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AR882(氘泊替诺雷)
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一品红又一自研创新药获批临床 拟用于子宫内膜异位症治疗
在此之前,一品红于2024年7月披露,其自主研发的创新药物APH01727片获得临床试验批准, APH01727片是一种高活性高选择性的胰高血糖素样肽-1受体激动剂(GLP1RA),目标成为每天给药一次 的口服小分子GLP-1R激动剂,拟用于2型糖尿病、超重/肥胖患者的治疗。 此外,对于外界关注度较高的在研痛风创新药AR882(氘泊替诺雷),一品红在日前举行的业绩说明会上 表示,2025年8月,AR882全球关键Ⅲ期临床试验均已完成全部入组,预计于2026年第二季度披露Ⅲ期 REDUCE2试验数据,2026年第四季度披露Ⅲ期REDUCE1试验数据。目前,各项工作正在快速、高效推 进中。 公告称,GnRH是一种主要由下丘脑神经元分泌的线性十肽,在垂体门静脉循环系统中以脉冲方式释 放,从而调控下丘脑-垂体-性腺轴。GnRH流向垂体前叶,与其相应的GnRH受体相互作用,刺激垂体前 叶分泌黄体生成素(LH)和促卵泡激素(FSH)。这些激素迁移到性腺,促进性类固醇(睾酮、雌激素和黄体 酮)的生成,并协助配子发生(女性的卵子发生和男性的精子发生)。GnRH主要通过结合和激活GnRH受 体发挥作用。 资料显示,子宫内膜异位 ...
一品红左卡尼汀口服溶液获注册证书 近期已有多款药品获批
Core Viewpoint - Yipinhong (300723) has received approval from the National Medical Products Administration for its oral solution of L-carnitine, indicating a significant step in expanding its product portfolio in the pharmaceutical market [1] Group 1: Product Approvals - Yipinhong's subsidiary has obtained a drug registration certificate for L-carnitine oral solution, which is indicated for primary systemic carnitine deficiency and related symptoms [1] - The approved L-carnitine oral solution is classified as a Category B product under the national medical insurance, with an estimated sales scale of approximately 1.257 billion yuan in 2024 [1] - In addition to L-carnitine, Yipinhong has received approvals for several other drugs, including escitalopram oxalate drops (estimated sales of 1.88 billion yuan in 2024) and clindamycin palmitate ester granules (estimated sales of 100 million yuan in 2024) [2][2] - The company has also received approval for oseltamivir phosphate capsules, which are used for the treatment and prevention of influenza in adults and children [2] Group 2: Innovative Drug Development - Yipinhong has disclosed that its innovative drug APH03621, a GnRH receptor antagonist for endometriosis treatment, has received clinical trial registration acceptance [3] - The company is advancing its gout drug AR882, with global Phase III clinical trials expected to complete enrollment by August 2025, and data from these trials anticipated in 2026 [3]