September 18, 2025 — The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has officially accepted the Investigational New Drug (IND) application (Application No.: JXHL2501015) for ¹⁷⁷Lu-PSMA-VG01 Injection, a radioligand therapy independently developed by VitsGen Therapeutics, Inc. (“VitsGen”). This acceptance marks a significant milestone in VitsGen’s advancement of its radionuclide drug conjugate (RDC) pipeline.

¹⁷⁷Lu-PSMA-VG01 Injection is designed to target prostate-specific membrane antigen (PSMA) for the treatment of patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).

Prostate cancer is the second most common malignancy among men worldwide and remains a serious public health challenge. In March 2022, Novartis’ RDC drug Pluvicto® (¹⁷⁷Lu-PSMA-617) was approved by the U.S. FDA for patients with mCRPC who progressed after androgen receptor pathway inhibitors and taxane-based chemotherapy. Pluvicto has since achieved strong commercial success, with global sales reaching USD 1.392 billion in 2024—a 42% year-over-year increase—solidifying its status as a blockbuster therapy with significant clinical and market value.

Compared to Pluvicto, ¹⁷⁷Lu-PSMA-VG01 Injection has demonstrated clear advantages in preclinical studies. In vitro and in vivo data show:

•       2.6x higher binding affinity to PSMA

•       2.4x greater internalization efficiency

•       Prolonged tumor uptake and retention with no significant increase in uptake in healthy organs

•       Lower kidney accumulation than Pluvicto, suggesting an improved safety profile

Multi-dose level and multi-model efficacy studies further revealed that, at equivalent doses, ¹⁷⁷Lu-PSMA-VG01 provided stronger tumor suppression. Even at reduced doses, its efficacy remained comparable or superior to Pluvicto. These findings demonstrate that the drug holds promise for maintaining same efficacy while reducing the dosage of radionuclides and minimizing potential radiotoxicity, or for achieving stronger tumor suppression at the same dosage, thereby offering patients a safer and more efficient treatment option.

As an emerging leader in targeted radiopharmaceuticals, VitsGen is leveraging its proprietary MAP technology platform to build a diversified pipeline of seven candidates across multiple tumor types. Several programs are currently in preclinical development or in clinical candidate optimization. Looking ahead, VitsGen remains committed to accelerating innovation in precision oncology and delivering superior diagnostic and therapeutic solutions to patients worldwide.