Shine-On Biomedical announced on the 30th that its independently developed global breakthrough anticancer drug, SOA101, a nano trivalent T-cell engager antibody, has been submitted to the Taiwan Food and Drug Administration (TFDA) for Phase I/IIa clinical trials in Taiwan. Last week, the same drug also received approval from the U.S. FDA to proceed with clinical studies.
Additionally, on the 24th of this month, Shine-On signed a memorandum of understanding (MOU) with Singapore's leading exosome manufacturer, ESCO Aster, for the licensing of SOB100 technology, valued at NT$150 million. This collaboration is expected to generate long-term revenue and help the company achieve profitability by 2025.
According to CEO Hung-Che Jiang, the current cancer immunotherapy market is dominated by PD-1 and PD-L1 antibodies, which account for 40% of the market share. However, these therapies often come with inconsistent efficacy and high costs. The SOA101 drug, with its trivalent design, effectively addresses the limitations of PD-1 and PD-L1 therapies, such as adverse side effects and variable treatment outcomes. The drug is intended for use in treating advanced and metastatic non-small cell lung cancer, colorectal cancer, breast cancer, oral cancer, ovarian cancer, and other solid tumors. Currently, there are no similar dual immune checkpoint antibody drugs on the market globally.
The antibody-based anticancer drug market is growing rapidly, with global sales reaching $120 billion in 2023 and projected to rise to $200 billion by 2028. The trend in new drug development is shifting from monoclonal antibodies to bispecific and trispecific antibodies. According to a GII market research report, the bispecific antibody market was valued at $5.71 billion in major markets in 2023 and is expected to reach $41.29 billion by 2030, with a compound annual growth rate of 32.64%.
Hung-Che Jiang emphasized that during the early development of SOA101, the company integrated big data analytics and AI-powered drug discovery technologies to optimize the antibody structure and stability. SOA101 is currently the world’s only successfully developed trispecific nanobody, leveraging the nanobody’s high affinity for cancer cell targets, minimal off-target effects, and high safety profile. Its flexible design inhibits two immune checkpoints on cancer cells simultaneously, overcoming the immune escape and resistance commonly observed with PD-1 and PD-L1 antibodies. This innovation is expected to address the challenge of existing cancer immunotherapies, which only benefit around 30% of patients.
Chairman Chiu-Ching Huang noted that Shine-On Biomedical possesses two key technology platforms: the "trispecific T-cell engager antibody" and "exosome therapy." The company has been recognized by the Clarivate New Drug Development Competitiveness Database as one of the world’s top ten new drug development firms, with eight pipeline products currently in development.
Globally, no trispecific T-cell engager antibody drug has been approved for market release. However, as the platform technology matures and target diversification expands, the development of various anticancer drugs has attracted the attention of major pharmaceutical companies such as Roche and Merck. Among 45 ongoing trispecific antibody product developments, 24 involve early-stage co-development or technology transfer deals. The highest-value agreement is a $22.2 billion deal between Merck and Japan’s Daiichi Sankyo for a trispecific antibody platform to develop three anticancer drugs. Other notable deals include technology transfers with GSK, Boehringer Ingelheim, and AbbVie, valued between $300 million and $500 million each.
Resource: 聖安SOA101新藥 向TFDA申請臨床一／二期a試驗
