[Click eStock] "Hanmi Pharm Faces Sanofi Contract Termination Risk... Bad News Ends, Only Good News Remains"

[Asia Economy Reporter Oh Ju-yeon] Hana Financial Investment evaluated on the 15th that the notification from multinational pharmaceutical company Sanofi to terminate the approximately 4 trillion KRW diabetes treatment drug technology export contract with Hanmi Pharmaceutical actually resolved a negative issue, leaving only positive prospects for the 'LabTriple Agonist' going forward.

Hanmi Pharmaceutical announced on the 14th through a public disclosure that its partner Sanofi had notified its intention to return the rights to Epeglenatide, and that both parties will finalize this after a 120-day consultation period according to the contract. This technology return comes six months after Sanofi announced on December 10 last year that it was seeking the optimal partner to handle the sales of Epeglenatide.

Seon Min-jung, a researcher at Hana Financial Investment, diagnosed, "This series of actions began after Sanofi's CEO change in September last year, which led to the discontinuation of diabetes research, their previous core area, and the winding down of most pipelines. This decision is unrelated to the efficacy and safety of Epeglenatide."

It is expected that Sanofi will complete the Phase 3 clinical trials of Epeglenatide.

Researcher Seon explained, "Currently, five clinical trials of Epeglenatide are underway; three of these have completed patient recruitment, while the other two are still recruiting. Most of the trials are scheduled to conclude in 2021."

He added, "Hanmi Pharmaceutical mentioned that since Epeglenatide's clinical trials are in the final stages, they have agreed to discuss with Sanofi the completion of Phase 3 trials. Clinical trials are agreements among patients, doctors, and sponsors (usually pharmaceutical companies) based on trust, and since no safety issues have arisen, it would be difficult for Sanofi to unilaterally halt the trials." However, while finding a new partner is possible, the likelihood of a large-scale technology transfer deal with a global pharmaceutical company as in the past is somewhat uncertain. This is because the sustained-release GLP-1 market is currently led by Eli Lilly's Trulicity and Novo Nordisk's Ozempic.

With this return of Epeglenatide technology, all four substances licensed out by Hanmi Pharmaceutical to global pharmaceutical companies since 2015 have been returned. Only the anticancer drug Veliparib, licensed to Roche in September 2016, remains with a global pharmaceutical company. However, this technology return notification is interpreted as having resolved the uncertainties remaining for Hanmi Pharmaceutical, marking the end of negative factors.

Researcher Seon said, "After Sanofi's decision last year, many investors were concerned about the return of Epeglenatide technology, which remained an uncertainty for Hanmi Pharmaceutical. Now that Epeglenatide has been returned as the market feared, the last remaining uncertainty for Hanmi Pharmaceutical has truly been resolved."

He explained that now all negative factors have been resolved, leaving only the positive prospect of the 'LabTriple Agonist.' Hanmi Pharmaceutical's Glucagon/GIP/GLP-1 triple agonist, developed as a treatment for non-alcoholic steatohepatitis (NASH), is attracting attention as a novel mechanism therapy that can overcome the limitations of single-target oral treatments. The triple agonist was designated last year by the FDA as an orphan drug for the treatment of primary sclerosing cholangitis and primary biliary cholangitis, respectively.

Researcher Seon said, "Novo Nordisk announced in its Q1 earnings report that the sustained-release GLP-1 semaglutide met the primary endpoint in a Phase 2 clinical trial targeting NASH patients," adding, "Expectations for GLP-1-targeted NASH drug development are rising." He also noted, "The LabTriple Agonist is expected to present Phase 1 clinical trial results conducted in the U.S. at the European Association for the Study of the Liver (EASL) conference in August." Considering that last July, Yuhan Corporation's NASH treatment GLP-1/FGF21 dual agonist YH25724 was licensed to Boehringer Ingelheim in a technology transfer deal worth about 1 trillion KRW at the preclinical toxicity (GLP-Tox) stage, he anticipates a large-scale technology transfer for the LabTriple Agonist in the future."

This content was produced with the assistance of AI translation services.