Investment Rating - The report maintains a "Buy" rating for 康诺亚 (2162.HK) with a target price of 58 HKD [2][3]. Core Insights - Recent data for CM310 and CMG901 aligns with expectations, showing stable and positive trends. CM310 demonstrates superior efficacy compared to Dupixent in treating moderate to severe atopic dermatitis, with a 52-week EASI-75 response rate of 92.5% and a low rate of anti-drug antibodies [2]. - CMG901 shows promising results in the treatment of 2L+ gastric cancer, with an overall objective response rate (ORR) of 35% and a disease control rate (DCR) of 70%, indicating its potential as a best-in-class therapy [2]. - Key upcoming catalysts for 2024 include potential approvals for CM310 in adult atopic dermatitis and chronic rhinosinusitis with nasal polyps, as well as important data readouts for other candidates [2]. Summary by Sections CM310 Efficacy Data - CM310 shows a 52-week EASI-75 response rate of 92.5% and an EASI-90 response rate of 77.1%, outperforming Dupixent [2]. - Serious adverse events (SAE) were reported at 5.1%, with no new safety signals identified compared to previous data [2]. CMG901 Update - The updated 1b phase data for CMG901 in gastric cancer shows an ORR of 35% and a DCR of 70%, with the 2.2 mg/kg dose group achieving an ORR of 48% [2]. - The median progression-free survival (mPFS) is reported at 4.8 months, and median overall survival (mOS) is 11.8 months [2]. Financial Projections - Revenue projections for 2024 estimate 1,175 million RMB, with a significant increase from 2023 [8]. - The report anticipates a net loss of 803 million RMB for 2024, reflecting ongoing investment in R&D [8]. Market Performance - The current stock price is 31.5 HKD, with a potential upside of 84% to the target price of 58 HKD [4]. - The stock has traded within a 52-week range of 26.6 to 64.8 HKD, indicating volatility [4].

Investment Rating - The report assigns a "Buy" rating for the company, indicating a positive outlook based on the anticipated approval of its core product and the progress of its pipeline [4][6]. Core Insights - The company focuses on autoimmune and oncology sectors with a differentiated pipeline, aiming to advance multiple innovative products in clinical research [4][13]. - The core product, IL4Rα monoclonal antibody CM310, is expected to receive domestic approval this year, with other innovative pipelines progressing well [4][18]. - The company has established a commercial team to prepare for the upcoming commercialization phase, targeting dermatology and otolaryngology departments [15]. Summary by Sections 1. Autoimmune/Oncology Flagship Innovative Pharmaceutical Company - Founded in 2016 and listed on the Hong Kong Stock Exchange in 2021, the company has established R&D and clinical centers in multiple cities [13]. - The management team is experienced, with the founder having over 20 years in drug development and a history of leading successful projects [13]. 2. CM310: The First Domestic Product Approaching Commercialization - CM310 is a humanized monoclonal antibody targeting IL-4Rα, with its NDA accepted for priority review in December 2023, expected to be approved this year [18]. - The product has multiple indications in clinical trials, including atopic dermatitis and chronic rhinosinusitis with nasal polyps, with significant market potential [18][24]. 3. Differentiated Pipeline Progressing Well - The company has a robust pipeline with 10 candidate drugs in clinical or preclinical stages, including CMG901, a Claudin18.2 ADC for gastric and pancreatic cancers, which is in global clinical trials [28][30]. - CM326, targeting TSLP, is also in clinical trials for multiple indications, showcasing the company's diverse therapeutic focus [32]. 4. Profit Forecast and Valuation - Revenue projections for 2024-2026 are estimated at 1.19 billion, 5.78 billion, and 12.72 billion RMB respectively, with a DCF valuation suggesting a fair equity value of 16 billion RMB [6][4]. - The anticipated approval of core products and positive pipeline developments support the bullish rating [6].

