Echobiotech Establishes China's First GMP Pilot Plant for Engineered Exosomes, Advancing Commercialization of Exosome Therapeutics

In recent years, research on exosomes has become increasingly popular. In China, there are more than 3,000 related research papers published each year, and over 2,000 National Natural Science Foundation projects have been applied for. While the scientific community is actively conducting research, no exosome-based drugs have yet reached the market in the industrial sector.

Compared to academic research, the industrial development of exosome-based therapeutics is far more stringent, and companies worldwide capable of undertaking such industrial-scale R&D are exceedingly rare. The gap between academia and industry lies not only in differences in research precision and requirements but also in infrastructure, technological platforms, and the capacity for independent intellectual property (IP) development.

“An engineered exosome technology platform capable of efficiently loading active ingredients, a stable industrialized production process and quality control system, and GMP-compliant infrastructure are the key elements for the druggability of engineered exosomes at the current stage.” This is how Kong Guanyi, founder of ECHO BIOTECH, a leader in engineered exosome research and therapeutic translation, distinguishes between exosome scientific research and industrial development. ECHO BIOTECH is one of the few biotechnology companies in China with the capability for industrialized development of exosome-based drugs. TheyA complete production process and quality control system for pharmaceutical exosomes has been established, and the construction of China’s first GMP pilot-scale workshop for engineered exosomes is nearing completion.。

ECHO BIOTECH, or Beijing ECHO Biotechnology Co., Ltd., was established in 2017 as an innovative high-tech company dedicated to the development and clinical translation of exosome technologies. The company leverages its proprietary platform (Exoomics^TM、ModiExo^®) provides leading life science research services, and on the other hand, leverages its core intellectual property-based engineered exosome platform (Echosome^®) to conduct R&D of innovative exosome-based drugs. ECHO BIOTECH aims to empower clinical research and accelerate clinical translation by providing systematic solutions for exosome research and translation, striving to become a global leading partner in exosome research and translation.

The commitment to pursuing long-term, high-value initiatives has been the driving force behind Kong Guanyi’s entrepreneurial journey as the founder of ECHO BIOTECH. A graduate of the Life Sciences and Technology Base Program at Wuhan University, Kong subsequently joined gene sequencing companies such as Novogene and BGI Genomics (formerly known as Feisha Gene), where he engaged in bioinformatics research. He led or participated in multiple collaborative research projects, resulting in several published outcomes, and has filed over 20 invention patents, 15 of which have already been granted.

Kong Guanyi, Founder of ECHO BIOTECH

Having experienced the full cycle of industry development, Kong Guanyi has strengthened his reflection on the essence of corporate value. On another front, through collaborations with top experts across numerous research fields based on bioinformatics technology, he has gradually cultivated both scientific and engineering mindsets. “For a technical or research professional to embark on entrepreneurship, possessing only a scientific mindset is insufficient; one must also integrate an engineering mindset. Scientific thinking helps us qualitatively grasp the broader direction, while engineering thinking is more grounded in implementation, employing quantitative analysis to break down milestones and phases, and focusing effective resources on achieving breakthroughs in key issues,” said Kong Guanyi.

In 2016, while collaborating with experts in the field of exosomes, Kong Guanyi recognized the sector’s promising development prospects based on real-world data. This sparked his strong interest in translational opportunities within the exosome field and prompted him to conduct systematic research across the entire domain. Kong stated, “Translational opportunities for exosomes lie in two directions: therapeutics and diagnostics. Based on our own strengths and our assessment of industry value, we have focused on the therapeutic direction.”

“Founding ECHO BIOTECH was driven by the aspiration to build a biotechnology company with solid fundamentals and international competitiveness, using exosomes as its strategic entry point,” Kong Guanyi told VCBeat. Among the four founding partners who initially assembled the team, three were Kong’s alumni from Wuhan University. The critical role of Chief Technology Officer (CTO) was assumed by Dr. Zhao Libo, who brings nearly a decade of research experience in the field of exosomes.

Zhao Libo, CTO of ECHO BIOTECH, holds a Ph.D. from Wuhan University and completed his postdoctoral research at UCLA. He previously served as an Associate Researcher at the Key Laboratory of Molecular Nanoscience, Institute of Chemistry, Chinese Academy of Sciences. Currently, he is a member of the CSEV Committee and a Standing Committee Member of the Exosome Group under the Tumor Marker Committee of the China Anti-Cancer Association. Dr. Zhao contributed to drafting China’s first consensus on exosome research and translation, released by the China Anti-Cancer Association, demonstrating profound expertise in the field of exosome-based therapeutics.

