Xu Xiaochun of Shengyin Group: A Tech Entrepreneur’s Two Ventures in Cell and Gene Therapy

Since the 1970s, when scientists discovered the existence of “stem cells” in the human body—remarkable cells with diverse regenerative properties—stem cell technology and cell therapy have rapidly emerged as a pivotal pillar supporting the development of the biopharmaceutical industry in less than half a century. Over the past decade, the medical community has further validated that various types of cells within the human body possess distinct therapeutic effects, including immune cells, chondrocytes, and platelets. In 2017, the U.S. Food and Drug Administration (FDA) approved Kymriah, the world’s first CAR-T therapy, which utilizes patients’ own immune cells to treat advanced hematologic malignancies refractory to chemotherapy and radiotherapy, achieving an efficacy rate of up to 93%. This milestone marked the inaugural year of commercialization for the entire cell and gene therapy sector. Cell and gene therapy, abbreviated as CGT, has a relatively short industrial history; however, successive landmark breakthroughs have underscored the immense potential unleashed in this field.

In the field of cell and gene therapy, we interviewed Dr. Xu Xiaochun, a renowned tech entrepreneur in this sector and the founder of Shengyin Group.From Technical Expert to Entrepreneur: A Path Many Dream of, but Few Fully ExperienceThe journey from technical expert to entrepreneur is a path many dream of taking, yet the numerous hurdles along the way are not fully appreciated by everyone. Dr. Xu Xiaochun went abroad for advanced studies in the early 1990s, returned to China in 2010 to launch his first startup, and later embarked on a second entrepreneurial venture overseas. Over the past three decades, the economic dynamics and entrepreneurial landscapes in both China and the United States have undergone profound changes. Dr. Xu has been both a witness to and an active participant in this historical transformation. We also spoke with Dr. Xu about his perspectives on entrepreneurship.

Xu Xiaochun was born in Shanghai. In the late 1980s, he was admitted to Fudan University, but he later dropped out before completing his degree to pursue further studies in the United States. Perhaps from that time on, an unconventional spirit was ingrained in his very bones. During his studies in the U.S. in the 1990s, he dedicated himself to research on genetically modified pig organs, aiming to address the shortage of human organs through genetic engineering, and earned a Ph.D. in Immunology from the University of Washington School of Medicine. This experience provided the core technological foundation for his newly established synthetic biology enterprise. Xu Xiaochun stated, “Cherish every life experience. Everything one has gone through and experienced in the past is useful; it is hard to say when a particular experience might become valuable again at some point in the future.”

After earning his Ph.D., he immediately joined Pfizer, then the world’s largest pharmaceutical company, where he engaged in new drug development and project management, accumulating over a decade of industry experience in pharmaceutical R&D. While many of his peers anticipated high salaries and stable careers at multinational corporations, Xu Xiaochun made a different choice: he returned to China to launch his own venture.

In 2010, Dr. Xu Xiaochun returned to China and founded Boyalife, the first company dedicated to the storage and application of placental stem cells.At that time, stem cell technology in China was still in its nascent stage. Xu Xiaochun founded the first stem cell enterprise aligned with international quality standards and, within five years, established the company’s influence within the industry. By then, Boyalife had 13 subsidiaries and branches and operated five stem cell banks, further promoting the standardization of China’s stem cell industry and setting a benchmark for the sector.Boyalife Stem CellSelected by CCTV as “CCTV 2012 China Brand of the Year”Xu Xiaochun has also received numerous social honors, being successively recognized as a Jiangsu Province Innovation and Entrepreneurship Talent, a National Advanced Individual by the All-China Federation of Returned Overseas Chinese, and one of the “2013 China Economic Person of the Year” selected by People’s Daily and Economic Daily.

By 2015, Boyalife had grown into an influential enterprise in the stem cell field. Its rapid development and expansion also attracted the attention of numerous investment institutions.

At the end of 2015, Boyalife completed a major asset restructuring with Ningxia Xinri Hengli, a company listed on the Shanghai Stock Exchange. “The greatest good news is often accompanied by the greatest crisis. Although the restructuring brought us our first pot of gold, it also embroiled Boyalife in disputes, plunging the company into a painful struggle,” said Xu Xiaochun. However, this minor setback was ultimately resolved when Boya Group repurchased all equity interests in Boyalife in June 2022, bringing the disputes to a complete close.

Years later, looking back on this chapter of his past, Xu Xiaochun reflects with even greater emphasis on the arduousness and perilous nature of entrepreneurship. He hopes to share his lessons learned with more entrepreneurs in the pharmaceutical sector: “Scientists must learn to protect themselves through lawful means; engaging a competent legal advisor is a critical aspect that cannot be overlooked when starting a business.”

Due to changes in his personal life, Dr. Xu Xiaochun stepped back from the day-to-day operations of Boyalife Group after late 2022. He no longer holds any position at Boyalife Stem Cell Technology Co., Ltd., nor does he retain any equity interest in the company.Nevertheless, Xu Xiaochun still speaks of Boyalife with deep affection. “Although I have left Boyalife, many members of the management team were recruited and trained by me personally. I am delighted that Boyalife has become the ‘Whampoa Military Academy’ of the stem cell industry, nurturing a wealth of talent for the sector. I also believe that under the leadership of President Li Yishu and the current team, the company will achieve even greater success and go further.” This reflects Xu Xiaochun’s high hopes for Boyalife.

