Investment Rating - The report maintains a "Buy" rating for the company [4]. Core Insights - The core product CM310 for moderate to severe AD has submitted its NDA and is expected to be approved by the end of 2024, becoming the first domestically produced IL-4R monoclonal antibody [2][3]. - The company reported a revenue of 354 million in 2023, a 254% increase, primarily driven by upfront payments from the licensing of CMG901 to AstraZeneca [2]. - Adjusted net loss for the year was 318 million, with R&D expenses amounting to 596 million, reflecting an 18% increase due to rising employee costs and depreciation of new equipment [2]. - Cash and cash equivalents totaled 2.719 billion as of December 31, 2023, a decrease of 456 million from the end of 2022, indicating high capital utilization [2]. Financial Summary - Revenue projections for 2024 and 2025 have been revised down to 156 million and 526 million respectively, from previous estimates of 231 million and 697 million [2]. - The new revenue forecast for 2026 is set at 1.441 billion [2]. - The company is expected to initiate commercialization of CM310 in 2025 following its anticipated approval [2]. Clinical Development - CM310's Phase III trial data presented at EADV in October 2023 showed significant efficacy, with 66.9% of patients achieving EASI-75 compared to 25.8% in the control group [2]. - The company plans to start a Phase III double-blind trial for adolescents with moderate to severe AD in February 2024 [2]. - CMG901 has shown promising early data, with an overall response rate of 33% in a recent study, and is currently undergoing multiple Phase II clinical trials [2]. Pipeline Progress - The company has multiple products in its pipeline, including CM313 for ITP and CM326 for AD and asthma, both showing promising early results [2]. - The clinical data for CM350, CM355, and CM336 are also progressing steadily [2].

Investment Rating - The report reiterates a "Buy" rating for ConnoMed (2162 HK) with a slightly adjusted target price of HKD 58 [3] Core Views - ConnoMed's 2023 revenue met expectations at RMB 350 million, but the net loss of RMB 360 million was slightly higher than expected due to higher R&D and administrative expenses [3] - CM310, an IL-4Rα inhibitor, has a first-year sales target of RMB 500 million for 2025, with a long-term peak sales target of RMB 5 billion [3] - CMG901, a CLDN18 2 ADC, has entered Phase 3 trials for second-line gastric cancer, with promising efficacy data (ORR: 33%, n=89) and potential to become a first-in-class drug [3] - Key catalysts for 2024 include CM310's approval for adult atopic dermatitis, long-term efficacy data, and the submission of a new indication for chronic rhinosinusitis with nasal polyps [3] Financial Analysis - 2023 revenue was RMB 350 million, with a net loss of RMB 360 million [3] - 2024E revenue is projected at RMB 70 million, with a net loss of RMB 803 million [6] - 2025E revenue is expected to surge to RMB 563 million, with a net loss of RMB 797 million [6] - 2026E revenue is forecasted at RMB 1,175 million, with a net loss of RMB 690 million [6] - Gross margins are expected to remain strong, with 2024E at 100%, 2025E at 82 5%, and 2026E at 82 8% [7] Commercialization and Pipeline - CM310 is expected to be approved by the end of 2024, with a commercial team of around 200 people planned [3] - CMG901 is advancing rapidly in Phase 3 trials, with potential milestone payments of USD 10 million from AstraZeneca [3] - Other pipeline highlights include CM326 (TSLP) for rhinitis, CM313 (CD38) for SLE, and CM336 (BCMAxCD3) for multiple myeloma [3] Valuation and Forecast - The target price is adjusted to HKD 58 based on a DCF model with a WACC of 9 5% and a perpetual growth rate of 3% [3] - 2025E and 2026E revenues are revised upward by 16 6% and 8 4%, respectively, due to updated sales guidance [3] - The report highlights a potential upside of 80% based on the current price of HKD 32 3 [3]

