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Janssen gets FDA approval to start phase I study of Hanmi’s diabetes drug

Collected: 2017.08.22

Distributed: 2017.08.23

Source: Go Direct

Multinational pharmaceutical company Janssen Pharmaceuticals Inc. has received a go-ahead from the U.S. Food and Drug Administration (FDA) to start a phase I clinical study on American patients with diabetes and obesity with lead candidate JNJ-64565111, the investigational drug it has license to sell globally from its developer Hanmi Pharm of South Korea.

Janseen bought the exclusive right from the Korean counterpart in 2015 to test and market the drug known to be effective in both glycemic control and weight loss in all countries outside Korea and China under a deal worth up to $810 million.

At 1:15 p.m. Tuesday, shares of Hanmi Pharm were 0.4 percent down at 367,000 won ($323).

According to industry sources on Tuesday, Janssen recently registered its clinical development plan of the JNJ-64565111 with regulatory approval on the U.S. Clinical Trials Database.

Janssen submitted the new phase I study plan to the FDA in June after it closed an unsettled early clinical trial due to suspended patient recruitment, which had raised concerns about a commercial success for the drug. The confirmed plan will help ease market anxiety regarding the clinical development that affects Hanmi’s financial performance in the future.

The planned trial will evaluate the efficacy and safety of JNJ-64565111 in 56 type 2 diabetes patients. Recruitment has yet to begin.

A phase I study usually involves healthy volunteers to check a drug’s toxicity and safety, but a drug for chronic diabetes can be tested on patients from a phase I.

By Kim Hye-soon

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