重组人神经生长因子SMR001滴眼液
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ST未名获得一类创新药重组人神经生长因子SMR001滴眼液III期临床试验伦理批件
Zhi Tong Cai Jing· 2025-11-06 11:18
Core Viewpoint - ST Unimed (002581.SZ) announced that its wholly-owned subsidiary, Shandong Yandu Biotechnology Co., Ltd., has received ethical approval for the Phase III clinical trial of its innovative drug, recombinant human nerve growth factor SMR001 eye drops, for the treatment of moderate to severe dry eye syndrome [1] Summary by Categories Clinical Development - The ethical approval from the Ethics Committee of Beijing Tongren Hospital, affiliated with Capital Medical University, allows the project to officially commence [1] - The approval signifies that the project has a compliant ethical foundation for conducting clinical trials [1] Financial Impact - The short-term impact on the company's operating performance is not expected to be significant due to the nature of the clinical trial approval [1]
ST未名:获得一类创新药重组人神经生长因子SMR001滴眼液III期临床试验伦理批件
Ge Long Hui· 2025-11-06 11:13
Core Viewpoint - ST Unimed (002581.SZ) announced that its wholly-owned subsidiary, Shandong Yandu Biotechnology Co., Ltd., has received ethical approval from the Beijing Tongren Hospital for the Phase III pivotal registration clinical trial of its innovative drug, SMR001 eye drops, aimed at treating moderate to severe dry eye syndrome [1] Company Summary - SMR001 eye drops are a key development for the company, representing the first recombinant human nerve growth factor-based eye drop formulation in China [1] - The product utilizes a Chinese hamster ovary (CHO) cell expression system, indicating a sophisticated biopharmaceutical development process [1] - SMR001 is designed to repair damaged corneal nerves and promote epithelial regeneration, positioning it as a novel treatment option for moderate to severe dry eye syndrome [1]
ST未名(002581.SZ)获得一类创新药重组人神经生长因子SMR001滴眼液III期临床试验伦理批件
智通财经网· 2025-11-06 11:13
Core Viewpoint - ST Unimed (002581.SZ) announced that its wholly-owned subsidiary, Shandong Yandu Biotechnology Co., Ltd., has received ethical approval from the Ethics Committee of Beijing Tongren Hospital, affiliated with Capital Medical University, to conduct a Phase III clinical trial for its innovative drug, recombinant human nerve growth factor SMR001 eye drops, aimed at treating moderate to severe dry eye syndrome [1] Summary by Categories Company Developments - The ethical approval for the Phase III clinical trial signifies that the project has met the necessary ethical compliance requirements to proceed [1] - The initiation of this clinical trial is not expected to have a significant impact on the company's operating performance in the short term [1]
ST未名:重组人神经生长因子SMR001滴眼液III期临床试验伦理批件获批
Xin Lang Cai Jing· 2025-11-06 11:09
Core Viewpoint - The announcement highlights that ST Unimed's wholly-owned subsidiary, Shandong Yandu Biotechnology Co., Ltd., has received ethical approval for its innovative drug SMR001 eye drops, aimed at treating moderate to severe dry eye disease, allowing the commencement of Phase III clinical trials [1] Group 1 - The innovative drug SMR001 is a recombinant human nerve growth factor [1] - The ethical approval was granted by the Ethics Committee of Beijing Tongren Hospital, affiliated with Capital Medical University [1] - The Phase III key registration clinical trial is now officially set to begin [1]
未名医药:一类创新药SMR001滴眼液获III期临床试验伦理批件
Xin Lang Cai Jing· 2025-11-06 11:09
Core Viewpoint - The announcement highlights that Weiming Pharmaceutical's wholly-owned subsidiary, Shandong Yandu Biological, has received ethical approval for its innovative drug SMR001 eye drops, aimed at treating moderate to severe dry eye syndrome, marking a significant step in its clinical development [1] Company Summary - Weiming Pharmaceutical's SMR001 eye drops have completed key Phase II clinical studies, demonstrating effectiveness for moderate to severe dry eye syndrome [1] - The product has now progressed to the critical Phase III registration clinical trial after receiving approval from the ethics committee of Beijing Tongren Hospital, affiliated with Capital Medical University [1] Industry Summary - The global prevalence of dry eye syndrome ranges from approximately 5% to 50%, with China reporting a prevalence of about 21% to 30%, indicating a substantial market opportunity [1] - The market for dry eye treatments is expected to grow, although the high risk and long development cycles associated with drug research may limit short-term impacts on financial performance [1]