At the beginning of 2026, significant news emerged from China’s gastric cancer treatment landscape: the National Medical Products Administration (NMPA) officially approved Livafusp Alfa Injection (Brand name: Aizeli®). Recently, our hospital administered the first prescription for this drug in Guangzhou, marking the official clinical launch of the world’s first PD-L1/TGF-βRII bispecific antibody fusion protein, offering a new treatment option for patients with advanced gastric cancer.

Dual-Target Synergy Unlocks a New Approach to Immunotherapy

The concept of a “bispecific antibody” may be unfamiliar to many. A simple analogy can help: our body’s immune system acts like a “police force,” while tumor cells are cunning “criminals.”

In the past, tumor cells used two main tactics to evade attack: first, they applied the “brakes” (the PD-L1 pathway) to the immune “police,” rendering them ineffective; second, they built a “defensive wall” (the TGF-β immunosuppressive microenvironment) to keep the “police” out. Traditional immunotherapy could only remove one of these obstacles, limiting its effectiveness.

Livafusp Alfa Injection, however, is a true “all-in-one fighter”: one end of the molecule releases the PD-L1 “brake,” restoring the immune cells’ killing ability; the other end precisely blocks the TGF-β signal, dismantling the tumor’s “defensive wall” and improving the immune microenvironment, allowing the “police force” to successfully penetrate the tumor core. This dual-target synergistic design is the key to overcoming the limitations of traditional therapies.

Impressive Clinical Data, Survival Benefits Even in Hard-to-Treat Populations

The approval of this new drug is based on outstanding results from a Phase III clinical study. Data show that for patients with PD-L1-positive (CPS≥1) advanced gastric cancer, the median overall survival (mOS) for those treated with Livafusp Alfa in combination with chemotherapy reached 16.7 months, extending survival by 6.4 months compared to traditional chemotherapy and reducing the risk of death by 43%.

More notably, it offers hope for patients with gastric cancer liver metastases, a particularly challenging group to treat. In this subgroup, the median overall survival increased to 16.8 months, with a substantial 54% reduction in the risk of death, positioning this regimen as a potential preferred immunotherapy option for these patients.

Regarding safety, the incidence of key adverse events with this drug was comparable to traditional treatments. Furthermore, it demonstrated a unique bone marrow protective effect by reducing chemotherapy-induced hematologic toxicities such as thrombocytopenia, helping patients complete their treatment cycles more smoothly.

Precision Treatment Takes Hold, Domestic Innovation Leads a New Landscape

China has a high incidence of gastric cancer, with a significant proportion of patients diagnosed at an advanced stage. Situations like liver metastases have long posed considerable challenges for both doctors and patients. With authoritative guidelines such as the CSCO Gastric Cancer Diagnosis and Treatment Guidelines 2025 emphasizing precise, stratified treatment, the launch of Livafusp Alfa is particularly timely.

Its approval represents not only the world’s first clinical breakthrough for a PD-L1/TGF-βRII bispecific antibody but also marks a shift in China’s gastric cancer immunotherapy from a “single-target” to a “dual-target synergistic” second-generation era. As a domestically developed innovative drug, it ensures efficacy advantages while making precision treatment more accessible to gastric cancer patients.

With the first prescription now successfully issued in Guangzhou, this new drug has officially entered clinical application. For patients with PD-L1-positive locally advanced or metastatic gastric cancer, this is undoubtedly a timely development, bringing new hope for prolonged survival and improved quality of life.

Important Note

This article is for academic reference by healthcare professionals only and does not constitute any medical advice or recommendation. Individual patient conditions vary significantly; suitability for this drug requires a comprehensive evaluation by a qualified physician at a formal medical institution. Do not purchase or switch medications on your own.

Forging Ahead with New Therapies – Advancing Patient Care

Guangzhou Royal Lee Hospital is consistently dedicated to providing patients with superior, cutting-edge diagnostic and treatment services. Our Pharmacy Department actively maintains close collaborations with domestic and international pharmaceutical companies, establishing a rapid access pathway for new drugs to ensure that innovative therapies reach our pharmacy promptly upon approval, allowing patients to benefit from the latest medical advancements without lengthy delays.