[ T able_StockInfo] 2024 年 08 月 28 日 证券研究报告•2024 年半年报点评 当前价：32.55 港元 康诺亚-B（2162.HK）医疗保健 目标价：——港元 自免双抗授权，期待 CM310 上市 基础数据 [Table_BaseData] 52 周区间(港元) 27.45-61.65 3 个月平均成交量(百万) 0.78 流通股数(亿) 2.80 市值(亿) 91.05 [Table_Summary 事件：公司发布] 2024 半年度报告，2024 上半年收入达 0.5 亿元，主要来源于 阿斯利康支付的 CMG901 项目第一笔研发里程碑付款。 CM310三项适应症处于 NDA阶段，即将迎来密集落地期。CM310治疗成人中 重度特应性皮炎的新药上市申请于 2023年 12月获 CDE 受理，治疗青少年中重 度特应性皮炎的注册行临床于 2024 Q1启动。CM310治疗慢性鼻窦炎伴鼻息肉 的药品上市许可申请于 2024年 6月获国家药监局受理，并纳入优先审评审批程 序。CM310治疗 SAR适应症的Ⅲ期临床试验达到主要终点，NDA 申请于 2024 年 4 月获 CDE 受理 ...

Investment Rating - The report maintains a "Buy" rating for the company 康诺亚 (2162 HK) with a target price of HKD 66.00, indicating a potential upside of 105.9% from the current closing price of HKD 32.05 [1][7]. Core Insights - The company is steadily advancing its commercialization preparations for CM310 and pipeline research, with sufficient cash reserves to support operations for the next 3-4 years. The target price has been slightly adjusted downwards due to revised sales forecasts for 2025-26, but the "Buy" rating remains intact [1][2]. - In 1H24, the company reported revenues of RMB 0.55 billion, primarily from a collaboration with AstraZeneca related to CMG901. The net loss increased to approximately RMB 3.9 billion, attributed to rising R&D and sales expenses [2][3]. - CM310 has submitted three indications for NDA approval, with expectations for approval for atopic dermatitis by year-end. The company is also focusing on developing additional indications and expanding its clinical pipeline [2][3]. Financial Model Update - Revenue forecasts for 2024E have been reduced to RMB 78 million, reflecting a 27.7% decrease from previous estimates. For 2025E and 2026E, revenue forecasts are RMB 788 million and RMB 1.404 billion, respectively, with slight adjustments of -1.0% and -2.8% [3][9]. - The gross profit for 2024E is projected at RMB 73 million, with a gross margin of 93.2%, which is a decrease of 6.8 percentage points from prior estimates [3][9]. Cash Flow and Capital Expenditure - As of 1H24, the company holds cash reserves of RMB 2.58 billion, which is expected to support operations for the next 3-4 years. The capital expenditure budget for the year is approximately RMB 200 million, mainly for the construction of a new headquarters and the development of drug platforms [2][9]. Clinical Pipeline Development - The company is advancing its clinical pipeline with multiple indications for CM310 and other candidates like CD38 monoclonal antibody CM313 and CM383, which have shown promising preclinical results [2][3].

