Investment Rating - The report maintains a "Buy" rating for the company 康诺亚 (2162 HK) with a target price adjusted to HKD 57.00, indicating a potential upside of 42.7% from the closing price of HKD 39.95 [2][3][12]. Core Insights - 康诺亚 is expected to achieve sales of RMB 500 million in its first year, driven by multiple competitive advantages such as multi-indication approvals and superior clinical data compared to competitors [3][7]. - The company has a robust cash reserve of RMB 2.16 billion, which is projected to support stable development over the next three years [7]. - The sales growth for 康悦达 (the company's product) is anticipated to be propelled by its approval for multiple indications, a well-established commercialization team, and effective market access strategies [7][8]. Financial Forecasts - Revenue projections for 2025 are set at RMB 689 million, reflecting a decrease of 12.6% from previous estimates, with further declines expected in 2026 and 2027 [6][13]. - The gross profit for 2025 is forecasted at RMB 478 million, with a gross margin of 69.5%, down from 74.4% in prior estimates [6][13]. - The net loss for 2025 is projected to be RMB 870 million, widening from RMB 840 million in the previous forecast [6][13]. Market Position and Strategy - 康诺亚 has established a commercialization team of approximately 300 personnel, effectively covering over 1,100 hospitals across more than 220 cities [7]. - The company is expected to submit applications for additional indications in the first half of 2025, which could further enhance its market presence [7]. - Despite competitive pricing pressures, 康诺亚 is positioned to leverage its superior efficacy data to capture market share [7].

Investment Rating - The report maintains a "Buy" rating for 康诺亚 (2162 HK) with a target price adjusted to HKD 57.00, indicating a potential upside of 42.7% from the closing price of HKD 39.95 [2][3][12]. Core Insights - 康诺亚 is expected to achieve sales of RMB 500 million in its first year, driven by multiple competitive advantages including broad indication approvals and superior clinical data compared to competitors [3][7]. - The company anticipates a revenue of RMB 428 million in 2024, representing a 21% year-on-year growth, primarily from collaboration income and initial sales of 康悦达 (司普奇拜单抗) [7]. - Despite facing increased competition, 康诺亚's management is optimistic about the long-term sales growth potential of 康悦达, which has already received approvals for multiple indications [7][8]. Financial Forecasts - Revenue projections for 康诺亚 have been revised downwards for 2025 and 2026, reflecting a more cautious outlook on collaboration income, with expected revenues of RMB 689 million and RMB 1,212 million respectively [6][13]. - The gross profit margin is projected to decline from 69.5% in 2025 to 79.6% in 2026, indicating increased cost pressures [6][13]. - The company is expected to incur a net loss of RMB 870 million in 2025, widening from RMB 515 million in 2024, primarily due to increased R&D and sales expenses [6][13]. Market Position and Strategy - 康诺亚 has established a commercialization team of approximately 300 people, effectively covering over 1,100 hospitals across more than 220 cities, which positions the company well for market penetration [7]. - The company plans to maintain R&D expenses at levels similar to 2024 while increasing sales expenses, indicating a focus on expanding market presence [7]. - 康诺亚's competitive edge is expected to be bolstered by superior efficacy data, which may help it withstand pricing pressures from competitors [7].

