Shine-On Biomedical has received approval from Taiwan’s Food and Drug Administration (TFDA) on June 3 to initiate Phase I/IIa clinical trials for its novel anti-cancer drug SOA101, a nanobody-based trispecific T-cell engager targeting solid tumors. This approval follows earlier clearance by the U.S. FDA, allowing the company to proceed with human clinical trials in both Taiwan and the United States. The trials aim to evaluate the therapeutic effects of SOA101 on five hard-to-treat cancers: lung cancer, colorectal cancer, breast cancer, ovarian cancer, and head and neck cancer.
To date, no trispecific antibody has been approved for market use globally. Shine-On stated that this globally leading antibody design has been recognized as one of the top ten trispecific antibody technologies under development worldwide. The company also plans to launch multi-country, multi-center clinical studies in the future to support regulatory approvals across global markets, enhancing the international visibility of Taiwan’s biomedical innovation in drug development.
According to Hung-Che Jiang, CEO of Shine-On Biomedical, the development of SOA101 incorporated data-driven approaches and AI-powered drug design from its early stages, successfully overcoming the complexity of multispecific antibody structures. This resulted in significantly improved production scalability and molecular stability. SOA101 is the world’s first and currently only successfully developed trispecific nanobody. It features three key advantages: (1) one antibody simultaneously exerts three distinct anti-cancer mechanisms; (2) the nanobody maintains stable anti-tumor activity in hypoxic and acidic tumor microenvironments; and (3) it helps restore immune function in patients experiencing immunosuppression following long-term cancer treatment. SOA101 is expected to address the current clinical limitation wherein only about 30% of cancer patients benefit from existing immunotherapies.
Globally, trispecific antibody drug development remains in its early clinical stages. According to Clarivate Analytics data on drug development and licensing transactions, as of January 2025 there have been 25 technology transfer deals involving trispecific antibodies, with those in the clinical phase valued between US$500 million and US$1 billion. Furthermore, according to Precedent Research’s 2023 analysis, the global monoclonal antibody market reached US$240.9 billion and is projected to grow to US$737.59 billion by 2033, representing a compound annual growth rate (CAGR) of 11.48%. Shine-On aims to capture a significant share of this growing market once SOA101 reaches commercialization.
Chairwoman Huang, Chiu-Ching expressed hopes that clinical trials will demonstrate the safety and efficacy of SOA101 in cancer treatment. In just four years, Shine-On has established two proprietary technology platforms: the “Trispecific T-cell Engager Antibody Platform” and the “HLA-G Targeted Exosome Drug Delivery Platform.” Both have earned Shine-On a place in Clarivate Analytics’ global ranking of the top ten most competitive new drug developers. Shine-On is committed to playing a key role in the field of precision oncology, striving to improve survival rates and quality of life for cancer patients around the world.
Resource: 聖安SOA101三特異性抗體，獲准啟動台、美Phase I/IIa臨床試驗
