XianShi Bio Completes Tens of Millions RMB Financing to Advance Next-Generation Decellularized Matrix-Based Regenerative Therapies
VCBeat has learned that Xianshi Biotechnology recently completed a new round of financing worth tens of millions of yuan, led by Shulan Fund.Sanjie Investment、Huaiji InvestmentCo-investment. ThisThe funds raised in this round will be used for clinical trials of new products, expansion of the product pipeline and team, and corporate operations.
Xianshi Biotech is a high-tech company focused on the biomaterials and regenerative medicine industries. Founded by multiple U.S.-trained Ph.D. holders and professors, it leverages several provincial- and ministerial-level key laboratories at Zhejiang University, Shanghai Jiao Tong University, and other institutions to develop next-generation tissue regeneration materials.
Currently, Xianshi Biotechnology has leveraged its four proprietary technology platforms—decellularization, hydrogel microspheres, electrospun nanofibers, and biomimetic mineralization—to develop a range of tissue regeneration material products, such as endometrial repair materials and breast reconstruction fillers.
Since its establishment in 2020, why has Xianshi Biologics been able to secure financing so rapidly? Why is its product development progressing at such a fast pace? What constitutes its core competitiveness? To answer these questions, VCBeat conducted an exclusive interview with Dr. Yu Xiaohua, CEO of Xianshi Biologics.
Data indicate that the extracellular matrix (ECM), as an ideal material for tissue regeneration, is derived from human or natural animal tissues. It constitutes a three-dimensional network structure composed of macromolecules secreted by cells into the extracellular interstitium, playing a crucial role in regulating tissue repair and regenerative reconstruction.
However, direct implantation of extracellular matrix into patients can trigger immune responses, leading to graft failure. Consequently, decellularization technology has emerged. This technique removes antigenic components from the extracellular matrix while preserving its three-dimensional spatial structure and bioactive constituents, including numerous growth factors, adhesion proteins, and proteoglycans.
It is reported that the extracellular matrix processed using decellularization technology is referred to as acellular matrix. Acellular matrix not only exhibits excellent biocompatibility but also possesses potent endogenous tissue-inducing capacity, making it highly suitable for cell adhesion and growth, and enabling it to regulate and accelerate the tissue repair process after implantation.. Based on these advantages, decellularized matrices play a significant role in filling tissue defects, inducing tissue regeneration, repairing damaged tissues, and achieving integration with surrounding tissues.
Currently, decellularized matrix products are widely used in fields such as burn and scald treatment, plastic surgery, breast reconstruction, hernia repair, abdominal wall reconstruction, periodontal regeneration, orthopedic surgery, dural repair, urology, ophthalmic filling, and sports medicine.
Yu Xiaohua stated: “Given the extensive clinical application of acellular matrix materials across a wide range of medical specialties and their highly diverse indications, we believe their market prospects are extremely promising. We are confident that with iterative technological advancements and the expansion of their applications, the market size for acellular matrix materials will reach hundreds of billions of yuan.”
In addition to Xianshi Biotech, decellularized matrix materials have also attracted the attention and strategic involvement of numerous companies, driven by their excellent clinical outcomes and promising market potential. In this regard, Yu Xiaohua stated: “The core competitiveness of decellularized matrix materials lies in decellularization technology.Currently, decellularization techniques available on the market damage the native nano-crosslinked structure of the extracellular matrix. Furthermore, the use of chemical crosslinking agents leads to uncontrolled degradation of the decellularized matrix materials and significant loss of bioactive components, thereby compromising their regenerative capacity and ultimately limiting their clinical indications.
Unlike the decellularization technologies used by other companies, Xianshi Biotech has adopted a new generation of decellularization technology.: Enzymatic Assistance Technology + Microfabrication. Yu Xiaohua introduced, “First, we introduced specific biological enzymes that have extremely high specificity for immunogens, enabling efficient removal of immunogenic components, with a DNA removal rate exceeding 99%. Second, we employed microfabrication technology, increasing decellularization efficiency by more than tenfold compared to existing standards. Finally, we maintained a neutral environment during the decellularization process, causing almost no damage to tissue structure. As a result, not only are the natural components and structures fully preserved, but also a significant amount of active growth factors and bioactive components is retained.”