Financial Performance - Revenue for the year ended December 31, 2024, was RMB 428,124,000, representing a 21% increase from RMB 354,095,000 in 2023[3]. - Gross profit increased by 31% to RMB 415,924,000 in 2024, compared to RMB 317,217,000 in 2023[3]. - The adjusted net loss for the year was RMB 480,561,000, a 51% increase from RMB 317,706,000 in 2023[3][4]. - Total cash and cash equivalents decreased by 21% to RMB 2,155,612,000 as of December 31, 2024, down from RMB 2,719,186,000 in 2023[3]. - The company reported a pre-tax loss of RMB 508,647 million for 2024, compared to a loss of RMB 356,188 million in 2023, reflecting increased investment in R&D[75]. - The net loss for the year was RMB 514,907,000, compared to a net loss of RMB 357,785,000 in 2023, indicating a 43.8% increase in losses[116]. - Total liabilities increased from RMB 896 million as of December 31, 2023, to RMB 1,291 million as of December 31, 2024, resulting in a debt-to-asset ratio of 34%, up from 23% in the previous year[87]. - The company reported a significant increase in revenue, achieving a total of HKD 1.2 billion for the fiscal year, representing a 15% year-over-year growth[160]. Research and Development - Research and development expenses rose by 23% to RMB 735,192,000 in 2024, up from RMB 596,282,000 in 2023[3]. - The company has 12 drug candidates in clinical development or clinical trial application stages, with one product already in the commercialization phase[30]. - The company has developed a highly integrated platform for immunology and oncology research, facilitating the entire drug development process from discovery to clinical trials[69]. - The company has allocated RMB 1,705 million for the research and commercialization of core products and key candidates, with RMB 934 million utilized by the end of 2023[111]. - The company plans to utilize the remaining RMB 448 million for its core product development by the end of 2025[111]. - The company is committed to sustainability, with initiatives aimed at reducing carbon emissions by 20% over the next five years[160]. Clinical Trials and Drug Development - The drug application for CM310 for the treatment of moderate to severe atopic dermatitis was approved by the National Medical Products Administration in September 2024[6]. - The III phase clinical trial for CM310 in chronic rhinosinusitis with nasal polyps showed significant improvement in nasal polyp scores and nasal congestion scores, with P-values less than 0.0001[7]. - CM313 initiated a Phase I/II clinical study in 2024 for treating relapsed/refractory multiple myeloma, focusing on safety, tolerability, pharmacokinetics, and preliminary efficacy[12]. - CM512's Phase I clinical study for safety and tolerability in healthy subjects and moderate to severe atopic dermatitis patients was initiated, with a licensing agreement with Belenos Biosciences, Inc. for global rights excluding Greater China, involving an upfront payment of $15 million[16]. - CM336 is in the dose expansion phase of a Phase I/II clinical study for treating relapsed or refractory multiple myeloma, with an exclusive licensing agreement with Platina Medicines Ltd, including an upfront payment of $16 million and potential additional payments of up to $610 million[17]. - CM383's Phase Ia study for safety and pharmacokinetics in healthy subjects has been completed, and the Phase Ib study for Alzheimer's patients has initiated enrollment as of November 2024[19]. - The company submitted a clinical trial application for CM518D1 to evaluate its efficacy in treating advanced solid tumors[20]. - CM326's Phase II clinical study for moderate to severe asthma has completed enrollment, with ongoing follow-up work[21]. Licensing Agreements and Collaborations - AstraZeneca has been granted exclusive global rights for the research and commercialization of CMG901 (AZD0901), with clinical data showing a median progression-free survival of 4.8 months for patients with Claudin 18.2 high expressing gastric cancer[10]. - An exclusive licensing agreement with Timberlyne Therapeutics, Inc. was established in January 2025, granting Timberlyne global rights to develop and commercialize CM313, with an upfront payment of $30 million and potential additional payments of up to $337.5 million[14]. - The company entered into a licensing agreement with Platina Medicines Ltd., receiving an upfront payment of USD 10,000,000 (approximately RMB 71,865,000) in December 2024[137]. - The company, along with partners, has established an agreement with Prolium for the development and commercialization of CM355, with an upfront payment of $17.5 million and potential additional payments of up to $502.5 million based on clinical and regulatory milestones[98]. Employee and Operational Insights - As of December 31, 2024, the company has 1,258 full-time employees, with over 240 in the commercialization team and nearly 400 in drug discovery and clinical operations[28]. - The production capacity of the company's facilities totals 20,500 liters, compliant with national drug regulatory and FDA cGMP standards[28]. - The company is actively recruiting talent to support the growing demands of product commercialization, R&D, clinical, production, and operations[28]. - The company has not reported any significant adverse changes regarding regulatory approvals for its candidate drugs as of the announcement date[66]. Market and Future Outlook - The company provided an optimistic outlook for the next fiscal year, projecting a revenue growth of 20%[160]. - The company plans to expand its market presence in Southeast Asia, targeting a 30% market share within the next three years[160]. - A strategic acquisition of a biotech firm is expected to enhance the company's R&D capabilities and product pipeline[160]. - The management emphasized the importance of regulatory approvals, with plans to submit NDA applications for two new drugs in the next quarter[160].

Investment Rating - The investment rating for the company is "Buy" (maintained) [2][18] Core Views - The company announced that its self-developed new drug, Kangyueda (Supuqibai monoclonal antibody), for the treatment of seasonal allergic rhinitis (SAR) has been approved by NMPA ahead of expectations, indicating a significant opportunity in the nasal market [7] - The company has three approved indications for its IL-4R monoclonal antibody, with a competitive edge in the market, and is expected to achieve rapid growth in 2025 through its dermatology and nasal indications [7] - Revenue forecasts for 2024-2026 have been adjusted to 318 million, 467 million, and 1,003 million yuan respectively, with corresponding EPS of -2.01, -2.19, and -1.26 yuan [7] Financial Summary - The total market capitalization is 8.84 billion HKD, with a current stock price of 31.60 HKD [2] - The company’s revenue for 2022 was 100 million yuan, with a projected revenue of 354 million yuan for 2023, and a decline to 318 million yuan in 2024, followed by growth to 467 million yuan in 2025 and 1,003 million yuan in 2026 [10] - The net profit for 2024 is expected to be -563 million yuan, improving to -351 million yuan by 2026 [10] - The gross margin is projected to remain high at around 95% for 2024-2026 [10] Market Opportunity - The prevalence of allergic rhinitis in China has increased from 11.1% to 17.6%, with approximately 200 million patients affected, indicating a large unmet clinical need [8] - Despite the use of existing treatments, 62% of moderate to severe allergic rhinitis patients do not achieve effective symptom control, highlighting the potential for new therapies [8] Product Details - Supuqibai monoclonal antibody is the first globally approved biological agent for treating moderate to severe seasonal allergic rhinitis in adults, showing significant symptom relief compared to existing treatments [9] - Key clinical trial results indicate rapid relief of nasal congestion symptoms within two days of the first dose, with nearly half of the patients achieving mild to complete relief after the first treatment [9]

