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康方生物:全球首个头对头Keytruda单药III期取得PFS优效结果,重申买入评级
交银国际证券· 2024-06-04 09:01
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].
康方生物AK112vsK药头对头交流
2024-06-03 03:44
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 ...
康方生物:AK112头对头K药成功,符合预期,推动股价反弹
浦银国际证券· 2024-06-03 02:01
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].
康方生物:AK112头对头K药达到优效,有望成为免疫治疗新基石
国信证券· 2024-06-02 06:02
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- ...
康方生物公司跟踪点评:依沃西头对头战胜K药,研发布局迎来收获期
国泰君安· 2024-05-31 10:31
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].
康方生物20240531
2024-05-31 05:08
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 ...
康方生物公司跟踪点评:依沃西获批上市,ASCO展现显著PFS获益
国泰君安· 2024-05-28 08:32
股 票 研 究 [Table_industryInfo] 医药 [ Table_Main[ 康 TIna 方fbole] 生 _T 物itle (] 9926) [评Tab级le_:Inv est] 增持 当前价格(港元): 35.40 依沃西获批上市,ASCO 展现显著 PFS 获益 2024.05.28 海 ——康方生物公司跟踪点评 [ 交Ta易bl数e_据M arket] 外 丁丹(分析师) 甘坛焕(分析师) 姜铸轩(研究助理) 52周内股价区间(港元) 31.25-51.95 当前股本(百万股) 866 公 0755-23976735 021-38675855 021-38674878 当前市值(百万港元) 30,651 司 dingdan@gtjas.com gantanhuan028803@gtjas.com jiangzhuxuan029022@gtjas.com 证书编号 S0880514030001 S0880523080007 S0880123100004 ( [ Table_PicQuote] 中 本报告导读: 52周内股价走势图 国 依沃西获批上市,ASCO数据展现显著PFS获益趋势, ...
康方生物20240524
2024-05-25 09:58
【康方生物】交流纪要(2024-05-24): 一、EGFR TKI耐药ASOO数据:PFS、OS双阳性结果 1、OS趋势线两条完全分开非常漂亮的曲线,我们是唯一做出阳性的。我们给药 监局看到了OS的曲线,才会这么快获批。 2、对脑转移控制非常好(入组的脑转移患者更加贴近真实世界情况)。 3、80%入组患者是三代EGFR TKI耐药。所有亚组分析是很优秀的。 4、HR值是目前最好的0.46,这才是三期对照试验的关键数据。信达orient-31 HR 是0.51(三代EGFR TKI而药患者是38%)OS曲线是重合的,没有分开; checkmate(没有加贝伐珠单抗)是0.75(三代EGFR TKI耐药患者23%)。用了一代 再用三代的患者身体状态是很差的,是远差于只用一代、二代的患者的。 二、后续临床布局双抗ADC,以及单药头对头K药数据快读出 1、单药头对头K药数据快要出结果了,可以更好的看出跟K药的优势。三代 EGFR TKI耐药只是小试牛刀,后续的适应症试验会持续跟进,后续开发不会 止于此。 2、ADC自己做了平台,三季度进入IND,双抗NECTIN-4ADC、TROP2 ADC明年 进入IND,双抗+ ...
康方生物午间交流
2024-05-25 05:50
此会议为中信剑投证券股份有限公司中信剑投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各位好 各位好 我是那个康康生物的夏博士 我想看看你们是不是都能听得到我说话因为我也是在一个就是会议上就是上来拿着手机在打电话我怕你们听不到都能听到吧夏伯春您好我是建筑研究会非常清楚好呀那太好了那我们这个会议就开始了上线了的各位投资人也应该都是关心我们双方生物的 我们的这个支持者我也不知道我该说什么好今天的这个场景是的的确确把我也吓了一跳因为本来是觉得一切都是好消息我是指望着说是走另外一个方向的的确也是看到了咱们的股市的变化多端结果走的是另外一个方向就是蛮有趣的 但是首先想给大家来说一下一个很好的消息就是我们今天早上在CDE就是在咱们中国药监局的官方网站上已经发出了我们的112借着我们的第一个试验证你们也知道我们后面还有很多 ...