Beijing Balance Medical Technology Co., Ltd. (688198.SH): The registration application for the ophthalmic biological patch has not been approved.

Beijing Balance Medical Technology Co., Ltd. (688198.SH) announced that on September 4, 2026, it received the "Medical Device Registration Rejection Notice" from the National Medical Products Administration. The company's registration application for the ophthalmic biological patch was not approved by the National Medical Products Administration and was officially published on the NMPA's official website. According to the National Medical Products Administration's Center for Medical Device Evaluation, "The applicant conducted clinical evaluation through a clinical trial path. This clinical trial used a prospective, multicenter, single-arm target design and did not employ a randomized controlled design. The clinical trial simultaneously included minors and adults, and the pathophysiological characteristics, disease progression patterns, prognosis, and risk-benefit ratios of different populations vary and require separate prospective multicenter randomized controlled clinical trials. The existing data cannot support the assessment of the product's risk-benefit and cannot demonstrate the safety and efficacy of the declared product."