业绩简评 2024 年 8 月 28 日，公司发布半年度业绩，1H24 实现营收 10.25 亿元，同比下降 72%（1H23 和 1H24 当期确认的许可费收入分别为 29.15 亿元和 0.80 亿元）；其中，产品销售收入 9.39 亿元，同比 增长 23.96%；1H24 亏损 2.49 亿元。业绩符合预期。 经营分析 商业化强劲：卡度尼利增长，依沃西首月告捷，2 款新品获批在即。 （1）2024 上半年，产品收入 9.39 亿元，同比增长 23.96%。其中， 开坦尼（卡度尼利）收入 7.06 亿元，较 1H23 的 6.06 亿元收入， 同比增长16.50%。1H24公司收到/确认许可费收入0.85/0.80亿元， 主要来自 Summit 支付的依沃西拓展许可市场范围的授权许可首付 款（2）报告期内，①依沃西，于 2024 年 5 月 24 日首次获批上市， 用于治疗 EGFR-TKI（表皮生长因子受体-酪氨酸激酶抑制剂）治疗 进展后的 EGFR 突变的局部晚期或转移性非麟非小细胞肺癌患者； 获批一周内，即实现首批发货，一个月左右实现收入 1.03 亿元。 ②派安普利单抗，于 2024 年 4 月 ...

华福证券 康方生物（09926.HK） 依沃西头对头 K 药成功，一线肺癌 NDA 获受理 投资要点： 卡度尼利稳定增长，依沃西肺癌 TKI 耐药获批贡献业绩增量 24H1 实现收入 10.2 亿元（-72.13%），其中产品销售收入 9.39 亿元 （+23.96%）。分产品看：卡度尼利实现收入 7.06 亿（+16.5%），依沃西 发货收入 1.03 亿元，其他产品收入 1.31 亿元。24H1 产品销售毛利为 8.58 亿元，产品毛利率高达 91.3%。销售费用 5.16 亿元（同比+16.6%），研发 费用 5.94 亿元（同比+3.4%），净亏损 2.49 亿。公司研发高效，4 个新适 应症 NDA 已递交并审评、5 款产品新启动 7 个三期临床(包括 3 个新产品）。 卡度尼利在 1L 胃癌和 1L 宫颈癌全人群获益，将填补临床空白 1）1L 胃癌：NDA 于今年 1 月获 NMPA 受理，是目前唯一在 PD-1 低表达 人群做出 OS 获益的 IO 产品。2）1L 宫颈癌：NDA 于 4 月获 NMPA 受理， III 期研究已达到 PFS 和 OS 双主要终点，是目前唯一在全人群获益的 3 期 ...

