Zhitong Finance App News, Weilizhibo-B (09887.HK) announced that the company's core product, Velisin® (opatisumimab, PD-L1/4-1BB bispecific antibody), has been certified by the US Food and Drug Administration (FDA) for first-line treatment of advanced biliary tract cancer (BTC). This is the second FDA Fast Track qualification for Velisign® after extrapulmonary neuroendocrine carcinoma (EP-NEC). Based on impressive data from Velisign® in first-line BTC clinical studies, it only took 9 days from submission to approval. The FDA also recommended that the company communicate about the registration plan for Velisign® combination chemotherapy on BTC as soon as possible. The certification is expected to accelerate the development, registration and commercialization of Velisign® in the US for treating BTC.
Zhitongcaijing · 1d ago
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Zhitong Finance App News, Weilizhibo-B (09887.HK) announced that the company's core product, Velisin® (opatisumimab, PD-L1/4-1BB bispecific antibody), has been certified by the US Food and Drug Administration (FDA) for first-line treatment of advanced biliary tract cancer (BTC). This is the second FDA Fast Track qualification for Velisign® after extrapulmonary neuroendocrine carcinoma (EP-NEC). Based on impressive data from Velisign® in first-line BTC clinical studies, it only took 9 days from submission to approval. The FDA also recommended that the company communicate about the registration plan for Velisign® combination chemotherapy on BTC as soon as possible. The certification is expected to accelerate the development, registration and commercialization of Velisign® in the US for treating BTC.
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