华辉安健:从NTCP到立贝韦塔,助力消除肝炎危害
Xin Jing Bao·2025-10-09 02:47

Core Insights - The event "Innovation Source, Health Navigation" highlighted Beijing's focus on the pharmaceutical and health sectors, showcasing how clinical needs and supportive policies drive innovation and economic growth in the capital [1] Company Overview - Huahui Anjian (Beijing) Biotechnology Co., Ltd. was established in 2015 and focuses on developing "first-in-class" or "best-in-class" drugs, particularly in virology, hepatology, and related oncology fields [2] - The company has six potential "First-in-Class" or "Best-in-Class" drugs in various stages of clinical development [2] Scientific Breakthroughs - The discovery of NTCP (sodium taurocholate co-transporting polypeptide) by Dr. Li Wenhui's team in 2012 was a significant advancement in hepatitis research, laying the groundwork for innovative drug development against hepatitis B and D [3] - Huahui Anjian has developed new drugs HH-0003 and HH-006 based on this discovery, with HH-003 being the world's first neutralizing antibody targeting the PreS1 region of the hepatitis B virus [3] Regulatory Milestones - HH-003 has received "Breakthrough Therapy" designation from both China's CDE and the FDA, with its New Drug Application (NDA) accepted by the National Medical Products Administration of China, expected to receive conditional approval by late 2025 or early 2026 [3] Talent and Capital Strategy - The company emphasizes a dual approach to talent acquisition, integrating global and local expertise to enhance scientific innovation and commercial operations [5] - Huahui Anjian's growth is supported by local government and social capital, facilitating the commercialization of HH-003 and the development of other innovative drugs [5] Product Pipeline - Huahui Anjian has established a diversified product matrix centered around the innovative drug HH-003, with iterative product HH-006 and strategic product HH-1270, creating a comprehensive pipeline that enhances therapeutic efficacy and expands indications [6]