Medicilon Supports Partner Nuoyuan Medical Equipment Co., Ltd. in Securing FDA IND Approval for Class 1 Innovation Drug Pemefolacianine

On December 20, Nanjing Nuoyuan Medical Devices Co., Ltd. ("Nuoyuan Medical") received FDA approval for an IND application for Pemefolacianine, an innovative Class 1 drug. This marks the first FDA IND approval for a folate receptor-targeted imaging agent developed in China, following Cytalux (OTL-38), the world's first FDA-approved agent of its kind. Pemefolacianine has obtained patents in China, the U.S., Europe, and Japan, showcasing its global innovation strength.

As a partner, Medicilon provided one-stop R&D services for Pemefolacianine, including pharmaceutical research (API and formulation), preclinical studies (pharmacology, pharmacokinetics, and safety evaluations), and IND filing support, expediting the drug’s development process.

Pemefolacianine: Solving OTL-38 Issues and Advancing Molecular Imaging in China

To address issues such as false positives and stability challenges with OTL-38, Nuoyuan developed Pemefolacianine using AIDD technology. As a folate receptor α (FRα)-targeted fluorescence imaging agent, Pemefolacianine selectively binds to FRα, with several times the affinity compared to FRβ, potentially reducing clinical false positives. Stability studies demonstrated improved storage and transportation conditions compared to OTL-38, lowering costs and enhancing accessibility.

This groundbreaking molecule represents a leap forward for China's molecular imaging field, underscoring Nuoyuan’s expertise in precision medicine and its global competitiveness in the field.

Medicilon: 440⁺ Tumor Models Accelerating Oncology Preclinial R&D

In the competitive landscape of drug development, speed and quality are critical. Over the past 20 years, Medicilon has established a one-stop preclinical R&D platform, seamlessly integrating drug discovery, pharmaceutical research, and preclinical studies to accelerate the path to clinical trials.

With over the past 20 years preclinical R&D endevor, Medicilon has built an over 440 tumor efficacy model platform, including 118 PDXs, CDXs, and humanized mouse models. Additionally, it has developed models and evaluation methods for immunotherapies, including CAR-T, TCR-T, CAR-NK, oncolytic viruses, antibodies (monoclonal, bispecific, and multispecific), siRNA, and AAV. These resources bolster the development of innovative therapies.

Medicilon congratulates Nuoyuan on the FDA IND approval of Pemefolacianine and looks forward to its NMPA IND approval, enabling dual filing and dual approval in China and the U.S. Medicilon remains committed to advancing its preclinical oncology drug R&D platform, accelerating innovation for global cancer therapies.

About Nuoyuan Medical Equipment

Founded in Nanjing, Nuoyuan specializes in developing, manufacturing, and commercializing high-end medical devices and innovative targeted imaging drugs. The company focuses on solutions for tumor precision diagnostics and treatment, integrating technologies such as molecular fluorescence, Raman spectroscopy, and AI-assisted drug design. Recognized as a national high-tech enterprise, Nuoyuan Medical has received numerous accolades, including the BioCon Awards for Investment Value Innovation Company in 2024 and the Global Targeted Molecular Fluorescent Tracer Development Leadership Award.

About Medicilon

Founded in 2004, Medicilon (Stock Code: 688202.SH) provides comprehensive preclinical drug research services for global pharmaceutical companies and institutions. With over 2,000 clients and 490 IND-approved drugs, Medicilon accelerates drug development through efficient project management and innovative solutions.