证券研究报告：医药生物 | 公司点评报告 研究所 分析师:盛丽华 SAC 登记编号:S1340525060001 Email:shenglihua@cnpsec.com 研究助理:徐智敏 SAC 登记编号:S1340125080012 Email: xuzhimin@cnpsec.com 智翔金泰(688443) 感染类双产品牵手康哲，聚焦研发质效与自免商业 化 发布时间：2025-10-09 股票投资评级 增持|首次覆盖 个股表现 -21% -16% -11% -6% -1% 4% 9% 14% 19% 24% 2024-10 2024-12 2025-02 2025-05 2025-07 2025-09 智翔金泰 医药生物 资料来源：聚源，中邮证券研究所 公司基本情况 | 最新收盘价（元） | 30.55 | | --- | --- | | 总股本/流通股本（亿股）3.67 / 1.17 | | | 总市值/流通市值（亿元）112 / 36 | | | 52 周内最高/最低价 | 37.02 / 22.86 | | 资产负债率(%) | 32.4% | | 市盈率 | -14.08 | | 第一大股东 | ...

Core Viewpoint - LZM012, a humanized monoclonal antibody injection targeting IL-17A/F developed by the company, has successfully met its primary endpoint in Phase III clinical trials for moderate to severe plaque psoriasis, showing non-inferiority and superiority compared to Secukinumab [1][2] Group 1: Clinical Trial Results - The primary endpoint of the Phase III trial was the proportion of subjects achieving PASI 100 at week 12, with LZM012 showing a PASI 100 response rate of 49.5% compared to 40.2% for Secukinumab [2] - The secondary endpoint at week 4 showed a PASI 75 response rate of 65.7% for LZM012 versus 50.3% for Secukinumab, indicating a faster onset of action and good safety profile for LZM012 [2] Group 2: Market Landscape - The IL-17 market remains competitive, with only three IL-17 inhibitors approved overseas: Novartis' Secukinumab, Eli Lilly's Efalizumab, and UCB's Bimekizumab [1] - In 2024, projected sales for these drugs are $6.14 billion for Secukinumab, $3.26 billion for Efalizumab, and $630 million for Bimekizumab [1] Group 3: Future Prospects - The company has submitted a pre-application for marketing authorization to the CDE, with expectations for continued growth as its pipeline products enter the market [1] - Profit forecasts indicate net profits of 2.2 billion, 2.5 billion, and 2.8 billion yuan for 2025-2027, reflecting an optimistic outlook on business structure optimization and accelerating growth [2]

Core Viewpoint - The path of domestic innovative drugs in China is becoming clearer, with companies like Livzon Pharmaceutical demonstrating the potential to lead in the market through differentiated treatment mechanisms and successful clinical trials [1][4]. Group 1: Clinical Trial Success - Livzon Pharmaceutical's LZM012, a recombinant anti-IL-17A/F humanized monoclonal antibody, achieved its primary endpoint in a Phase III clinical trial for moderate to severe plaque psoriasis, outperforming Novartis's Cosentyx (secukinumab) [1][3]. - The trial results showed a PASI 100 response rate of 49.5% for LZM012 compared to 40.2% for the control group (secukinumab) at week 12, indicating superior efficacy [3]. - LZM012 also demonstrated faster onset of action with a PASI 75 response rate of 65.7% at week 4, compared to 50.3% for secukinumab [3]. Group 2: Market Potential - The psoriasis drug market in China reached 13.9 billion yuan in 2023 and is projected to grow to 89.4 billion yuan by 2032, with a compound annual growth rate of 59.1% [5]. - The impending patent expiration of secukinumab presents an opportunity for LZM012 to capture market share [5][6]. Group 3: Competitive Landscape - LZM012 faces competition from several other IL-17 targeted therapies already approved in China, including Eli Lilly's etanercept and others, which may impact its market entry [5][6]. - The competitive landscape is further complicated by the aggressive pricing strategies of established products like secukinumab, which has seen significant price reductions since its launch [6]. Group 4: Company Performance - Livzon Pharmaceutical reported a revenue decline of 4.97% in 2024, with net profit increasing by 5.5%, indicating challenges in core business growth despite cost-cutting measures [7]. - The company has successfully reduced sales, management, and R&D expenses, leading to improved net profit margins [7]. Group 5: Strategic Challenges - The success of innovative drugs like LZM012 hinges not only on clinical efficacy but also on navigating the complexities of commercialization, including market competition and pricing strategies [9]. - Livzon Pharmaceutical must maintain strategic focus to effectively respond to market dynamics and ensure the successful launch of its new products [9].

Investment Rating - The report maintains a "Buy" rating for the company [5] Core Insights - The company has successfully entered the global market with its product GR1803 through a licensing agreement with Cullinan Therapeutics, which includes a total milestone payment of up to $712 million [1] - The company is rapidly expanding its domestic and international business lines, with significant clinical trial progress and new drug applications [2] - The leading product, Celeric monoclonal antibody, is expected to launch in August 2024 and participate in medical insurance negotiations in 2025 [2] Financial Projections - Revenue projections for 2025-2027 are estimated at 206 million, 500 million, and 1.078 billion yuan respectively, with net losses expected to decrease from 622 million to 275 million yuan over the same period [2][4] - The company anticipates a significant year-on-year revenue growth rate of 2,384.1% in 2024 and 584.5% in 2025 [4] - The latest diluted EPS is projected to improve from -2.19 yuan in 2023 to -0.75 yuan in 2027 [4] Business Development - The company has submitted a new drug application for GR2001, which has reached the primary efficacy endpoint in its Phase III clinical trial for tetanus passive immunity [2] - The collaboration with Cullinan Therapeutics focuses on the CD3/BCMA target, indicating a strategic enhancement in the company's autoimmune TCE dual antibody layout [1]

Investment Rating - The investment rating for the company is "Buy" [7] Core Viewpoints - The report is optimistic about the commercialization prospects of the company's products, including the monoclonal antibody "Sai Li Qi" and the bispecific antibodies GR2002 and GR1803, anticipating data readouts that could enhance valuation [1] - The company achieved significant revenue growth in 2024, with total revenue reaching 30.10 million yuan, and a slight narrowing of net losses to 797 million yuan [1] - The company has a differentiated pipeline with key products progressing steadily, including the approval of Sai Li Qi for moderate to severe plaque psoriasis and ankylosing spondylitis [1][2] Financial Performance - In Q1 2025, the company reported revenue of 20.16 million yuan and a net loss of 121 million yuan, with R&D expenses at 10.30 million yuan [1] - Revenue projections for 2025-2027 are estimated at 199 million yuan, 533 million yuan, and 1.07 billion yuan respectively, reflecting a strong growth trajectory [4][6] - The company maintains high R&D expenditure, with 610 million yuan in 2024, indicating a commitment to innovation [1] Pipeline Development - The GR1802 monoclonal antibody is progressing through clinical trials for multiple indications, with significant market potential [2] - The GR1801 rabies virus antibody is currently under review for market approval, with promising commercial prospects [2] - Other pipeline products, including GR2001 and GR1803, are advancing through clinical stages and partnerships, demonstrating the company's innovative capabilities [3]