证券研究报告 2024 年 07 月 07 日 行 业: 医药生物/生物制品 投资评级: 买入(维持) 当前价格: 38.90 港元 双抗国产化先锋,非肿瘤布局丰富 投资要点: 康方生物为国内首个国产双抗商业化落地的企业,布局肿瘤类双抗、自免 和降脂。公司 2012 年成立,现有过亿品种包括卡度尼利、派安普利 2 款抗 体药,其中宫颈癌药物卡度尼利首个完整年度销售额过 10 亿元;在研肺癌 药物依沃西对外授权首付款达到 5 亿美元,2024 年在国内上市并有望后续 在海外上市;非肿瘤领域 2024 年有望迎来 2 款自免和降脂药的上市批准。 ➢ 双抗药物市场商业化前景好 截至 2023 年底,FDA 一共批准 11 个双抗,其中 2022-2023 年批准 8 个双 抗,而 2010-2021 年仅批准 3 个双抗,双抗类药物商业化进程加速。2022/23 年 FDA 批准的双抗销售规模合计分别为 56.68/85.08 亿美元,其中肿瘤类 双抗规模约 7/12 亿美元,根据百济神州的预计到 2028 年肿瘤类双抗的市 场规模将达到 150 亿美元,2023-28 年 CAGR 达到 65%,双抗商业化价值高 ...

康方生物 (9926 HK) 1 年股价表现 7/23 11/23 3/24 7/24 -30% -20% -10% 0% 10% 20% 30%9926 HK 恒生指数 资料来源: FactSet 专家解读:看好依沃西海外成功率,安全性或成关键优势;重申买入 个股评级 买入 医药 2024 年 7 月 4 日 收盘价 目标价 潜在涨幅 港元 36.50 港元 70.00 +91.8% | 股份资料 | | |------------------------|-----------| | 52 周高位 (港元 ) | 51.95 | | 52 周低位 (港元) | 31.25 | | 市值 ( 百万港元 ) | 31,508.63 | | 日均成交量 (百万) | 5.14 | | 年初至今变化 (%) | (21.34) | | 200 天平均价 (港元 ) | 44.40 | | | | 财务数据一览 | 年结 12月31 日 | 2022 | 2023 | 2024E | 2025E | 2026E | |--------------------------------|----------|----- ...

港股通 决胜肺癌,依沃西单抗带来新曙光 | 华泰研究 | 深度研究 | 投资评级(维持 ): | 买入 | |---------------------------------------|--------------|---------------------|--------| | 2024 年 6 月 26 日│中国香港 | 生物医药 | 目标价 (港币): | 60.54 | 依沃西单抗获得两大临床阳性结果,维持公司"买入"评级 近日,公司连续披露两项 PD-1/VEGFR 双抗依沃西单抗的 III 期临床结果, 在 PD-L1 TPS ≥ 1%的 NSCLC 患者中头对头击败帕博利珠单抗(全球首个 在 III 期临床单药头对头胜出的 PD-1 抗体)、和在 EGFR-TKI 耐药 NSCLC 患者中取得 PFS 7.1 vs 4.8 月的显著获益。依沃西单抗于 5 月 24 日在国内 获批上市,我们预计其国内峰值销售额 71 亿元。我们预计 2024/2025/2026 年公司营收为 25.72/42.20/62.93 亿元,归母净利润为(3.60)/3.77/10.30 亿 元,对应 EPS (0 ...

Investment Rating - The report assigns a "Buy" rating for the company, with a target market price of HKD 35.5 and a total valuation of HKD 377 billion [3][4]. Core Insights - The company is positioned as a leading player in the dual antibody market, with significant advancements in internationalization and product commercialization, particularly with its innovative therapies targeting various cancers [5][6]. - The company has successfully launched multiple products, including AK105, AK104, and AK112, and is actively pursuing global market opportunities, especially for AK112 [5][6]. - The report highlights the company's strong growth trajectory, with projected revenues of CNY 24.73 billion, CNY 37.43 billion, and CNY 55.81 billion for 2024, 2025, and 2026, respectively [6]. Summary by Sections Company Overview - The company, established in 2012, focuses on developing innovative antibody drugs for major diseases, including cancer and autoimmune disorders. It has launched several products in the domestic market and is expanding its pipeline into non-cancer areas [13][14]. Product Pipeline - AK105 is the first commercialized product, approved for multiple indications, including first-line NSCLC and relapsed cervical cancer. The company has established partnerships for its overseas sales [22][25]. - AK104 is the world's first PD-1/CTLA-4 dual-specific antibody, recently approved for treating recurrent cervical cancer, with ongoing studies for additional indications [28][30]. - AK112 targets non-small cell lung cancer (NSCLC) and has received approval for its first indication, with further studies underway to expand its application [5][6]. Financial Projections - The company anticipates significant revenue growth driven by its product launches and international collaborations, with a total valuation of HKD 377 billion based on a segmented valuation approach [6][4].

