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

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]