When many entrepreneurs achieve success, they often choose to step away at the peak of their careers. However, Xu Xiaochun has never paused since embarking on his entrepreneurial journey. In 2019, he acquired U.S.-based Shengyin Life, and in 2023, he established Shengyin Group in Shanghai, launching his second entrepreneurial venture. Shengyin Group is an industrial ecosystem enterprise specializing in investments in cell and gene therapies and synthetic biology, with a strong emphasis on integrating upstream and downstream segments of the industry chain.“If Boyalife focuses on a specific niche within the stem cell field, Shengyin Group is dedicated to the entire industrial ecosystem of cell and gene therapies,” said Xu Xiaochun, head of Shengyin Group.

Xu Xiaochun realized that cell and gene therapies would play a pivotal role in the pharmaceutical industry over the next 30 years. Meanwhile,He also keenly recognized the challenges that this industry is about to face: issues with large-scale manufacturing, as well as the drugability and standardization of cell therapies.

“Over the nearly 20-year development of cell and gene therapies, one of the core challenges we have encountered is the manufacturing of cell and gene therapy products. If the production process fails to meet pharmaceutical manufacturing standards, the potential harms may outweigh the therapeutic benefits,” pointed out Xu Xiaochun. “For instance, while stem cell therapies are undoubtedly a promising treatment modality, not all stem cell products manufactured by different institutions offer equivalent efficacy and safety profiles. We must ensure their quality and safety to avoid exposing patients to unknown risks.”

Xu Xiaochun hopes that Shengyin Group will become a full-chain pharmaceutical enterprise focused on cell and gene therapies, capable of addressing upstream manufacturing challenges as well as mid- and downstream standardization issues in cell therapy. To this end, Shengyin Group not only owns TG Medical, an industry leader dedicated to clinical-grade automated equipment, but also All-around Medical, which is developing a clinical pipeline for cell-based drugs, and Anji Bio, which leverages synthetic biology and cloning technologies for large-scale production of biopharmaceuticals.

Xu Xiaochun stated that Shengyin Group is committed to reducing costs and increasing efficiency in the CGT industry. This is not only the original intention behind the company’s founding but also its core philosophy in pharmaceutical development. “Technology should contribute to the extension of life. Our goal is not merely entrepreneurship and profitability; more importantly, we aim to enable more patients to benefit from technological advancements.”

With 25 years of industry experience, Xu Xiaochun has witnessed the transformation of the pharmaceutical sector. From small-molecule chemical drugs to large-molecule antibody therapies, and now to cell and gene therapies, the title of “blockbuster drug” has continuously shifted, with sales records being repeatedly broken. In Xu Xiaochun’s view, cell and gene therapies will become the mainstream over the next three decades. However, an unavoidable reality is that these therapies come with high unit prices; patients must pay tens to hundreds of times more than they would for small-molecule or antibody drugs to access these innovative treatments, thereby significantly increasing their financial burden.

Therefore,One of the core objectives behind the establishment of Shengyin Group is to bring the prices of cell and gene therapies down to a range affordable for the general public. To achieve this goal, a key approach is to enhance production efficiency and significantly reduce costs.

Shengyin Group has proposed a plan to build a “super cell factory,” leveraging its automated manufacturing platform to provide comprehensive cell and gene therapy manufacturing services.

This business model can be likened to the “Foxconn of cell and gene therapies,” focusing on end-to-end services ranging from automated immune cell storage, development of cell therapy manufacturing processes, and GMP-compliant production of cellular products to overseas Investigational New Drug (IND) filings. Under this model, Shengyin Group has launched CARTxpress.^TMHigh-Efficiency Automated Cell Therapy Manufacturing Platform: This closed, modular large-scale cell production platform can increase manufacturing efficiency by more than fourfold, thereby reducing the cost of cell therapies by 50%.

As a global enterprise, Shengyin Group operates three cell manufacturing facilities in the United States. These facilities enable numerous Chinese CGT companies to transition from the widely adopted open, manual production processes to automated, closed GMP-compliant manufacturing processes accepted by regulatory authorities worldwide, while also assisting these companies with clinical trial applications both domestically and internationally.

The entrepreneurial journey is fraught with challenges, often akin to surviving against overwhelming odds. Xu Xiaochun’s resilience as a serial entrepreneur, coupled with his deep insights into cell and gene therapies, has led him to be highly optimistic about the industry’s development prospects over the next 30 years.

In his view, the current development trajectory of the cell and gene therapy industry will closely resemble the 30-year period of rapid growth seen in antibody-based therapeutics. With more than 6,000 rare diseases still lacking effective treatments, cell and gene therapies hold significant promise in these areas.

“As technology advances and the market expands, the field of cell and gene therapies is also poised to nurture new industry leaders, bringing revolutionary treatment options to patients and driving the development of the entire biopharmaceutical industry,” said Xu Xiaochun.

"We believe Dr. Xu Xiaochun's second entrepreneurial venture will go further and have greater impact than his first."