Verissimo B (09887): Updated clinical and translational data on the treatment of extrapulmonary neuroendocrine cancer, biliary tract cancer and colorectal cancer was presented at the 2026 European Society of Medical Oncology (ESMO) Conference

Zhitong Finance App News, Verishibo-B (09887) issued an announcement. Updated clinical and translational data from the four studies of Velissin® (opatisumimab, PD-L1/4-1BB bispecific antibody) were presented at the 2026 European Society of Medical Oncology Annual Meeting (2026 ESMO). The publication of these reports includes (i) an oral report on the latest breakthrough summary (LBA) on Verisign® single-agent treatment of third-line or posterior-line extrapulmonary neuroendocrine cancer (EP-NEC); (ii) selected oral reports on first-line treatment of EP-NEC with Velisign® combined chemotherapy; (iii) a poster presentation on Verisign® first-line treatment of biliary tract cancer (BTC); and (iv) a research poster presentation on Verisign® treatment of microsatellite-stabilized (MSS) colorectal cancer (CRC).

Updated data further verified that Velisign® can trigger a strong and long-lasting anti-tumor immune response, leading to long-lasting survival benefits, particularly in cold tumors (such as EP-NEC and BTC). The translational findings of MSS CRC further support the 4-1BB activation mechanism of Verisign® in tumor local conditions and its potential to transform immune “cold” tumors into “hot” tumors.

Velisign® is a bispecific antibody that targets both PD-L1 and 4-1BB, and has the potential to become a pan-tumor IO 2.0 cornerstone therapy with survival benefits. Currently, Verisign® has carried out clinical studies for 14 indications, including 1 single-arm critical registration clinical study, 1 confirmatory phase III clinical study, and 9 proof-of-concept studies, covering multiple major cancer types and “cold tumors”. Among the 7 types of cancer supported by clinical data, Verisign® has shown excellent clinical value and broad treatment prospects, including extrapulmonary neuroendocrine cancer (EP-NEC), non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma (ESCC), and ovarian cancer (OC).

Using our self-developed platform X-body™, which has full intellectual property rights, Velisign® can conditionally activate 4-1BB, remove PD-1/PD-L1 immunosuppression while enhancing T-cell activation regulated by 4-1BB, and achieve the effect of collaboratively eliminating tumors. Velisign® is as safe as PD-1/PD-L1 inhibitors and has greater potential for broad-spectrum cancer treatment. In particular, it is worth pointing out that activating 4-1BB can reactivate depleted T cells and expand massively, so that therapies targeting 4-1BB may be suitable for treating immunological “cold tumors” that are resistant or ineffective against PD-1/PD-L1 inhibitors, and can bring survival benefits with long-lasting effects.

In October 2024, Velisin® was recognized as a breakthrough therapeutic drug by the NMPA; in November 2024, it was certified as an orphan drug by the US Food and Drug Administration (FDA). In January 2026, Velisign® was granted FDA Fast Track certification and EU orphan drug certification. In September 2026, Velisign® was certified as an orphan drug by the Ministry of Health, Labor, and Welfare (MHLW) of Japan. In October 2026, it obtained the FDA's fast-track qualification for first-line treatment of advanced BTC.

In July 2026, the marketing application for Velisign® innovative biological products was included in the priority review and approval process by the NMPA and officially accepted in August 2026. It is expected to become the world's first approved 4-1BB antibody drug, the world's first approved agonist antibody drug, and the world's first approved therapeutic drug for EP-NEC.