Starmab Announces FDA Acceptance of IND Application for SM2275, Pioneering a New Era in Broad-Spectrum Solid Tumor Therapy

On March 7, 2025, Zhuhai Shuoxing Biopharmaceutical Technology Co., Ltd. (hereinafter referred to as “Shuoxing Biopharma”) announced today that its Investigational New Drug (IND) application for SM2275, a globally first-in-class drug independently developed by the company, has been formally accepted by the U.S. Food and Drug Administration (FDA). SM2275 is an innovative dual-targeting agent directed against EGFR and PD-L1 in tumors. By enabling CD28-restricted activation of T cells within the tumor microenvironment, it demonstrates broad-spectrum potential against solid tumors and is poised to become the world’s first broad-spectrum anti-solid tumor drug with this unique mechanism of action.

SM2275 represents another major breakthrough by Shuoxing Biologics in the field of cancer immunotherapy, following the approval of SM3321. By simultaneously targeting EGFR and PD-L1, this drug effectively inhibits the growth and spread of tumor cells while enhancing the immune system’s cytotoxic activity against tumors by activating T cells within the tumor microenvironment. This unique dual-target mechanism not only improves anti-tumor efficacy but also significantly reduces the development of drug resistance, offering a new therapeutic option for patients with solid tumors.

Shuoxing Bio stated, “The development of SM2275 is based on our in-depth understanding of the tumor microenvironment and immunomodulatory mechanisms. We believe that the unique mechanism of action of SM2275 will bring new hope to patients with solid tumors worldwide. The submission of the Investigational New Drug (IND) application to the FDA marks a significant step toward clinical trials for SM2275. We will continue to advance the clinical development of this drug, striving to deliver benefits to patients as soon as possible.”

To date, no public reports indicate that other companies have developed drugs with the same dual-target mechanism (EGFR and PD-L1) that activate T cells in a CD28-restricted manner. Therefore, SM2275 is poised to become the world’s first broad-spectrum anti-solid tumor drug with this unique mechanism of action.

Since its inception, Shuoxing Biotech has been dedicated to the research and development of innovative drugs, achieving multiple breakthroughs particularly in the field of tumor immunotherapy. The company boasts a research and development team composed of top-tier scientists from around the world and has established close collaborative relationships with numerous internationally renowned medical and research institutions.

The submission of this Investigational New Drug (IND) application marks a significant milestone for Shuoxing Biopharma in the field of global innovative drug research and development. Moving forward, the company will continue to uphold its philosophy of “innovation-driven and patient-first,” accelerating the clinical development of SM2275 and other investigational drugs to provide more effective and safe treatment options for patients worldwide.

Zhuhai Shuoxing Biopharmaceutical Technology Co., Ltd. is a biopharmaceutical company dedicated to the research and development of innovative drugs, committed to providing breakthrough therapeutic solutions for patients worldwide. With tumor immunotherapy as its core focus, the company concentrates on cutting-edge areas such as tumor microenvironment modulation and immune cell activation, and possesses multiple independently developed intellectual property rights for its innovative drug R&D platforms.