Core Viewpoint - The approval of the first domestically produced nine-valent HPV vaccine in China marks a significant milestone in the fight against cervical cancer, breaking the monopoly previously held by Merck's vaccine [1][2][3]. Group 1: Market Dynamics - The nine-valent HPV vaccine, named Xinkening 9, is the first domestic vaccine and the second globally, addressing a critical health issue as cervical cancer rates have been rising in China, particularly among younger women [1][2]. - The approval of Xinkening 9 has intensified competition in the HPV vaccine market, with other domestic companies like Watson Bio and Kanglaite also advancing their nine-valent HPV vaccines into Phase III clinical trials [1][4]. - The market for HPV vaccines in China has faced supply challenges, with Merck's vaccine previously being in high demand and often out of stock. However, Merck has indicated plans to increase supply to meet the growing health needs of Chinese women [3][4]. Group 2: Clinical Development - The nine-valent HPV vaccine from Wantai Biopharma is noted for its rapid development, with plans to submit for female indications by August 2024, and has been prioritized for review [3]. - The male indication for HPV vaccines is emerging as a new competitive area, with Merck's four-valent HPV vaccine recently approved for male use, highlighting the need for increased awareness and vaccination among men [6][10]. - Domestic companies are actively pursuing male indications, with several candidates, including those from Bowe Bio and Kanglaite, already in advanced clinical trials [8][9]. Group 3: Market Potential - The potential market for HPV vaccination among males is substantial, with an estimated 2.151 billion suitable candidates globally, projected to grow to 2.228 billion by 2025 [7]. - In China, the target male population for vaccination is estimated to exceed 300 million, indicating a significant opportunity for market expansion [7].

这里是《21健讯Daily》，欢迎与21世纪经济报道新健康团队共同关注医药健康行业最新事件！ 政策动向 国家药监局3月批准注册308个医疗器械产品 4月14日消息，国家药监局2025年3月共批准注册医疗器械产品308个。其中，境内第三类医疗器械产品 248个，进口第三类医疗器械产品34个，进口第二类医疗器械产品19个，港澳台医疗器械产品7个。 药械审批 成都赛璟生物熊去氧胆酸口服混悬液获批上市 近日，成都赛璟生物研发的熊去氧胆酸口服混悬液作为国内首仿3.1类新药，正式获批上市。熊去氧胆 酸由德国Dr.Falk Pharma GmbH原研，包含了片剂、胶囊、口服混悬剂等剂型。据介绍，本次获批产品 是国内企业首个且唯一获批治疗罕见病囊性纤维化相关肝病(CFALD)的药物，填补了国内目前上市的熊 去氧胆酸片剂/胶囊剂无此适应证的空白。 21点评：世界卫生组织表明，约80%男人和女人一生中会感染至少一种HPV型别。HPV对外界的抵抗力 相对较强；性行为是感染HPV的主要途径，但不是唯一途径，HPV的感染还可通过母婴传播以及直接接 触传播，如皮肤黏膜接触。长期以来，HPV疫苗主要针对女性，用于预防宫颈癌。这一获批也将提 ...