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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
Core Viewpoint - The company Yipinhong (300723) has received approval from the National Medical Products Administration for its innovative drug APH03621, which is set to undergo clinical trials for the treatment of endometriosis, marking a significant advancement in the field of gynecological health [1][2]. Group 1: Drug Development - APH03621 is a novel oral, non-peptide small molecule GnRH antagonist aimed at treating endometriosis, with no approved oral GnRH antagonists currently available in China [1][2]. - The drug is classified as a Class 1 chemical drug under the Drug Registration Management Measures, indicating it is an innovative drug not yet marketed domestically or internationally [2]. Group 2: Endometriosis Overview - Endometriosis is a common benign gynecological condition characterized by the growth of endometrial tissue outside the uterus, leading to symptoms such as pain, infertility, and pelvic masses [2]. - The disease primarily affects women of reproductive age and has shown a trend of increasing incidence among younger populations, with its pathogenesis still not fully understood [2]. Group 3: Other Drug Developments - The company previously announced the approval of another innovative drug, APH01727, which is a GLP-1 receptor agonist intended for the treatment of type 2 diabetes and obesity, expected to be administered once daily [2]. - The company is also advancing its gout drug AR882, with global Phase III clinical trials expected to complete patient enrollment by August 2025, and data from these trials anticipated in 2026 [3].
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]