丽珠集团（000513）(000513.SZ)公告，公司截至2025年10月31日通过集中竞价交易方式回购了公司A股 股份共计1537.68万股，占公司总股本的比例为1.70%，已使用的资金总额为5.7亿元(不含交易费用)。 ...

证券代码：000513、01513 证券简称：丽珠集团、丽珠医药 公告编号：2025-066 丽珠医药集团股份有限公司关于回购公司股份的进展公告 后续公司将根据实施回购股份的进展情况，严格按照《深圳证券交易所上市 公司自律监管指引第 9 号——回购股份》及《香港联合交易所有限公司证券上市 规则》等相关规定，及时履行信息披露义务，敬请广大投资者注意投资风险。 特此公告。 丽珠医药集团股份有限公司董事会 根据公司于 2024 年 12 月 25 日发布的《丽珠医药集团股份有限公司回购报 告书》（公告编号：2024-079），公司将以不低于人民币 60,000.00 万元（含）， 不超过人民币 100,000.00 万元（含）的回购总金额，以及不超过人民币 45.00 元 /股的回购价格，回购公司部分 A 股股份，用于注销减少注册资本。 截至 2025 年 10 月 31 日，公司通过集中竞价交易方式回购了公司 A 股股份 共计 15,376,845 股，占公司总股本的比例为 1.70%，购买的最高价为人民币 41.99 元/股，最低价为人民币 33.21 元/股，已使用的资金总额为人民币 570,228,471. ...

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Insights - The company's performance has shown stable growth, with a significant advancement in research and development [1] - The company achieved a total revenue of 9.116 billion yuan in the first three quarters of 2025, a year-on-year increase of 0.38%, and a net profit attributable to the parent company of 1.754 billion yuan, up 4.86% year-on-year [7] - The R&D pipeline is entering a harvest period, with ongoing overseas expansion efforts [7] Financial Performance Summary - Total revenue (in million yuan) for 2022A was 12,630, with projections of 12,223 for 2025E and 14,303 for 2027E, reflecting a growth rate of 3.48% in 2025E and 8.92% in 2027E [4] - Net profit attributable to the parent company (in million yuan) is projected to be 2,382 for 2025E, increasing to 2,941 by 2027E, with corresponding EPS of 2.64 and 3.25 respectively [4] - The company maintains a healthy profit margin, with a gross profit margin of 67.20% in Q3 2025, an increase of 1.73 percentage points year-on-year [7] Segment Performance Summary - The formulation segment has shown stable growth, with major products in digestion, mental health, reproductive health, and traditional Chinese medicine experiencing year-on-year growth [7] - The raw material segment has seen a slight decline due to weakened downstream demand, but high-margin antibiotic pet raw materials have contributed positively to profits [7] - The diagnostic reagent segment's revenue has decreased year-on-year due to a high base in 2024, although self-immune diagnostic products have shown significant growth [7] R&D and Market Expansion Summary - The company has made significant progress in its R&D pipeline, with several products entering clinical trials and expected to launch in the coming years [7] - The acquisition of Vietnam's Imexpharm is underway, which will enhance the company's market channels and facilitate the expansion of innovative drug products into overseas markets [7]

