On September 2, 2025, RGL-305 Injection (hereinafter referred to as "RGL-305")—the first cell therapy product targeting malignant tumors independently developed by Shanghai Ruihongdi Pharmaceutical Co., Ltd. (hereinafter referred to as "Ruihongdi Pharmaceutical")—officially received tacit approval for clinical trials from the National Medical Products Administration (NMPA). This milestone marks a significant advancement for the company in the field of cell therapy and brings new hope to patients with malignant tumors who are in urgent need of effective treatment options.

An Integrated Platform with High Capacity, Robust Quality Control, and Low Costs

The approval of RGL-305 is underpinned by Ruihongdi Pharmaceutical’s proprietary "Cell Therapy Platform"—a system independently established and continuously optimized by the company—which incorporates industry-leading capabilities in end-to-end cell process development and manufacturing quality control. The platform’s key attributes—including off-the-shelf applicability, highly efficient processes, and scalable manufacturing—collectively drive a significant reduction in the cost per treatment while demonstrating exceptional industrialization capabilities, thereby laying the economic foundation to benefit a wider patient population in the future.

Platform-Driven Pipeline: Accelerating the Resolution of Unmet Clinical Needs      

Dr. Liao Cheng, Chairman of Ruihongdi Pharmaceuticals, stated that the approval of RGL-305 serves as a significant validation of our scientific innovation capabilities and our strength in integrating platform technologies. "Our cell therapy platform—particularly its deeply integrated, end-to-end process development and quality control modules—systematically addresses and overcomes the bottlenecks regarding cost, accessibility, and large-scale manufacturing that currently confront cell therapies. We will fully dedicate ourselves to advancing the clinical research of this product, exploring its efficacy and safety across a range of malignant tumors, and fully leveraging its potential for combination therapies. Concurrently, leveraging this robust platform, Ruihongdi will continue to accelerate the development of other cell therapy candidates within our pipeline, thereby fulfilling our corporate mission to 'benefit patients worldwide through innovative therapies.'"

About Shanghai Ruihongdi Pharmaceutical Co., Ltd.

Established in August 2021, Ruihongdi Pharmaceutical is an innovative biopharmaceutical company dedicated to the field of Cell and Gene Therapy (CGT). The company possesses a proprietary "AAV + mRNA + Cell Therapy" tri-core technology R&D platform. This platform integrates industry-leading, end-to-end process development and quality control modules—spanning plasmids, viral vectors, mRNA, and cell therapies—all engineered to deliver high yield, high recovery rates, superior quality, and cost-efficiency, thereby providing robust support for drug development. The company’s R&D pipeline is strategically focused on disease areas characterized by urgent clinical needs and vast market potential, including neurology, ophthalmology, metabolic disorders, and oncology. Upholding the mission of safeguarding human health, Ruihongdi Pharmaceutical continuously strengthens its core competencies and maintains a pioneering, innovative spirit, striving to create healthier and better lives for patients worldwide.