Il-Yang Pharm said Tuesday that it has received a go-ahead from Chinese health authorities to proceed with phase 3 clinical studies for Supect (radotinib), a novel drug to treat blood cancer.

The clinical research will be led by Il-Yang Pharm’s Chinese entity and contract research group IQVIA (formerly known as Quintiles IMS) and involve patients with chronic myeloid leukemia (CML) at 24 large hospitals in China around Peking University People`s Hospital.

Il-Yang Pharm, the first Asian drugmaker that developed a blood cancer therapy, is going all out to up Supect sales beyond Korea. Efforts are now underway to enter initial clinical trials in Russia, Colombia, Turkey and Kazakhstan among others.

The global CML market valued at roughly $933 million as of 2015 is largely driven by Gleevec from Novartis, but the industry pays growing attention to second-generation novel drugs that prevent resistance. There are only three second-generation leukemia drugs available in the world: Tasigna (Novartis), Sprycel (BMS) and Supect (Il-Yang Pharm).

Given there are more than 12,000 new cases of leukemia in China annually, demand for cheaper but effective treatment options is expected to rise sharply in the future.

Il-Yang Pharm has already completed a production line for Supect at local facilities that meet the EU-GMP requirements and is strengthening pre-launch efforts, including intensive market research in China for Supect sales.

The company has released significant data from its pivotal clinical trial several times through major medical societies in the U.S. and Europe. In Russia, Supect was designated as an orphan drug.

Il-Yang Pharm shares closed Wednesday up 0.48 percent at 41,500 won.

By Kim Hye-soon and Minu Kim

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