FDA Greenlights SOB100 for Phase I; Breakthrough Study Published in Nature Communications
TAICHUNG, June 9, 2025 /PRNewswire/ — A research team led by Dr. Der-Yang Cho, Superintendent of China Medical University Hospital (Taiwan), in collaboration with Shine-On Biomedical Co., has developed the world’s first targeted exosome drug delivery platform aimed at HLA-G, marking a major milestone in the field of precision oncology. The novel platform, named SOB100, has completed preclinical studies and demonstrated promising efficacy in treating aggressive cancers such as breast cancer and glioblastoma.
China Medical University Hospital (Taiwan) and Shine-On Biomedical Co. developed SOB100, the world’s first HLA-G targeted exosome therapy. Backed by FDA Phase I approval and featured in Nature Communications, it shows promise against aggressive cancers.
The team’s findings were published in the prestigious journal Nature Communications, and on March 8, 2025, the platform received approval from the U.S. Food and Drug Administration (FDA) to begin Phase I clinical trials in humans.
SOB100: A First-in-Class Exosome Platform Targeting HLA-G
Ms. Hui-Chun Ho, Vice President of Shine-On Biomedical Co., noted that SOB100 is globally the only exosome-based platform engineered to target HLA-G, a molecule often overexpressed by tumor cells to evade immune surveillance. Built using nanobody (VHH) technology, SOB100 has demonstrated the ability in multiple animal studies to effectively deliver both small molecules and nucleic acid drugs across the blood-brain barrier, offering a new hope for treating hard-to-treat cancers like triple-negative breast cancer and glioblastoma.
While HLA-G is typically restricted to placental tissue, many tumors exploit this mechanism to suppress immune detection. SOB100 uses a gene-engineered exosome membrane embedded with nanobodies that bind to HLA-G, allowing for precise delivery of therapeutic agents in SOB100 to tumor cells while minimizing the systemic toxicity often seen with conventional chemotherapy.
From Breakthrough Research to Global Commercialization
Mr. Hung-Che Chiang, CEO of Shine-On Biomedical Co., highlighted that the company has been named one of the top 10 global developers of exosome-based therapies by the Clarivate global pharmaceutical innovation database. SOB100 has earned numerous accolades, including the National Innovation Award (Taiwan), the International Innovation Award (Taiwan), and the Merck Emerging Biotech Special Award (U.S.).
Poised to replace viral vectors and liposome carriers in gene and cancer therapies, SOB100 offers a safer, more specific, and highly scalable alternative for the global market. Shine-On Biomedical has also signed a memorandum of understanding (MOU) with a Singapore-based exosome manufacturer for co-development and licensing of SOB100-based therapies, including methods for loading chemotherapy drugs into HLA-G-targeted exosomes. This international partnership is expected to accelerate SOB100’s global clinical adoption and commercial expansion.
A New Frontier for Overcoming Drug Resistance in Cancer
The advent of SOB100 offers a novel solution to one of oncology’s most persistent challenges: target specificity and drug resistance. By homing in on the tumor cells and overcoming immune suppression, SOB100 is expected to become a next-generation platform for the delivery of nucleic acid and small molecule drugs.
With FDA clearance, growing international recognition, and advancing clinical trials, SOB100 is poised to play a critical role in the future of precision medicine, offering new hope to cancer patients around the world.
CONTACT: Carolyn Chen, [email protected]