Financial Performance - Total revenue for the six months ended June 30, 2024, was RMB 1,024.7 million, a significant decrease from RMB 3,676.9 million for the same period in 2023[1]. - Gross profit for the six months ended June 30, 2024, was RMB 943.2 million, down from RMB 3,599.7 million in the same period last year[2]. - The company recorded a loss of RMB 249.3 million for the six months ended June 30, 2024, compared to a profit of RMB 2,489.5 million in the previous year[3]. - Other income and net gains for the six months ended June 30, 2024, were RMB 211.8 million, down from RMB 380.1 million in the same period in 2023[42]. - The company reported a loss before tax of RMB 249,348 thousand for the six months ended June 30, 2024, compared to a profit of RMB 2,489,544 thousand in the same period of 2023[72]. - The basic loss per share for the current period was RMB (0.28), compared to earnings of RMB 3.01 per share in the previous year[74]. - The company did not declare or pay any dividends for the six months ended June 30, 2024, consistent with the previous year[97]. Revenue Sources - Product revenue increased by 23.96% to RMB 939.4 million compared to RMB 757.9 million in the previous year[1]. - Sales of the product Akeso® (Cadonilimab) reached approximately RMB 705.7 million, a 16.50% increase from RMB 605.8 million in the same period last year[7]. - The main revenue source was from Kadtunili® (Cardunili, PD-1/CTLA-4), generating RMB 705.7 million, up 16.50% from RMB 605.8 million in the previous year[39]. - Revenue from licensed fees for the six months ended June 30, 2024, was RMB 85,318,000, a substantial drop from RMB 2,918,988,000 in the same period of 2023[86]. - Revenue from customers in mainland China for the six months ended June 30, 2024, was RMB 938,131,000, up from RMB 756,189,000 in 2023, reflecting an increase of approximately 24.0%[89]. Research and Development - The company has over 50 innovative projects in development, with 10 products in commercialization or Phase III clinical trials[5]. - The company is actively pursuing clinical development for Ivosidenib in various indications, including a Phase III trial for biliary cancer and another for pancreatic cancer[16]. - The company is advancing multiple clinical trials, including AK111 (IL-17) for psoriasis and ankylosing spondylitis, and AK120 (IL-4Rα) for moderate to severe atopic dermatitis[21]. - The company is focusing on expanding its ADC platform, with IND applications submitted for AK138D1 (HER3 ADC) for late-stage malignancies[37]. - The company is committed to advancing its clinical development and exploration of various therapeutic areas, ensuring efficient progress across its pipeline[22]. Clinical Trials and Approvals - The sNDA for Cadonilimab as a first-line treatment for gastric cancer was accepted by NMPA in January 2024, with positive Phase III trial results presented at the AACR annual meeting[8]. - Cardinili has entered the third phase of clinical trials for its combination therapy with chemotherapy for advanced gastric and gastroesophageal junction cancer, with the first patient enrolled[11]. - The company received approval for the new drug Yida Fang® (Ivosidenib) for treating locally advanced or metastatic non-squamous NSCLC after progression on EGFR-TKI therapy, marking its second core dual antibody entering commercialization[12][13]. - The company has initiated a Phase III clinical trial for the combination therapy of AK117 (CD47) and other agents in head and neck squamous cell carcinoma[20]. - The company is currently enrolling patients for a study involving AK117 combined with chemotherapy for first-line gastric cancer[26]. Market Expansion and Strategy - The company expects to become a global leader in biopharmaceuticals through innovative R&D and commercialization platforms[5]. - The company is preparing for commercialization of its products by developing comprehensive business plans considering patient affordability, market accessibility, and competitive landscape[20]. - The company is actively pursuing market expansion and new product development strategies, focusing on immunotherapy and metabolic disease treatments[29]. - The company aims to enhance its market presence globally, leveraging innovative therapies to benefit patients worldwide[38]. - The company is expanding its commercialization team to enhance hospital and commercial insurance access, aiming to explore more clinical opportunities with its core bispecific products[38]. Financial Position - As of June 30, 2024, the group's current assets totaled RMB 6,746.5 million, with cash and cash equivalents, time deposits, and financial products amounting to RMB 5,693.6 million, an increase of RMB 799.2 million from RMB 4,894.4 million as of December 31, 2023[49]. - The group has pledged assets and land use rights totaling RMB 1,301.2 million to secure its loans and bank credit facilities as of June 30, 2024[51]. - The group's capital commitments as of June 30, 2024, were RMB 778.5 million, up from RMB 770.0 million as of December 31, 2023, primarily for the construction of world-class production facilities[57]. - The company's total assets minus current liabilities reached RMB 9,049,598 thousand, compared to RMB 7,976,508 thousand in 2023, indicating an increase of approximately 13.46%[75]. - The company’s total current liabilities rose to RMB 1,409,717 thousand, up from RMB 1,204,582 thousand, reflecting an increase of about 17.03%[75]. Employee and Operational Metrics - As of June 30, 2024, the total number of employees is 2,815, with 642 in clinical roles and 575 in production and quality control[30]. - The total employee compensation cost was RMB 539.2 million, an increase from RMB 408.0 million as of June 30, 2023, primarily due to an increase in employee numbers[59]. - The company operates a total production capacity of 54,000 liters, with plans for continuous expansion to meet future clinical and commercialization needs[31]. - The Zhongshan Cuixing Kangfang Bay Technology Park has a planned production capacity exceeding 100,000 liters, equipped with advanced biopharmaceutical facilities[31]. - The company has established production facilities compliant with GMP requirements, supporting the entire drug development process from discovery to commercial production[31].