From a data perspective, the residual DNA content in decellularized matrix materials is a widely recognized core indicator for validating the efficacy of decellularization technology. Currently, the residual DNA content in commercially available decellularized matrix materials is approximately tens of nanograms per milligram, whereas Xianshi Bio can control it to 2–3 nanograms per milligram, representing a more than 20-fold reduction in residual DNA levels.。
As can be seen, leveraging next-generation decellularization technology, Xianshi Bio’s acellular matrix material products demonstrate significant advantages in safety, efficacy, and efficiency compared to other products on the market.
Currently, Xianshi Biotech is primarily focused on the treatment of human degenerative diseases. In terms of its product pipeline, Xianshi Biotech’s endometrial repair materials and breast reconstruction fillers have both completed registration testing and are poised to enter the clinical trial phase.
Meanwhile,Xianshi Biotech is developing pelvic floor repair meshes and artificial eardrums based on its decellularization technology platform; creating products for arthritis treatment using its hydrogel microsphere platform; and engineering nanofiber membranes via its electrospun nanofiber platform. Additionally, Xianshi Biotech has established a biomimetic mineralization platform, collectively forming its four major technology platforms.。
So, why did Xianshi Biotech choose to enter the clinical market with endometrial repair materials?
Yu Xiaohua stated, “Currently, there are nearly 40 million people in China affected by infertility. With socioeconomic development, the infertility rate in our country has been rising year by year, reaching 17% in 2020 and is projected to reach 20% by 2030. Among the factors contributing to female infertility, endometrial issues are one of the five most significant elements affecting patients. On the other hand, due to the annual increase in the number of surgical procedures such as dilation and curettage (D&C) and hysteroscopy, endometrial damage caused by these procedures may lead to infertility.”
Infertility caused by endometrial disorders not only harms patients’ families but will also become a serious social issue as China’s population ages. In terms of treatment options, most endometrial repair products currently available on the market are gel-based formulations that solely prevent adhesions and cannot be retained in the body after administration. Furthermore, these products lack tissue repair and regenerative capabilities, failing to effectively modulate the endometrial tissue microenvironment and stem cell behavior, thereby making it difficult to restore normal endometrial function in patients.
Unlike gel-based products, Xianshi Biologics’ endometrial repair product is a highly adhesive, injectable acellular matrix material that efficiently adheres to the damaged endometrial surface and binds with the patient’s endogenous stem cells to facilitate intrinsic tissue repair. This thickens the endometrium, enhances its receptivity and adhesiveness, and ultimately improves implantation and conception rates.
Yu Xiaohua stated, “A comprehensive clinical trial protocol for the endometrial repair material has been established, and clinical trial centers have been designated. The first patient enrollment is expected to commence in the first quarter of 2022, with enrollment of all cases to be completed by the end of 2022.”
As for breast reconstruction filler products, only about three companies worldwide have initiated R&D efforts. Xianshi Biology is at the forefront internationally, with clinical trials for its product expected to commence in the third quarter of 2022.
Since its establishment in 2020, Xianshi Biotechnology has developed a pipeline of multiple products and advanced them into clinical trials.Why Has Xianshi Biologics Been Able to Advance Its Product Pipeline So Rapidly? Yu Xiaohua Summarizes Three Key Reasons。
First, the innovative technologies applied by Xianshi Biotechnology, such as decellularization technology, are developed in a targeted manner around clinical issues, forming a closed loop that starts from and returns to clinical practice, with a high level of technological maturity. These innovative technologies have accumulated over many years in the early stages and already possess mature industrialization solutions. At the same time, Xianshi Biotechnology collaborates closely with top domestic university research institutes, providing strong technical support.
