Haodingrui Biotechnology: Pioneering China's First Fecal Microbiota Transplantation Health Center to Capture the Billion-Dollar Gut Microbiome Market

In recent years, the gut microbiota has emerged as a prominent focus in medical research, with related findings frequently published in top-tier journals. The number of funded projects and the amount of funding allocated to gut microbiome research have also shown a sustained upward trend in recent years.

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MarketWatch's relevant market research reports indicate:The global microbiome therapeutics and diagnostics market was valued at $1.13 billion in 2018 and is projected to grow at a compound annual growth rate (CAGR) of 19.03% over the next five years, reaching $2.7 billion by 2023.Among these, the majority of markets will be dominated by the field of microbiome therapeutics. As the technology gradually matures, gut microbiota-related diagnostics and treatments have the potential to become a disruptive force in the healthcare sector.

Many scientists refer to the gut microbiota as the human body’s “eighth organ” or even “another you.” Why is the gut microbiota so important?

Currently, numerous studies have confirmed that the gut microbiota is closely associated with a wide range of diseases, including irritable bowel syndrome, inflammatory bowel disease, diabetes, obesity, metabolic syndrome, allergic disorders, and autism.This is also the reason why numerous research institutions and enterprises have devoted substantial efforts and financial resources to this endeavor in recent years.

Beijing Haodingrui Biotechnology Co., Ltd. (hereinafter referred to as “Haodingrui Biotech”) recognized early on the critical importance of gut health to overall human well-being. Established during the challenging period of the pandemic, the company has achieved rapid growth, earning favorable attention from major players in the healthcare industry and prestigious investment funds.Having secured tens of millions of yuan in angel financing within less than a year of its establishment, the company has now entered a new round of Pre-A financing.

Haodingrui Bio adheres to the research philosophy of "research-translation-clinical validation,"In numerous fields, including cardiovascular diseases, metabolic disorders, neuropsychiatric conditions, and anti-aging, we have established R&D pipelines for microbiome-based drugs, probiotic products, and functional foods, along with a comprehensive fecal microbiota transplantation (FMT) therapeutic system, thereby creating an industrial closed loop encompassing gut microbiota testing, diagnosis, intervention, and follow-up.Haodingrui not only provides comprehensive health management services to consumers, but also offers full-suite product solutions and one-stop technology services to enterprises and public institutions.

Currently, Haodingrui possesses a self-developed Microbiome Resource Center (comprising a microbial strain repository and a microbiome database), established in accordance with the highest international standards. Located in Beijing, the center covers an area of 1,000 square meters and complies with ISO quality management systems. Its current annual production capacity reaches 10,000 doses of fecal microbiota capsules and 3,000 doses of fecal microbiota liquid preparations. Haodingrui is committed to establishing the largest microbiome biobank for Asian populations in Asia.

Haodingrui was established in July 2020. Although it has only recently emerged on the market, its core team members have been deeply engaged in the field of gut microbiota for nearly a decade. The company’s core R&D team hails from renowned domestic and international academic and research institutions, including Harvard University, the University of Kansas, Peking University, Peking Union Medical College, and the Academy of Military Sciences.

“In 2010, while conducting postdoctoral research at Harvard Medical School, the company’s founder began focusing on the field of gut microbiota. Upon returning to China, he published the first article in the country describing the correlation between gut microbiota and hypertension,” the head of Haodingrui Biotechnology told VCBeat. The exploration of the correlation between gut microbiota and hypertension, followed by investigations into its relationship with heart disease, and the subsequent gradual expansion into other disease areas, laid the foundation for the establishment of Haodingrui.

All core members of the Haodingrui team have clinical physician backgrounds, which has brought the company abundant and high-quality clinical resources. This ensures that every Haodingrui product is purposefully developed—based on clinical needs and validated through clinical trials.

How to Understand the Industrial Closed Loop of Gut Microbiota Testing, Diagnosis, Intervention, and Follow-up?

According to the head of Haodingrui, the company initially provides gut microbiome metagenomic testing services. Based on the test results, it assesses customers’ health status and formulates appropriate treatment plans. By ultimately adjusting the relative abundance of gut microbiota, Haodingrui aims to reconstruct or restore the gut microecology, thereby improving gut health and positively influencing overall physical condition.

Regarding the detection, diagnosis, and treatment of gut microbiota, Haodingrui primarily relies on its nationwide chain of offline health centers based on fecal microbiota transplantation (FMT) technology—the Dongyuan Yikang Microecological Health Center.

 Figure Note: Post-renovation rendering

This health center employs gut microbiota metagenomic testing and personalized interventions, in conjunction with fecal microbiota transplantation (FMT), to provide precise diagnosis of intestinal microecology and effective treatment for both intestinal and extra-intestinal diseases.