Exosomes are natural extracellular vesicles, approximately 100 nm in diameter, produced by cells. They can serve as carriers to deliver various macromolecules, including nucleic acids, proteins, and carbohydrates. As drug delivery vehicles, the advantages of exosomes are closely related to their inherent natural properties.

Due to their widespread presence in the body, exosomes exhibit low immunogenicity. As mediators of intercellular protein and RNA transfer, exosomes are primarily utilized for the delivery of proteins and RNA molecules. Furthermore, exosomes can carry small-molecule drugs, complementing virus-based vectors used for DNA delivery in therapeutic applications. Compared with the more widely known liposomes, exosomes hold greater potential for protein loading and delivery, as well as for the targeted delivery of nucleic acid therapeutics.

However, if we are to apply exosomes for drug development and delivery, we must first address the challenges of efficient drug loading and CMC standardization.

ECHO BIOTECH has established the exosome omics platform, Exoomics.^TM, ModiExo Engineered Exosome Modification Platform^®. Engineered Exosome Platform Echosome^®. Among them, the engineered exosome technology platform Echosome^®It enables efficient loading and delivery of various types of drugs (proteins, nucleic acids, and small molecules) and adopts two distinct strategies—endogenous engineering (pre-modification) and exogenous engineering (post-modification)—based on molecular type, to improve the utilization and PK/PD profiles of protein and small-molecule drugs, as well as to facilitate intracellular delivery of functional proteins and targeted delivery of nucleic acid therapeutics.

Based on this, ECHO BIOTECH’s R&D efforts are primarily focused on oncology immunotherapy and rare diseases. Currently, all candidates remain in the preclinical stage due to limitations in pilot-scale production. However, the company will commission its GMP-compliant pilot plant by the end of June this year, enabling 500-liter scale pilot production and accelerating the further development of its pipeline products.

Regarding the CMC system for engineered exosomes, Kong Guanyi, founder of ECHO BIOTECH, stated that this is the result of continuous iteration and accumulation. Currently, the company’s technology platform has achieved drug-development readiness, but there remains room for further improvement and optimization. Therefore, ECHO BIOTECH remains committed to the ongoing iterative upgrading of its technology platform and CMC processes.

Furthermore, regarding the bottleneck in exosome delivery technology—namely, targeted delivery—ECHO BIOTECH has already initiated relevant research. Building upon its platform technologies, the company will integrate emerging scientific advancements to achieve targeted delivery to specific organs and tissues, as well as the effective release of cargo.

In addition to independently developing exosome-based therapeutics and actively pursuing external collaborations, ECHO BIOTECH also provides leading life science research services based on its proprietary intellectual property platform, such as Exoomics^TMhigh-throughput multi-omics solutions centered on ModiExo^®core basic research solutions, and continuously launch efficient exosome research tools tailored to customer needs.

The company has established collaborations with over 100 key hospitals in China, co-authored more than 100 SCI-indexed papers, and secured over 10 authorized invention patents. It has participated in drafting domestic and international expert consensus statements on exosomes, and jointly organized the "Exosome Grand Lecture Series" and the "EV Elite Academy" with the Chinese Society for Extracellular Vesicles (CSEV).

“The essence of corporate development lies in the dual-wheel drive of science and data. We are committed to making precise drug delivery via exosomes a reality through our own efforts,” said Kong Guanyi, founder of ECHO BIOTECH, looking ahead. “In the long term, the company will position itself as a platform enterprise focused on exosome-based drug R&D, dedicating itself to the iteration of its engineered exosome technology platform, expansion of applications, and exosome CMC (Chemistry, Manufacturing, and Controls). We will actively engage in external collaborations and work with more industry peers to jointly advance the field of exosome therapeutics.”

It is reported that ECHO BIOTECH has completed four rounds of financing to date and is currently planning to initiate a new round. The funds raised will be primarily used to accelerate the iteration of its engineered exosome technology platform and to advance Investigational New Drug (IND) applications for pipeline candidates following the commencement of pilot-scale production.