexion Therapeutics OA Drug Meets Primary Endpoint,” and “Flexion Therapeutics’ Drug Trumps Saline for OA Pain Relief.”