Financial Performance - Revenue for the six months ended June 30, 2024, was RMB 54,682 thousand, a decrease of 83% compared to RMB 327,124 thousand for the same period in 2023[2] - Gross profit for the same period was RMB 50,946 thousand, down 84% from RMB 312,107 thousand year-on-year[2] - The net loss for the six months ended June 30, 2024, was RMB 336,603 thousand, representing a 799% increase in losses compared to a profit of RMB 48,145 thousand in the same period of 2023[2] - Adjusted net loss, excluding share-based payment expenses, was RMB 318,969 thousand, a 600% increase from a profit of RMB 63,828 thousand in the prior year[3] - The company's revenue for the six months ended June 30, 2024, was RMB 54,682 thousand, a decrease of 83.3% compared to RMB 327,124 thousand for the same period in 2023[64] - Gross profit for the same period was RMB 50,946 thousand, down 83.7% from RMB 312,107 thousand in 2023[64] - Research and development expenses increased to RMB 331,026 thousand, up 32.5% from RMB 249,757 thousand in the previous year[64] - The company reported a loss of RMB 336,603 thousand for the period, compared to a profit of RMB 48,145 thousand in 2023[64] Research and Development - Research and development expenses increased by 33% to RMB 331,026 thousand from RMB 249,757 thousand in the previous year[2] - The company advanced its core pipeline product, CM310, completing Phase III clinical trials for chronic rhinosinusitis with nasal polyps and seasonal allergic rhinitis[4] - The drug application for CM310 for chronic rhinosinusitis was accepted for priority review by the National Medical Products Administration in June 2024[4] - Long-term efficacy and safety data for CM310 in treating moderate to severe atopic dermatitis were presented at the EAACI annual meeting in June 2024, showing an EASI-75 response rate of 92.5%[5] - The company is currently enrolling patients for ongoing Phase III clinical studies of CM310 in various indications, including atopic dermatitis and prurigo nodularis[4] - The company has initiated key Phase II/III clinical studies for CM310, a monoclonal antibody for treating moderate to severe asthma and chronic obstructive pulmonary disease in China[6] - For CMG901/AZD0901, an international Phase III study has been launched, showing an objective response rate (ORR) of 35% and a disease control rate (DCR) of 70% among 89 evaluable patients with Claudin 18.2 positive gastric cancer[6] - The company is advancing a Phase I/II clinical study for CM313, a CD38 antibody, in relapsed/refractory multiple myeloma and lymphoma, with ongoing evaluations of safety and preliminary efficacy[7] - In a study of CM313 for immune thrombocytopenia, 95.5% of patients achieved a platelet count of ≥50 × 10^9/L within 8 weeks, with a durable response rate of 63.6%[7] - The company has initiated a Phase II clinical study for CM326, a TSLP antibody, targeting chronic rhinosinusitis with nasal polyps, with patient enrollment currently ongoing[8] - CM355, a CD20xCD3 bispecific antibody, is in an ongoing Phase I/II trial for relapsed or refractory non-Hodgkin lymphoma, showing promising preliminary efficacy in follicular lymphoma and diffuse large B-cell lymphoma patients[9] - CM336, a BCMAxCD3 bispecific antibody, is in the dose expansion phase of its Phase I/II clinical study for relapsed or refractory multiple myeloma[10] - CM350, a GPC3xCD3 bispecific antibody, is also in the dose escalation phase of its Phase I/II clinical study for advanced solid tumors[11] - The company is advancing a Phase I clinical trial for CM369 in patients with advanced solid tumors and relapsed or refractory non-Hodgkin lymphoma (NHL) in the first half of 2024[12] - The company has submitted a clinical trial application for CM380 and plans to conduct a multicenter, open-label Phase I/II clinical study for patients with relapsed or refractory multiple myeloma[12] - The company is focused on developing its core product, CM310, and is actively pursuing regulatory approvals and market expansion strategies[94] Financial Position - The cash and cash equivalents as of June 30, 2024, were RMB 2,576,748 thousand, a decrease of 5% from RMB 2,719,186 thousand as of December 31, 2023[2] - Total current assets as of June 30, 2024, were RMB 2.788 billion, a decrease from RMB 2.939 billion as of December 31, 2023[47] - The total liabilities increased to RMB 1.168 billion from RMB 896.109 million, indicating a rise in financial obligations[47] - Cash and cash equivalents decreased to RMB 2.577 billion from RMB 2.719 billion, primarily due to cash used in daily operations[48] - As of June 30, 2024, the company's debt-to-asset ratio increased to 31%, up from 23% as of December 31, 2023, representing an 8 percentage point increase[51] - The company has capital commitments of RMB 223 million for the acquisition or construction of properties, plants, and equipment as of June 30, 2024[52] - The company has pledged machinery and equipment valued at RMB 441 million, along with construction in progress and land use rights totaling RMB 80 million, to secure bank borrowings[53] - The company has no contingent liabilities as of June 30, 2024[52] Strategic Initiatives - In July 2024, the company entered into a licensing agreement with Belenos, granting exclusive rights to develop, manufacture, and commercialize CM512 and CM536 outside Greater China, with an upfront payment of $15 million and potential additional payments of up to $170 million[12] - The company is actively exploring strategic partnerships for co-development and licensing to maximize the commercial value of its drug candidates[41] - The company plans to expand its cGMP-compliant production capacity to meet increasing production demands for candidate drugs[41] - The company has 11 clinical-stage candidates in internal development, leveraging its innovative antibody discovery platform and new T cell engagers (nTCE) technology[13] - The company operates primarily in the biopharmaceutical research and development sector, with no further segment analysis provided as it is considered a single reportable segment[75] Market Outlook - The company provided a future outlook projecting a revenue growth of 10% for the next fiscal year, driven by new product launches[96] - The company is expanding its market presence in Southeast Asia, targeting a 30% market share by 2025[96] - A strategic acquisition of a biotech firm was announced, expected to enhance the company's R&D capabilities and product pipeline[97] - The company plans to launch two new products in Q4 2024, anticipated to contribute an additional 200 million USD in revenue[96] - A new partnership with a leading pharmaceutical company was established to co-develop innovative therapies, enhancing competitive positioning[97]

