Core Viewpoint - The company has completed the long-term safety trial for its newly developed tyrosinase inhibitor KT-939, which effectively inhibits melanin production and has antioxidant and anti-inflammatory properties, positioning it as a promising new ingredient for cosmetics [1][2]. Group 1: Trial Details - The long-term safety trial is an open-label, single-arm, single-center study aimed at assessing the potential adverse skin reactions from long-term use of cosmetics containing 0.2% KT-939 over 48 weeks [2]. - The trial received ethical approval from the Shanghai Skin Disease Hospital in mid-August, with Professor Tan Yimei as the principal investigator [2]. - The primary endpoints include all adverse events reported by participants and those observed by the research institution during the trial [2]. Group 2: Safety and Efficacy - KT-939 has completed multiple safety and toxicology assessments, as well as a 28-day efficacy trial, showing good performance in both efficacy and safety [2]. - The company is preparing for the registration application of KT-939, aiming to submit it to the National Medical Products Administration in the third quarter of next year [2]. Group 3: Market Position and Strategy - KT-939 is expected to become the first domestically developed and approved whitening cosmetic ingredient in China, marking a significant milestone in the field of independent intellectual property rights [3]. - The company has officially launched nationwide recruitment for strategic partnerships with whitening cosmetic brands to jointly promote product development and market positioning [3].
开拓药业-B：KT-939人体长期安全性试验完成全部受试者入组