Korean pharmaceutical corporations are continuing to develop drug candidates that were licensed out to global big pharma and then returned.
Instead of abandoning assets that came back before they could bloom, they are pursuing a "repositioning" and "repurposing" strategy—expanding to other indications (diseases to be treated) or changing the dosing regimen. As some corporations have recently produced visible results in the development of returned candidates, people in the industry are saying, "It's not over until it's over."
According to the pharmaceutical industry on the 27th, Hanmi Pharmaceutical, JW Pharmaceutical, and Yuhan are pursuing strategies to redevelop assets whose licenses were returned.
First, Hanmi Pharmaceutical has completed trials for Efpeglenatide, a glucagon-like peptide (GLP)-1 receptor agonist candidate, and last month applied to the Ministery of Food and Drug Safety for product approval, awaiting the decision.
Hanmi Pharmaceutical licensed out Efpeglenatide to the French drugmaker Sanofi in 2015, but the rights were returned after Sanofi halted its global phase 3 in 2020.
Hanmi Pharmaceutical shifted this asset, initially developed as a diabetes treatment, to an obesity therapy in line with the rapid expansion of the global obesity drug market and pushed forward redevelopment. Based on safety confirmed in existing clinical data, the company conducted a domestic phase 3 and is nearing commercialization. The company is targeting a Korea launch in 2026.
There are also cases where a returned candidate was licensed out again. A representative example is "Efinopegdutide," a candidate for metabolic dysfunction–associated steatohepatitis (MASH) that Hanmi Pharmaceutical licensed to Merck (MSD) and is under development. Hanmi Pharmaceutical had licensed this to J&J Innovative Medicine (formerly Janssen) under Johnson & Johnson (J&J) in 2015, but it was returned in 2019.
Efinopegdutide was originally a GLP-1/glucagon receptor dual-agonist candidate developed as an obesity treatment, but after the return, Hanmi Pharmaceutical shifted strategy to develop it as a MASH therapy, focusing on the mechanism of inhibiting liver fibrosis, a condition in which the liver hardens. MSD has since continued development and last month completed a global phase 2.
Choi In-young, head of Hanmi Pharmaceutical's R&D Center, said, "Top line results for Efinopegdutide are expected to be presented at major conferences in the first half of this year."
Although license returns weigh on the securities market, it is commonplace for development of out-licensed drug candidates to be halted or returned as global corporations' new drug strategies and market conditions change frequently. As in Hanmi Pharmaceutical's case, there is also the possibility that another company will buy back a returned drug for re-licensing.
JW Pharmaceutical is also pushing to develop JW1601, a novel atopic dermatitis candidate that was previously licensed out and returned, as a new drug for ophthalmic diseases. Denmark-based Leo Pharma acquired it at the preclinical stage in 2018, then terminated the technology transfer agreement in 2023 and returned the rights. The upfront payment JW Pharmaceutical received under the transfer agreement was $17 million (about 24.6 billion won).
JW Pharmaceutical has reviewed future development directions, including the potential to secure new indications, and is continuing development after pivoting to eye diseases. JW1601 targets the histamine H4 receptor, which is involved in immune and inflammatory responses, and has a dual mechanism that suppresses immune cell activation and migration.
The company said, "We are currently preparing for a domestic phase 2," adding, "However, for strategic reasons, we cannot disclose the specific target disease at this time."
Yuhan is preparing in-house development of YH25724, a MASH candidate that was licensed to C. H. Boehringer Sohn AG & Co. KG in 2019 and returned last year. The company said, "We are preparing for YH25724 to enter clinical trials."
In preclinical studies, YH25724 demonstrated efficacy in improving both fatty liver, in which fat accumulates in the liver, and fibrosis, in which liver tissue hardens, and it completed a global phase 1 in Europe, the United States, and Japan. The company believes that experience conducting early clinical trials in collaboration with a global drugmaker will help accelerate development.
If, contrary to the original out-licensing (transfer) agreement, the partner does not see development through to the end and returns it, the new drug development project remains unfinished. The money domestic corporations retain is limited to the nonrefundable upfront payment and some milestones.
Industry officials say in unison, "Because the reasons for a partner returning a license vary, a license return does not necessarily mean failure."
It also means that, having secured some revenue including the upfront payment and having validated the asset's safety and development value through trials led by big pharma, there can be new opportunities depending on the post-return development strategy.
Noh Young-su, executive director overseeing oncology clinical R&D at Hanmi Pharmaceutical, said, "After a license return, repositioning and repurposing are strategies that can reduce development time and expense and increase the chance of success."
A pharmaceutical company official who requested anonymity said, "Due to the hierarchical dynamic between global big pharma and domestic drugmakers, there is still a tendency for domestic firms not to press hard on the reasons for license returns."
He added, "For domestic corporations to strengthen their competitiveness in licensing out, they need to bolster not only late-stage clinical development capabilities but also global negotiating strategies."