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 ...

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 ...

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].

[ 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].

浦银国际研究 公司追踪 | 医药行业 康诺亚（2162.HK）：CM310 52 周数据 阳景 浦 首席医药分析师 银 和 CMG901 更新胃癌数据均符合预期 Jing_yang@spdbi.com 国 (852) 2808 6434 际 整体来说，公司近日披露的 CM310 中重度特应性皮炎 52 周数据和 胡泽宇，CFA CMG901 更新的 1b 期胃癌数据，与之前历史数据趋势一致，符合预 期，稳中向好。重申“买入”评级和目标价 58 港元。 医药分析师 ryan_hu@spdbi.com ● CM310（IL-4Rα）52周特应性皮炎疗效数据仍然维持较 Dupixent更 (852) 2808 6446 优的趋势，符合预期；52周用药病人抗药性目前看起来低于Dupixent， 令人惊喜：第52 周时，司普奇拜单抗（CM310）组（剂量:300mg Q2W） 2024年6月3日 EASI-75 达标率为 92.5%，IGA 评分为 0/1 分且较基线下降≥2 分达标 公 率为67.3%，EASI-90 达标率为77.1%，每日PP-NRS 评分周平均值较基 司 评级 线降低≥4 分，达标率为67.3% ...