原料+制剂战略

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力生制药:预计半年度净利增长222.42%—246.85% 培哚普利氨氯地平片国内上市许可申请获批
Zheng Quan Shi Bao Wang· 2025-07-15 09:22
7月15日,力生制药(002393)发布2025年半年度业绩预告,预计上半年公司实现净利3.3亿元—3.55亿 元,同比增长222.42%—246.85%。对于业绩大幅增长,公告表示,公司克服产品降价因素,积极开拓 市场,扩大产品销量,加之天士力(600535)集团分红的积极影响,均对业绩有所贡献。 2024年11月,公司精氨酸培哚普利原料药率先获批,是公司"原料+制剂"战略的关键落子,标志着力生 制药在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"的全链条突破,将有望为公司打 开增量市场空间,增加新的利润增长点。(燕云) 7月15日晚间,力生制药发布公告,由力生制药研发的两个规格的培哚普利氨氯地平片近日获得国家药 品监督管理局上市许可批准,其中培哚普利氨氯地平片(Ⅰ)为国内第二家、培哚普利氨氯地平片(Ⅲ)为 国内第四家。按化学药品新注册分类批准的仿制药,均视同通过一致性评价。培哚普利氨氯地平片(Ⅰ) 规格为每片含精氨酸培哚普利5mg、苯磺酸氨氯地平5mg(按C20H25ClN2O5计),力生制药为该规格国内 第一家仿制药获批企业。力生制药表示,培哚普利氨氯地平片的获批上市将进一步丰富公司产品结构 ...
力生制药首个分散片剂型新产品获批
Zheng Quan Shi Bao Wang· 2025-06-06 09:29
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].