Anaerobe Biotech Advances China's First Multi-Strain Live Biotherapeutic into Phase II Clinical Trials
The human body harbors up to 100 trillion microorganisms, with over 80% residing in the gut and more than 80% belonging to anaerobic species. Their total weight reaches 1.5–2 kg, earning them the designation of a “quasi-organ.”
The gut microbiota is significantly associated with a variety of diseases, including digestive system disorders, chronic metabolic diseases, cardiovascular diseases, mental illnesses, and neurodegenerative diseases.
In recent years, research on live biotherapeutic products (LBPs) has become one of the most cutting-edge and prominent fields in the pharmaceutical industry. Major pharmaceutical companies such as Pfizer, BMS, Takeda, Merck & Co., and Genentech have actively invested in the development of LBP-based therapeutics. Leveraging its extensive experience in the R&D of gut and vaginal microbiota products, Sichuan YANYANG Biotechnology Co., Ltd. (hereinafter referred to as “YANYANG”) is strategically focusing on the research and development of live biotherapeutic drugs, guided by its philosophy of “Harmony Between Humans and Microbes for Universal Health.”
“Microorganisms are truly fascinating. I have been studying them for many years. They are widely distributed throughout the human body and are closely linked to human health, yet there remains much we do not know about their presence,” said Dr. Cheng Lei.
Dr. Cheng Lei is a Research Fellow and Doctoral Supervisor at the Biogas Institute of Ministry of Agriculture. As early as 2015, Dr. Cheng established a research team to commence the development of microbial consortium-based therapeutics. With 16 years of research experience in the field of anaerobic microbiology, he has developed long-term preservation techniques for anaerobic microorganisms, established China’s largest culture collection of anaerobic type strains, and isolated and reported multiple new families and orders of anaerobic microorganisms. He discovered the fifth metabolic pathway of methanogenic archaea, with related research published in Nature. His findings hold significant strategic value for energy security and in-depth resource exploitation, and have been featured by various media outlets, including Guangming Daily, China Science Daily, and Economic Daily.
Building on its R&D expertise in gut and vaginal microbiota, Dr. Cheng Lei established Sichuan Yanyang Biotechnology Co., Ltd. (YANYANG) in 2019 with the support of the Biogas Institute of the Ministry of Agriculture and Rural Affairs, focusing primarily on the development of innovative live biotherapeutic products for human use.
YANYANG
Currently, YANYANG possesses the largest human microbial strain library in western China. It has mastered the end-to-end R&D process for live biotherapeutic products (LBPs) derived from human anaerobic microbes, encompassing strain discovery, pharmacological and toxicological evaluation, and CMC process development. Additionally, it has established production processes, manufacturing technologies, and quality standard systems that comply with the requirements of the Center for Drug Evaluation (CDE). Focusing on the R&D of innovative drugs targeting the human microbiome, YANYANG is developing multi-strain combination live biotherapeutics, specifically tailored to the gut and vaginal microbiota segments.
Since the establishment of the team, the R&D department has comprehensively evaluated scientific rigor, commercial viability, and practical applicability, choosing to enter the live biotherapeutic product (LBP) development market by focusing on vaginal microbiota research. “The vaginal microbiome is an emerging field of study with a close link to women’s vaginal health. YANYANG is targeting the women’s vaginal health market and conducting in-depth research, and its findings are poised to bring transformative changes to this field,” said Dr. Cheng Lei.
Currently, market research on the vaginal microbiome remains insufficient, and the clinical needs of women suffering from vaginal diseases are often unmet. Clinical treatment for postmenopausal atrophic vaginitis primarily relies on oral or topical estrogen therapy; however, this approach is associated with side effects such as carcinogenic risk, drug resistance, and high recurrence rates, leading to poor patient compliance. YANYANG is attempting to identify effective therapeutic solutions from the perspective of microecological balance. By restoring the vaginal microecological balance in patients, it may be possible to establish a novel pathway for disease treatment.
Based on the novel concept of dominant microbiota transplantation, leveraging the ecological synergy of microbial communities, YANYANG has developed a high-density multi-strain Lactobacillus consortium drug—“Vaginal Quadruple Lactobacillus Live Capsules” for the treatment of postmenopausal atrophic vaginitis and bacterial vaginosis. The vaginal quadruple live Lactobacillus formulation primarily contains four distinct strains of live Lactobacillus, designed to mimic the healthy vaginal microecology in women. Taking into account the age and regional differences among Chinese women, as well as the inhibition of pathogenic microorganisms, YANYANG conducted multi-dimensional screening from thousands of bacterial strains based on criteria such as effective in vivo colonization, growth, and metabolism. Through extensive in vitro and in vivo testing, this multi-strain probiotic pharmaceutical formulation was developed to compensate for the physiological limitations of individual strains and leverage the synergistic advantages of the formulated microbial community.
It is reported that YANYANG’s independently developed Class I innovative drug, “Live Quadruple Lactobacillus Capsules for Vaginal Use,” is about toConduct Phase II Clinical Trials, this isChina's First Multi-Strain Live Bacterial Drug to Enter Clinical Trials, also isChina’s first non-hormonal drug for the treatment of “postmenopausal atrophic vaginitis,” filling a clinical gap in this field in China. As a pioneering clinical trial project undertaken by YANYANG, the vaginal microbiome therapeutic has not only achieved phased results in China but has also initiated the FDA application process in the United States.
Dr. Cheng Lei expressed his outlook: “We hope the company will advance steadily, solidify its foundation, and ultimately achieve significant breakthroughs in the R&D of innovative microbial drugs through sustained accumulation of expertise.”
Leveraging core full-chain R&D technologies encompassing high-throughput screening, preservation, evaluation of anaerobic microorganisms, and the development of live biotherapeutic products, YANYANG has established the largest human anaerobic microbiome resource bank in Southwest China, along with an innovative intelligent manufacturing platform for microbial therapeutics. Through its independently developed platforms for high-throughput automated microbial screening, formulation-based microbial drug R&D, and microbial product manufacturing, YANYANG possesses a portfolio of self-developed microbial consortium formulation drugs.
YANYANG’s first gut microbiome drug formulation is expected to initiate its Investigational New Drug (IND) application in the second half of 2022, with multiple candidates advancing rapidly and systematically in its pipeline. The company anticipates that 5–8 innovative drugs will enter clinical stages over the next 2–3 years.
Looking ahead, Dr. Cheng Lei stated that YANYANG will seize the opportunities presented by the rapid global development of the microbiome industry, continue to deepen its expertise in the R&D of microbial therapeutics, continuously optimize business processes, enhance R&D capabilities, and integrate its R&D platform with talent development to build a leading platform for microbial therapeutic drug research and development.