Second, the Xianshi Biotech team demonstrates strong execution capabilities. In terms of R&D, core members Dr. Yu Xiaohua and Professor Cui Wenguo possess extensive experience in product development. Dr. Yu holds more than 10 domestic and international invention patents and previously co-founded a medical device company that secured RMB 60 million in financing. Professor Cui holds over 40 patents and has received more than 20 provincial- and ministerial-level awards from entities such as the Ministry of Science and Technology and the Chinese Medical Association. Regarding the R&D quality system, all team members have over ten years of experience in pharmaceutical product development, enabling them to rapidly establish a robust quality system and ensure compliance and regulatory adherence throughout the entire R&D process.
It is worth noting that 60%–70% of the team members at Xianshi Biotech are either former students mentored by Dr. Yu Xiaohua or individuals who have worked under his supervision for many years. This shared background has fostered strong familiarity among team members, enabling them to assume multiple roles, collaborate effectively, and execute tasks with high efficiency, thereby accelerating product development.
Third, Xianshi Biotechnology demonstrates strong capabilities in resource integration. The company has established deep collaborations with top-tier domestic universities and renowned Grade-A tertiary hospitals from the product planning stage, engaging in joint research projects, academic publications, patent applications, and clinical trial filings. For instance, Xianshi Biotechnology collaborates with universities on project declarations and jointly files patents and publishes papers with medical institutions. During product development, the company has received substantial support from these external resources, enabling it to rapidly address issues and challenges encountered during the development process and accelerate product progress.
Returning to the initial question, why has Xianshi Biotech garnered favor from investment institutions? What are its core competencies?
Yu Xiaohua stated, “Xianshi Bio’s core competitiveness lies in its robust capability to develop platform-based technologies. From an investor’s perspective, what they value is the company’s sustained R&D capacity and its ability to continuously launch new products that address clinical pain points.”
Currently, Xianshi Biotechnology possesses four major technology platforms: the decellularization technology platform, the hydrogel microsphere platform, the electrospun nanofiber platform, and the biomimetic mineralization platform. These four platforms can be continuously integrated with one another to develop and produce innovative products that truly address key clinical challenges.
Leveraging its four major technology platforms, Xianshi Bio will maintain robust innovation momentum and a continuous source of innovation.。
Shulan Junjie Capital was jointly established by early investors and the founding team of Shulan Medical Group. It serves the translation of medical technology innovations into industry applications by leveraging clinical resources on a global scale. Through the establishment of a science and technology investment fund, the SATOL Life Sciences Accelerator, and the SATOL Global Medical Innovation and Entrepreneurship Center, as well as by hosting the World Life Sciences Conference and the Global Medical Innovation and Entrepreneurship Competition, it promotes the integrated development of clinical practice, scientific research, and industry via three core businesses: community services, fund investment, and research incubation. It supports medical technology professionals in innovation and entrepreneurship and has invested in a number of outstanding technology enterprises in fields such as digital diagnosis and treatment, biotechnology, and innovative therapies.
Hangzhou Huaiji Investment Management Co., Ltd. (hereinafter referred to as “Huaiji Investment”) was established on April 17, 2015, and is a qualified private fund manager. To date, Huaiji Investment has issued and currently manages a total of 11 equity-type private investment funds, with investments in or partnerships with more than 50 companies, many of which have successfully been listed on stock exchanges. Currently, Huaiji Investment primarily focuses on sectors such as information technology, biopharmaceuticals, and intelligent manufacturing.
Sanjie Investment is an industrial investment firm dedicated to the global life and health sector. Guided by the fundamental mission of enhancing quality of life and fostering well-being, we serve entrepreneurial teams and startups that address clinical needs, drive sustained innovation, and uphold the principle of equitable access to healthcare. By mitigating risk aversion in venture creation and partnering closely with founders, we strive to contribute to public health.