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 ...

证券研究报告 资料来源：S&P 康诺亚-B (2162 HK) 港股通 前程万里，首款国产 IL-4Rα 单抗获批 投资评级(维持): 买入 目标价(港币): 58.76 华泰研究 公告点评 2024 年 9 月 13 日│中国香港 生物医药 司普奇拜单抗迈入商业化阶段，管线开发不断推进 9 月 11 日，司普奇拜单抗在国内获批治疗成人中重度 AD，成为首款国产、 全球第二款上市的 IL-4Rα 单抗，我们看好其商业潜力：1）该药疗效优异且 国内进度领先；2）公司积极建设销售团队；3）皮肤自免市场持续火热。 AD 适应症外，CRSwNP、过敏性鼻炎分别有望在 1H25 和 25 年内获批， 产品销售潜力有望逐步兑现。此外，公司早期管线亦前景可期，CM313 继 ITP 后有望在 SLE 实现 POC，CMG901 全球 III 期继续推进。我们预计 24-26 年 EPS 为(3.02)/(3.26)/(1.57)元，基于 DCF 的目标价为 58.76 港币（WACC： 11.4%，永续增长率 2.5%）。维持"买入"评级。 成人 AD 获批上市，看好商业化前景 我们认为司普奇拜单抗商业化前景乐观，基于：1 ...

Investment Rating - The report maintains an "Accumulate" rating for 康诺亚-B (2162) [2][5] Core Viewpoints - CM310, the first domestically produced IL-4R monoclonal antibody, was approved for adult moderate to severe atopic dermatitis (AD) on September 12, filling a gap in the domestic AD biopharmaceutical market [4][5] - The commercial team, consisting of nearly 200 members, is expected to rapidly advance sales following the early commercialization of CM310, with revenue forecasts for 2024 raised to 197 million RMB from the previous 156 million RMB [5] - Clinical data from Phase III trials show that CM310 has a 66.9% EASI-75 response rate at 16 weeks and a 92.5% response rate at 52 weeks, indicating excellent efficacy and safety [5] - The market potential for CM310 is significant, with the domestic AD market still having unmet needs and only one other IL-4R drug currently available [5] - The company has a strong pipeline and has been recognized for its R&D capabilities, with multiple collaborations and licensing agreements in place [5] Financial Summary - Revenue projections for 2024, 2025, and 2026 are 197 million RMB, 526 million RMB, and 1.441 billion RMB respectively, reflecting significant growth [6] - The company experienced a revenue decline of 9.3% in 2022, but is expected to rebound with a projected revenue increase of 253.9% in 2023 [6] - The net profit is projected to remain negative in the coming years, with estimates of -854 million RMB in 2024 and -434 million RMB in 2026 [6]

证券研究报告 | 2024年09月03日 康诺亚-B（02162.HK） 优于大市 临床开发快速推进，商业化准备积极进行 司普奇拜单抗临床开发快速推进，积极为商业化做准备。康诺亚的核心产品 IL4R 单抗司普奇拜单抗（CM310）治疗成人中重度特应性皮炎（AD）的上市 申请于 23 年 12 月获药监局受理并纳入优先审评，有望在 24 年下半年获批， 成为首个获批上市的国产 IL4R 单抗。并且，司普奇拜单抗读出了成人 AD 优 秀的长期随访数据。CRSwNP、过敏性鼻炎适应症的上市申请也已经获得 CDE 受理。其他适应症中，青少年 AD、结节性痒疹等的 3 期临床正在进行中。司 普奇拜单抗开发进度领先，覆盖人群广泛，有望成为自免领域的重磅产品。 截至 2024 年 7 月，公司商业化团队已接近 200 人规模，积极为司普奇拜单 抗的商业化进行前期准备。 管线布局丰富，临床推进顺利。公司的 CLDN18.2 ADC（CMG901）早期临床数 据优秀，合作伙伴阿斯利康已开启针对 2/3L 胃癌的全球多中心 3 期临床， 并在胰腺癌、胃癌等实体瘤中进行联合用药的 2 期临床探索。CM313（CD38 单抗）在 I ...

Investment Rating - The report maintains a "Buy" rating for the company [3][6]. Core Views - CM310 for adult AD indication is expected to be approved by the end of the year, with two additional indications having submitted NDAs. The pipeline is continuously advancing, indicating strong future growth potential [5][6]. - The company reported a revenue of 54.68 million yuan for H1 2024, primarily from the first milestone payment for CMG901, with an adjusted net loss of 319 million yuan due to R&D expenses of 331 million yuan, which increased by 32.5% [6]. - The company has a cash reserve of 2.58 billion yuan as of June 30, 2024, indicating a solid financial position to support ongoing R&D efforts [6]. Summary by Sections Pipeline Development - CM310 for adult AD is expected to submit NDA in December 2023 and is included in the priority review process, with approval anticipated by the end of 2024. The commercialization team is nearing 200 members and plans to expand to 200-300 by year-end [6]. - Other indications such as CRSwNP and allergic rhinitis have also submitted NDAs, with expected approvals in 2025 [6]. - CMG901 is undergoing clinical trials for gastric and pancreatic cancers, showing promising early efficacy and safety data [6]. Financial Performance - The company forecasts revenues of 156 million yuan in 2024, 526 million yuan in 2025, and 1.441 billion yuan in 2026, reflecting significant growth [7]. - The gross profit is projected to increase from 97 million yuan in 2024 to 1.217 billion yuan in 2026, while net losses are expected to decrease over the same period [7]. Market Position - The current stock price is 35.25 HKD, with a market capitalization of 9.861 billion HKD [8]. - The stock has traded between 27.45 and 61.65 HKD over the past year, indicating volatility but also potential for growth [8].