依沃西第二项适应症 NDA 受理，看好重磅潜力 2024 年 07 月 31 日 ➢ 事件：7 月 29 日，康方生物宣布，公司独立自主研发的全球首创 PD-1/VEGF 双抗依沃西单抗单药一线治疗 PD-L1 表达阳性（PD-L1 TPS≥1%）的局部晚期 或转移性 NSCLC 的新药上市申请已经获得中国国家药品监督管理局受理。 ➢ 单药头对头优于 K 药，一线 NSCLC 适应症潜力巨大。此次依沃西新适应症 上市申请是基于 HARMONi-2（AK112-303）研究。HARMONi-2 是一项评估 依沃西单药对比帕博利珠（K 药）单药一线治疗 PD-L1 表达阳性（PD-L1 TPS≥ 1%）的局部晚期或转移性 NSCLC 的注册性 III 期随机、双盲临床试验，共入组 398 例受试者，其中 PD-L1 TPS 1-49%的受试者占比为 57.8%，PD-L1 TPS≥ 50%的受试者占比为 42.2%，与真实世界患者表达水平分布一致。2024 年 5 月 31 日公司宣布 HARMONi-2 研究的期中分析已经取得了强阳性结果：在意向治 疗人群中，依沃西单抗单药相较于帕博利珠单抗单药显著延长了患者无 ...

国泰君安版权所有发送给上海东方财富金融数据服务有限公司.东财接收研报邮箱.ybjieshou@eastmoney.com p1 股 票 研 究 证 券 研 究 报 告 52周内股价走势图 -25% -15% -5% 6% 16% 27% 康方生物 恒生指数 2023/72023/82023/9 2023/102023/112023/122024/12024/22024/32024/42024/52024/6 ——康方生物公司跟踪点评 本报告导读： 投资要点： [Table_Report] 相关报告 | --- | --- | --- | --- | |----------|-------------------|----------------------------|------------------------------| | | 丁丹(分析师) | 甘坛焕(分析师) | 姜铸轩(研究助理) | | | 0755-23976735 | 021-38675855 | 021-38674878 | | | dingdan@gtjas.com | gantanhuan028803@gtjas.com | j ...

证券研究报告 医药生物 首次覆盖报告 2024 年 07 月 29 日 康方生物 (9926.HK) 买入（首次覆盖） ——打造新一代 I/O 创新药旗舰，强势出海未来可期 投资要点： 证券分析师 刘闯 S1350524030002 liuchuang@huayuanstock.com 康方生物 恒生指数 -29% -14% 0% 14% 29% 43% 57% 2023-07 2023-11 2024-03 相关研究 ➢ 持续进化的新一代创新药旗舰，两大 FIC 双抗加速驱动商业化。康方生物是一家集研究、开发、 生产及商业化的创新抗体新药于一体的生物制药公司，2020 年 4 月在港交所上市。两大核心 双抗 AK104(PD-1/CTLA4)和 AK112(PD-1/VEGF)已在国内获批上市，公司迈入创新收获期。 ➢ AK112(PD-1/VEGF)国内获批上市，两大临床均取得积极阳性结果，海外确定性逐渐明朗。 1）AK112-301(国内)/HARMONi(海外)：国内首个适应症 EGFR-TKI 进展的 NSCLC 已于 24 年 5 月获批上市，86%患者既往接受过 3 代 TKI 治疗，更符合真实 ...

[Table_Main] 证券研究报告 | 公司深度报告 康方生物(09926.HK) 2024 年 07 月 19 日 买入(维持) 所属行业:医疗保健业/药品及生物科技 当前价格(港币):40.25 港元 证券分析师 周新明 资格编号:S0120524060001 邮箱:zhouxm@tebon.com.cn 李霁阳 资格编号:S0120523080003 邮箱:lijy7@tebon.com.cn 市场表现 康方生物 恒生指数 -29% -14% 0% 14% 29% 43% 57% 2023-07 2023-11 2024-03 | --- | --- | --- | --- | |------------------|-------|--------|--------| | 恒 生 指 数 对比 | 1M | 2M | 3M | | 绝对涨幅(%) | -1.51 | -20.22 | -18.14 | | 相对涨幅(%) | -0.31 | -13.17 | -24.94 | 资料来源:德邦研究所,聚源数据 相关研究 1.《康方生物(9926.HK):管线矩阵丰 富,多个产品将获批,收入有望继续高 ...

