April 24, 2024

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[THE INVESTOR]  Hanmi Pharmaceutical's shares extended losses for the second day on Dec. 8 on rising concerns over suspended clinical trials of its new diabetes drug.

Risks surrounding its drugs in the pipeline under research and development have resurfaced following its global partner Janssen Pharmaceuticals’ decision to postpone recruiting participants for the clinical trials of its diabetes drug HM12525A, or JNJ-64565111, licensed by Hanmi in 2015. 

Analysts suggested investors will be conservative toward Hanmi stocks until the clinical studies resume.

“Expectations on Hanmi Pharmaceutical’s R&D have faded due to the delay,” said Seo Keun-hee, an analyst at Daishin Securities.

More than half of HM12525A’s market value, which was set at around 641 billion won (US$553.11 million) by brokerage firms, has been wiped off following an over 10 percent plunge in Hanmi’s stock on Dec. 7, a Samsung Securities’ analyst said.

Hanmi shares shed 2.09 percent to close at 304,500 won, after a steep fall of 10.75 percent in the previous session.

Jeong Bo-ra at Korea Investment & Securities was one of the most conservative analyst, cutting the target price by 35 percent to 500,000 won from the previous 790,000 won in a rare move.

Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, has “suspended participant recruitment” for phase 1 clinical trials of HM12525A, a biologic drug for the treatment of diabetes, originally developed by Hanmi, according to the US National Institutes of Health’s Clinical Trials Register.

Janssen had begun phase 1 clinical trials of JNJ-6456511 in the US from July, testing the drug’s efficacy on adult patients with Type 2 diabetes mellitus. The study’s estimated completion date was April 2017.

“Persistent news about clinical trial delays have triggered concerns over risks regarding out-licensing deals,” Jeong said.

In October, Hanmi said it would delay Phase 3 clinical trials of its long-acting diabetes treatment licensed out to Sanofi, which was initially set to begin in the fourth quarter this year to next year.

In September, Hanmi shares plummeted following its announcement that Boehringer Ingelheim will return its license of HM61713, a third-generation drug for treating lung cancer patients who have developed a tolerance to existing cancer-fighting drugs.

“After the cancellation of Boehringer Ingelheim’s license, investor sentiment has deeply deteriorated with shares in the pharmaceutical index plunging 30 percent,” she said.

Jeong added that she reflected possible delay of the milestone and royalty payments in accordance with the postponed clinical trials of HM12525A. 

Meanwhile, a spokesperson for J&J said the delay in patient recruitment was due to “a manufacturing-related delay,” according to a report by Endpoints News.

By Park Han-na (hnpark@heraldcorp.com)