Investment Rating - The report maintains a "Buy" rating for the company, with a target price of HKD 57.73 per share [5][3]. Core Views - The company reported a revenue of RMB 354 million for 2023, a significant increase of 254% year-on-year, primarily due to the upfront payment from AstraZeneca for the licensing of CMG901. However, the company incurred a loss of RMB 358 million during the year [2][3]. - CM310 is set to be commercialized soon, with multiple autoimmune pipelines progressing well. The application for CM310 to treat moderate to severe atopic dermatitis in adults has been accepted by the CDE and is included in the priority review process [2][3]. - The oncology pipeline includes CMG901, which has initiated Phase III trials overseas and has received FDA fast track and orphan drug designations. The report highlights the potential of early-stage pipelines [2][3]. Financial Summary - Revenue projections for 2024-2026 are estimated at RMB 1.50 billion, RMB 4.90 billion, and RMB 7.83 billion, respectively, driven mainly by the commercialization of CM310 [3][9]. - The company expects to incur losses of RMB 804 million in 2024, with a gradual improvement in subsequent years [4][18]. - The report indicates a significant increase in R&D expenses, which rose by 18% year-on-year to RMB 596 million, attributed to increased employee costs and depreciation from new equipment [2][3]. Pipeline Development - CM310's application for atopic dermatitis is progressing, with expectations for market entry in 2025. The report notes a delay in the inclusion of CM310 in the medical insurance system, which may affect its market penetration [9][10]. - The report outlines the ongoing clinical trials for various indications, including chronic rhinosinusitis with nasal polyps and asthma, with CM310 showing promising results [2][3]. - The oncology pipeline is highlighted with CMG901's potential in treating Claudin18.2 positive gastric cancer, with AstraZeneca leading the Phase III clinical trials [2][3]. Valuation - A DCF valuation method was employed, resulting in a fair value estimate of HKD 57.73 per share, reflecting the company's innovative pipeline and clinical operational efficiency [3][14].