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 70.00, indicating a potential upside of 59.1% from the current price of HKD 44.00 [1][2]. Core Insights - The company has achieved positive results in its Phase III clinical trial (AK112-303/HARMONi2) against Keytruda for PD-L1 positive NSCLC, demonstrating a significant improvement in progression-free survival (PFS) [1][2]. - AK112 is the first drug to show survival benefit improvement in a head-to-head Phase III trial against a PD-1 monotherapy, with expected hazard ratio (HR) below 0.7 [1][2]. - The company plans to submit a supplemental application for new indications to the National Medical Products Administration soon [1]. Summary by Sections Clinical Trial Results - The HARMONi-A study reported a median PFS of 7.1 months for the treatment group (AK112 + chemotherapy) compared to 4.8 months for the control group, with an HR of 0.46 (P<0.001) [5]. - Subgroup analyses showed significant PFS benefits across various patient populations, including those with brain metastases and specific mutations [7][9]. Financial Projections - Revenue is projected to grow from RMB 838 million in 2022 to RMB 4,526 million in 2023, with a subsequent decline to RMB 3,097 million in 2024, followed by recovery in the following years [12]. - The net profit is expected to turn positive in 2023, reaching RMB 2,220 million, before experiencing fluctuations in the following years [12]. Market Position - The company is positioned as a leading player in the biopharmaceutical sector, with a market capitalization of HKD 37,983 million and a significant trading volume [3][11]. - The report highlights the company's strong potential in the global market, particularly in the oncology segment, following the successful trial results [2][5].

感谢大家来参加公司的电话会议我是中兴电头的医药分析师贺居英那么首先要非常恭喜公司那么根据公司的公告我们也看到AK12这个一线头对头K药的三期临床取得了非常好的成绩无论是PFS还是这个HFV都 有一个非常好的表现同时我们也要非常感谢公司我想昨天晚上公司的管理层和很多同事可能都是没有休息的但是还是在今天早上第一时间来召开了这个针对全市场投资人的这样一个公开的电话会议那么今天跟我一起主持的还有我们团队制药和生物科技的首席原金会和分析师沈亿 以及来自中京、中信、国军、华泰和里昂的各位分析师那我接下来就把接下来的环节交给秦慧秦慧主持接下来的环节好的 谢谢何老师那我们也是看到康康生物这个公告非常鼓舞人心然后因为今天夏博士跟李博士也在美国之间开会时间比较紧张那我们的环节就先让夏博士 来跟我们开场的发言然后我们进入QA的环节下面我把时间交给夏博士好的 谢谢清慧你们能听清楚我说话吧非常清楚好呀 谢谢清慧也谢谢各位投行咱们的分析师在很短的 真的可能就是昨天我们半夜我印象中是半夜之后才 发出的邀请今天就来帮我们组织了这个大会也谢谢各位一直关心支持我们的投资人今天也是在第一时间看到我们有一个这样的会议来参加我们这个会议最近以来大家也 ...

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 63, indicating a potential upside of 43% from the current price of HKD 44 [4][5]. Core Insights - The interim analysis of the AK112 head-to-head trial against Keytruda (K drug) for the treatment of 1L PD-L1+ NSCLC has shown positive results, aligning with expectations and driving a significant rebound in the company's stock price [2][3]. - The specific interim analysis data from the HARMONi-2 trial is expected to be presented at the WCLC 2024 conference in September, which could further influence market sentiment [3]. - The success of the HARMONi-2 trial is anticipated to accelerate the company's ongoing trials and open up new potential combination therapies, although the commercial potential in the 1L NSCLC market remains to be clarified by the results of the HARMONi-3 trial [3]. Financial Projections - Revenue is projected to grow significantly from RMB 838 million in 2022 to RMB 6,200 million by 2026, with a notable increase of 440.3% in 2023 [7][8]. - The company is expected to return to profitability with a net profit of RMB 1,501 million by 2026, following a loss of RMB 1,168 million in 2022 [7][8]. - The price-to-sales (PS) ratio is forecasted to decrease from 35.1 in 2022 to 5.0 by 2026, indicating improved valuation metrics as the company scales [7][8].