In addition, through collaboration with relevant hospitals, Haodingrui has established an in-house Fecal Microbiota Transplantation (FMT) Center at the Second People's Hospital of Xinxiang, Henan Province.In the future, Haodingrui will establish a total of 30 Microecological Health Centers across first- and second-tier cities and economically developed regions in China.

To further support the operations of its offline clinics, the Haodingrui team has built an “Internet + Hospital” platform and obtained an internet hospital operating license, enabling health services such as online consultations, AI-assisted diagnosis, online prescription issuance, full-cycle health management, and health follow-ups.

By integrating online and offline services, Haodingrui not only provides patients with health services such as gut microbiota metagenomic testing, fecal microbiota transplantation (FMT), nutritional counseling, and dietary guidance, but also offers continuous health follow-up, thereby achieving comprehensive, full-cycle health management for patients.

In addition, the establishment of internet platforms has played a “traffic-driving” role for offline health management centers, while online customer reviews and strong reputations have further “fueled” brand promotion.

In terms of commercialized products,Haodingrui has launched gut microbiota transplantation products to help patients restore their gut microecology: Dongyuan Yikang Gut Microbiota Capsules/Gut Microbiota Liquid.

Dongyuan Yikang Intestinal Flora Capsules enable fecal microbiota transplantation via oral administration, making them suitable for most patients with normal consciousness and no swallowing difficulties. This approach is cost-effective, convenient, and highly acceptable.

Dongyuan Yikang Intestinal Bacterial Solution requires intestinal microbiota transplantation via nasojejunal tube, painless gastroscopy, or endoscopic intestinal catheterization, and is indicated for patients with autism spectrum disorder, disorders of consciousness, and dysphagia.

It is reported that Dongyuan Yikang Gut Microbiota Capsules can be stably stored for one year at -80°C and for one week at -18°C, with the active ingredients in the capsules remaining above 90%. Haodingrui ensures the safety, efficacy, and traceability of its gut microbiota capsules and bacterial suspensions through a mature Quality Management System (QMS) and strict Standard Operating Procedures (SOPs).

In addition, Haodingrui has also developed several adjunctive therapy products:Currently, the main offerings include tartary buckwheat products with antihypertensive effects and "Qingbixin" yogurt, which helps alleviate anxiety and depression and improve constipation.

After a decade of follow-up surveys and an investigation into the distribution of hypertensive patients across China, the Haodingrui team discovered that the number of hypertension patients in a certain region had consistently remained the lowest in the country. To elucidate the underlying reasons, the Haodingrui team conducted multiple in-depth investigations into the dietary patterns and lifestyles of local residents, revealing that their staple food was predominantly self-produced tartary buckwheat—a crop whose efficacy in lowering blood pressure and lipids has been extensively studied by the scientific community. Through rigorous comparative analysis, Haodingrui scientists found that the tartary buckwheat cultivated in this region contained higher levels of active ingredients with antihypertensive and lipid-lowering properties compared to varieties grown in other areas.

On this basis,Haodingrui signed a strategic cooperation agreement with the China National Research Institute of Food and Fermentation Industries to develop a series of tartary buckwheat-based functional foods, including tartary buckwheat meal replacement powder, tartary buckwheat biscuits, and tartary buckwheat noodles, using locally sourced tartary buckwheat as the raw material.Suitable for different dietary scenarios such as breakfast, afternoon tea, and main meals.

Currently, Haodingrui is conducting a multicenter, centrally randomized, blinded, placebo-controlled clinical trial at Fuwai Hospital of the Chinese Academy of Medical Sciences and West China Hospital of Sichuan University to further validate the antihypertensive and lipid-lowering efficacy of its tartary buckwheat functional food. The subsequent trial results will be published in renowned academic journals. The tartary buckwheat functional food has also been registered with a trademark and barcode, and multiple national invention patent applications have been completed.

“Qingbixin” yogurt’s core ingredient is a rare probiotic strain isolated from human breast milk, combined with multiple probiotic strains and various dietary fibers. Currently, the product is being contract-manufactured by Beijing Sanyuan Foods Co., Ltd. Clinical trials to validate its efficacy in alleviating depression are underway at Beijing Huilongguan Hospital, and the results will be published in a prestigious academic journal in the future.

The gut microbiome sector is currently at a pivotal industry inflection point, experiencing rapid growth. However, the greatest challenge lies in educating the market, physicians, and patients about the critical link between gut health and overall human health.

Developed countries are at the forefront of research and industrialization in the field of gut microbiota, and public awareness of gut microbiota is relatively widespread. During the outbreak of the COVID-19 pandemic in 2020, many people abroad took probiotic supplements to boost their immunity against the novel coronavirus. This also reflects, to some extent, the emphasis placed on gut health and the level of understanding thereof in foreign countries.

The industry trend is clear; it just needs time to develop. How will Haodingrui, as an emerging player, establish its foothold in the gut microbiome field and continue to open new chapters of development? We shall wait and see.