Investment Rating - The report maintains a "Buy" rating for the company, considering its core pipeline is nearing approval and the progress of its R&D pipeline is positive [3] Core Views - The company has entered into a licensing agreement with Belenos Biosciences, granting exclusive rights for the research, development, registration, production, and commercialization of two bispecific antibodies (CM512 and CM536) outside Greater China [2] - The company will receive an upfront payment of $15 million and a 30.01% equity stake in Belenos, with potential additional payments of up to $170 million based on development, regulatory, and commercial milestones [2] - The company's R&D pipeline is differentiated and progressing well, with CM310 (IL4Rα) expected to be approved in China for adult moderate-to-severe atopic dermatitis this year, and other indications such as chronic rhinosinusitis with nasal polyps and seasonal allergic rhinitis also progressing [2] - CMG901 (CLDN 18.2 ADC) has global rights granted to AstraZeneca, with a global Phase III trial for second-line gastric cancer completed in April 2024 [2] - Other pipeline candidates, including CM326 (TSLP), CM338 (MASP-2), CM313 (CD38), and several CD3 bispecific antibodies, are also advancing through clinical trials [2] Financial Forecasts and Valuation - The company's revenue is projected to be RMB 224 million, RMB 532 million, and RMB 1.216 billion for 2024, 2025, and 2026, respectively [3] - Using a DCF valuation method with a perpetual growth rate of 2% and a WACC of 9.46%, the company's fair equity value is estimated at RMB 16.3 billion, equivalent to HKD 17.6 billion (exchange rate: RMB 1 = HKD 1.08) [3] - The company's gross margin is expected to remain stable, ranging from 89.44% to 91.00% from 2024 to 2026 [4] - Net profit attributable to shareholders is forecasted to be negative, with losses of RMB 704 million, RMB 772 million, and RMB 512 million for 2024, 2025, and 2026, respectively [4] - ROE is expected to remain negative, ranging from -30.7% to -50.4% over the same period [4]

Investment Rating - The report maintains an "Overweight" rating for the company [3][12]. Core Views - The company recently updated the Phase I follow-up data for CMG901, demonstrating initial efficacy and manageable safety. The Phase III 52-week follow-up data for CM310 shows excellent results, with expectations for approval by the end of the year, contributing to future performance [3]. - Revenue forecasts for 2024-2026 are maintained at 156 million, 526 million, and 1.441 billion RMB respectively, reflecting significant growth [3]. Summary by Sections Clinical Data - CMG901's Phase I trial shows preliminary efficacy with a median follow-up of 10.1 months, including 133 G/GEJ patients. The overall response rate (ORR) for evaluable Claudin 18.2 high-expressing patients is 33%, with a disease control rate (DCR) of 70% [3]. - The safety profile indicates that 55% of patients experienced grade 3 or higher treatment-related adverse events (TRAE), with 8% discontinuing due to TRAE [3]. Product Pipeline - CM310 is expected to receive approval by the end of 2024, with promising data from its Phase III trial for moderate to severe atopic dermatitis (AD) showing an EASI-75 of 92.5% compared to 88.7% for the control group [3]. - Other indications are progressing steadily, including trials for adolescent AD and chronic rhinosinusitis with nasal polyps (CRSwNP) [3]. Financial Overview - The company reported a revenue of 100 million RMB in 2023, with projections of 354 million in 2024 and 1.441 billion in 2026, indicating a significant growth trajectory [7]. - The gross profit for 2023 is estimated at 317 million RMB, with net losses projected to decrease from 637 million in 2024 to 419 million in 2026 [7].

Investment Rating - The report maintains a "Buy" rating for the company with a target price of 58 HKD, indicating a potential upside of 84% from the current price of 31.5 HKD [2][4][5]. Core Insights - The recent data for CM310 (treatment for moderate to severe atopic dermatitis) and CMG901 (treatment for gastric cancer) align with historical trends and expectations, showing stable and positive results [2][3]. - CM310 demonstrates superior efficacy compared to Dupixent, with a 52-week EASI-75 response rate of 92.5% and a significant reduction in patient-reported outcomes [3]. - CMG901 shows promising results in gastric cancer, with an overall objective response rate (ORR) of 35% and a disease control rate (DCR) of 70% in a cohort of patients with high CLDN18.2 expression [3]. Summary by Sections CM310 Efficacy Data - CM310's 52-week data shows a lower rate of drug resistance compared to Dupixent, with serious adverse events at 5.1% and severe treatment-emergent adverse events at 2.9% [3]. - The treatment group exhibited a 67.3% rate of achieving a significant reduction in daily pain scores [3]. CMG901 Clinical Data - The updated 1b phase data for CMG901 indicates an ORR of 35% and a DCR of 70%, with the 2.2 mg/kg dose group achieving an ORR of 48% [3]. - The median progression-free survival (mPFS) is reported at 4.8 months, and median overall survival (mOS) at 11.8 months [3]. Future Catalysts - Key upcoming catalysts include the expected approval of CM310 for adult atopic dermatitis by the end of 2024 and the submission for chronic rhinosinusitis with nasal polyps in mid-2024 [3]. - Additional important data readouts are anticipated for CM326 and CM313 in 2024 [3].

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].