On September 17, 2026, RGL-185 Injection, an AAV gene therapy product independently developed by Shanghai Regenelead Therapies Co., Ltd., successfully completed the dosing of the first subject at the First Affiliated Hospital of Soochow University, in close collaboration with Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. RGL-185 is China's first AAV gene therapy product for radiation-induced xerostomia to formally enter the clinical validation stage.
Previously, on July 14, 2026, RGL-185 Injection had officially obtained implied clinical trial authorization from the National Medical Products Administration (NMPA) of China, intended for the treatment of moderate-to-severe radiation-induced xerostomia caused by radiotherapy for head and neck cancer.
The IND approval of RGL-185 marks another milestone achievement for the company's proprietary, patented AAV gene therapy technology platform, and the dosing of the first subject now further validates the clinical translation capability of the company's innovative gene therapy platform.
Addressing a Clinical Pain Point: Patients with Radiation-Induced Xerostomia Urgently Need a Curative Treatment
Radiation-induced xerostomia (RIX) refers to dry mouth, mucositis, and related symptoms in cancer patients undergoing radiotherapy, caused by radiation damage to the salivary glands. Patients with severe long-term reactions may experience difficulty swallowing and speaking, sleep disturbance, loss of taste, dental caries, and oral fungal infections. RIX is one of the most common complications of radiotherapy in patients with malignant tumors: the incidence reaches as high as 93% during radiotherapy and about 80% after radiotherapy, and more than 60% of patients still suffer from moderate-to-severe dry mouth three years after radiotherapy. In severe cases, symptoms can persist for years to decades, or even for life, seriously diminishing patients' quality of life. At present, there is no curative treatment for radiation-induced xerostomia in clinical practice; existing options mainly provide symptomatic relief, leaving a significant unmet clinical need in this field.
Innovative Mechanism: AAV Gene Delivery Enables Long-Lasting Reconstruction of Salivary Gland Function
RGL-185 is a gene therapy product that uses an adeno-associated virus (AAV) vector to deliver a gene encoding an optimized protein. After administration, high-efficiency AAV delivery drives expression of the functional target protein in target cells, increasing saliva production and effectively relieving dry-mouth symptoms. As a cellular functional compensation strategy, and despite the pathological disadvantage of a sharply reduced absolute number of acinar cells, this approach enhances per-cell output at the molecular level, ultimately rebuilding and restoring the overall secretory capacity of the salivary glands at its root. In contrast to the short-term relief offered by conventional symptomatic treatments, a single administration of RGL-185 is expected to deliver long-lasting functional improvement.
Dr. Cheng Liao | Founder and Chief Executive Officer of Regenelead
"As China's first AAV gene therapy product for radiation-induced xerostomia to enter clinical validation, Regenelead's RGL-185 Injection offers patients a new treatment option with the potential to rebuild function, and is expected to resolve the dilemma that existing treatments can only relieve symptoms without achieving long-term restoration of salivary gland function. The successful first subject dosing of RGL-185 Injection also validates our clinical translation capability. The company will continue to fully advance the clinical development of RGL-185, strictly adhering to scientific, standardized, and high-quality development principles, accelerating the verification of its safety and efficacy, and striving to bring this innovative treatment option to patients as soon as possible."
About Regenelead
Founded in August 2021, Regenelead is an innovative biopharmaceutical company focused on cell and gene therapy (CGT). The company has built an AI-powered, self-developed "AAV + mRNA + Cell Therapy" tri-core technology R&D platform, equipped with industry-leading, full-chain process development and manufacturing quality-control modules for plasmids, viral vectors, mRNA, and cell therapies — all achieving high capacity, high recovery, high quality, and low cost, providing strong support for drug development. The company's R&D pipeline is precisely positioned in disease areas with urgent clinical needs and broad market prospects, including neurology, ophthalmology, metabolism, and oncology. With safeguarding human health as its mission, Regenelead continuously strengthens its core competitiveness, upholds a pioneering and innovative spirit, and is committed to creating a better and healthier life for patients worldwide.
About Hengrui Medical
Hengrui Medical is affiliated with Jiangsu Hengrui Pharmaceuticals Group Co., Ltd. As the group's vehicle for medical device industry development and capital operations, it carries Hengrui's strategic mission of expanding from the pharmaceutical industry into the broader healthcare industry. Upholding Hengrui's tradition of innovation and internationalization, the company continuously builds a strong product pipeline and establishes areas of market advantage through independent R&D, industry-academia-clinic research collaboration, and equity capital operations, providing systematic solutions that help healthcare professionals deliver high-quality medical services to patients. The company is deeply engaged in high-value consumable fields such as oncology intervention, peripheral intervention, and neurointervention; develops medical equipment for life support, imaging support, and interventional support; has moved early into frontier areas such as drug delivery devices; and continues to expand its product pipeline to build market advantages.