Ruibo Bio Advances Domestic Substitution in ART with Over 10 NMPA-Approved Devices Led by NMPA Assisted Reproductive Technology Standards Committee

“China’s trillion-yuan big health market is fundamentally about addressing two critical issues: ‘life’ and ‘death.’ Death relates to diseases such as tumors and cancer, while life pertains to assisted reproductive technology (ART),” remarked Dr. Feng. “The ART market is enormous. In China alone, there are an estimated 50 million couples recognized as infertile, with the number of treatment cycles roughly equivalent to the combined total of Europe and the United States. Over the past three decades, the Chinese government has provided substantial support for the establishment of ART centers, expanding ART qualifications and enhancing the scope and quality of diagnosis and treatment for infertility. However, key upstream products in the ART treatment chain—reagents and consumables—have been largely overlooked and remain almost entirely dependent on imports, creating a significant bottleneck that hinders the development of assisted reproduction in China.”

Based on this, the “Proposal on Standards and Localization of Assisted Reproductive Products” submitted by Dr. Feng received significant attention and directives from the leadership of the National Medical Products Administration (NMPA). State support and leadership concern have accelerated the approval and market launch of domestically produced brands.

Insight into the industry’s pain points underpins this assessment, which is far from mere theoretical speculation. Dr. Feng is a world-renowned expert in assisted reproductive technology, serving as an Embryology Laboratory Director (ELD), Andrology Laboratory Director (ALD), and High-Complexity Clinical Laboratory Director (HCLD) certified by the American Board of Bioanalysis (ABB).Member of the Assisted Reproductive Technology Standards Committee, National Medical Products Administration (NMPA), and is also a member of several reproductive medicine research societies. He studied under a renowned embryologist, and isThe Inheriting Disciple of Mr. Tong Dizhou, a Founder of Life Sciences, has accumulated extensive experience and achievements in the treatment and research of test-tube animals and in vitro fertilization (IVF), published over one hundred academic papers and related works, and was recognized as a World Distinguished Scientist by the Cambridge International Certification Center.

Dr. Feng likened ART reagents and consumables to the “chips” of the semiconductor industry, highlighting how the sector is monopolized by foreign brands. If China fails to master core manufacturing technologies and establish its own domestic brands, a halt in imports would leave hundreds of downstream assisted reproductive technology (ART) centers facing an “embryo weaning” crisis. Therefore, only by achieving product localization can the industry ensure its independent and sustainable development.

According to the World Health Organization, infertility has become the third major disease after cancer and cardiovascular diseases. With the development of science, technology, and industry in recent years, environmental and food pollution have led to a significant increase in the incidence of human infertility, affecting nearly one in five couples. Since the birth of China’s first test-tube baby in 1988, although assisted reproductive treatment has undergone substantial development over the past three decades, the domestic upstream market for reagents and consumables remains virtually empty.

Regarding the underlying reasons behind this situation, Dr. Feng stated: “Talent is one aspect; there is a need for experts in the field of assisted reproduction who possess not only extensive professional knowledge but also expertise in technology and manufacturing processes. Secondly, from the perspective of national policy, standardization for assisted reproductive products has only begun to receive attention in recent years, and the approval thresholds for related products are relatively stringent.”

Reprobiotech was founded with the original mission of filling the gap in China’s upstream reagents and consumables market. Established in Shandong Province in 2016, the company is a national high-tech enterprise dedicated to the comprehensive commercialization of products for assisted reproduction. Led by a team of renowned experts and professors from diverse disciplines—including reproductive biology, reproductive medicine, reproductive genetics, and management—the company leverages over three decades of cumulative innovative achievements at the global forefront of reproductive medicine in treatment, education, research and development, and translation. This expertise provides critical technical support for the translation, regulatory approval, manufacturing, quality control, market launch, and iterative upgrading of its new products.

Since imported brands hold the majority of the market share in the upstream equipment and consumables segment of China’s assisted reproductive technology (ART) industry, the primary objective for domestic ART medical device manufacturers is to achieve import substitution. However, such substitution does not merely entail matching the performance of imported products. It remains debatable whether ART devices, such as embryo culture media designed for Caucasian populations, are fully suitable for treating Chinese patients, and their safety requires further scrutiny.

