The marketing application for Vilizhibo-B (09887) Class 1 new drug opatisumimab was accepted

The Zhitong Finance App learned that on August 21, the official website of the Drug Evaluation Center (CDE) of the China Drug Administration showed that the marketing application for the new class 1 drug opatisumimab was accepted. In July of this year, the drug was included in the CDE priority review. The indication is single drug treatment for advanced extrapulmonary neuroendocrine cancer (EP-NEC).

Opatisumimab (LBL024) is a dual antibody targeting PD-L1 and 4-1BB using Verishibo's proprietary technology platform X-body™. It can conditionally activate 4-1BB, enhance T-cell activation regulated by 4-1BB while relieving PD-1/PD-L1 immunosuppression, and achieve the effect of collaboratively eliminating tumors. It has safety comparable to PD-1/PD-L1 inhibitors and has stronger broad-spectrum cancer treatment potential.

Currently, opatisumimab has carried out clinical studies on 13 solid tumor indications in China, including 1 key registered clinical trial and 8 proof-of-of-concept studies, covering various indications such as EP-NEC, non-small cell lung cancer, small cell lung cancer, biliary tract cancer, ovarian cancer, esophageal squamous cell cancer, liver cancer, gastric cancer, triple-negative breast cancer, and malignant melanoma.

In October 2024, patients with advanced extrapulmonary neuroendocrine cancer treated with opatisumimab were recognized as CDE breakthrough therapy; in November of the same year, it was certified as an orphan drug for neuroendocrine cancer by the US FDA. In January 2026, opatisumimab obtained FDA fast track certification and EU orphan drug certification to treat EP-NEC.

According to the Insight database, no 4-1BB targeted drugs have been approved for marketing in the world. Verishibo's opatisumimab is not only the world's first PD-L1×4-1BB dual antibody to be declared for marketing, but also the world's first 4-1BB targeted drug to be declared for marketing. In addition, there are currently two PD-L1×4-1BB dual antibodies that have entered clinical phase II, from Qilu Pharmaceutical and Anke Biotech, respectively.