Investment Rating - The investment rating for the company is "Outperform the Market" (maintained) [2][5][11] Core Views - The approval of the new indication for Supqi Baidankang (司普奇拜单抗) for seasonal allergic rhinitis marks it as the first domestically approved IL4R monoclonal antibody for this indication. This is the third indication approved for Supqi Baidankang, following approvals for moderate to severe atopic dermatitis in adults and chronic sinusitis with nasal polyps [4][6][7] - The commercialization of Supqi Baidankang is progressing smoothly, with expectations to capture a significant market share due to its differentiated indications and strong clinical data. The competitive landscape for IL4R monoclonal antibodies is favorable, providing Supqi Baidankang with a first-mover advantage over other domestic products [4][5] - The company has a rich pipeline of products, including CM336, CM313, CM355, and CM512, which have been authorized for overseas markets. CMG901 has entered global Phase 3 clinical trials, indicating a robust future product pipeline [4][10] Summary by Sections Company Announcement - The company announced that Supqi Baidankang for the treatment of seasonal allergic rhinitis has been approved by the National Medical Products Administration (NMPA) [4] Financial Forecast - Revenue projections for the company from 2024 to 2026 are estimated at 1.04 billion, 6.49 billion, and 13.83 billion yuan, respectively, with year-on-year growth rates of -71%, 525%, and 113%. The net profit attributable to the parent company is forecasted to be -6.41 billion, -7.76 billion, and -3.55 billion yuan for the same period [5][11] Clinical Development - Supqi Baidankang's approval is based on a multi-center, randomized, double-blind, placebo-controlled Phase 3 study, demonstrating significant clinical benefits in controlling typical nasal allergy symptoms compared to standard treatment [6][7] - The competitive landscape includes Sanofi's Dupilumab, which has rapidly entered the insurance reimbursement system in China after its approval [6][8] Pipeline and Partnerships - The company has several products in its pipeline that have been authorized for international markets, with CMG901 already in Phase 3 trials globally. This indicates a strong potential for future growth and market presence [10][11]

Investment Rating - The report initiates coverage with a "Buy" rating for the company, highlighting its leading position in the autoimmune and oncology sectors, particularly with its core product CM310, which is the first domestically approved IL-4Rα antibody drug [31]. Core Insights - The company is focused on innovative drug development in the fields of autoimmune diseases and oncology, with a robust pipeline that includes high-potential candidates such as CM310 and CMG901. The report emphasizes the commercial potential of these products and the company's strategic partnerships [31][30]. - CM310 has been approved for multiple indications, including moderate to severe atopic dermatitis and chronic rhinosinusitis with nasal polyps, positioning it as a market leader in these therapeutic areas [20][31]. - The company has established a strong commercialization team and production capacity, with over 1,200 employees and a significant increase in the commercialization team size [6][31]. Summary by Sections 1. Pipeline Overview - The company has a diverse pipeline with 12 key candidates at various stages of development, focusing on IL-4Rα, TSLP, and CD38 targets, which are leading in the domestic market [31]. - CM310 is the first domestically approved IL-4Rα antibody, with significant clinical data supporting its efficacy and safety across multiple indications [20][31]. 2. Product CM310 - CM310 is positioned as a leading product with a large market potential, having received approval for atopic dermatitis and chronic rhinosinusitis with nasal polyps, with additional indications in the pipeline [20][31]. - The report notes that CM310's clinical data shows superior efficacy compared to competitors, establishing a strong competitive advantage [31][49]. 3. Product CMG901 - CMG901 is highlighted as a globally leading CLDN18.2 ADC with promising clinical data and a strong competitive position in the market [31]. - The product has received breakthrough designations and is advancing through clinical trials, with a focus on gastric cancer [31]. 4. Dual-Antibody Platform - The company has developed a proprietary dual-specific antibody platform, with several candidates entering clinical trials, demonstrating the platform's value and potential for future collaborations [31][30]. 5. Financial Projections and Valuation - The report provides a valuation range for the company, estimating a reasonable present value between 15.1 billion to 17.2 billion RMB, reflecting the anticipated growth from its product pipeline [31].