Core Insights - The recombinant protein industry in China, despite its late start, has rapidly developed due to continuous support from national industrial policies, leading to significant breakthroughs in technology, production processes, and quality control [1][15] - The market for recombinant proteins is expected to grow steadily, driven by increased investment in innovative drug research, rising demand for precision medicine, and the expansion of downstream application scenarios [1][15] Industry Overview - Recombinant proteins are proteins obtained through genetic engineering and cell engineering, essential for the development and production of biopharmaceuticals, cell immunotherapy, and diagnostic reagents [4] - The industry has experienced three stages: the initial stage (1970-1990), rapid development (1990-2000), and transformation and upgrading (2000-present) [8][9] Market Growth - The market size of China's recombinant protein industry is projected to grow from 5.1 billion yuan in 2015 to 27 billion yuan in 2024, with a compound annual growth rate (CAGR) of 20.34% [1][15] - The global recombinant protein market is expected to increase from $7 billion in 2015 to $18.5 billion in 2024, with a CAGR of 11.4% [13][14] Policy Support - The Chinese government has implemented various policies to encourage technological innovation and market expansion in the biopharmaceutical sector, including funding support for research and expedited drug approval processes [9][10] Industry Chain - The upstream of the recombinant protein industry includes raw materials and equipment, while the midstream consists of recombinant protein products, and the downstream includes customers such as research institutions and pharmaceutical companies [10] Competitive Landscape - The recombinant protein market is characterized by a diverse and dynamic competitive landscape, with major multinational pharmaceutical companies like Pfizer, Roche, and Novartis leading the market, while numerous small and medium-sized enterprises focus on innovative technologies [16][17] Development Trends - The industry is moving towards high-end products, focusing on complex structures and high-value proteins, with an emphasis on product activity, purity, and consistency [18] - Intelligent technologies, including AI and machine learning, are expected to enhance research and production processes, improving efficiency and product quality [19][20] - Chinese recombinant protein companies are increasingly participating in global competition, aiming to meet international standards and establish a strong global presence [21]

Core Points - The 2025 National Medical Insurance Directory negotiations have officially commenced, highlighting the importance of pharmaceutical innovation and patient access to medications [1] - The atmosphere at the negotiations is characterized by a cautious and low-key approach from pharmaceutical representatives, with an increased emphasis on confidentiality [3][4] - A total of 535 drugs are under review, with 311 outside the directory and 224 within it, alongside 121 high-value drugs reviewed under the commercial insurance innovation drug directory [9][10] Group 1: Negotiation Atmosphere - The entry process for pharmaceutical representatives was notably quieter and more orderly compared to previous years, reflecting a more subdued approach [3][4] - Representatives from both domestic and multinational pharmaceutical companies, including notable names like 恒瑞医药 and 阿斯利康, participated in the negotiations [4][9] Group 2: Key Drug Categories - Antibacterial drugs are expected to be a significant focus in the afternoon session of the negotiations, with specific products like 万古霉素 being highlighted [9][10] - Innovative drugs, including CAR-T products and new lipid-lowering medications, are also under consideration, with 恒瑞医药 presenting multiple products for initial review [10][12] Group 3: Market Insights - The PCSK9 inhibitor 瑞卡西单抗 has gained attention for its long-acting properties, with a market size of 1.32 billion yuan in 2023, representing 7.8% of the national lipid-lowering drug market [10][11] - The long-acting 阿立哌唑微球 from 丽珠集团 is another product of interest, potentially replacing oral formulations and capturing market share if included in the insurance directory [12]

Core Viewpoint - Lijun Group has established a clear上市计划 for its innovative drugs, with a pipeline of products expected to launch annually starting this year, enhancing its sales growth and revenue structure [1] Group 1: Product Pipeline - The company plans to launch the innovative drug Aripiprazole microspheres in 2025, followed by products in the self-immune field for IL-17A/F psoriasis and ankylosing spondylitis, as well as P-CAB products in the digestive field within the next 2-3 years [1] - In three years, additional products such as NS-041 tablets for mental health, H001 capsules for cardiovascular health, flu vaccines, SG1001 for infections, and newly introduced oral GnRH antagonists are expected to be launched [1] Group 2: Business Stability and Growth - The company's main business remains stable, with multi-sector collaborative development, which will support sales growth as innovative drugs are launched [1] - The proportion of innovative drugs in the revenue structure is expected to increase over time, providing stronger support for overall sales growth [1] Group 3: Additional Product Developments - Besides the first and second category innovative drugs, the company is also developing high-barrier complex formulations and other products that synergize with Lijun, which are expected to launch in the coming years [1] - These include Semaglutide for diabetes and weight loss, recombinant FSH, Leuprolide microspheres (three-month sustained release), and long-acting products in the mental health field, further enhancing the company's growth momentum [1]

