S.Korea's FutureChem gets approval for phase 3 clinical trials in China

South Korean radiopharmaceutical development company FutureChem Co. announced on Thursday that China's National Medical Products Administration (NMPA) has granted approval for a phase 3 clinical trial of its radiopharmaceutical drug FC303 for diagnosing prostate cancer in China.

Compared to conventional diagnostic techniques, FC303 is expected to more accurately locate microtumors and distantly metastasized prostate cancer. The latest approval came four months after the application for clinical trials in November last year.

Based on the positive results of phase 1 in Korea and the United States, the company skipped phase 1 and 2 clinical trials, and phase 3 was directly approved in China.

FutureChem plans to evaluate the diagnostic performance of FC303 positron emission tomography and computed tomography (PET-CT) imaging in 267 Chinese patients with medium-risk or higher prostate cancer.

In Sept. 2020, FutureChem signed an agreement with HTA Co. Ltd. to transfer FC303's copyright in China. HTA is the largest radiopharmaceutical company in China.

FutureChem plans to receive royalties of up to 16% of annual sales in China for 15 years, as well as part of the milestone payment following FC303's product approval.

Write to Jeong Min Nam at peux@hankyung.com