Core Insights - Nicorandil tablets, a classic anti-angina drug with over 40 years on the market, have seen a resurgence in interest, with annual sales exceeding 1.4 billion yuan in hospitals, marking it as a new "hot" product in the industry [1][4][15] Regulatory Developments - Shandong New Era Pharmaceutical Co., Ltd. has had its application for the registration of Nicorandil tablets accepted by the CDE, indicating a move towards market entry [1][14] - The drug is classified as a generic under the 4th category of chemical drugs, with the application date noted as August 26, 2025 [2][14] Market Performance - Nicorandil has accumulated sales of over 10.3 billion yuan in China, with a peak sales figure of 1.9 billion yuan in 2022, followed by a decline to 1.464 billion yuan in 2024, representing an 8.53% year-on-year decrease [4][10] - The sales of Nicorandil tablets have shown a steady increase, reaching 789 million yuan in 2023, a 16.81% increase year-on-year, and projected to rise to 875 million yuan in 2024, a 10.95% increase [8] Competitive Landscape - There are currently 60 companies approved to produce Nicorandil tablets in China, with 14 having passed or deemed equivalent in consistency evaluation [11][14] - The original manufacturer, Chugai Pharmaceutical Co., Ltd., holds a 50% market share, making it a significant player in the field [11] Industry Trends - The treatment of coronary heart disease is seeing an increase in incidence and mortality rates, leading to a competitive environment where generic drugs like Nicorandil are becoming increasingly relevant [10] - The recent national procurement policies have created a challenging landscape for generic drugs, with companies needing to act quickly to secure market opportunities [15]
“老药翻红”+ 国采加持!14 亿抗心绞痛大品种,山东新时代入局分羹!
Ge Long Hui·2025-09-03 02:26