Financial Performance - Keymed Biosciences Inc. reported a significant increase in revenue for the fiscal year 2023, reaching approximately $50 million, representing a growth of 25% compared to the previous year[2]. - The company reported a net loss of $5 million for the fiscal year, a decrease from a $7 million loss in the previous year, indicating improved financial health[2]. - In 2023, the company reported a revenue of RMB 354,095,000, representing a 254% increase compared to RMB 100,063,000 in 2022[21]. - The gross profit for 2023 was RMB 317,217,000, reflecting a 225% increase from RMB 97,478,000 in 2022[21]. - The net loss for the year was RMB 357,785,000, an 18% increase compared to RMB 303,597,000 in 2022[21]. - Adjusted net loss, excluding certain non-cash items, was RMB 317,706 thousand for 2023, reflecting a 25% increase from RMB 255,030 thousand in 2022[23]. Research and Development - Keymed is actively developing new technologies, including a novel monoclonal antibody therapy, with expected completion of clinical trials by Q4 2024[2]. - The company aims to submit a Biologics License Application (BLA) for its core product by mid-2024, which could significantly impact future revenue streams[2]. - Research and development expenses rose to RMB 596,282,000, an 18% increase from RMB 507,374,000 in 2022[21]. - The company plans to submit multiple IND applications for new molecules in 2024, including CM383, an Aβ monoclonal antibody targeting neurodegenerative diseases[17]. - The innovative antibody discovery platform has enabled the development of multiple candidates, including bispecific antibodies and antibody-drug conjugates, enhancing therapeutic efficacy and specificity[74]. Clinical Trials and Product Development - The company completed a Phase III clinical trial for CM310 in adult patients with moderate to severe atopic dermatitis, with positive results leading to a drug application submission by the end of 2023[25]. - CMG901, a Claudin 18.2 antibody-drug conjugate, showed an objective response rate (ORR) of 33% in a Phase I clinical trial for advanced gastric cancer, with a confirmed ORR of 42% in the 2.2 mg/kg dose group[27]. - CM313, an anti-CD38 antibody, demonstrated preliminary efficacy in treating relapsed/refractory multiple myeloma, with a good safety profile reported in a Phase I clinical trial[29]. - The company initiated a Phase III clinical study for CM310 in patients with chronic rhinosinusitis with nasal polyps, achieving all primary endpoints with significant statistical differences[25]. - CM326, an anti-TSLP antibody, is undergoing Phase II clinical trials for moderate to severe atopic dermatitis and chronic rhinosinusitis with nasal polyps, with patient enrollment completed in 2023[31]. Market Expansion and Strategic Plans - Future outlook indicates a projected revenue growth of 30% for the next fiscal year, driven by new product launches and market expansion strategies[2]. - The company plans to expand its market presence in Southeast Asia, targeting a 15% market share within the next two years[2]. - Keymed is considering strategic acquisitions to enhance its R&D capabilities, with a budget allocation of $20 million for potential mergers and acquisitions[2]. - The commercial team is expected to grow to over 250 members by the end of 2024, focusing on key hospitals for rapid product sales[15]. Corporate Governance and Management - The company has a strong board of directors with members holding significant experience in biopharmaceuticals, including independent directors with extensive academic and industry backgrounds[110][111]. - The management team includes professionals with backgrounds in finance and technology, enhancing the company's strategic decision-making capabilities[106][109]. - The board consists of three executive directors, three non-executive directors, and three independent non-executive directors, ensuring a balanced governance structure[124]. - The company is committed to maintaining high standards of corporate governance and independent oversight to ensure strategic alignment and accountability[110][111]. ESG and Compliance - The company has released its 2023 Environmental, Social, and Governance (ESG) report, detailing its responsibilities and responses to key ESG issues of interest to stakeholders[165]. - The report is prepared in accordance with the ESG reporting guidelines issued by the Hong Kong Stock Exchange, ensuring transparency and accountability[167]. - The company has established risk management procedures to identify, assess, and manage significant risks, with senior management responsible for the risk reporting process[160]. - The company has implemented a robust anti-corruption framework, including training for employees and a whistleblower protection system[185]. Production and Operational Efficiency - Keymed's operational efficiency improved, with a reduction in production costs by 10% due to optimized supply chain management[2]. - The production capacity at the Chengdu facility is currently 18,600L, sufficient to meet the commercialization needs of CM310[18]. - The company is focusing on enhancing internal production capabilities to ensure high-quality antibody drug supply at reasonable costs[72]. - The company plans to expand its cGMP-compliant production capacity to meet increasing demand for candidate drug production[78].

Investment Rating - The investment rating for the company is "Buy" and is maintained [5][6]. Core Insights - The company reported a total revenue of 354 million CNY for the year 2023, which includes collaboration income generated from the authorization to AZ. The adjusted net loss for 2023 was 318 million CNY, compared to a loss of 255 million CNY in the previous year. The total R&D expenditure for 2023 was 596 million CNY, up from 507 million CNY in 2022 [5][6]. - The core product CM310 has submitted a marketing application for adult moderate to severe atopic dermatitis and has been accepted, marking the company’s entry into a new commercialization cycle. The product has shown promising efficacy data in clinical trials [5][6]. - The company has also made progress with CMG901, which has demonstrated potential in treating gastric and gastroesophageal junction cancers, and has received orphan drug designation and fast track designation from the FDA [6]. Summary by Sections Financial Performance - In 2023, the company achieved a revenue of 354 million CNY, with an adjusted loss of 318 million CNY and R&D expenses of 596 million CNY [5][6]. Product Pipeline - CM310 has completed its Phase III clinical trials for adult moderate to severe atopic dermatitis, achieving an EASI-75 responder rate of 66.9% and an IGA 0/1 rate of 44.2%. The product is also undergoing trials for chronic rhinosinusitis with nasal polyps and has initiated studies for adolescent atopic dermatitis and seasonal allergic rhinitis [5][6]. - CMG901 has shown a confirmed objective response rate of 33% in patients with Claudin 18.2 positive gastric and gastroesophageal junction cancers, with a disease control rate of 70% [6]. Future Outlook - The company is expected to incur net losses of 768 million CNY, 633 million CNY, and 239 million CNY for the years 2024 to 2026, respectively, with corresponding EPS of -2.75, -2.26, and -0.85 CNY [6].