Core Viewpoint - Lijun Group (000513) announced on October 27 that it is actively advancing the national negotiation process for the pricing of Aripiprazole microspheres, expecting results within the year, indicating significant future sales potential for long-acting psychiatric products in China [1] Group 1: Market Potential - The penetration rate of long-acting psychiatric formulations in China is currently low, with the clinical usage rate of long-acting antipsychotic injections being less than 1%, compared to an average usage rate of 25%-30% in Europe and the U.S. [1] - The company has initiated various market preparation activities for Aripiprazole microspheres, including forming a nationwide team covering key departments [1] Group 2: Research and Evidence - A real-world evidence study has been launched, covering 60 centers and involving 1,200 patients, to accumulate clinical evidence for Chinese patients [1] - The "Psychiatric Expert Says" column has seen significant growth in followers, effectively reaching different groups from doctors to patients [1] Group 3: Future Outlook - If the national negotiation is successful, it will provide strong support for the volume release of Aripiprazole microspheres and promote the continuous expansion of the long-acting psychiatric formulation market [1]

Core Viewpoint - Lijun Group (000513) focuses on the development of microsphere technology, particularly in the areas of GnRH-α and mental health products, with significant advancements in long-acting formulations and international market expansion [1] Group 1: Product Development - The core product, Leuprolide microsphere (one-month release), is the first GnRH-α long-acting formulation approved by the FDA based on individual drug guidelines [1] - The injectable Triptorelin microsphere has received approval for prostate cancer and is expected to be approved for endometriosis in 2024, with ongoing Phase III clinical trials for central precocious puberty [1] - A three-month release Leuprolide microsphere application has been submitted, with expected approval in 2026 [1] - The company is also developing a microsphere formulation of Ganirelix, which currently has no market presence globally [1] Group 2: Mental Health Product Line - The company has launched an injectable Aripiprazole microsphere, which offers the longest dosing interval (once a month) for schizophrenia treatment globally [1] - Additional products like Brexpiprazole microsphere are in development to strengthen the long-acting product line for mental health [1] Group 3: Market Expansion in Vietnam - The acquisition of Imexpharm in Vietnam is under approval, with the company showing over 20% growth in revenue, profit, and EBITDA in the third quarter [1] - Imexpharm has the largest EU-GMP product line in Vietnam, and both companies are planning product and process transfers to leverage Imexpharm's established market channels and EU-GMP certification for expanding innovative drug products overseas [1]

Core Viewpoint - Lijun Group (000513) is focusing on enhancing its R&D pipeline by introducing multiple products and aims to accelerate clinical transformation through collaboration and acquisition of promising molecules in key therapeutic areas [1] Group 1: R&D Strategy - The company has established a rich R&D pipeline by introducing various products in recent years [1] - Future R&D efforts will concentrate on "strong advantage areas and chronic diseases," including digestive, mental health, cardiovascular, metabolic, and autoimmune diseases [1] - The company emphasizes collaboration to introduce high-potential molecules to support innovative R&D [1] Group 2: Collaboration Focus - Key considerations for collaboration include patent barriers, future commercialization potential, and addressing unmet clinical needs [1] - The company currently holds or shares global market rights for several innovative drug projects, including IL-17A/F, H001 capsules, and a quadrivalent recombinant protein influenza vaccine [1] Group 3: Project Development - The company is actively promoting external licensing collaborations for the IL-17A/F project while engaging with other projects [1] - For early-stage projects, the company plans to accumulate clinical data before advancing business development based on maturity [1]

Core Viewpoint - Lijun Group (000513) reported an increase in sales expenses in Q3, attributed to the market promotion costs for new drugs such as Aripiprazole microspheres and Triptorelin microspheres, indicating a temporary phase rather than a long-term trend [1] Group 1 - The increase in sales expenses is primarily due to the initial market promotion of new drugs [1] - The sales structure changed in Q3, with a significant growth in the formulation drug segment, leading to an increased sales proportion [1] - Overall, the increase in sales expenses is characterized as a short-term fluctuation rather than a trend for the entire year [1]