ShuoXing Bio's First-in-Class Dual-Target Anti-Tumor Drug SM2275 Receives FDA IND Approval, Pioneering a New Era in Cancer Immunotherapy

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The approval of SM2275 marks a significant breakthrough in the field of tumor immunotherapy and is expected to provide a new treatment option for patients with various solid tumors such as lung cancer, gastric cancer, breast cancer, and head and neck cancer.

The innovation of this drug lies in its mechanism design of "dual targets + conditional co-stimulation": On one hand, it blocks the EGFR signaling pathway and the PD-L1 immune checkpoint to precisely target tumors; on the other hand, it enhances the immune response of tumor-infiltrating T cells by conditionally activating CD28 co-stimulatory signals, thereby improving anti-tumor efficacy and overcoming resistance to PD-1/PD-L1 therapy.

Preclinical study data show that SM2275 demonstrates stronger and more sustained antitumor activity in various tumor models.

Currently, there are no drugs with a similar mechanism of action that have entered the clinical stage globally. The IND approval of SM2275 marks another significant breakthrough for StarMab BioMed in the field of cancer immunotherapy.

Dr. Yanbin Liang, founder and CEO of StarMab BioMed, stated: "The approval of SM2275 marks an important milestone for the company in its globalization journey. As the world's first anti-tumor drug based on this mechanism, we hope it will bring new hope to patients with solid tumors who lack effective treatment options. Moving forward, the company will fully advance global clinical trials, accelerate the drug’s market entry, and benefit patients as soon as possible."

StarMab BioMed is a biopharmaceutical company focused on the research and development of innovative drugs for cancer immunotherapy, committed to developing breakthrough therapies with global competitiveness. As a pioneer in nano-multiantibody technology, StarMab BioMed has established a proprietary nano-multiantibody drug development platform with significant advantages in targeting, stability, and therapeutic efficacy.

Based on this platform, the company has developed multiple innovative drug pipeline products in clinical stages, including SM2275 and SM3321. Among them, SM3321 has received clinical trial approval from China's NMPA and the U.S. FDA and is currently in Phase Ib/II clinical research.

StarMab BioMed will continue to uphold the concept of "Science-led, Patient-first," continuously promoting the global development and accessibility of innovative drugs for the benefit of patients worldwide.

Qidian Capital Served as the Financing Financial Advisor for StarMab BioMed.

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