Investment Rating - The report maintains a "Buy" rating for the company [4]. Core Viewpoints - The approval of Supacibab (anti-IL-4Rα monoclonal antibody) by the NMPA for the treatment of moderate to severe atopic dermatitis is expected to enhance the company's commercialization prospects [1][2]. - Supacibab is the first domestically developed IL-4Rα antibody drug approved by the NMPA, targeting key cytokines IL-4 and IL-13, which are crucial in type II inflammation [3]. Financial Forecasts and Valuation - The net profit forecast for 2024 and 2025 has been revised down to -704 million and -737 million CNY, respectively, from previous estimates of -413 million and -242 million CNY. A new forecast for 2026 is set at -304 million CNY [4]. - The estimated earnings per share (EPS) for 2024, 2025, and 2026 are -2.51, -2.63, and -1.09 CNY, respectively [4]. - The company anticipates significant revenue growth, with projected revenues of 150 million CNY in 2024, 520 million CNY in 2025, and 1.3 billion CNY in 2026, reflecting growth rates of -58%, 247%, and 150% respectively [5].

INTERIM REPORT 中期報告 2024 Keymed Biosciences Inc. 康諾亞生物醫藥科技有限公司 | --- | --- | --- | --- | |--------------------------------------------------------|-------|-------|----------| | | | | | | | | | | | ( ) Keymed Biosciences Inc. 康諾亞生物醫藥科技有限公司 | | | | | 於開曼群島註冊成立的有限公司 股份代號 : 2162 | | | | | | | | | | | | | | | | | | | | | | | | | | | 2024 | 中期報告 | 目 錄 | --- | --- | |-------|--------------------------| | 2 | 釋義 | | 6 | 公司資料 | | 8 | 管理層討論與分析 | | 22 | 補充資料 | | 34 | 獨立審閱報告 | | 35 | 中期簡明綜合損益表 | | 36 | 中期簡明綜合全面收益表 | | ...

证券研究报告 医药生物 买入（维持） ——首个国产 IL-4Rα单抗获批，开启商业化新征程 证券分析师 刘闯 S1350524030002 liuchuang@huayuanstock.com 市场表现： -46% -32% -19% -5% 8% 22% 23-0923-1023-1123-1224-0124-0224-0324-0524-0624-0724-0824-09 康诺亚-B 恒生指数 公司点评 康诺亚-B(2162.HK) 2024 年 9 月 19 日 投资要点： ➢ 事件：2024 年 9 月 12 日，公司自主研发的 1 类新药康悦达®（司普奇拜单抗注射液）正式 获批上市，用于治疗成人中重度特应性皮炎，是国内首个、全球第二个获批上市的 IL-4Rα抗 体药物，填补了国产特应性皮炎生物制剂领域的空白。 ➢ 司普奇拜单抗疗效优异，国内特应性皮炎市场空间较大。 1）临床疗效显著，具备同类最佳潜力：临床数据显示，司普奇拜单抗首剂治疗一天，患者的 瘙痒症状即迅速改善；治疗两周，患者的全身各部位皮损均明显改善；治疗 52 周，达到 EASI-75 的患者比例高达 92.5%，达到 EASI-90 的患 ...

证券研究报告 医药生物 买入（维持） ——首个国产 IL-4Rα单抗获批，开启商业化新征程 证券分析师 刘闯 S1350524030002 liuchuang@huayuanstock.com 市场表现： -46% -32% -19% -5% 8% 22% 23-0923-1023-1123-1224-0124-0224-0324-0524-0624-0724-0824-09 康诺亚-B 恒生指数 公司点评 康诺亚-B(2162.HK) 2024 年 9 月 19 日 投资要点： ➢ 事件：2024 年 9 月 12 日，公司自主研发的 1 类新药康悦达®（司普奇拜单抗注射液）正式 获批上市，用于治疗成人中重度特应性皮炎，是国内首个、全球第二个获批上市的 IL-4Rα抗 体药物，填补了国产特应性皮炎生物制剂领域的空白。 ➢ 司普奇拜单抗疗效优异，国内特应性皮炎市场空间较大。 1）临床疗效显著，具备同类最佳潜力：临床数据显示，司普奇拜单抗首剂治疗一天，患者的 瘙痒症状即迅速改善；治疗两周，患者的全身各部位皮损均明显改善；治疗 52 周，达到 EASI-75 的患者比例高达 92.5%，达到 EASI-90 的患 ...