Renyuan Bio Announces Seed Funding to Accelerate Development and Commercialization of Vascular Repair Stem Cell Therapies

Cardiovascular and cerebrovascular diseases are the “leading killer” threatening human health. Data released by the World Health Organization (WHO) shows that approximately 17.9 million people died from cardiovascular diseases in 2019, accounting for 32% of all global deaths. This means that one out of every three deaths worldwide is attributable to these conditions. Currently, the number of patients with cardiovascular diseases worldwide has exceeded 500 million, with China accounting for 330 million of these cases.

After more than half a century of development, significant progress has been made in the prevention and treatment of cardiovascular and cerebrovascular diseases. Currently, numerous therapeutic drugs and medical devices are available on the market. However, despite the availability of many treatment options, the prevention and management of cardiovascular and cerebrovascular diseases still face multifaceted challenges, one of which is the repair of damaged cardiovascular tissues.

“In traditional therapies for cardiovascular and cerebrovascular diseases, most pharmacological and device-based interventions often merely alleviate patient symptoms, without effectively repairing damaged cardiovascular and cerebrovascular tissues.”Dr. Zhang Lei, Founder and Chairman of Renyuan Biotechnology (Shenzhen) Co., Ltd. (hereinafter referred to as “Renyuan Biotech”), stated.

Recently, Renyuan Biotechnology has achieved another important milestone in its corporate development.In July 2024, Renyuan Biotechnology announced the completion of a seed funding round amounting to several million yuan, with investment from Shenzhen Puhe Asset Management Co., Ltd. (hereinafter referred to as “Puhe Capital”), a well-known technology venture capital firm.

Renyuan Biotechnology, founded by Dr. Zhang Lei in 2023, is an innovative company dedicated to developing stem cell therapies for vascular repair. Leveraging its proprietary vascular repair stem cell technology, Renyuan Biotechnology has established a leading R&D platform for vascular repair stem cell therapies with broad application prospects.Currently, Renyuan Biotechnology has established four major product pipelines in the cardiovascular and cerebrovascular fields, specifically comprising three drug candidates for the treatment of cardiovascular and cerebrovascular diseases—VCP01, VCP02, and VCP03—as well as the MV3D-01 3D vascular chip series. The VCP01/02/03 product series is expected to file Investigational New Drug (IND) applications in 2025.

Stem cells are a class of cells with self-renewal capacity and multi-directional differentiation potential, capable of differentiating into various functional cell types under specific conditions. Theoretically, due to their unique biological characteristics, stem cells hold immense potential for medical applications. Current scientific research and clinical trials also indicate that transplanting healthy stem cells or stem cell-derived exosomes into patients can replace or repair damaged cells or tissues, thereby achieving therapeutic goals. In recent years, the rapid advancement of stem cell technology has brought an increasing number of innovative solutions to human health.

In the field of cardiovascular and cerebrovascular disease treatment, stem cells have also demonstrated diverse therapeutic potentials. Clinical studies have revealed that stem cells possess the functions of regulating blood lipid levels, inhibiting inflammation, repairing damaged tissues, and supporting hematopoiesis, thereby facilitating the repair and modulation of vascular injury and vascular inflammation. For instance, in 2018, Alice Plein and colleagues from University College London discovered that, in experimental studies, erythroid-myeloid progenitors (EMPs) originating from the yolk sac are recruited to pre-existing vasculature following differentiation.¹. This discovery makes it possible to generate new blood vessels and repair damaged ones using stem cells.

Specifically, stem cells can differentiate into cardiomyocytes and vascular endothelial cells, promoting the repair and regeneration of the heart and blood vessels, thereby improving cardiac function and vascular elasticity. Furthermore, stem cells can secrete various bioactive factors, such as vascular endothelial growth factor (VEGF) and fibroblast growth factor (FGF), which promote angiogenesis and vascular repair while reducing vascular inflammation and injury.

In this context, based on the mechanisms by which vascular repair stem cells participate in regulating injured vascular repair and angiogenesis, as well as modulating vascular patency,Renyuan Biotechnology focuses on the culture and activation of vascular repair stem cells. Leveraging endothelial progenitor cell technology, it has established a proprietary R&D platform for vascular repair stem cell therapies and develops innovative treatments through stem cell extraction, culture, and transplantation.

Throughout the therapeutic workflow of “extraction–purification–culture–activation and enhancement–reinfusion,” Renyuan Biotechnology possesses core technologies at every critical stage. Specifically, in the extraction and culture of stem cells, Renyuan Biotechnology employs a full suite of GMP-grade cytokines and culture media, enabling the production of vascular-repair stem cell preparations that integrate basal medium with activating factors, peripheral blood, and cell induction and enhancement capabilities.

In terms of manufacturing processes, Renyuan Biotechnology has innovatively overcome the technical barriers in vascular stem cell preparation, enabling high-efficiency, stable, and high-purity production. Data shows that,By employing a proprietary culture process that combines suspension and adherent culture techniques, high-purity CD45+CD31+ cells can be produced, with a labeling purity exceeding 95%.It is worth noting that Renyuan Biotechnology extracts hematopoietic stem cells from autologous peripheral blood to prepare vascular repair stem cells. According to its data, Renyuan Biotechnology requires as little as 15 mL of enriched autologous peripheral blood to produce vascular repair stem cell preparations, while achieving consistent batch-to-batch output.

