Phileach Bio Successfully Completes Clinical Enrollment for Next-Generation Endometrial Repair Product, Filling a Domestic Gap

As China’s fertility rate continues to decline, safeguarding female fertility has become an urgent national priority. Statistics show that over 5 million hysteroscopic procedures and 14 million induced abortions are performed annually in hospital obstetrics and gynecology departments. These procedures carry a high risk of damaging the endometrium, leading to intrauterine adhesions and endometrial scarring and fibrosis, which in turn cause various gynecological clinical symptoms and ultimately result in infertility. Among the 40 million individuals affected by infertility each year, more than 40% of cases are associated with endometrial injury.

Currently, the treatment of endometrial injury typically relies on hysteroscopic adhesiolysis combined with pharmacological therapy, such as oral estrogen, or the use of anti-adhesion medical devices, including intrauterine balloons, intrauterine devices (IUDs), and hyaluronic acid hydrogels. Although these methods demonstrate certain efficacy, they are technically complex and fail to achieve fundamental regeneration of the endometrium.

Addressing this urgent clinical need, Xianshi Biotech has successfully developed a next-generation endometrial repair product, leveraging its extensive technical expertise in biomedical materials. Using natural animal tissues as raw materials and employing unique decellularization technology alongside advanced manufacturing processes, the company has engineered distinctive decellularized biological matrix microfibers. This innovation holds promise for overcoming the significant clinical challenge of endometrial injury.

This product leverages the unique electrostatic interactions between biomaterials and the endometrial surface to rapidly form a three-dimensional scaffold layer upon entry into the uterine cavity. This layer covers and adheres to damaged wound sites, serving not only as a stable physical barrier to prevent intrauterine adhesions but also improving the local microenvironment of the uterine cavity through extracellular matrix components. By promoting endogenous endometrial repair, it fundamentally restores endometrial function.

In April 2024, Xianshi Biology successfully completed the enrollment of all clinical cases for its endometrial repair product, a trial led by Sir Run Run Shaw Hospital, Zhejiang University School of Medicine. The entire process took only about six months, fully demonstrating the team’s efficient project execution capabilities and indirectly underscoring the significant market potential of endometrial repair therapies. To date, more than half of the enrolled cases have completed clinical follow-up. Preliminary clinical results indicate that the company’s product has achieved satisfactory outcomes in terms of intrauterine adhesion prevention, degree of endometrial repair, and ease of use for physicians. Moreover, several pregnancy cases have already been reported. The product is expected to be submitted for regulatory registration in the third quarter of this year, with commercialization officially launching next year. Currently, the company is actively preparing for commercial rollout. Both clinicians and distribution partners are eager for the product’s imminent market entry, aiming to benefit women’s health on a broad scale.

Dr. Yu Xiaohua, Founder and CEO of the company, earned his bachelor’s degree from Southwest Jiaotong University and later obtained his Ph.D. in Materials Science from the University of Connecticut in the United States. During his postdoctoral fellowship, he studied under Professor Cato T. Laurencin, a member of the U.S. National Academies of Sciences, Engineering, and Medicine. Dr. Yu has extensive academic expertise and rich product development experience in the field of biomedical materials. Since founding Xianshi Biotech, he has adhered to the core philosophy of “starting from clinical needs and ending with clinical solutions,” leveraging the unique advantages of integrating medicine and engineering to accurately identify unmet clinical demands and leading the Xianshi team to rapidly achieve product commercialization and clinical translation.

Xianshi Biologics is one of the very few development teams that has achieved a high level of integration among industry, academia, research, and clinical practice. Since its establishment, the company has leveraged its advanced product philosophy and profound technical expertise to forge robust strategic partnerships with many leading hospitals in China, including Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine, Sir Run Run Shaw Hospital affiliated with Zhejiang University School of Medicine, Renji Hospital affiliated with Shanghai Jiao Tong University School of Medicine, and Shanghai Ninth People’s Hospital affiliated with Shanghai Jiao Tong University School of Medicine. These collaborations also involve multiple academician-led teams. The insights and feedback from these experts are crucial for the company to understand genuine clinical needs.

Prior to initiating clinical trials for its endometrial repair product, the company jointly launched rigorous academic research with Renji Hospital, Ruijin Hospital, and Sir Run Run Shaw Hospital to investigate the product’s mechanism of action and efficacy. The relevant findings were published last year, laying a solid evidence-based medical foundation for the subsequent success of the clinical trials. Notably, part of the collaborative work with Professor Sun Yun’s team at Renji Hospital and Professor Cui Wenguo’s team at Ruijin Hospital on bioactive decellularized extracellular matrix short fibers (DEFs) was published in March 2024 in the prestigious international journal Advanced Science, under the title “Injectable ‘Homing-Like’ Bioactive Short-Fibers for Endometrial Repair and Efficient Live Births.” Commenting on these findings, Professor Sun Yun, Director of the Center for Reproductive Medicine at Renji Hospital, Shanghai Jiao Tong University School of Medicine, and Professor Cui Wenguo from the Institute of Traumatology and Orthopaedics at Ruijin Hospital, stated: “The combination of bioactive extracellular matrix with endometrial cells can repair damaged endometrium and serve as a physical barrier, helping to prevent intrauterine adhesions. This study opens up a new direction for endometrial repair and treatments to improve fertility.”

Another study, conducted in collaboration with Professor Zhang Songying from Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, which utilized an injectable acellular matrix to deliver stem cell-derived exosomes for the treatment of infertility caused by endometrial factors, was published in November 2023 in a subsidiary journal of *Materials Today*, a top-tier journal in the field of materials science. The paper is titled “ADSC-derived exosomes-coupled decellularized matrix for endometrial regeneration and fertility restoration.” Commenting on these findings, Professor Zhang Songying, Leader of the Reproductive Medicine Center and the Discipline of Obstetrics and Gynecology at Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, stated: “Promoting endometrial regeneration and repair is central to the current treatment of uterus-related infertility. The use of extracellular matrix to treat the uterine cavity and damaged endometrium can significantly reduce the recurrence rate of moderate-to-severe intrauterine adhesions, improve endometrial thickness and angiogenesis, and promote endometrial regeneration, thereby achieving the goal of restoring fertility. These research results will provide a new option for endometrial repair.”

Xianshi Bio, established in 2020, is a high-tech company focused on the biomaterials and regenerative medicine industries, dedicated to developing next-generation biomedical materials and tissue reconstruction products with induced regenerative capabilities. Xianshi Bio boasts an efficient R&D and project management team that integrates expertise from materials science, medicine, biology, chemistry, and other disciplines. With its domestically leading extracellular matrix platform as the core, the company integrates its distinctive electrospinning platform, biomimetic mineralization platform, and hydrogel microsphere platform, possessing sustained platform-based capability for product development.

In addition to its first endometrial repair product, the company’s regenerative medicine portfolio—including breast surgical repair materials and oral biomimetic mineralized bone powder—has already entered clinical stages. It is expected that one to two blockbuster products will enter clinical trials annually in the coming years. Xianshi Biology is deeply committed to addressing the actual clinical needs of the local market. By collaborating closely with renowned domestic and international research institutions and leading clinical experts, the company rapidly translates advanced technologies into practical products. Beyond focusing on product development and innovation, Xianshi Biology aims to expand the boundaries of the biomedical materials market together with partners within its ecosystem. Through such collaborations, Xianshi Biology is dedicated to driving progress across the entire industry and bringing hope and change to more patients.

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