大家好欢迎参加华福医药为什么我们看好康方收入深度报告解读及上市公司近况交流电话会目前所有参会者均处于静音状态下面开始播免责声明声明完毕后主持人可直接开始发言本次会议顶面向华福证券的专业投资机构客户或受邀客户第三方专家发言内容仅代表其个人观点所有信息或观点不构成投资建议 根据监管规定会议不得交流敏感内幕信息未经华福证券事先书面许可任何机构或个人严禁录音制作纪要转发转载传播复制编辑修改等涉嫌违反上述情形等我们将保留一切法律权利感谢您的理解和支持谢谢好的那个大家晚上大家下午好那个我是华福的医药研究员胜利华 首先非常感谢大家抽空参加我们今天下午的会议本次我们会议我们前段时间也发了康方生物的一个深度报告我们本次会议前20分钟将会对我们深度报告进行一个解读之后的时间我们也请到了咱们上市公司的IR的团队的领导们 那接下来的话大家就是各位投资者也可以就大家关心的问题上公司进行请教那接下来的话就是我们先进入到第一个环节就是请我的同事对我们刚刚外发的一个康康生物的深度报告进行一个解读好的 谢谢孙老师 大家好,我是华府药组的杨峰宇。因为篇幅有限,所以我们的深度报告里面阐述了三个问题,就是跟大家讨论一下。首先我想回顾一下科药的一个发 ...

大家好欢迎参加华福医药为什么我们看好康方收入深度报告解读及上市公司近况交流电话会目前所有参会者均处于静音状态下面开始播免责声明声明完毕后主持人可直接开始发言本次会议顶面向华福证券的专业投资机构客户或受邀客户第三方专家发言内容仅代表其个人观点所有信息或观点不构成投资建议 根据监管规定会议不得交流敏感内幕信息未经华福证券事先书面许可任何机构或个人严禁录音制作纪要转发转载传播复制编辑修改等涉嫌违反上述情形等我们将保留一切法律权利感谢您的理解和支持谢谢好的那个大家晚上大家下午好那个我是华福的医药研究员胜利华 首先非常感谢大家抽空参加我们今天下午的会议本次我们会议我们前段时间也发了康方生物的一个深度报告我们本次会议前20分钟将会对我们深度报告进行一个解读之后的时间我们也请到了咱们上市公司的IR的团队的领导们 那接下来的话大家就是各位投资者也可以就大家关心的问题上公司进行请教那接下来的话就是我们先进入到第一个环节就是请我的同事对我们刚刚外发的一个康康生物的深度报告进行一个解读好的 谢谢孙老师 大家好,我是华府药组的杨峰宇。因为篇幅有限,所以我们的深度报告里面阐述了三个问题,就是跟大家讨论一下。首先我想回顾一下科药的一个发 ...

华福证券 康方生物(09926.HK) 肺癌大适应症先发优势占位,IO 2.0 的未来已来 投资要点: 公司双抗开发全球领先,临床开发策略借鉴 K 药的"成王之路" 公司自主研发的全球首创肿瘤免疫双抗药物 AK104(PD-1/CTLA-4,卡度 尼利单抗)和 AK112(PD-1/VEGF 双抗,依沃西单抗)已在国内获批,目 前展现的关键优势在于:1)机制上通过内部协同机制增强了肿瘤响应率, 从而扩大了 PD1 单药获益人群;2)安全性好,区别于两个单抗,停药率 低并且可以给联用 ADC 留下安全窗口,作为"IO2.0"联合"化疗 2.0"的 ADC,提高疗效并扩大获益人群。 依沃西单抗和卡度尼利单抗作为 IO 新一代基石药物,在临床开发策略上充 分借鉴了 K 药的"成王之路",即先窄后宽+大适应症占位+扩大癌种+早 期辅助疗法。首先通过 2L 宫颈癌和 2L EGFR TKI 耐药这两个尚无免疫治 疗获批且存在较大未满足需求的适应症建立起先发优势和护城河,然后分 别通过在肺癌、胃癌大癌种建立核心优势地位,并持续扩大适应症从而为 增长提供动力。以卡度尼利单抗为例:1)宫颈癌从 2/3L 做到 1L,胃癌 1 ...