证券研究报告 | 2024年04月01日 康诺亚-B（02162.HK） 买入 司普奇拜单抗商业化在即，看好国内销售潜力 核心观点 公司研究·海外公司财报点评 司普奇拜单抗提交上市申请，适应症拓展快速推进。康诺亚的核心产品IL4R 医药生物·生物制品 单抗司普奇拜单抗（CM310）治疗成人中重度特应性皮炎的上市申请于23年 证券分析师：张佳博 证券分析师：陈益凌 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 021-60375487 021-60933167 zhangjiabo@guosen.com.cnchenyiling@guosen.com.cn 批上市的国产IL4R单抗。此外，司普奇拜单抗针对青少年特应性皮炎的3 S0980523050001 S0980519010002 期临床已于24年2月启动；针对慢性鼻窦炎伴鼻息肉的3期临床已于23年 证券分析师：陈曦炳 底达到主要临床终点，预计将在24年提交上市申请；针对过敏性鼻炎的3 0755-81982939 chenxibing@guosen.com.cn 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 S0 ...

[Table_Main] 证券研究报告 | 公司点评 康诺亚-B(02162.HK) 2024年03月29日 买入（维持） 康诺亚-B（2162.HK）：管线进展顺 所属行业：医疗保健业/药品及生物科技 利，CLND18.2 ADC 进入全球三期 当前价格(港币)：33.90元 投资要点 证券分析师 李霁阳 业绩：2024年3月26日，公司发布2023年度业绩，实现收入3.5亿人民币，主 资格编号：S0120523080003  要收入来自与阿斯利康的授权合作；年度研发支出增长至5.9亿人民币；截止2023 邮箱：lijy7＠tebon.com.cn 年底，公司定期存款、现金及银行理财产品约27亿；公司已建立一体化的药物开 发平台，具备商业化大规模生产能力。核心产品CM310推进顺利，开发多个大适 应症。公司10款候选药物已处于临床研发/IND申报阶段。 CM310（IL-4Rα抗体）：1）成人中重度特应性皮炎（AD）获得上市申请获CDE 市场表现  受理，并被纳入优先审评审批程序；2）2024年2月，启动青少年中重度AD Ⅲ 康诺亚-B 恒生指数 期临床研究，目前正在进行患者入组。3）慢性鼻窦炎伴鼻息肉 ...

研究报告Research Report 27 Mar 2024 康诺亚生物 Keymed Biosciences (2162 HK) CM310上市前准备有序推进，新技术平台管线进展积极 CM310 Expected to Commercial Launch in 2024, Pipelines of New Modality Progressing Smoothly [观Ta点ble聚_y焦em Ieniv1e]s tment Focus [Tab维le_持Info优] 于大市Maintain OUTPERFORM (Please see APPENDIX 1 for English summary) 事件 评级 优于大市OUTPERFORM 现价 HK$32.65 康诺亚生物 2023 年收入 3.5 亿元，主要来自阿斯利康授权许可的 目标价 HK$68.44 合作收入。研发费用 6.0 亿元（+17.5%），行政开支 1.8 亿 HTI ESG 2.7-3.0-3.0 （+32.1%）。归母净利润-3.6 亿元，2022 年同期为 3.1 亿元。截 E-S-G: 0-5, (Please refer t ...

[ 2T 0a 2b 4l 年e_S 0t 3o 月ckI 2n 7f 日o] 证券研究报告•2023年报点评 当前价： 32.65港元 康诺亚-B（2162.HK） 医疗保健 目标价： ——港元 司普奇拜单抗递交 NDA，商业化在即 投资要点 西南证券研究发展中心 [T ab事le件_S：u公mm司a发ry布] 2023 年度报告，2023 年收入达 3.5 亿元(+254%)，主要为 [分Ta析bl师e_：Au杜th向or阳] CMG901授权合作的首付款。研发开支达 5.9亿元（+18%），现金及现金等价 执业证号：S1250520030002 物、定期存款及以公允价值计量且其变动计入当期损益的金融资产 27.2 亿元 电话：021-68416017 （+14%）。 邮箱：duxy@swsc.com.cn  CM310成人中重度特应性皮炎成功 NDA，CRSwNP适应症有望 2024年 NDA。 分析师：汤泰萌 公司于2023年推进并完成了一项评价司普奇拜单抗(CM310)在成人中重度特应 执业证号：S1250522120001 电话：021-68416017 性皮炎受试者中的有效性和安全性的随机、 ...