In terms of cell induction and empowerment, Renyuan Biotechnology utilizes its proprietary drug factor formulation for cell activation, which can significantly increase the expression of VEGFA and eNOS.

According to the company, by continuously optimizing cell manufacturing processes, Renyuan Biotechnology has been able to reduce production costs by at least 20%, thereby lowering prices and improving product accessibility. Currently, Renyuan Biotechnology has filed for technical patents, establishing technological barriers, and has obtained cell quality testing reports issued by a national-certified third-party institution.

Currently, Renyuan Biotechnology has established corresponding R&D pipelines targeting various indications, specifically including the drug candidates VCP01, VCP02, and VCP03 for the treatment of cardiovascular and cerebrovascular diseases, as well as the MV3D-01 3D vascular chip.

 Image source: Renyuan Biotechnology

Among them,VCP01 is a vascular stem cell therapy developed for the treatment of peripheral artery disease (PAD) and is currently in the preclinical research stage.Peripheral artery disease (PAD) is a condition characterized by reduced blood flow to the limbs, primarily the lower extremities, due to arterial stenosis, leading to ischemic manifestations such as intermittent claudication, rest pain, ulcers, and gangrene in the lower limbs. Critical limb ischemia (CLI), the most advanced stage of peripheral artery disease progression, involves lower extremity arterial occlusion that restricts blood flow and may even necessitate lower limb amputation. Currently, there are no effective curative drugs for CLI available in China.

It is reported that,VCP01 has demonstrated favorable data in animal studies. In a mouse model of peripheral ischemia treated with vascular stem cell transplantation, it achieved a 97% rate of distal limb ischemia recovery, alleviated pain associated with lower-limb ischemic disease, and prevented the onset of thromboangiitis obliterans.

Renyuan Biotechnology has developed VCP02 for cardiovascular and cerebrovascular diseases such as ischemic/dilated cardiomyopathy and myocardial infarction.Currently, VCP02 has taken the lead in completing proof-of-concept (POC) studies for the indication of myocardial infarction. Animal experimental data demonstrate that intracoronary administration for the treatment of myocardial infarction significantly enhances myocardial contractile function, mitigates the development of congestive heart failure, and consequently reduces the utilization of cardiovascular medications.

During the research process, Renyuan Biotechnology simultaneously assessed a novel biomarker: the hematopoietic stem cell antigen CD133. CD133 is a glycoprotein located on the surface of hematopoietic stem cells; it serves as a key molecule regulating stem cell fate and acts as a functional marker for stem cells. By isolating and enriching CD133+ cells, Renyuan Biotechnology can enhance specific subpopulations of vascular stem-like cells, thereby achieving improved therapeutic outcomes for cardiovascular diseases.

Building on existing research, Renyuan Biotechnology’s VCP-01/02/03 product series is expected to file for an Investigational New Drug (IND) application in 2025.

Building on the research of VCP01 and VCP02, Renyuan Biotechnology will advance the development of its MV3D-01 3D vascular chip. This technology enables the in vitro fabrication of capillary networks with complex structures and physiological functions. Transplantation of these capillary networks into the body can promote tissue repair and regeneration, offering a novel therapeutic approach for ischemia-related diseases.

Currently, the MV3D-01 3D vascular chip has completed its second-generation demo prototype. In the future, Renyuan Biotechnology will advance the commercialization of this product through collaborations with pharmaceutical and biotechnology companies.

Currently, Renyuan Biotechnology is building a global resource network. The company has established collaborative partnerships with renowned research institutes and clinical institutions, including the U.S. National Academy of Sciences, Northwestern University, the University of Chinese Academy of Sciences, Shanghai University, and Sun Yat-sen University, to jointly promote the innovation and development of candidate products.

While advancing the R&D and commercialization of its core pipeline, Renyuan Biotechnology achieves self-sustainability by offering technical services externally.Leveraging its proprietary vascular repair stem cell technology, Renyuan Biotechnology has provided technical services to multiple research institutions and downstream enterprises, thereby advancing research and progress in related fields.

From the perspective of industry development, China’s stem cell sector is currently entering a new phase of growth. First, at the policy level, the government has successively issued a series of documents to support and encourage the research and development of innovative stem cell technologies and the commercialization of related products. In terms of market demand, as population aging continues to deepen, the incidence of cardiovascular and cerebrovascular diseases is projected to keep rising, creating an urgent need for more effective innovative therapies.

According to a report released by the Qianzhan Industry Research Institute, more than 20 stem cell products have been approved for marketing worldwide to date. The approved products are primarily composed of hematopoietic stem cells or mesenchymal stem cells. These products cover a range of indications, from subcutaneous tissue defects, acute myocardial infarction, and Crohn’s disease to spinal cord injury. In the future, with continuous advancements in science and technology, stem cell therapies will play an increasingly important role in the medical field.

Facing this promising market, Dr. Zhang Lei stated, “Currently, Renyuan Biotechnology has resolved many critical challenges. With further advancement in R&D and continuous optimization of processes, Renyuan Biotechnology aims to provide high-quality, efficient, and more cost-effective treatment solutions for patients with cardiovascular and cerebrovascular diseases worldwide.”

References:

1. Plein, A., Fantin, A., Denti, L. et al. Erythro-myeloid progenitors contribute endothelial cells to blood vessels. Nature 562, 223-228 (2018).