HuaWei HengYuan Secures Tens of Millions in Pre-A Funding to Advance Clinical-Grade Immune-Privileged Cell Manufacturing

VCBeat learned at the earliest opportunity,Huawei Hengyuan (Beijing) Biomedical Technology Co., Ltd. (“Huawei Hengyuan”) recently completed a Pre-A financing round of tens of millions of yuan,This round of financing was led by TusStar Venture Capital, with participation from existing and new investors including Shuimu Ventures, Hua’an Jingyin, Jihe Ventures, and the Global Health Industry Innovation Center. It is reported that the funds raised will be primarily used to establish clinical-grade manufacturing processes for immune-privileged cells and to further strengthen teams related to quality, production, and operations.

Huawei Hengyuan was established in late 2018 as a biotechnology company dedicated to the development of human-derived immune-privileged cell therapy products. Leveraging cellular reprogramming and stem cell induction technologies, the company focuses on mitigating host immune rejection by creating an immune-privileged microenvironment for the development of immune-privileged therapeutics, thereby protecting transplanted cells or tissues from host attack.

In clinical applications, Huawei Hengyuan utilizes immune-privileged products to treat autoimmune diseases or as carriers for transplanted cells, thereby circumventing the limitations of HLA matching between donor cells and the host and expanding the scope of cell transplantation. Its related products hold broad prospects in the treatment of autoimmune diseases, cell and tissue transplantation, and Sertoli Cell-Only Syndrome (a form of male infertility).

Leveraging the platform technology of human immune privilege, Huawei Hengyuan has currently developedRheumatoid Arthritis Cell Injection, Immune-Privileged Artificial Pancreas, and Male Assisted Reproductive Testing Systemamong other specific products, the rheumatoid arthritis cell injection project has basically completed preclinical animal studies with favorable results and will subsequently proceed to the application phase for human clinical trials.

Sertoli cells (testicular supporting cells) are present in the male testes and represent a type of human testicular somatic cell. These cells reside within the seminiferous tubules alongside germ cells, playing a pivotal role in initiating and regulating spermatogenesis. Sertoli cells are also an indispensable component in the construction of in vitro systems for sperm induction.

However, the most noteworthy aspect is the unique immune privilege exhibited by Sertoli cells—Sertoli cells can protect male germ cells from attack by the autoimmune system.Based on this property, Sertoli cells have been applied in therapeutic areas such as allogeneic transplantation to exempt host immune rejection against transplanted cells, thereby prolonging the survival time of the transplanted cells.

Immune rejection has always been a major obstacle facing regenerative medicine therapies. The discovery of Sertoli cells holds significant importance for humanity’s efforts to overcome this century-old challenge of immune rejection. “This enables patients receiving organ transplants to avoid long-term use of anti-rejection medications, thereby reducing adverse effects and fundamentally improving their quality of life. Furthermore, combining immune privilege with cell transplantation removes the dependency on HLA matching, paving the way for the development and application of universal off-the-shelf cell products.”Liang Jianlin, CEO & Co-founder of Huawei HengyuanHe expressed his vision for immune-privileged cell products to benefit patients in the future.

To provide a more vivid description of the role played by Sertoli cells, Dr. Liang offered an interesting analogy: Sertoli cells act like “Sun Wukong,” drawing a “protective circle” to shield the transplanted cells (“Tang Seng”) from attacks by the body’s immune system.

However, obtaining Sertoli cells is not easy.Internationally, the acquisition of Sertoli cells remains largely limited to the isolation and transformation of animal-derived Sertoli cells.However, Sertoli cells of animal origin raise numerous safety and ethical concerns. Huawei Hengyuan is internationallyFirst Successful Generation of Human Sertoli Cells Using In Vitro Induction Technologythe enterprise, this research achievement is actually derived from the commercialization of the latest scientific and technological achievements of Tsinghua University.

Professor Ji Jiakui, Chief Scientist at Huawei HengyuanDr. Liang Jianlin is a professor and doctoral supervisor at the School of Medicine, Tsinghua University, and a leading authority in the field of stem cell differentiation. He is the principal inventor of domestic Chinese patents and PCT patents for immune-privileged cell induction technology. During his doctoral studies at Tsinghua University, Dr. Liang conducted research on immune-privileged cell reprogramming technology under the supervision of Professor Ji Jiakui.

