The company and Genya Biotechnology Co., Ltd. jointly developed a new drug for the treatment of lupus erythematosus, GV17, and submitted a pre-IND meeting application to the US FDA, and received a reply recently; Suggestions on the design of clinical trials such as preclinical and clinical trial data and efficacy indicators that should be provided before IND and NDA.
The main ingredient of GV17 is hydroxyquinine (HCQ), which is an important drug for the treatment of lupus erythematosus and chronic rheumatoid arthritis.
GV17 is a right-handed optical isomer of HCQ [(S)-(+)HCQ], which has been shown by the literature and the research completed by the Company in collaboration with Genya, which has a better safety profile for patients taking long-term medication, and has the advantages of smaller blood concentration fluctuations, longer efficacy and lower side effects compared with commercially available products. The development of GV17 is based on a patented preparation method to manufacture (S)-(+)HCQ crystal form raw materials, and then to develop new drugs for formulations and indications.
![Central News Agency [Announcement] Jianya's new drug for the treatment of lupus erythematosus, GV17, received a reply from the US FDA's Pre Indmeeting](https://i0.wp.com/uni-pharma.com.tw/wp-content/uploads/2024/11/%E8%B2%A1%E8%A8%8A%E6%96%B0%E8%81%9E-%E3%80%90%E5%85%AC%E5%91%8A%E3%80%91%E5%81%A5%E4%BA%9E%E6%B2%BB%E7%99%82%E7%B4%85%E6%96%91%E7%8B%BC%E7%98%A1%E6%96%B0%E8%97%A5GV17%EF%BC%8C%E6%8E%A5%E7%8D%B2%E7%BE%8E%E5%9C%8BFDA%E4%B9%8Bpre-INDmeeting%E5%9B%9E%E8%A6%86.png?w=1440&ssl=1)
