Ruining Bio Completes Clinical Enrollment for China's First Radioprotective Hydrogel, Respacio®

Recently, Shanghai Ruining Biotechnology Co., Ltd. (hereinafter referred to as “Ruining Bio”) announced thatRespacio: Radiotherapy Protection and Isolation Hydrogel Led by Peking Union Medical College Hospital^®The registration clinical trial for the cervical cancer indication has successfully completed enrollment of all cases.This represents the most cutting-edge research progress achieved among similar products globally, marking the formal entry of the company’s product registration and filing into a new phase.

 Respacio^®Group Photo of Director Zhang Fuquan’s Core Team Upon Completion of Enrollment for All Cervical Cancer Cases in the Hydrogel Study

Respacio Biotech^®The product was also recently unveiled at the Multidisciplinary Symposium of the Chinese Collaborative Group on Radiation-Induced Intestinal Injury and the 2nd China Summit Forum on Pelvic Radiation Injury. Professor Zhang Fuquan’s team from the Department of Radiation Oncology at Peking Union Medical College Hospital announced the product’s global debut.Summary Report on Phase I of Registered Clinical Studies and Outstanding Clinical Cases, clinical data met favorable expectations: the product demonstrated a high injection success rate, established a stable separation space between the tumor and the rectum in the human body, and significantly reduced rectal radiation dose, thereby confirming its safety and efficacy in humans.

Meanwhile, Ruining Biotech is accelerating the expansion of indications for its radiotherapy protection and isolation hydrogel to benefit a broader population of cancer patients: Respacio^®ProductProstate CancerPatient enrollment has also been completed for multiple cases in this indication.

Respacio^®Clinical Experts and Patients Pose for a Photo After Successful Injection of Hydrogel Product in Prostate Cancer Patients

In 2020, there were over 4 million new cases of pelvic malignancies (gynecological, urological, rectal, and anal canal cancers) worldwide, with more than 700,000 new cases in China. Pelvic and abdominal radiotherapy is an indispensable treatment modality for malignant tumors, utilized in 20–60% of cases. Consequently, radiation-induced injuries are unavoidable, commonly affecting the rectum, sigmoid colon, pelvic small bowel, and ileocecal region, with radiation-induced rectal injury being the most prevalent and refractory. Literature reports indicate that approximately 75–90% of patients experience acute radiation-induced rectal injury to varying degrees, while the incidence of late-onset injury ranges from 5% to 20%. The Chinese Multidisciplinary Expert Consensus on the Diagnosis and Treatment of Radiation-Induced Rectal Injury (2021 Edition) recommends preventing such injuries through precise radiotherapy techniques, particularly advocating for the injection of spacer hydrogel between the tumor and the rectum to significantly reduce rectal radiation dose and the incidence of injury.

Boston Scientific's SpaceOAR^®SpaceOAR is the world’s first and only FDA-cleared polyethylene glycol (PEG) hydrogel spacer for prostate cancer radiotherapy protection. Long-term clinical data demonstrate that patients receiving the hydrogel injection exhibit significant benefits in bowel, urinary, and sexual function at 3- and 5-year follow-ups after radiotherapy. Under the protection afforded by PEG-based hydrogels, pioneering exploratory studies on novel radiotherapy paradigms conducted by U.S. clinical experts have shown that hypofractionated regimens can reduce the radiotherapy course from over 8 weeks to less than 2.5 weeks, achieving tumor control rates comparable to those of conventional long-course radiotherapy while lowering the risk of secondary malignancies. Emerging clinical evidence increasingly indicates that radiotherapy-protective hydrogels have the potential to disrupt traditional radiotherapy models, substantially shorten treatment durations, and improve oncological outcomes.

Although PEG hydrogel products have been developed abroad for a considerable period, the regulation of their gelation properties remains a significant technical challenge. For instance, the complex delivery environment in radiation therapy protection, long-term stability, and appropriate degradation and absorption timelines impose higher performance requirements on hydrogels. These technical barriers have resulted in only one PEG-based hydrogel product for radiation therapy protection being available globally to date.

Ruining Bio has pioneered an innovative PEG hydrogel technology platform, leveraging unique PEG derivative and storage technologies to significantly enhance product storage stability and ease of use. This advancement extends the stability of PEG derivatives in aqueous solutions from one hour to over two years.Furthermore, through continuous technological breakthroughs, Ruining Biology has achieved precise control over a series of properties of hydrogels, including gelation characteristics, mechanical properties, swelling behavior, degradation profiles, and biocompatibility, ultimately obtainingRuining’s Proprietary, World’s First “Ready-to-Use” PEG Hydrogel Platform. Ruining Biotechnology’s outstanding technical capabilities have endowed its core products with unique originality on a global scale; related research achievements have been granted multiple Chinese invention patents, and PCT and U.S. patent applications have been filed.

Shanghai Ruining Biotechnology Co., Ltd. (hereinafter referred to as “Ruining Biotech”), established in 2018, is a Shanghai-based enterprise recognized for its specialization, refinement, uniqueness, and innovation. The company focuses on the research, development, and industrialization of high-end biomedical materials. Its founding team originates from top-tier biomaterials laboratories in China and the United States. By establishing deep industry-academia-research collaborations with leading cancer treatment centers in China, Ruining Biotech effectively promotes the clinical and medical application of next-generation innovative biomaterial technologies, boasting comprehensive talent and technical reserves.Currently, Ruining Biology has established a globally leading medical hydrogel technology platform.Leveraging this technological platform, we have developed multiple Class III implantable and interventional medical devices that are first-of-their-kind in China, boasting a rich and comprehensive product pipeline. In addition to the radiotherapy protection isolating hydrogel product, which has completed clinical enrollment, the portfolio includes tumor embolization hydrogel products and solutions for tissue filling, tissue regeneration, drug delivery, and other applications.