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2023年12月31日止年度之 年度業績公告 及建議修訂本公司組織章程大綱及章程細則 | --- | --- | --- | --- | --- | |-----------------------------------------------------------|--------------------------|--------------------------|-------------------|------------| | | | | | | | 財務摘要 | 2023 年 人民幣千元 | 2022 年 人民幣千元 | 變動 人民幣千元 | 同比變動 % | | | | | | | | 收入 | 354,095 | 100,063 | 254,0 ...

Investment Rating - The report assigns a "Buy" rating for the company, with a target price based on a DCF valuation method estimating the company's reasonable equity value at 19.2 billion HKD [2][4]. Core Insights - The company focuses on both autoimmune and oncology drug development, with over 30 innovative drugs in its pipeline, 9 of which are in various clinical stages. The IL-4R monoclonal antibody CM310 has submitted an NDA as of December 2023, indicating strong progress in its autoimmune pipeline [4][15]. - The oncology pipeline emphasizes new technology platforms such as ADCs and bispecific antibodies, with CMG901 being the first Claudin 18.2 ADC product approved for clinical trials globally. The company has established strategic partnerships with notable pharmaceutical firms to enhance drug development and commercialization [4][19]. Summary by Sections Company Overview - The company, established in 2016, specializes in innovative drug development for autoimmune and oncology diseases, with a strong R&D platform in Chengdu and Shanghai. It has built a cGMP-compliant production facility to support regulatory submissions [15][20]. Autoimmune Drug Pipeline - The IL-4R monoclonal antibody CM310 is leading the pipeline, with significant clinical advancements. It has submitted an NDA for treating moderate to severe atopic dermatitis and has shown superior clinical efficacy compared to competitors [5][18]. - Other drugs in the autoimmune pipeline, such as CM326 and CM338, are also progressing well, with CM326 entering II phase clinical trials for asthma and CM338 for IgA nephropathy [18][29]. Oncology Drug Pipeline - The oncology pipeline includes CMG901, which has received FDA fast track designation and is expected to enter Phase III clinical trials for gastric cancer in early 2024. The company has partnered with AstraZeneca for global development and commercialization rights [6][19]. - CM313 is the first domestically developed CD38 monoclonal antibody to enter clinical trials, and multiple bispecific antibody products are in early clinical stages, showcasing the company's competitive edge in this area [19][24]. Financial Projections - The company anticipates significant revenue growth, with projected sales for CM310 reaching approximately 6.77 billion HKD by 2033. The expected revenue share from CMG901 is around 750 million HKD [4][12]. Strategic Partnerships - The company has formed strategic collaborations with major pharmaceutical companies like AstraZeneca, Stone Pharmaceutical, and Innovent Biologics to mitigate drug development risks and maximize pipeline value [4][23].

| --- | --- | --- | |-------|-------|-------| | | | | | | | | | --- | --- | |-------|--------------------------| | 目 | 錄 | | | | | 2 | 釋義 | | 5 | 公司資料 | | 7 | 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 | | 37 | 中期簡明綜合財務狀況表 | | 39 | 中期簡明綜合權益變動表 | | 41 | 中期簡明綜合現金流量表 | | 43 | 中期簡明綜合財務資料附註 | 2023 中期報告 2 康諾亞生物醫藥科技有限公司 釋 義 | --- | --- | --- | |-----------------------------------|-------|-------------------------------------------------------------------------------------------- ...

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。 經調整期內利潤（如「非《國際 財務報告準則》計量」所示） 63,828 25,720 38,108 148% 2023年 2022年 6月30日 12月31日 變動 人民幣千元 人民幣千元 人民幣千元 % （未經審核） （經審核） 現金及現金等價物、定期存款及 以公允價值計量且其變動計入 當期損益的金融資產 2,978,750 3,175,326 (196,576) (6%) 1 KeymedBiosciences 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2023年6月30日止六個月之 中期業績公告 | --- | --- | --- | --- | --- | |--------------|----------------------------------------------------|------------------------ ...