On January 22, 2026, Nanjing Veolizhibo Biotechnology Co., Ltd. (hereinafter referred to as "Velizhibo" or the "Company", stock code: 9887.HK) announced that its core product, Verizon® ( LBL-024, anti-PD-L1/4-1BB bispecific antibody), has been granted Orphan Drug Designation (ODD) by the European Commission (EC) for the treatment of extrapulmonary neuroendocrine carcinoma (EP-NEC). This is another important milestone in the global development of Verizon®. Currently , Verizon® has demonstrated first-in-class (FIC) or best-in-class (BIC) potential in Phase II or registrational clinical trials for three indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and EP-NEC .

According to the EC definition, an orphan drug is a medicine used to diagnose, prevent, or treat a life-threatening or chronically debilitating disease, and the number of patients is no more than five per ten thousand of the total EU population. Obtaining orphan drug designation provides several key incentives, including but not limited to:

0 1Solution Assistance
The European Medicines Agency (EMA) provides scientific advice to assist with the program, including advice on different types of research questions such as drug quality, benefits, and risks.
0 2Ten-year exclusive rights to the EU market
It enjoys a ten-year market exclusivity right from the date of approval of marketing authorization. During this period, EU and member state regulatory agencies shall not approve other companies to market similar drugs for the same indication. The market exclusivity right is independent of the patent and remains valid even without patent protection.
0 3Regulatory fee reduction
This includes reductions or exemptions related to program guidance, listing approval application and verification, post-listing changes, and annual maintenance fees.
04Funding subsidies
Once orphan drug designation is obtained, funding can be obtained from other sources such as the European Commission and Horizon Europe.
05Additional incentives for micro, small or medium-sized enterprises
This includes assistance with regulations, administration, and procedures, as well as fee reductions.

Dr. Tsai Shengli, Chief Medical Officer of Veolia Biotech, stated
This Orphan Drug Designation from the European Union signifies renewed recognition of the company's technology platform and clinical data by international regulatory authorities. This designation will provide policy support for the development, registration, and commercialization of Verizon® in the EU, accelerating its global development and helping this innovative therapy reach patients worldwide as soon as possible.

About Verizon®
Verizon® ( LBL -024) is a bispecific antibody targeting PD-L1 and 4-1BB. It is the world's first molecule targeting the co-stimulatory receptor 4-1BB to be in a pivotal single-arm clinical trial, and is expected to become the first approved drug for the treatment of EP-NEC. Verizon® is developed using Verizon's proprietary X-body® technology platform , employing a 2:2 structural design. It can relieve PD-1/PD-L1 immunosuppression and enhance 4-1BB-regulated T-cell activation, achieving a synergistic effect in eliminating tumors and demonstrating stronger broad-spectrum cancer treatment potential than PD-1/PD-L1 inhibitors.

In two clinical trials in China, Verizon® demonstrated encouraging efficacy signals and a good safety profile for advanced EP-NEC, whether used as monotherapy or in combination with chemotherapy. Due to the lack of standard treatments for EP-NEC, Verizon® received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China on April 30, 2024, to conduct a single-arm pivotal registration clinical study, with full patient enrollment completed in August 2025. In October 2024, Verizon® received Breakthrough Therapy Designation from the CDE, and in November of the same year, it received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA). In January 2026, Verizon® received Fast Track Designation from the FDA.

It is worth noting that 4-1BB, as an agonist, can reactivate and proliferate apoptotic T cells, making it particularly suitable for treating cold tumors that are resistant to or ineffective with PD-1/PD-L1. Therefore, in addition to EP-NEC, Verizon® has been approved for clinical trials in areas with significant unmet clinical needs, including small cell lung cancer (SCLC), biliary tract cancer (BTC), ovarian cancer (OC), non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), liver cancer (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), and malignant melanoma. Encouraging clinical results have been observed in multiple cancer types, including NSCLC, SCLC, BTC, and OC, suggesting its potential as a promising and effective anti-tumor drug targeting a broad range of indications.

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