The China Food and Drug Administration (CFDA) has given the green light to Sillajen to start its phase 3 clinical trials of Pexa-Vec for liver cancer, the company said Thursday.
The news comes four months after Silljaen passed the screening by Chinese Center for Drug Evaluation (CDE), which is composed of 19 advisory committee members, in March. Sillajen신라젠’s clinical trial (PHOCUS) passed on a 15-2 vote.
In July 2015, the CFDA reformed its drug application system, making clinical trial application and registration procedures more rigorous.
“We have passed the CFDA’s rigorous clinical trial application procedures, which is considered to be one of the most strict clinical trial regulations in the world,” a Sillajen official said. “We believe that Pexa-Vec will be able to acquire a feasible Chinese license as we are conducting clinical trials with Chinese patients, which is looked upon favorably by the CFDA.”
The Phase 3 clinical trial targeted patients with progressive hepatocellular carcinoma without prophylaxis in a randomized, open-label study.
Dr. Qin Shukui, vice president of the Chinese People’s Liberation Army Bayi Hospital, will serve as the principal overseer of the clinical trials in China. The clinical trials will recruit patients at several Chinese hospitals, including the Anhui Provincial Hospital which is known as one of the three hospitals in the world having the most liver cancer patients.
According to Globocan statistics, the number of hepatocellular carcinoma patients is estimated to reach 440,000, nearly more than half of the total 850,000 people hit by liver cancer a year.
The Chinese pharmaceutical market is expected to reach up to $220 billion in the next three years, according to IMS Health, making it the second largest market after the United States. However, despite its size, industry experts consider it a costly investment with high barriers to new entrants.
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