{"editorial":{"content_id":"a4c1ceb8-de56-49fd-8cf2-3b2fe58f1104","slug":"anvisa-20261110-479a14","content_type":"news","title":"巴西Anvisa批准两款司美格鲁肽注射笔，2026年注册总数达22支","summary":"巴西国家卫生监督局11月10日批准两款以司美格鲁肽为活性成分的GLP-1注射药物，用于治疗2型糖尿病。","body":"巴西国家卫生监督局（Anvisa）11月10日（周二）批准两款新的GLP-1受体激动剂注射药物，活性成分均为司美格鲁肽，适应症为糖尿病治疗。此次获批后，2026年注册的GLP-1注射笔数量达到22支。\n\n两款产品以Owozy为基质产品，注册授予Ávita Care Importação e Distribuição de Produtos Ltda.公司（CNPJ: 31.203.582/0001-37）。获批药物通过与生物制品Ozempic比对注册，适用于血糖控制不充分的2型糖尿病成人患者。\n\n此外，11月4日Anvisa还注册了首款口服司美格鲁肽药物，用于肥胖症治疗。\n\n据Anvisa说明，自2025年8月起对司美格鲁肽和利拉鲁肽药物实施优先审评，原因是卫生部为统一卫生系统（SUS）在卫生经济工业综合体（CEIS）框架下提出请求，以及国内市场供应需求，最终促成Anvisa第12/2025号征集公告的发布。相关决议为第4.411/2026号，已在《联邦官方公报》（DOU）公布。","why_it_matters":null,"cbi_observation":null,"direction_tag":"巴西","primary_category":"科技平台","secondary_topics":["合规","行业趋势","市场进入","br-health"],"content_level":"编辑整理","event_type":"政策法规","audience_tags":[],"event_location":null,"verification_status":"source_verified","published_at":"2026-11-10T17:02:13.229Z","display_date":"2026-11-10","source_published_at":null,"source_url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-registra-duas-novas-canetas-de-semaglutida","source_name":"Anvisa","source_language":"pt","author_name":"编辑部","risk_level":"low","risk_flags":[],"opportunity_flags":[],"trend_signals":[]},"intelligence":null,"meta":{"canonical_url":"https://chinabrazilinsight.com/news/anvisa-20261110-479a14","api_url":"https://chinabrazilinsight.com/api/public/content/anvisa-20261110-479a14","markdown_url":"https://chinabrazilinsight.com/api/public/content/anvisa-20261110-479a14?view=markdown","json_url":"https://chinabrazilinsight.com/api/public/content/anvisa-20261110-479a14?view=json","last_updated":"2026-11-10T17:02:38.892Z","platform":"China Brazil Insight","platform_url":"https://chinabrazilinsight.com"}}