April 26, 2024

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[THE INVESTOR] Hanmi Pharmaceutical shares soared 7.29 percent from the previous trading day to a close of 397,500 won on Aug. 28, fueled by an improved development outlook for the firm’s drugs that were out-licensed to global companies.

Janssen, Johnson & Johnson’s drug development subsidiary, recently obtained the US Food and Drug Administration’s approval to carry out a new set of phase 1 clinical trials for Hanmi-developed drug candidate JNJ-64565111.

Janssen had suddenly suspended the trials of Hanmi’s drug back in November, citing manufacturing-related issues, igniting investor concerns over the drug’s development outlook.

JNJ-064565111, also known as HM12525A, is a long-lasting biologic drug for the treatment of diabetes and obesity. It was licensed out by Hanmi to Janssen in November 2015 in a $915 million deal.

According to the National Institutes of Health’s ClinicalTrials.gov, the new trials will be taking place in the US, instead of Germany. The number of patient cohorts has been expanded from 4 to 5, while the number of participants has changed from 24 to 56, alongside other patient criteria changes.

Janssen’s phase I trials are slated to end within the first quarter of next year, according to the clinical trials information website. 

In addition to Janssen, Sanofi earlier this month announced plans to begin phase III trials of efpeglenatide, a longer-lasting insulin drug candidate licensed in from Hanmi, by the fourth quarter. The drug has shown to be superior to Novo Nordisk’s semaglutide, currently under review by the US FDA. 

“That Janssen has reinitiated its clinical trials signifies that there are no more manufacturing issues. And Sanofi is highly likely to begin phase III trials of efpeglenatide by the fourth quarter,” Mirae Asset Daewoo analyst Kim Tae-hee said in a note on Aug. 28.

“With additional R&D milestones expected next year, Hanmi Pharmaceutical is set to fully recover lost investor trust over its R&D capabilities.”

By Sohn Ji-young/The Korea Herald (jys@heraldcorp.com)