Changes in Hong Kong stocks | Verishibo-B (09887) rose more than 2% Recently, its core product, Velisin®, was certified as an orphan drug in Japan

Zhitongcaijing · 3d ago

The Zhitong Finance App learned that Weilizhibo-B (09887) rose more than 2%. As of press release, it had risen 1.69% to HK$51.25, with a turnover of HK$3,5403 million.

According to the news, on September 28, Verishibo-B announced that the company's core product, Velisin ® (opatisumimab, PD-L1/4-1BB bispecific antibody), was granted orphan drug qualification by the Ministry of Health, Labor, and Welfare (MHLW) of Japan to treat extrapulmonary neuroendocrine cancer (EP-NEC). This is the third orphan drug qualification obtained by Verisign ® after the US Food and Drug Administration (FDA) and the European Commission (EC), marking the further expansion of the global regulatory approval map of Villison® to major Asian markets.

After receiving this certification, Velisign ® will enjoy a series of incentives in Japan, including funding for clinical development, professional guidance and advice from agencies such as the Ministry of Health, Labor, and Welfare (MHLW), priority consultation and priority review channels, reduction in consultation and marketing application fees, and an extension of the review period. These incentives are expected to accelerate the development, registration and commercialization of Verisign® in Japan.