Editor's note:

In response to the Belt and Road Initiative, and with the aim of sharing expertise and addressing shared health challenges, our hospital has launched the Overseas Promotion Program for New Medical Technologies. If you are interested in any of the medical technologies covered under this program, please feel free to contact the International Cooperation Office at faowch@163.com.

Universal Cellular Vaccine for Epstein-Barr Virus Infection

This is a pioneering universal cellular vaccine designed to treat both EBV-associated tumors, such as nasopharyngeal carcinoma, Hodgkin lymphoma, NK/T-cell lymphoma, certain gastric cancers, and non-malignant conditions like chronic active EBV infection. By activating the patient’s immune system, this vaccine reduces EBV viral load, and provides sustained antitumor and antiviral effects.

Importantly, this universal cellular vaccine has received orphan drug designation from the U.S. FDA and has been approved as an advanced therapy at Huaxi Lecheng Hospital in the Boao Lecheng Pilot Zone for Medical Innovation in Hainan.

Preliminary clinical studies demonstrate promising therapeutic outcomes. Even in advanced patients who had failed multiple prior therapies, exhibited widespread metastatic disease, and were PD-1-resistant, the overall objective response rate (ORR) reached 50%, the disease control rate (DCR) was 83.3%, and all patients demonstrated a significant reduction in EBV viral load. Notably, the best-responding patient achieved complete remission (CR), with total tumor disappearance and undetectable EBV DNA in peripheral blood. This patient has now survived for nearly three years.

Moreover, this vaccine exhibits an excellent safety profile. No Grade 2 or higher adverse events were reported. Only mild and self-limiting reactions, such as low-grade fever or localized rash, occurred in a small subset of patients, resolving without intervention. More importantly, this vaccine is extremely convenient to use—it is an “off-the-shelf” universal vaccine, allowing patients to use it directly without waiting. Its subcutaneous administration route further improves clinical accessibility, and it also boasts a low adverse reaction rate and high patient acceptance.

The substantial public health burden imposed by EBV-related diseases, especially the high incidence of malignancies like nasopharyngeal carcinoma and lymphoma in Belt and Road countries, such as China, Southeast Asian nations like Thailand, Malaysia, and Indonesia, as well as North African countries like Kenya, underscores an imperative for targeted therapeutic solutions. Meanwhile, these countries have large population bases; some of them have underdeveloped medical infrastructure, low self-sufficiency in pharmaceuticals, and rely on imports. The development of EBV-targeted therapies represents a promising therapeutic breakthrough, poised to fulfill a critical unmet need while underscoring significant commercial potential.