振东制药（300158.SZ）9月18日在投资者互动平台表示，公司创新药乳杆菌二联活菌胶囊Pre-NDA申请 已获CDE受理。后续尚需完成提交新药上市申请，经过审评、现场核查等严格的审批审评程序方可上市 销售。公司将根据后续进展情况及时履行信息披露义务，敬请广大投资者谨慎决策，注意防范投资风 险。 每经AI快讯，有投资者在投资者互动平台提问：公司创新药乳杆菌二联活菌胶囊在官网查询已经亮 灯，是否代表本月可以拿到生产批件？ （文章来源：每日经济新闻） ...

Core Insights - The company reported a revenue of 1.457 billion yuan and a net profit of 7.93 million yuan for the first half of 2025, with a basic earnings per share of 0.0077 yuan [1] Group 1: Strategic Development - The company has shifted its focus towards innovative drugs and core areas such as dermatology, optimizing resource allocation and enhancing operational efficiency [2] - The company has implemented asset structure optimization by shutting down loss-making enterprises and reducing low-margin businesses, which has effectively improved revenue quality [2] - The core product matrix has contributed stable revenue, with the star product, Dafeixin Minoxidil Solution, leading the market with a 43% market share in the hair loss treatment sector [2] Group 2: Product Pipeline and Innovation - The company has expanded its innovative drug pipeline, focusing on areas such as oncology, dermatology, and gynecology, with several drugs in development [4] - A significant breakthrough was achieved with the Lactobacillus dual live bacteria capsule developed by a subsidiary, which reached the primary endpoint in Phase III clinical trials [4] Group 3: Women's Health Sector - The company is transitioning from a single product supplier to a comprehensive solution provider for women's health, establishing a product matrix for health management throughout women's life cycles [5] - The company has built a clinical network covering 3,000 tertiary hospitals and 5,000 maternal and child health hospitals, and has formed strategic partnerships with platforms like JD Health and Alibaba Health [5] - This "pharmaceutical + health management" model enhances user engagement and opens new growth opportunities beyond drug sales [5]

Group 1: Industry Overview - The innovation in China's pharmaceutical research and development has significantly increased, with the National Medical Products Administration approving 43 innovative drugs in the first half of 2025, a year-on-year growth of 59%, marking a historical high for the same period [1] - From 2018 to 2024, a total of 197 innovative drugs have been approved in China, with the annual approval rate rising from 11 in 2018 to 48 in 2024, indicating a steady growth trend [1] - Multiple supportive policies have contributed to the rapid development of innovative drugs in China, including the issuance of measures to support high-quality development of innovative drugs by the National Healthcare Security Administration and the National Health Commission [1] Group 2: Company Focus - Zhendong Pharmaceutical has made significant investments in innovative drug research and development, with R&D expenditure reaching 251 million yuan in 2024, a year-on-year increase of 25.27%, accounting for 8.44% of its operating revenue [2] - The company is focusing on innovative drug development in oncology and dermatology, with ongoing projects including ZD09 for gastric cancer, ZDH02 for breast cancer bone metastasis, and SH003 for atopic dermatitis [2] - Zhendong Pharmaceutical plans to leverage the capabilities of its newly established Shanghai New Drug Creation Center to accelerate breakthroughs in innovative drug development and enhance the quality of its product pipeline [2] Group 3: Future Outlook - The company aims to continue its transformation towards research and development innovation, aligning its existing product pipeline with advancements in collaboration with top domestic and international research institutions [3] - Zhendong Pharmaceutical is committed to injecting vitality into innovative drug research and development, ultimately providing more high-quality medications for global patients [3]

Group 1: Financial Performance - In 2024, the company reported a revenue of 2.971 billion yuan, a decrease of 18.06% year-on-year, and a net loss of 1.329 billion yuan, with a decline of 2920.55% [32] - The net cash flow from operating activities in 2024 was -149.8 million yuan, an improvement of 39.87% compared to -249 million yuan in the previous year [11] - In Q1 2025, the company achieved total revenue of 755 million yuan, a decrease of 3.53% year-on-year, while the net profit attributable to shareholders was 1.1572 million yuan, down 94.99% [14] Group 2: Market Strategy and Product Development - The company plans to enhance its market presence by focusing on product innovation, efficiency improvement, and structural optimization to achieve sustainable development [12] - In 2024, the company launched new products such as hair growth capsules and white blood cell-enhancing granules, with plans for continued expansion in 2025 [12] - The company aims to improve its market share for core products, including the compound Ku Shen injection and Minoxidil lotion, which has a market share of 47.3% [25] Group 3: Response to Industry Challenges - The company is adapting to industry challenges such as centralized procurement and medical insurance cost control by optimizing its product structure and focusing on high-value drugs [10] - The company has implemented measures to improve cash flow, including better management of accounts receivable and reducing long payment terms in wholesale business [11] - The company is continuously monitoring market dynamics and adjusting strategies to ensure stable growth despite external pressures [15] Group 4: R&D and Innovation - In 2024, the company invested 251 million yuan in R&D, a year-on-year increase of 25.27%, focusing on innovative drugs and modern traditional Chinese medicine [18] - The company has established a new drug creation center in Shanghai and initiated clinical research for new anti-tumor drugs [18] - The company is committed to enhancing its R&D capabilities and has made significant progress in various projects, including the registration of traditional Chinese medicine with the FDA [18] Group 5: Corporate Governance and Investor Relations - The company is implementing a share repurchase plan, having repurchased 51.025 million yuan worth of shares by April 30, 2025, which will be included in the cash dividend calculation [4] - The company emphasizes transparency and will disclose any significant developments regarding acquisitions and financial management in accordance with legal requirements [12] - The company acknowledges investor concerns regarding stock performance and is focused on improving operational efficiency and communication with the market [3]