HWHG(SH:600079) Zheng Quan Zhi Xing·2025-09-02 16:15Core Viewpoint - The approval of Eicosapentaenoic Acid Ethyl Ester Soft Capsules marks a significant milestone for the company, allowing it to sell the product in the domestic market, which is expected to positively impact its product line and overall business performance [1][3]. Group 1: Product Registration Details - The product name is Eicosapentaenoic Acid Ethyl Ester Soft Capsules, with registration numbers 2025S02630 and 2025S02631 [1]. - The dosage forms are capsule forms with specifications of 0.5g and 1.0g [1]. - It is classified as a Class 4 chemical drug, with approval numbers H20255247 and H20255248, valid until August 25, 2030 [1]. Group 2: Clinical Application and Market Potential - The soft capsules are indicated for lowering triglyceride levels in adult patients with severe hypertriglyceridemia (≥500 mg/dL) and for reducing cardiovascular event risks in patients with cardiovascular diseases or diabetes with additional risk factors [2]. - The company has invested approximately RMB 6 million in the research and development of this product [2]. - The projected national sales for the product in 2024 are estimated to be around RMB 5 million, with key competitors including Amarin Pharmaceuticals Ireland Ltd. and Sichuan Guowei Pharmaceutical Co., Ltd. [2]. Group 3: Future Outlook - The approval allows the company to enhance its product portfolio, and production and market launch will be arranged based on market demand [3]. - Future sales performance may be influenced by industry policies and market conditions, indicating a level of uncertainty [3].