Vilishibo-B (09887): Vilisin™ (opatisumimab, PD-L1/4-1BB bispecific antibody, LBL-024) new drug marketing application accepted by NMPA

Zhitong Financial App News, Weilizhibo-B (09887) announced that the National Drug Administration (NMPA) Drug Evaluation Center (CDE) of the People's Republic of China has officially accepted the new drug marketing application (NDA) for the drug under study independently developed by the company, Vilisin™ (opatisumimab, PD-L1/4-1BB bispecific antibody, LBL-024) to treat advanced extrapulmonary neuroendocrine cancer (EPNEC) with a single drug. Verisign™ is the world's first PD-L1/4-1BB bispecific antibody to be declared for marketing. The application was approved for priority review by CDE on July 10, 2026. If successfully approved, Velixin™ will become the world's first antibody drug directly targeting 4-1BB, and the first approved agonist antibody drug. At the same time, it will also make 4-1BB the fourth most developed immunotherapy target in the world after PD-1/PD-L1, CTLA-4, and LAG-3, marking an important milestone in the field of cancer immunotherapy in China.

This NDA application is based on the positive results of a key registered clinical study led by Professor Shen Lin of Peking University Cancer Hospital and the participation of 34 hospitals. The study enrolled all 96 EPNEC patients in August 2025. Detailed clinical findings are scheduled to be presented at top international academic conferences.

Neuroendocrine carcinoma (NEC) is a highly malignant immunological cold tumor, accounting for approximately 10% to 20% of neuroendocrine tumors. NEC can occur in a variety of organs, including the lungs, digestive tract, and bladder. NEC can be divided into pulmonary NEC and EP-NEC. EP-NEC has similar highly invasive metastatic characteristics to small cell lung cancer (SCLC). The disease progresses rapidly, and most NEC patients are advanced or have distant metastases at the time of diagnosis. Systematic treatment strategies for NEC are limited, with poor efficacy and poor prognosis.

Currently, there are no regulatory approvals worldwide for the specific treatment of EP-NEC. First-line treatment for advanced EP-NEC is mainly platinum-containing chemotherapy. The objective response rate (ORR) is about 30% to 50%, and the median overall survival (MoS) is only about 1 year. After first-line treatment progresses, there is no standard treatment plan. For second-line treatment, options such as FOLFOX with oxaliplatin, FOLFIRI with irinotecan as the main treatment, CAPTEM with or without bevacizumab or temozolomide monotherapy can be selected. However, the efficacy of these treatment options is limited, with an ORR of about 10% to 25%, and MoS of about 8 months. Therefore, advanced EP-NEC patients still have huge unmet clinical needs, and there is an urgent need for new effective treatment options to break through the status quo.

Velisin™ is a bispecific antibody targeting PD-L1 and 4-1BB at the same time. It is a pan-tumor IO2.0 cornerstone therapy with potential survival benefits. Using X-body™, a platform developed independently by us and with full intellectual property rights, Velisin™ 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. Velisin™ has safety comparable to PD-1/PD-L1 inhibitors and has a stronger broad-spectrum cancer treatment potential, and has shown the world's first (FIC) or best-in-class BIC (BIC) potential in tumors such as non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), extrapulmonary neuroendocrine cancer (EP-NEC), and biliary tract cancer (BTC).

As the world's first molecule targeting costimulatory receptor 4-1BB, which is already in the critical clinical phase of single-arm registration, Velisin™ is expected to be the first drug approved for the treatment of EP-NEC. Verisign™ has conducted 13 clinical studies on solid tumor indications in China, including 1 key registered clinical trial and 8 proof-of-concept studies, covering areas with high unmet clinical needs such as EP-NEC, NSCLC, SCLC, BTC, ovarian cancer (OC), esophageal squamous cell carcinoma (ESCC), liver cancer (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), and malignant melanoma.

In particular, it is worth pointing out that activating the 4-1BB co-stimulatory pathway can restore and enhance apoptotic T-cell activity and promote their expansion, so that therapeutics targeting 4-1BB may be suitable for treating immunological cold tumors that are resistant or ineffective against PD-1/PD-L1 inhibitors, and have potential long-lasting survival benefits with long lasting effects. In October 2024, Velisin TM was certified as a breakthrough therapeutic drug by the NMPA Drug Evaluation Center, and in November 2024, it was certified as an orphan drug by the US Food and Drug Administration (FDA). In January 2026, Velisin TM was granted FDA Fast Track certification and EU orphan drug certification.