JUNSHI BIO (01877): Deuteronamide hydrobromide tablets obtained routine approval from the National Medical Products Administration.

JUNSHI BIO (01877) announced that its holding subsidiary, Shanghai Wangshi Biomedical Technology Co., Ltd., has received the approval notice for the supplementary application of a drug from the National Medical Products Administration of China (NMPA). The indication for Hydrobromide Darunavir Tablets (brand name: Mindewi, product code: VV116/JT001) for the treatment of mild to moderate adult patients with novel coronavirus infection ("COVID-19") has been approved by the NMPA, transitioning from conditional approval to regular approval. The regular approval of Mindewi is based on multiple clinical and non-clinical studies, including the JT001-015 study and a real-world study involving nearly 8,000 patients. The results show that in patients with mild to moderate COVID-19, Mindewi can significantly accelerate symptom relief and resolution, shorten the course of illness, hasten viral clearance, reduce the occurrence of severe COVID-19 or all-cause mortality, with a more significant effect in elderly and high-risk patients. In patients with mild to moderate liver and kidney dysfunction, Mindewi has shown good safety and tolerability, with little or no adjustment of medication dosage required during treatment. Additionally, pharmacological studies show that Mindewi has minimal drug-drug interactions, greatly reducing contraindications and ensuring safe concurrent medication for patients, providing a safer and more effective option for special populations. Mindewi is an orally administered nucleoside antiviral drug that inhibits SARS-CoV-2 replication. Studies have shown that Mindewi exhibits significant antiviral activity against SARS-CoV-2 original strains and mutant strains including Omicron XBB.1.16, EG.5, and JN.1, without genetic toxicity. Mindewi was jointly developed by the Shanghai Institute of Materia Medica of the Chinese Academy of Sciences, the Wuhan Institute of Virology of the Chinese Academy of Sciences, the Xinjiang Technical Institute of Physics and Chemistry of the Chinese Academy of Sciences, the Central Asia Drug Development Center of the Chinese Academy of Sciences / China-Ukraine Medical Technology City (Ministry of Science and Technology's "Belt and Road" Joint Laboratory), Lingang Laboratory, Suzhou Wangshan Wanshui Biomedical Technology Co., Ltd. and the company. Mindewi was temporarily included in the medical insurance payment scope starting in January 2023, and will be officially included in the national medical insurance catalog starting in January 2024.