In October 2017, Professor Liang Jianlin and Ji Jiakui achieved a breakthrough in experimental research on human immune privilege technology. The related findings passed international peer review and were published in the prestigious international journal *eLife*. Currently, multiple domestic invention patents have been filed for this research achievement, and it has entered the United States, Europe, and several Southeast Asian countries through international patent channels. Following its commercial translation, the technology received support from the “Zhongguancun Disruptive Technology” project. Throughout the company’s development, Huawei Hengyuan (Beijing) Biomedical Technology Co., Ltd. has continuously optimized this technology and has now completed the development of the second-generation induction technology, achieving significant breakthroughs in both product development timelines and the order of magnitude of cell production volume.

On August 4, 2020, the Center for Drug Evaluation of the National Medical Products Administration organized the drafting of"Technical Guidelines for Clinical Trials of Human-Derived Stem Cell and Derived Cell Therapy Products (Draft for Comment)", with the aim of providing more targeted recommendations and guidelines to drug R&D and registration applicants as well as investigators conducting clinical drug trials. Dr. Liang Jianlin stated that the release of this guidance document clarifies that human-derived stem cell products can be submitted for approval as cellular drugs, representing a breakthrough advancement for the stem cell field.

During this year’s Two Sessions, the National Health Commission responded to a proposal from deputies calling for accelerated legislation on embryonic stem cells to promote and regulate development in the stem cell field. The Commission stated that the State Council is poised to issue the Regulations on the Administration of Clinical Research and Translational Application of New Biomedical Technologies, under which clinical research and translational applications of stem cell technologies will be regulated. Consequently, industry experts have widely speculated that stem cell products are likely to follow a “dual-track” approval pathway in the future. Even if they cannot be registered as cellular drugs, their application as internal-use technologies still holds significant market potential.

(Editor’s Note: China’s approval regulations primarily adopt a “dual-track” system. One track involves regulating cell-based products as pharmaceutical drugs, requiring completion of clinical trials under the drug regulatory framework and obtaining marketing approval through registration with the National Medical Products Administration (NMPA) and its subordinate agencies. The other track classifies them as cell therapy technologies, subject to the relevant restrictive regulations issued by the National Health Commission (NHC) and its subordinate agencies, allowing for clinical application within medical institutions.)

Of the two approaches, cell-based drugs fall under the jurisdiction of the National Medical Products Administration (NMPA), primarily targeting enterprises applying for clinical trials, with the goal of achieving market approval; whereas cell therapy technologies are owned by individual researchers and are governed by the Ministry of Health.

The introduction of relevant policies has bolstered confidence in the industry’s development, reigniting enthusiasm among companies and investment institutions within the sector. For the stem cell industry, 2021 was a year filled with continued anticipation; for human stem cell enterprises such as Huawei Hengyuan (Beijing) Biomedical Technology Co., Ltd., it was a year of poised readiness for growth.

TusStar Venture Capital’s Perspective: “TusStar Venture Capital has maintained a strong focus on the field of regenerative medicine. In this domain, immune rejection represents the primary bottleneck in cell and tissue transplantation. Leveraging its globally pioneering key technologies, Huawei Hengyuan has successfully prepared human Sertoli cells with immune privilege capabilities through in vitro reprogramming and stem cell induction techniques, holding the promise of fundamentally addressing the challenge of immune rejection in regenerative medicine. Based on its Sertoli cell induction platform, which offers broad clinical applications, the company can develop multiple product pipelines targeting various indications, thereby significantly reducing clinical development risks. The TusStar Venture Capital team is optimistic about Huawei Hengyuan’s technological advantages and its scalability across indications. The company currently boasts a robust R&D pipeline, and following this round of financing, it will accelerate the establishment of clinical-grade cell manufacturing processes and rapidly advance its R&D efforts. TusStar Venture Capital looks forward to continuing its strategic investments in the biotechnology sector, providing sustained support to China’s life and health industry.”

Shuimu Ventures’ Perspective: “As induced pluripotent stem cell and gene editing technologies continue to mature, the stem cell field is undergoing a profound transformation. As the company’s angel investor, we firmly believe that original life science technologies originating from Tsinghua University will come to fruition. We have full confidence in Huawei Hengyuan’s team, given their long-standing expertise and strong sense of mission in the areas of stem cell induction and immune privilege. Shuimu Ventures will provide steadfast, long-term support to the company, continuously accompanying the team as it grows into an industry leader.”