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]

Investment Rating - The investment rating for the company is "Buy" [1][4][10] Core Views - The commercialization of the core product, IL4R monoclonal antibody, is imminent, with significant domestic sales potential anticipated [1][5] - The company has submitted a listing application for its product, CM310, which is expected to be approved in the second half of 2024, making it the first domestically approved IL4R monoclonal antibody [1][5] - The company has a robust pipeline with multiple ongoing clinical trials, including CMG901, which has entered global multi-center Phase 3 clinical trials [1][5] - Financially, the company reported a revenue of 354 million yuan in 2023, a 254% increase, primarily driven by collaboration income from AstraZeneca [7][11] Summary by Relevant Sections Financial Performance - Revenue for 2023 was 354 million yuan, up 254% from 2022, while net profit was a loss of 359 million yuan [2][11] - The company expects revenues to decline to 104 million yuan in 2024, followed by a significant increase to 649 million yuan in 2025 and 1.383 billion yuan in 2026 [2][11] - R&D expenses were 596 million yuan in 2023, an 18% increase, while management expenses rose by 32% to 177 million yuan [7][11] Product Pipeline - CM310 is in advanced stages with multiple indications, including adult and adolescent atopic dermatitis, chronic rhinosinusitis with nasal polyps, and allergic rhinitis [1][5] - CMG901 is being explored for various cancers, with promising early clinical data [1][5] - Other products in the pipeline include CM313, CM338, and several bispecific antibodies, all in various stages of clinical development [1][5] Cash Position - As of the end of 2023, the company had approximately 2.7 billion yuan in cash and cash equivalents, indicating a strong liquidity position to support ongoing product development [7][11] - The company plans to build a commercialization team of 200-300 people by the end of 2024 to support the launch of CM310 [9][11]

[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 ...

Investment Rating - The report maintains an "outperform" rating for Keymed Biosciences (2162 HK) [20][24][26] Core Insights - Keymed Biosciences reported a revenue of 354 million yuan in 2023, primarily from AstraZeneca's licensing agreement. R&D expenses were 596 million yuan, up 17.5%, while administrative expenses rose by 32.1% to 177 million yuan. The net profit attributable to the parent company was -359 million yuan, compared to a profit of 308 million yuan in 2022. As of December 31, 2023, the company's cash position totaled 2.72 billion yuan, a decrease of 460 million yuan from the previous year [17][24][25] - The core product CM310 (IL-4Ra) is on track for commercial launch in 2024, having received NDA acceptance and priority review. The company is preparing for high-quality production and building a commercialization team, aiming to expand from 30+ personnel to 200-300 by the end of 2024 [18][25] - CM310 is progressing in expanding its applicable age and indications, with five indications in the registrational clinical stage. The Phase III trial for chronic rhinosinusitis with nasal polyps has reached its primary endpoint, and the company expects to submit an NDA in 2024 [18][25] Financial Forecasts and Valuation - Revenue forecasts for 2024 and 2025 have been adjusted to 113 million yuan and 515 million yuan, respectively, reflecting a year-on-year change of -68% and +358%. The expected net profit for the same years is projected at -1.062 billion yuan and -959 million yuan [20][26] - The target price has been adjusted to 68.44 HKD per share, down from 77.52 HKD, using a DCF valuation method with a WACC of 10.0% and a perpetual growth rate of 3.0% [20][26]