Umibio Files IPO Prospectus: Pioneering Exosome Therapeutics for Rare Diseases and Viral Infections

In just the past few years, exosomes have truly captured the spotlight.

In the field of basic scientific research, the number of published papers related to exosome studies has averaged over 3,000 per year in recent years. In the 2020 review results for National Natural Science Foundation of China (NSFC) grant applications, more than 2,000 exosome-related projects were funded, firmly securing exosomes a central position in NSFC funding.

In the field of industrial translation, the number and scale of startups in the exosome sector have been continuously growing in recent years. According to incomplete statistics from VCBeat, there are currently nearly 50 companies worldwide actively positioning themselves in the exosome track. Among them, the representative company Codiak BioSciences went public on NASDAQ in October 2020, with two of its drug candidates having entered Phase I clinical trials. Many pharmaceutical giants, including Roche, Takeda, and Eli Lilly, have also established significant collaborations with multiple exosome-related companies, all aiming to “get a share of the pie” in this market.

Meanwhile, the performance of the domestic exosome market cannot be overlooked. In just a few years, more than ten exosome-related companies have emerged in China. As one of the earliest pioneers to enter the domestic exosome market, Umbio Biotechnology has been cultivating the exosome industry for nearly six years.

Since its establishment, Yumeibo has not only actively provided specialized exosome research services and related reagent solutions to external clients, but also simultaneouslyRare Disease Therapeutics, Tumor-Targeted Drug Delivery, Vaccine Development...and other fields. Currently, Umibio has achieved hectoliter-scale mass production in exosome isolation and purification processes, which can meet the full demand for drugs prior to Phase III clinical trials.

In 2015, the industrialization trajectory of exosomes remained unclear. Research within the scientific community was still in a phase of “undercurrents,” having not yet reached its peak development. However, through statistical analysis of big data related to the global biotechnology sector, the Umibo Biotech team recognized that translational research on exosomes was experiencing exponential growth. Nevertheless, within China’s industrial landscape, exosomes remained an untapped frontier.

Targeting this field, the team at Yumeibo Biotechnology raised the “first banner” in the exosome industry both domestically and internationally, becoming one of the earliest innovative enterprises in China dedicated to the technological development and clinical translation of exosomes.

However, every coin has two sides. Being “early” not only means seizing the first-mover advantage in the market, but also implies that strategic decisions made by a company in its early stages are akin to “crossing the river by feeling the stones.” In its initial phase, UMW Bio was also uncertain about how to proceed with the industrialization of exosomes.

Initially, they attempted to engage in exosome-based diagnostics but encountered numerous intractable constraints and challenges. “The most critical issue was the lack of clearly identifiable and effective disease biomarkers, making it extremely difficult to develop related in vitro diagnostic (IVD) products. Secondly, as a biotechnology startup, it was challenging to obtain sufficient clinical samples for biomarker discovery research.”

Gao Bo, Founder & CEO of YumeiboIt was stated that while research and development in the field of exosome-based diagnostics has encountered numerous obstacles, encouraging breakthroughs and progress have gradually emerged in the field of exosome-based therapeutics. Exosome therapy companies represented by Codiak have successfully advanced exosome drugs into clinical trials, and Codiak successfully listed on the NASDAQ in 2020 (currently, Codiak’s two pipeline candidates, Exo-IL12 and Exo-STING, have both entered Phase I clinical trials).

Yumeibo swiftly adjusted its corporate direction, shifting its focus to research and exploration in exosome-based drug delivery and exosome therapeutics development. In 2020, breakthrough progress made by an Israeli company in exosome-based drugs further strengthened Yumeibo’s confidence in deepening its commitment to the field of exosome therapy.

In September 2020, the Israeli Ministry of Health approved a new anti-COVID-19 drug developed by Professor Nadir Arber’s team at Ichilov Hospital in Israel.EXO-CD24(CD24 Protein–Exosome Conjugate) Initiates Clinical Trials; Related Results Show That 29 Out of the First 30 Critically Ill Patients Were Fully Cured After 5 Days of Treatment, with No Severe Drug-Related Adverse Events Reported.In August 2021, the Phase II clinical trial of EXO-CD24 yielded positive results again—more than 90% of the severe patients participating in the trial were cured and discharged within five days.

These breakthrough achievements have greatly inspired the Yumeibo team. “We are particularly excited about the breakthrough results achieved by Israel in EXO-CD24.”EXO-CD24 utilizes exosomes as a delivery vehicle for CD24, primarily targeting the lungs. By suppressing the "cytokine storm" commonly observed in severe COVID-19 patients, it enables the immune system to clear the virus more safely. This approach effectively reduces the treatment of COVID-19 to a level of complexity comparable to managing a common cold.“Gao Bo elaborated excitedly.

He believes that the therapeutic potential demonstrated by exosomes during the critical phase of this epidemic will inevitably further accelerate the rapid development of this field. Currently, among the several product pipelines being developed by Umbio, there arePreventive vaccines specifically developed against the novel coronavirus（Covid-19 S Exosome）and Therapeutic Drugs(CD24 Exosome) pipeline, with multiple products such as UBK700 and UBK701 currently in the preclinical research stage.

