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Esco Aster Signs Exosome Clinical cGMP Manufacturing Contract With Shine-On Biomedical For A Novel First-In-Class HLA-G Targeting Exosome Drug Delivery Platform

16.12.2025 02:00:00 CET | Business Wire | Press release

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Esco Aster, a vertically integrated cell and derivatives CRDMO based at JTC LaunchPad Singapore, announced CMC manufacturing support for Shine-On Biomedical’s HLA-G targeted exosome program. Shine-On Biomedical sponsored Esco Aster in 2023 for cGMP services, starting with high-yield exosome development using Esco Aster’s cell line platform. The technical reports of process, analytical, and formulation development, exosome drug loading, GMP engineering runs, and stability studies supported Shine-On’s IND submission. The IND was cleared by the U.S. FDA in Q1 2025.

Furthermore, Esco Aster is providing technical services for exploratory exosome loading feasibility studies per Shine-On’s instruction. Shine-On Biomedical is an emerging innovator in exosome-based drug delivery.

ShineOn’s proprietary product, SOB100, a HLA-G targeted exosome drug delivery carrier, has passed the U.S. FDA IND review and ongoing Phase I study, making it as a first-in-class–potential HLA-G targeted exosome platform for drug development.

Statement From Hung-Che Chiang, General Manager of Shine-On Biomedical

“Preclinical studies have shown promising biodistribution characteristics supporting further exploration across small-molecule, nucleic acid, and protein-based payloads.”

In parallel, Esco Aster, providing Mitosis™ Enterprise Solutions to support potential future evaluation of single-use cGMP workflows at China Medical University Hospital.

This collaboration strengthens Esco Aster’s position as Singapore’s first fully homegrown CRDMO offering end-to-end engineered cancer exosome development—from cell line creation to GMP manufacturing using its patented 3D Tide Motion™ bioreactor. This technology lowers COGS by enabling multiple conditioned media harvests per run. Esco Aster also co-develops autologous cell therapy programs in ASEAN, including a T-cell reactivation platform targeting non-G12C KRAS mutation NSCLC.

Esco Aster supports Asia-Pacific innovators through biomanufacturing scale-up, market access, and commercialization across South Asia, ASEAN, and Oceania—a region valued at ~USD 10.5 trillion GDP with ~2.6 billion people. Supported by a network of medical centres and clinician-scientists, Esco Aster facilitates IIT and FIM studies, especially in Australia, where R&D incentives lower costs. The company advances its “One World BioSolutions for One Health” vision, enabling high yield at low GMP cost to strengthen Singapore’s and Asia’s bioeconomy.

© 2025 Esco Aster Pte. Ltd. and Shine-On Biomedical Co., Ltd. All rights reserved.

View source version on businesswire.com: https://www.businesswire.com/news/home/20251215708094/en/

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