Zhitong Finance App News, Weilizhibo-B (09887) announced that the company's core product, Velisin® (opatisumimab, PD-L1/4-1BB bispecific antibody), has been 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 Velisign®'s global regulatory approval map to major Asian markets.
After receiving this certification, Velisign ® will enjoy a series of incentives in Japan, including clinical development funding grants, 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.
In 2025, Japan is the fourth largest pharmaceutical market in the world, with a market size exceeding 73 billion US dollars. Its cancer immunotherapy market is over $8 billion, second only to the US, China, and Europe. Verisign ®'s entry into this strategic market with orphan drug qualification is not only a breakthrough in EP-NEC indications, but also means that the company has established a policy channel for priority communication and accelerated review within the Japanese regulatory system, which will facilitate the subsequent development and registration of other oncology indications in Japan.