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Marius Pharmaceuticals and Hims & Hers™ Collaborate to Expand Access to KYZATREX® (testosterone undecanoate) CIII Capsules, the First FDA-Approved Oral Testosterone Therapy Offered on the Hims & Hers Platform
Globenewswire· 2025-09-10 15:30
RALEIGH, N.C., Sept. 10, 2025 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, Inc. today announced a collaboration with Hims & Hers™, one of the largest digital health platforms for men, to make KYZATREX®, an FDA-approved oral testosterone replacement therapy for adult men with low or no testosterone levels due to certain medical conditions, available to patients through the Hims & Hers platform in the coming months. This marks the first time Hims & Hers will offer an FDA-approved oral testosterone therapy, und ...
Lipocine Announces License and Supply Agreement for TLANDO® in Brazil
Prnewswire· 2025-05-06 12:00
合作协议 - Lipocine与巴西制药公司Aché达成TLANDO在巴西的独家授权和供应协议 [1] - Aché将负责巴西市场的全部注册审批和商业化工作 [3] - Lipocine获得首付款并有资格获取监管里程碑付款及销售分成 [3] 市场机遇 - 巴西处方睾酮市场2019-2023年复合增长率达34% [2] - 巴西市场目前尚无口服睾酮疗法注册 [2] - Aché在巴西覆盖150个治疗类别和30个医疗专科领域 [6] 产品特性 - TLANDO是经美国FDA批准的口服睾酮替代疗法 [4] - 采用Lipocine专有Lip'ral口服给药技术平台开发 [4] - 适用于内源性睾酮缺乏的成年男性患者 [4] 合作伙伴实力 - Aché是巴西领先药企 拥有近60年历史 [5] - 产品覆盖拉美 非洲 亚洲和欧洲20多个国家 [6] - 拥有350多个品牌和900种药品规格 [6] 研发管线 - 公司临床管线包括LPCN1154(产后抑郁) LPCN2101(癫痫) LPCN2203(特发性震颤)等候选药物 [8] - LPCN2401为口服合成代谢雄激素受体激动剂 用于肥胖管理 [8] - LPCN1148为口服前药 针对肝硬化症状管理 [8]