Hua’an Jingyin’s Perspective: “Hua’an Jingyin is honored to participate in this round of investment. We have full confidence in the founding team of Huawei Hengyuan, which has achieved breakthrough progress in experimental research on human-derived immune privilege technology, providing a viable solution to the challenge of immune rejection.”

Jiuhe Venture Capital’s View: “Huawei Hengyuan represents one of the few technological pathways with the potential to resolve cellular immune rejection. It can not only serve as an adjunct for co-transplantation with islet cells, offering a definitive solution for diabetes, but also function as a standalone cell therapy solution for autoimmune diseases such as rheumatoid arthritis. These conditions present substantial unmet clinical needs and significant market opportunities.”

Perspective from the Global Health Industry Innovation Center: “As a technology commercialization project stemming from Tsinghua University’s scientific research achievements, Huawei Hengyuan represents a platform-based key technology. The company is currently applying its immune privilege technology to fundamental conditions such as rheumatoid arthritis, diabetes, and male-assisted reproduction. We look forward with confidence to Huawei Hengyuan leveraging its technological advantages to help patients overcome disease and regain their health.”

TusStar Venture Capital manages funds totaling over RMB 2 billion, covering angel fund-of-funds, market-oriented funds, and incubator funds. As of the end of 2020, the funds managed by TusStar Venture Capital had invested in more than 300 companies, with a cumulative investment amount exceeding RMB 600 million. Up to 90% of its investments were made in technology-driven innovative enterprises at the angel stage, and over 70% of these portfolio companies successfully secured subsequent rounds of financing. For five consecutive years, TusStar Venture Capital has been ranked among the “Top 30 Early-Stage Investment Institutions in China” by Zero2IPO. Focusing on technology sector investments, it prioritizes high-tech, high-growth startups, with particular emphasis on healthcare and life sciences, integrated circuits, big data, artificial intelligence, and advanced manufacturing.

Shuimu Venture Capital is a specialized investment institution for the industrialization of scientific and technological achievements, established under the Beijing Tsinghua Industrial R&D Institute. Leveraging nearly two decades of accumulated expertise from the Institute in the transformation and commercialization of scientific and technological achievements, Shuimu Venture Capital promotes the implementation and conversion of major technological breakthroughs from Tsinghua University through market-oriented approaches and professional management. To date, Shuimu Venture Capital has invested in more than 60 projects, including Tinavi Medical Technologies (688277), the first company listed on the STAR Market specializing in medical robots; SinoHytec (688339), a leader in China’s hydrogen energy industry; Huazhuo Jingke, a manufacturer of ultra-precision equipment for integrated circuits; and Pinchi Medical, a unicorn enterprise in the field of neuromodulation in China. The portfolio also includes a number of outstanding enterprises such as Daqing Biology, Topcon Imaging, Jetson Voice, Langshi Instruments, Shenli Technology, Syno United, and Qingpu Technology.

Hua’an Jingyin, established in February 2016, is a specialized fund focused on investments in the life sciences sector, covering areas such as basic life sciences research and services, early detection, diagnostics, clinical research services, biopharmaceutical R&D and manufacturing, regenerative medicine, novel drug delivery materials, and commercial health insurance services. Hua’an Jingyin will leverage its ecosystem advantages in the life sciences field to provide comprehensive empowerment throughout the development of Huawei Hengyuan.

Jiuhe Ventures was founded in 2011 by Wang Xiao, a founding team member of Baidu. Specializing in venture capital for early-stage startups, the firm invests from the angel round through Series A, with a focus on frontier technologies, enterprise services, industrial internet, biotechnology, and new consumption. Jiuhe has invested in more than 200 early-stage startups, with notable portfolio companies including 36Kr (KRKR.US), QingCloud Technologies (688316.SH), autonomous driving unicorn Momenta, and Airdoc, an AI-powered medical imaging auxiliary diagnosis platform.

GHIC, initiated and established by the Beijing Tsinghua Industrial R&D Institute, is an innovation incubation platform designed to connect with global medical innovation technologies and resources, strengthen the translation of scientific and technological achievements, and facilitate the effective implementation and development of innovative technologies in medical devices, diagnostics, and services, thereby providing comprehensive support for early- and mid-stage projects.