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康诺亚-B(02162) - 2024 - 年度业绩
2025-03-24 13:05
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致之任何損失承擔任何責任。 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) 截至2024年12月31日止年度之年度業績公告; 及 提名委員會組成變動 | 財務摘要 | | | | | | --- | --- | --- | --- | --- | | | 2024年 | 2023年 | 變動 | 同比變動 | | | 人民幣千元 | 人民幣千元 | 人民幣千元 | % | | 收入 | 428,124 | 354,095 | 74,029 | 21% | | 銷售成本 | (12,200) | (36,878) | 24,678 | (67%) | | 毛利 | 415,924 | 317,217 | 98,707 | 31% | | 研發開支 | (735,192) | (596,282) | (138,910) | 23% | | 年內虧損 | ...
康诺亚-B:港股公司信息更新报告:康悦达过敏性鼻炎获批快于预期,鼻科市场放量在即
开源证券· 2025-02-10 09:13
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]
康诺亚-B:司普奇拜单抗过敏性鼻炎适应症快速获批上市
国信证券· 2025-02-09 15:01
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]
康诺亚-B:康诺亚深度报告:深耕自免&肿瘤,IL-4R商业化领先
浙商证券· 2024-12-26 05:23
http://www.stocke.com.cn 资料来源:公司 2024 年中报,浙商证券研究所 http://www.stocke.com.cn 5/28 请务必阅读正文之后的免责条款部分 廉诺亚-B(02162)公司深度 1.2 股权:核心高管研发经验丰富 公司股权结构清晰,核心高管经验丰富。康诺亚于 2016年在成都成立,并于 2021 年 7 月在港交所主板上市。裁至 2024H1,Moonshot Holdings Limited 持有公司 27.79%的股份, 为公司最大股东。Moonshot 由 4名股东全资持有,其中 Bo Chen 拥有 Moonshot 65.36%的股 份,为公司的实际控制人及行政总裁,在创新药物开发方面拥有超过20年的经验,负责抗 体发现及项目管理。Wang 博士为广受赞誉的免疫肿瘤学领军专家,曾共同参与全球首创的 PD-1 抗体(即百时美施贵宝的 Opdivo)的研发。徐刚现任公司高级副总裁,在创新药物开 发方面拥有超过 10年的经验,负责抗体人源化及蛋白质工程。其余高管也拥有丰富的专业 水平及行业经验,为公司持续发展保驾护航。 图2:康诺亚股权结构图 Bo Che ...
康诺亚-B:公告点评:司普奇拜单抗获批上市,商业化前景可期
光大证券· 2024-10-29 15:09
2024 年 10 月 29 日 公司研究 司普奇拜单抗获批上市,商业化前景可期 ——康诺亚-B(2162.HK)公告点评 要点 事件: 中国国家药品监督管理局(NMPA)已于近日批准司普奇拜单抗(抗 IL-4Rα 单 克隆抗体;商品名:康悦达;研发代号:CM310)的新药上市申请,适应症为 成人中重度特应性皮炎。 点评: 司普奇拜单抗长期治疗可获得持续性临床获益,且安全性良好。 本次司普奇拜单抗获批上市是基于一项多中心、随机、双盲、安慰剂对照的Ⅲ期 研究,以第 16 周时达到湿疹面积和严重程度指数较基线改善至少 75%(EASI-75) 及研究者整体评分法(IGA)评分达到 0 分或 1 分且较基线下降≥2 分的达标率 为共同主要终点。结果显示,本试验在第 16 周达到了共同主要终点,长期治疗 可获得持续性临床获益,且安全性良好。 司普奇拜单抗是首个国产且获得 NMPA 批准上市的 IL-4Rα 抗体药物。 司普奇拜单抗是一种针对白介素 4 受体 α 亚基(IL-4Rα)的高效、人源化抗体,其 为首个国产且获得 NMPA 批准上市的 IL-4Rα 抗体药物。通过靶向 IL-4Rα,司普 奇拜单抗可双重阻断白 ...
康诺亚-B(02162) - 2024 - 中期财报
2024-09-23 13:01
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 | | ...
康诺亚-B:首个国产IL-4Rα单抗获批,开启商业化新征程
华源证券· 2024-09-19 02:10
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 ...
康诺亚-B:首个国产IL-4r单抗获批,开启商业化新征程
华源证券· 2024-09-19 02:03
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 ...
康诺亚-B:前程万里,首款国产IL-4Rα单抗获批
华泰证券· 2024-09-14 01:03
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 ...
康诺亚-B:CM310获批事件点评:首款国产IL-4R获批,商业化放量可期
国泰君安· 2024-09-13 00:37
股 票 研 究 首款国产 IL-4R 获批,商业化放量可期 康诺亚-B(2162) [Table_Industry] 医药 [Table_Invest] 评级: 增持 ——CM310 获批事件点评 [当前价格 Table_CurPrice] (港元): 37.75 | --- | --- | --- | --- | |----------|-----------------------------------|----------------------------|----------------------------| | | [table_Authors] 丁丹 ( 分析师 ) | 甘坛焕 ( 分析师 ) | 唐玉青 ( 研究助理 ) | | | 0755-23976735 | 021-38675855 | 021-38031031 | | | dingdan@gtjas.com | gantanhuan028803@gtjas.com | tangyuqing028689@gtjas.com | | 登记编号 | S0880514030001 | S0880523080007 | S08801230 ...