"Environmental Epigenetics Affects Human Reproduction Through Gametes"

A substantial body of research has demonstrated that culture media can significantly alter the epigenetics of embryos, thereby inducing heritable genetic changes in offspring. Epigenetics is the study of heritable changes in genome function that occur due to chemical modifications rather than alterations in the DNA sequence. For instance, DNA methylation is an epigenetic event that can lead to gene silencing and may be transmitted to subsequent generations.

As the saying goes, “Each place has its own way of nurturing its people.” Domestic brands should develop ART (Assisted Reproductive Technology) devices and reagents tailored to Chinese and Asian populations, based on China’s current conditions and local raw material supply, thereby ensuring the safety of assisted reproduction. In addition to complying with the standards of the Chinese Pharmacopoeia, the selection of raw materials for the company’s products must avoid human- and animal-derived sources as much as possible. The procurement department of Reprobiotech Corp China Ltd has devoted substantial time to sourcing and optimizing these materials, ensuring the quality and safety of the final products.

Currently, Reprobiotech plans to commercialize a total of 36 assisted reproductive technology products, among which 22 require registration. Of these, already13 ART Products Have Obtained NMPA Registration Certification, including 11 Class II medical devices and 2 Class III medical devices. The company currently has 2 Class II medical devices (consumables) and 7 Class III medical devices (reagents) under registration. Upon completion of the registration process, it will be able to provide end-users with comprehensive solutions for high-quality embryo culture.

Reprobiotech's Oocyte Retrieval Medium, the First Class III Culture Medium Approved in China

Most of the consumable products independently developed by Reprobiotech are patented. Each product is designed based on human physiological functions or natural nanotechnology principles, combined with years of clinical experience, offering unique advantages in usage. For instance, the company’s independently developed and market-unique product, “SperMagic,” has helped tens of thousands of patients with asthenozoospermia and oligozoospermia achieve their dream of starting a family. Another market-unique product independently developed by the company, the “One-Step Culture Medium,” can replace the conventional five-step culture media used for sperm washing, fertilization, cleavage, blastocyst culture, and embryo transfer. Once launched, it will significantly simplify the operational procedures of ART culture systems, thereby enhancing the convenience and success rate of assisted reproductive technology treatments.

Reprobiotech's Proprietary Sperm Motility Medium and One-Step Culture Medium

All culture media formulations developed by the company are built upon years of basic and clinical research outcomes. They employ optimal combinations of various components and precisely add small-molecule nutrients required by cells (sperm, oocytes, and embryos), such as amino acids, vitamins, and natural monosaccharides, to achieve optimal culture performance. The mission of Reprobiotech’s ART products is to make clinical laboratory use simpler, more natural, and safer, thereby enhancing product practicality, efficacy, and safety, and encouraging long-term customer adoption.

Reprobiotech's Sperm Swim-Up Capture Kit

It is only a matter of time before high-quality, premium products gain market recognition; the series of ART products developed by Reprobiotech Corp China Ltd has seen a gradually increasing adoption rate in assisted reproductive technology (ART) centers across China. Currently, among ART centers nationwide,79 centers have officially procured Reprobiotech products, capturing over 10% of the hospital market share., Reprobiotech is truly advancing the pace of domestic substitution through concrete actions.

In addition to its products, Reprobiotech Corp China Ltd also provides services related to ART (Assisted Reproductive Technology), primarily including technical guidance, technical training, technical support, and collaboration with reproductive medicine centers.

Notably, since 2018, Reprobiotech Corp China Ltd has participated in the formulation of draft standards by the National Institutes for Food and Drug Control (NIFDC), including “Test Methods for Blastocyst Staining and Counting for Medical Devices Used in Human Assisted Reproductive Technology,” “Test Methods for Amino Acid Detection in Culture Media for Medical Devices Used in Human Assisted Reproductive Technology,” “Oocyte Retrieval Needles for Assisted Reproduction as Medical Devices Used in Human Assisted Reproductive Technology,” and “Embryo Transfer Catheters as Medical Devices Used in Human Assisted Reproductive Technology,” significantly enhancing the company’s industry influence.

Looking ahead, Reprobiotech will remain steadfast in its commitment to independent innovation, continuously optimizing and upgrading its product portfolio. Simultaneously, the company will expand horizontally within the broader reproductive health sector, consistently launching competitive, high-quality products to achieve a comprehensive layout across the entire industry chain.