华润双鹤药业股份有限公司 关于全资子公司西安京西双鹤药业 有限公司平衡盐冲洗液获得药品注册证书的公告

Core Viewpoint - The company announced that its wholly-owned subsidiary, Xi'an Jingxi Shuanghe Pharmaceutical Co., Ltd., has received a drug registration certificate for the balanced salt irrigation solution from the National Medical Products Administration, which is expected to enhance the company's product line and market competitiveness [1][4]. Group 1: Drug Registration Certificate - The balanced salt irrigation solution is a sterile electrolyte solution suitable for surgical irrigation [1]. - The research and development of this drug began in January 2022, with the application for market approval submitted in April 2024 and the approval granted in February 2026 [1][2]. Group 2: Market Situation - The balanced salt irrigation solution was developed by ICU MEDICAL INC and was approved for sale in the U.S. in February 1978 under the brand name "Physiosol." It has not been marketed in China [3]. - In 2024, the global sales of balanced salt irrigation solutions are projected to be approximately $3.34 million [3]. - In the Chinese market, there are 10 approved manufacturers of balanced salt irrigation solutions, with only 3 having passed or been deemed to have passed the consistency evaluation, including Jingxi Shuanghe [3]. Group 3: Financial Investment - The total R&D investment for the balanced salt irrigation solution has reached approximately RMB 3.65 million (unaudited) [2].