In addition to deploying exosomes for vaccine development, YumeiboAdditionally, the pipeline layout includes the development of targeted drug delivery systems for oncology therapeutics, as well as exosome-based drugs for neurological disorders.

As the leading cause of death worldwide, cancer represents the most significant unmet clinical need. Tumor-derived exosomes serve as critical mediators in the interaction between tumor cells and their microenvironment. Therapeutic agents encapsulated within exosomes can be delivered specifically to tumor cells, modulating their activity and ultimately inducing tumor cell death. According to Gao Bo, UMW Biotech has established active collaborations with multiple research institutions to jointly advance pipeline development in the field of exosome-based drug delivery for oncology.

Focusing on exosome-based therapeutics developed for neurological disorders, UMEBIO has targeted the rare disease population affected by Krabbe disease.

Krabbe DiseaseKrabbe disease is a fatal neurological disorder caused by a genetic defect (autosomal recessive inheritance) that leads to a deficiency of galactocerebrosidase (GALC) in the brain. This deficiency results in the accumulation of galactocerebroside within the white matter, triggering the disease. The prognosis is extremely poor, with infants typically succumbing to the condition before the age of 1 to 10 years.

Gao Bo told VCBeat that the direct reason for initially choosing to develop this product pipeline was that a senior fellow student’s child was unfortunately diagnosed with the disease. Later, he learned that the patient population for such diseases in China is not small, with an incidence rate of approximately 1 in 100,000; however, there are currently no effective treatments or drugs available on the market.

Exosomes, composed of natural human proteins and lipids, can freely cross the blood-brain barrier. Therefore,Delivering active GALC to the brain via exosomes to degrade excess galactocerebroside accumulated in patients is a feasible therapeutic strategy.Yumeibo seeks to leverage exosome-based therapeutics to find an effective solution for children affected by Krabbe disease.

Before the project could advance to its milestone stage, the child sadly passed away. Nevertheless, pipeline research targeting Krabbe disease has not ceased; Yumeibo continues to actively collaborate with relevant children’s hospitals, striving to successfully develop exosome-based therapeutics for this condition, in the hope of granting affected children more time for healthy living.

Although the development path has included some “detours,” Yumeibo has not engaged in “futile efforts.” Whether in research on exosome-based diagnostics, exploration of exosome-mediated drug delivery, or development of exosome therapeutics, the underlying research foundation has remained constant.

In the past few years of the company’s development, Yumeibo has established a framework that includesExosome Expression Vector Construction Platform, Exosome Cell Line Mass Production Platform, Exosome Isolation and Purification Process Platform, and Exosome Drug Loading Technology Platformfour technology platforms, among which the platform represented by exosome isolation and purification processes constitutes Yumeibo's core competitiveness.

Currently, Yumeibo’s exosome isolation and purification process has achieved production capacity at the hundred-liter scale. What does “hundred-liter-scale production” mean? Gao Bo explained that this level of production can fully meet all exosome drug requirements prior to Phase III clinical trials.

Achieving such remarkable results in the isolation and purification of exosomes would not have been possible without the team’s decades of extensive experience accumulated in viral vector process development. Gao Bo told VCBeat that there are many similarities between the overall manufacturing process for exosomes and the process development for viral vectors. Building on their expertise in viral vector development, the team made targeted improvements and upgrades based on the specific characteristics of exosomes, achieving significant success.

Prior to founding UMO Biotech, Gao Bo served at Genomeditech for nearly a decade, where he was primarily responsible for the development and production management of recombinant viral vectors. His extensive experience accumulated over more than ten years in technical R&D, product commercialization, and corporate management laid a solid foundation for his subsequent establishment of UMO Biotech.

Gao Bo pursued his undergraduate, master’s, and doctoral studies at three different higher education institutions: he completed his bachelor’s degree at Xi’an Jiaotong University, while his master’s and doctoral research were conducted at Wuhan University and Fudan University, respectively. His academic and research focus shifted from bioengineering to molecular virology, and later expanded into the field of neurobiology. Although these disciplines appear distinct, they share a consistent underlying research logic. This is exemplified by the Yumei Biotech team, which leveraged its accumulated expertise in viral vector development processes to extend its capabilities into exosome isolation and purification technologies.

Dr. Shi, the company’s R&D Director and another core member of the Yumeibo team, was previously responsible for research on vesicle transport and anticancer drug development at the Curie Institute in France. Currently, Dr. Shi primarily leads the development of exosome-based therapeutic products, complementing Dr. Gao’s leadership in corporate operations and management.

Currently, as the company continues to expand and its team grows, Yumeibo has begun seeking support from the capital market to accelerate research on exosomes in drug delivery systems and pharmaceutical development, while also intensifying efforts to attract top talent to meet the demand for high-quality professionals driven by the company’s rapid growth.