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力生制药首个分散片剂型新产品获批
Core Viewpoint - The approval of Ticagrelor dispersible tablets by the National Medical Products Administration marks a significant milestone for the company, enhancing its product portfolio and business expansion opportunities [1][2]. Group 1: Product Approval and Significance - The company has received approval for Ticagrelor dispersible tablets, becoming the third domestic company to obtain such approval under the new chemical drug registration classification, which is equivalent to passing the consistency evaluation [1]. - This approval is the company's first for a dispersible tablet formulation, indicating a strategic move to diversify its product offerings [1]. Group 2: Research and Development Achievements - The company has established a key laboratory platform in Tianjin for the research of high-end formulations, leading to the successful development of a rapid disintegration formulation of Ticagrelor [2]. - The bioequivalence tests demonstrated that the product is equivalent to the original formulation in both fasting and postprandial states, ensuring safety and efficacy [2]. Group 3: Strategic Initiatives and Market Potential - Since 2020, the company has aggressively pursued new product development and has achieved breakthroughs in drug procurement, with multiple products receiving new registration certificates [2]. - The approval of Ticagrelor dispersible tablets is a critical step in the company's "raw material + formulation" strategy, aiming for a comprehensive breakthrough in the cardiovascular treatment sector, which is expected to open new market opportunities and profit growth [2].
力生制药替格瑞洛分散片获批上市 心脑血管治疗领域实现“原料自主化+剂型差异化+生产规模化”全链条突破
Quan Jing Wang· 2025-06-06 08:18
Core Viewpoint - The approval of the Ticagrelor dispersible tablets by the National Medical Products Administration marks a significant milestone for the company, enhancing its product portfolio and expanding its business scope in the cardiovascular field [1][3]. Group 1: Product Approval and Market Impact - The company received the drug registration certificate for Ticagrelor dispersible tablets (90mg), making it the third domestic generic drug approved under the new chemical drug registration classification [1]. - The market for oral anticoagulants in core hospitals in China exceeded RMB 10 billion in 2023, indicating a substantial market opportunity for Ticagrelor dispersible tablets, which are classified as a Category B product under national medical insurance [3]. - The sales figures for Ticagrelor in China are projected to be RMB 1.151 billion in 2022, RMB 1.050 billion in 2023, and RMB 1.174 billion in 2024, reflecting a stable market demand [3]. Group 2: Research and Development - The company has invested significantly in R&D, with a budget of RMB 127 million for 2024, representing a 20% increase from the previous year, and maintaining a research intensity of over 7% in recent years [3]. - The successful development of the Ticagrelor dispersible tablet involved rigorous testing and the establishment of strict quality standards, achieving bioequivalence with the original formulation [2]. - The company has been proactive in its R&D efforts since 2020, with multiple products, including Ticagrelor, receiving drug registration certificates and passing consistency evaluations [4]. Group 3: Strategic Positioning - The approval of Ticagrelor dispersible tablets is a key step in the company's "raw material + formulation" strategy, indicating a comprehensive breakthrough in the cardiovascular treatment sector [4]. - The company aims to enhance its core competitiveness through continuous innovation and strategic positioning, focusing on both industrial and capital-driven development [3][4]. - Future plans include deepening the synergy between R&D and industrialization to provide accessible quality medications for patients while creating long-term value for investors [4].