阿那曲唑
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海正药业:获得药品补充申请批准通知书
Ge Long Hui· 2025-12-23 09:19
Core Viewpoint - The company has received approval from the National Medical Products Administration for a supplemental application for Everolimus tablets, adding a new 2.5mg specification to the already approved 5mg version [1] Group 1: Product Approval - The new 2.5mg specification of Everolimus is intended for adult patients with advanced renal cell carcinoma who have failed previous treatments with Sunitinib or Sorafenib [1] - Everolimus is also indicated for various other conditions, including advanced pancreatic neuroendocrine tumors and tuberous sclerosis complex-related tumors [1] - The original manufacturer of Everolimus is Novartis, and the product has been approved under the new category 4, which is considered equivalent to passing the consistency evaluation [1] Group 2: Market Statistics - The global sales of Everolimus tablets are projected to be approximately $1.013 billion in 2024, with domestic sales around $11.7842 million [2] - For the first half of 2025, global sales are estimated at about $497 million, with domestic sales expected to be around $5.4255 million [2] - The company has invested approximately 7.4042 million RMB in the research and development of the 2.5mg specification of Everolimus [2]
以岭药业“盐酸美金刚”原料药上市获批
Zheng Quan Shi Bao· 2025-11-12 18:32
Group 1 - Yiling Pharmaceutical's subsidiary Hengshui Wanyang received approval from the National Medical Products Administration for the listing application of Memantine Hydrochloride, a drug used to treat moderate to severe Alzheimer's disease [1] - Memantine Hydrochloride is a non-competitive NMDA receptor antagonist that blocks pathological increases in glutamate concentration, preventing neuronal damage [1] - The Alzheimer's disease report of 2024 indicates approximately 16.9 million dementia patients in China, with a prevalence rate of about 1.19‰, which is rapidly increasing due to population aging [1] Group 2 - The anti-dementia market in China is valued at 1.56 billion yuan, with Memantine being a first-line treatment drug holding a market share of 22% [1] - The market capacity for Memantine Hydrochloride in China is expected to reach 340 million yuan by 2025, with a year-on-year growth of 11%, and sales volume projected to be 160 million tablets, reflecting a 19% increase [1] - Yiling Pharmaceutical aims to enhance its market share following the domestic approval of Memantine Hydrochloride, anticipating steady demand growth due to the aging population [1] Group 3 - Yiling Pharmaceutical also received approval for Anastrozole, a drug widely used for treating estrogen-related tumors, just days prior [2] - The company’s subsidiary Beijing Yiling Bio holds the formulation approval for Anastrozole tablets, which are expected to achieve integrated production of raw materials and formulations this year, enhancing market competitiveness [2] - Yiling Pharmaceutical plans to accelerate the international registration and overseas sales of Anastrozole raw materials, targeting markets in Europe and the United States [2]
以岭药业盐酸美金刚原料药获上市申请批准 用于治疗中重度至重度阿尔茨海默型痴呆
Zheng Quan Shi Bao Wang· 2025-11-12 11:53
Core Viewpoint - Yiling Pharmaceutical has received approval for the listing application of Memantine Hydrochloride, a drug for treating moderate to severe Alzheimer's disease, which is expected to see increasing market demand due to the aging population in China [1] Group 1: Memantine Hydrochloride Approval - Yiling Pharmaceutical's wholly-owned subsidiary, Hengshui Wanyang, has received approval from the National Medical Products Administration for the listing of Memantine Hydrochloride [1] - Memantine Hydrochloride is a non-competitive NMDA receptor antagonist that can block neuronal damage caused by elevated glutamate levels [1] - The Alzheimer's disease report indicates approximately 16.9 million dementia patients in China, with a prevalence rate of about 1.19‰, which is rapidly increasing due to population aging [1] - The anti-dementia market in China is valued at 1.56 billion yuan, with Memantine being a first-line treatment drug holding a market share of 22% [1] - The market capacity for Memantine Hydrochloride in China is expected to reach 340 million yuan by 2025, with a year-on-year growth of 11% [1] - Sales volume is projected to be 160 million tablets, reflecting a year-on-year increase of 19% [1] Group 2: Anastrozole Approval - Yiling Pharmaceutical's subsidiary, Hengshui Wanyang, has also received approval for Anastrozole, a drug widely used for treating estrogen-related tumors [2] - The global breast cancer drug market is projected to reach $37.6 billion by 2025 and $55 billion by 2030, with aromatase inhibitors holding 38% of the market share [2] - The demand for Anastrozole is expected to remain stable as the incidence of breast cancer in China continues to rise [2] - Yiling Pharmaceutical plans to enhance market competitiveness by integrating raw material and formulation production for Anastrozole [2] - The company aims to accelerate international registration and overseas sales of Anastrozole, targeting markets in Europe and the United States [2] Group 3: Financial Performance - Yiling Pharmaceutical reported total revenue of 5.868 billion yuan for the first three quarters of 2025, with a net profit of 1 billion yuan, reflecting a year-on-year increase of 80.33% [3] - In Q3 2025, the company achieved revenue of 1.827 billion yuan, a year-on-year growth of 3.78%, and a net profit of 332 million yuan, showing a significant increase of 1264.61% [3] - The company has four innovative drug candidates in clinical stages and several others in preclinical research [3] - The NDA application for the drug Benanilofen has been accepted, and XY0206 for treating acute myeloid leukemia is in phase III clinical trials [3]
以岭药业:收到化学原料药上市申请批准通知书
Zheng Quan Ri Bao Wang· 2025-10-29 13:41
Core Viewpoint - Yiling Pharmaceutical (002603) announced the approval of its subsidiary Hengtai Wanyang's application for the chemical raw material drug Anastrozole by the National Medical Products Administration [1] Group 1 - Yiling Pharmaceutical's wholly-owned subsidiary, Hengtai Wanyang Pharmaceutical Co., Ltd., received the approval notice for the listing application of Anastrozole [1]
以岭药业:孙公司获得阿那曲唑化学原料药上市申请批准
Zheng Quan Shi Bao Wang· 2025-10-29 08:28
Core Viewpoint - Yiling Pharmaceutical (002603) announced that its wholly-owned subsidiary, Wanyang Hengshui Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the marketing application of Anastrozole, a drug used primarily for treating estrogen-related tumors, particularly in postmenopausal women with hormone receptor-positive breast cancer [1]. Company Summary - Yiling Pharmaceutical's subsidiary, Wanyang Hengshui, has successfully obtained a marketing approval for Anastrozole [1]. - Anastrozole is widely used in the treatment of estrogen-related tumors, especially in postmenopausal women with HR+ breast cancer [1].
以岭药业:全资孙公司阿那曲唑原料药获上市申请批准通知书
Xin Lang Cai Jing· 2025-10-29 08:24
Core Viewpoint - Yiling Pharmaceutical (002603.SZ) announced that its wholly-owned subsidiary, Wanyang Hengshui Pharmaceutical Co., Ltd., has received the approval notice for the listing application of Anastrozole chemical raw material from the National Medical Products Administration [1] Group 1: Product Approval - The listing application for Anastrozole, a drug widely used for treating estrogen-related tumors, particularly in postmenopausal hormone receptor-positive (HR+) female breast cancer patients, has been approved [1] - Yiling Pharmaceutical's wholly-owned subsidiary, Beijing Yiling Biotechnology Co., Ltd., holds the formulation approval for Anastrozole tablets, which are part of a centralized procurement product [1] Group 2: Production Integration - The company expects to achieve integrated production of raw materials and formulations for Anastrozole this year [1]