Sanofi’s “efpeglenatide,” which was returned to Hanmi Pharmaceutical in 2020, is now on the verge of domestic commercialization as an obesity treatment six years later. After Sanofi reduced its research and development allocation in the diabetes and cardiovascular sectors, the global obesity treatment market expanded rapidly, driven by GLP-1–based incretin medicines. Hanmi Pharmaceutical redeveloped the returned efpeglenatide as an obesity treatment, and recently out-licensed a next-generation obesity drug candidate with a separate mechanism to Genentech in a deal worth up to USD 2.3 billion (approximately KRW 3.2 trillion).

Sanofi reduces diabetes/cardiovascular R&D share and returns Hanmi’s ‘Effe’

At the end of 2019, Sanofi announced a strategy to concentrate its research and development capabilities on oncology and immune diseases and to halt new research in the diabetes and cardiovascular fields. In the process, it also abandoned plans to launch efpeglenatide on its own.

Efpeglenatide is a once-weekly GLP-1 receptor agonist incorporating Hanmi Pharmaceutical’s long-acting platform technology “LAPSCOVERY.” Hanmi out-licensed it to Sanofi in 2015, and thereafter global phase 3 clinical trials were conducted as a treatment for type 2 diabetes.

As recently as early 2020, Sanofi maintained that it would seek a new partner to take over subsequent development and commercialization, but in May of the same year it notified Hanmi Pharmaceutical of its intention to return the rights. At the time, Hanmi explained that the decision to return was due to a change in Sanofi’s business strategy, not to any issues with efpeglenatide’s efficacy or safety.

Redeveloped by Hanmi as an obesity drug… Next-generation drug out-licensed for KRW 3.2 trillion

After efpeglenatide was returned to Hanmi Pharmaceutical, the obesity treatment market grew rapidly. GLP-1–based incretin medicines, initially developed primarily as diabetes treatments, expanded their scope into the obesity treatment segment. Representative examples include Novo Nordisk’s “Wegovy” and Eli Lilly’s tirzepatide-based products. In the United States, tirzepatide is sold under the name “Mounjaro” as a diabetes treatment and “Zepbound” as an obesity treatment.

Hanmi Pharmaceutical redeveloped the returned efpeglenatide as a domestic obesity treatment. It entered phase 3 clinical trials in Korea in 2023 and is currently under review by the Ministry of Food and Drug Safety following a marketing authorization application. In effect, efpeglenatide, originally developed as a diabetes treatment, has changed course and is now proceeding through commercialization as an obesity therapy.

This year, Hanmi Pharmaceutical also restarted development of efpeglenatide for a diabetes indication. It is conducting phase 3 clinical trials in combination with existing diabetes treatments in patients with type 2 diabetes.

Follow-up new drug development in the obesity and metabolic disease area is also under way. Hanmi Pharmaceutical developed “HM17321,” a non-incretin candidate with a mechanism distinct from efpeglenatide, and recently out-licensed it to Genentech, a subsidiary of the Roche Group.

The contract is worth up to USD 2.3 billion, or approximately KRW 3.2 trillion, including development, regulatory approval and commercialization milestones. The non-refundable upfront payment is USD 190 million. Genentech has secured the rights to develop, manufacture, and commercialize HM17321 worldwide, excluding Korea.

HM17321 is a candidate that may address the issue of lean body mass reduction that has been raised with existing GLP-1 class obesity treatments. It is being developed with the goal of reducing body fat while maintaining or improving muscle mass and muscle function, and is currently in phase 1 clinical trials in the United States.

Six years after Sanofi returned the rights to efpeglenatide, Hanmi Pharmaceutical is redeveloping it as an obesity treatment and pushing for commercialization. While Sanofi adjusted its R&D strategy at the time to reduce its focus on the diabetes and cardiovascular fields, Hanmi Pharmaceutical continued efpeglenatide’s development and has additionally secured new obesity and metabolic disease drug candidates. Most recently, it expanded its related pipeline by out-licensing the non-incretin obesity drug HM17321 to Genentech in a deal worth up to USD 2.3 billion.

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