GENFIT and Terns Announce $228MM Strategic Partnership to Develop and Commercialize Elafibranor in Greater China

GENFIT, a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver-related diseases, announced the signing of a licensing and collaboration agreement with Terns Pharmaceuticals, a global biopharmaceutical company based in the U.S. and China with a focus on developing novel and combination therapies to treat liver disease. Under the agreement, Terns will have the rights to develop and commercialize elafibranor, GENFIT’s proprietary compound, in Greater China, for the treatment of non-alcoholic steatohepatitis (NASH) and primary biliary cholangitis (PBC).

Under the terms of the licensing agreement, GENFIT will receive an upfront payment from Terns of $35 million and will be eligible to receive up to $193 million in potential clinical, regulatory and commercial milestone payments. Terns obtains the exclusive rights to develop, register and market elafibranor in mainland China, Hong Kong, Macau and Taiwan (“Greater China”) for both NASH and PBC. Upon commercial launch of elafibranor for the treatment of NASH in Greater China, GENFIT will be entitled to receive mid-teen percentage royalties from Terns based on sales in the territory.

As part of the deal, GENFIT and Terns will also undertake joint R&D projects in liver disease, including the development of elafibranor in combination with Terns’ proprietary compounds.

Backed by experienced investors in the pharmaceutical industry, including Orbimed, Lilly Asia Ventures, Vivo Capital and Decheng Capital, Terns has extensive clinical development capabilities in China and a robust pipeline of early-stage candidates that present promising opportunities for potential combination therapy with elafibranor.

GENFIT believes that, with a strong presence in China, a seasoned leadership team, and roots in the San Francisco Bay Area biotechnology hub, Terns is well-positioned to maximize elafibranor’s value in China. Terns’ large footprint in both geographies provides an advantage in navigating the development and regulatory processes required to obtain approvals in Greater China territories, while also ensuring the preparation for a strong commercial launch and long-term sales growth. New regulations currently being implemented in China are expected to accelerate and facilitate the approval of innovative therapies developed by both domestic and international companies.

Pascal Prigent, Executive Vice President Marketing and Commercial Development of GENFIT said: “The Terns management team has a strong track record at global pharma and biotech companies, combined with a good understanding of key scientific, regulatory and commercial challenges in China, which gives us a strong level of confidence as to what we can achieve in China through this strategic partnership. We believe mutual alignment on upcoming strategic development steps and priorities paves the way for a bright future together.”

Weidong Zhong, PhD., President and CEO of Terns Pharmaceuticals, added: ”Since our founding, we have been focused on taking a comprehensive approach to treating liver disease and NASH, and have been working hard to identify compounds with strong, complementary mechanisms of action to add to our portfolio. In addition to its appealing mechanism of action, elafibranor is well positioned in an ongoing Phase 3 program to demonstrate NASH resolution as defined by global regulatory authorities and to provide meaningful benefit for patients living with NASH and PBC. We are excited to work with GENFIT to advance elafibranor as the leading treatment for NASH and PBC in the Greater China region and as the basis for building future combination NASH therapies. We value the experience and accomplishments of GENFIT on disease awareness and non-invasive diagnosis which are essential for the management of NASH patients in all markets and look forward to a productive partnership between our two companies as we seek to improve treatment options for patients living with chronic liver disease.”