证券研究报告 | 2024年06月02日 康方生物（09926.HK） 优于大市 AK112 头对头 K 药达到优效，有望成为免疫治疗新基石  公司研究·海外公司快评  医药生物·生物制品  投资评级：优于大市（维持） 证券分析师： 张佳博 021-60375487 zhangjiabo@guosen.com.cn 执证编码：S0980523050001 证券分析师： 陈益凌 021-60933167 chenyiling@guosen.com.cn 执证编码：S0980519010002 证券分析师： 陈曦炳 0755-81982939 chenxibing@guosen.com.cn 执证编码：S0980521120001 事项： 康方生物的核心产品PD-1xVEGF双抗依沃西（AK112）在近期取得了一系列重要的研发和监管进展： 1）AK112获得中国药监局批准上市，适应症为联合化疗治疗EGFR-TKI进展的EGFRm nsqNSCLC； 2）AK112在ASCO年会上披露联合化疗治疗EGFR-TKI进展的EGFRm nsqNSCLC的3期临床数据； 3）AK112头对头帕博利珠单抗一线治疗PD- ...

Investment Rating - The report maintains an "Accumulate" rating for the company [1][3]. Core Insights - The company is entering a harvest period as its R&D pipeline accelerates, with revenue forecasts for 2024-2026 raised to 28.96 billion, 45.25 billion, and 63.86 billion RMB, respectively [3]. - The drug Ivoris has shown positive results in head-to-head trials against Keytruda (K drug) for PD-L1 positive patients, marking a significant advancement in treatment options [3]. - Ivoris has recently received approval from NMPA for its first indication, and multiple core indications are progressing [3]. - The company is actively developing its pipeline with several monoclonal antibodies and ADCs in various stages of clinical trials [3]. Summary by Sections Investment Rating - The company is rated "Accumulate" based on its strong market performance expectations [1][3]. Revenue Forecast - Revenue projections for 2024, 2025, and 2026 have been adjusted to 28.96 billion, 45.25 billion, and 63.86 billion RMB, respectively, indicating a positive growth outlook [3]. Clinical Development - Ivoris has outperformed K drug in a Phase III trial, achieving significant improvements in overall response rate (ORR) and progression-free survival (PFS) [3]. - The company has initiated several Phase III clinical trials for Ivoris in various lung cancer indications, with expected completion of enrollment in the second half of 2024 [3]. Pipeline and Long-term Growth - The company is advancing multiple monoclonal antibodies and ADCs, with several candidates in NDA and Phase III stages, ensuring a robust pipeline for future growth [3].

感谢大家参加本次会议会议即将开始,稍后 大家好欢迎参加康方生物业务更新会目前所有产物较均处于静音状态下面开始播报面条声明声明播报完毕后主持人可直接开始发言谢谢 本次会议为中信建筑证券股份有限公司中信建筑协助上市公司组织的白名单会议仅限受邀嘉宾参会本次会议内容在任何情形下都不构成对会议参加者的投资建议敬请会议参加者充分了解各类投资风险根据自身情况自主做出投资决策并自行承担投资风险 未经中信箭头和演讲嘉宾许可任何机构和个人不得以任何形式将会议内容和相关信息对外公布转发转载传播复制编辑修改等如有上述违法行为中信箭头保留追究相关方法律责任的权利康方生物的各位领导各位投资人大家早上好非常感谢大家来参加公司的电话会议我是中信箭头的医药分析师贺菊颖 那么首先要非常恭喜公司那么根据公司的公告我们也看到AK12这个一线投对投K1的三期临床取得了非常好的成绩无论是PFS还是Hazard Visual都有一个非常好的表现同时我们也要非常感谢公司我想昨天晚上公司的管理层和很多同事可能都是没有休息的但是还是在今天早上第一时间 来召开了这个针对全市场投资人的这样一个公开的电话会议那么今天跟我一起主持的还有我们团队制药和生物科技的首席袁钦 ...