August 12, 2026 — China — The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) formally accepted the Investigational New Drug (IND) application for ¹⁷⁷Lu-FAP-VG11 Injection, a Class 1 therapeutic radiopharmaceutical independently developed by Shandong VitsGen Pharmaceutical Co., Ltd. (“VitsGen”).

The IND application was assigned acceptance number CXHL2600985. The acceptance represents another important milestone for VitsGen in the development of radionuclide drug conjugates (RDCs).

1 | ¹⁷⁷Lu-FAP-VG11 is a radioligand therapy being developed for the treatment of patients with fibroblast activation protein (FAP)-positive advanced malignant solid tumors.

2 | ¹⁷⁷Lu-FAP-VG11 consists of the FAP-targeting ligand FAP-VG11 chelated with the radioisotope lutetium-177 (¹⁷⁷Lu).

Through its ligand, the drug selectively binds to FAP-positive cells. FAP is a membrane-bound serine protease that is highly expressed in a variety of solid tumors. Radiation emitted by ¹⁷⁷Lu, including beta particles, can directly induce DNA damage in targeted cells, leading to cell death.

In addition to direct cytotoxicity, ¹⁷⁷Lu-FAP-VG11 may kill neighboring tumor cells through the crossfire effect and generate additional antitumor activity through bystander effects and radiation-induced immune responses, including potential abscopal effects.

3 |In nonclinical studies, VitsGen’s proprietary ¹⁷⁷Lu-FAP-VG11 Injection demonstrated:Higher binding affinity;Higher tumor uptake;Longer tumor retention;A higher tumor-to-kidney ratio; andGreater tumor growth inhibition in animal models.

No significant increase in uptake by healthy organs was observed, while kidney uptake was relatively low and the predicted radiation dose to red bone marrow was also low.

As a novel radioligand therapy, ¹⁷⁷Lu-FAP-VG11 Injection is being developed as a potential new treatment option for patients with FAP-positive advanced malignant solid tumors. Its preclinical profile supports continued investigation of its potential efficacy, safety, and applicability across multiple tumor types.

To date, VitsGen has successfully advanced two innovative therapeutic radiopharmaceutical candidates into clinical development, marking meaningful progress in the company’s RDC research, development, and clinical translation capabilities and further strengthening its position in radiopharmaceutical innovation.

Looking ahead, VitsGen will continue to increase investment in innovative drug R&D and accelerate clinical development. Guided by scientific innovation and focused on clinical value, the company is committed to delivering more precise, effective, and accessible integrated diagnostic and therapeutic solutions to patients worldwide and translating advances in nuclear medicine into meaningful benefits for patients in need.