Financial Performance - Revenue for the six months ended June 30, 2024, was RMB 1,382,791 thousand, representing a 32.2% increase compared to RMB 1,046,226 thousand in the same period of 2023[7]. - Gross profit for the same period was RMB 1,076,690 thousand, a significant increase of 59.4% from RMB 675,660 thousand in 2023[7]. - The company reported a profit of RMB 310,226 thousand for the period, compared to a loss of RMB 31,130 thousand in 2023[7]. - Adjusted profit for the period was RMB 385,636 thousand, a remarkable increase of 1,068.0% from RMB 33,017 thousand in the prior year[7]. - Cash and financial assets as of June 30, 2024, totaled RMB 2,885,166 thousand, reflecting a 15.9% increase from RMB 2,488,349 thousand at the end of 2023[7]. - Other net income for the six months ended June 30, 2024, was RMB 94.40 million, up from RMB 24.12 million in 2023, mainly due to increased government subsidies and interest income[123]. - Financial costs for the six months ended June 30, 2024, were RMB 2.51 million, a decrease of 96.8% compared to RMB 78.73 million for the same period in 2023[130]. - Profit for the six months ended June 30, 2024, increased by 1,096.6% to RMB 310.23 million, up from a loss of RMB 31.13 million for the same period in 2023[135]. - Cash and cash equivalents increased to RMB 2,130.30 million as of June 30, 2024, from RMB 1,528.77 million as of December 31, 2023, reflecting the net proceeds from the placement and milestone payments from Merck[140]. - Current assets net value as of June 30, 2024, was RMB 2,604.16 million, a 53.4% increase from RMB 1,697.48 million as of December 31, 2023[145]. Research and Development - Research and development expenses rose to RMB 652,337 thousand, up 33.0% from RMB 490,347 thousand in the previous year[7]. - The company has over 30 drug candidates in development, focusing on oncology and other therapeutic areas[31]. - The company is actively exploring the clinical value of A167 in combination therapies to maximize its potential[69]. - The company is developing new ADC designs to expand its ADC product portfolio, including alternatives to chemotherapy-based cancer therapies[156]. - The company aims to enhance end-to-end drug development capabilities and plans to incorporate AI into various R&D processes to improve efficiency[160]. - The company has established three core platforms focusing on ADC, macromolecule, and small molecule technologies to address medical needs in oncology, autoimmune diseases, and metabolic diseases[91]. - The ongoing research focuses on innovative non-oncology candidates for chronic diseases with unmet treatment needs[90]. Clinical Trials and Drug Development - The sac-TMT product showed a median progression-free survival (PFS) of 6.7 months in a Phase III study, compared to 2.5 months for chemotherapy, indicating a 68% reduction in the risk of disease progression or death[11]. - The overall response rate (ORR) for sac-TMT was 45.4%, significantly higher than the 12% ORR for chemotherapy[11]. - The company has initiated a Phase III registration study for sac-TMT in HR+/HER2- breast cancer patients, following breakthrough therapy designation from the National Medical Products Administration[11]. - A new drug application for sac-TMT in treating EGFR mutation-positive NSCLC has been accepted for priority review by the drug regulatory authority[12]. - The ORR for patients receiving sac-TMT and KL-A167 Q3W was 48.6%, with a DCR of 94.6% and a median PFS of 15.4 months[15]. - For patients receiving sac-TMT and KL-A167 Q2W, the ORR was 77.6% and the DCR was 100%, with the median PFS not yet reached[15]. - A166 has achieved its primary endpoint in the pivotal phase 2 trial for 3L+ advanced HER2+ breast cancer, with an NDA submitted in May 2023[18]. - The NDA for A167 as a treatment for RM-NPC has been accepted, and a registration phase 3 trial for A167 in 1L NPC is underway[21]. - The company anticipates launching sac-TMT and A166 in the Chinese market in the second half of 2024 or the first half of 2025[21]. - The company is actively exploring sac-TMT for other solid tumors, including GC, EC, CC, OC, UC, CRPC, and HNSCC[15]. Collaborations and Partnerships - The collaboration with Merck includes the development of multiple ADC assets, with ten global phase 3 clinical studies initiated for sac-TMT[23]. - The company recorded a total of $90.0 million in milestone payments from Merck for multiple collaboration pipelines in the first half of the year, equivalent to approximately RMB 641.4 million[27]. - Merck will pay the company $37.5 million for the exclusive option exercise of SKB571, with additional milestone payments and tiered royalties based on net sales after commercialization[24]. - The company has established strategic partnerships with Merck and other collaborators for the development of multiple ADC assets, enhancing its global market potential[39]. - The company is exploring new global collaboration opportunities to maximize the commercial value of its pipeline, focusing on both short-term and long-term growth[164]. Commercialization and Market Strategy - The company has established a mature commercialization team to prepare for the marketing and commercialization of strategic products[21]. - The company plans to accelerate the development of SKB315 in the Chinese market, given the large patient population with gastric cancer[25]. - The company is positioned to expand its commercialization infrastructure and market channels, leveraging its parent company's extensive industry experience[38]. - The commercialization team is expected to expand to approximately 400 members by the end of 2024, focusing on pre-launch preparations and rapid distribution post-NDA approval[161]. - The company is actively recruiting talent with a strong background in oncology, particularly for indications such as BC, NSCLC, GI cancers, and NPC[161]. Awards and Recognition - The company received the "Best IPO Award" at the 2023 China Financing Awards in July 2024, highlighting its successful public offering[113]. - The company was awarded the "Excellence in ESG Governance Performance Award" by Ming Pao in June 2024, reflecting its commitment to sustainable development[114]. - The company was awarded the title of "ADC Pioneer Enterprise" by TONACEA in April 2024[111]. Corporate Governance and Structure - The company has established a comprehensive ESG governance structure to enhance its ESG responsibilities and sustainability[28]. - The company has obtained high-tech enterprise certification, allowing it to enjoy a preferential income tax rate of 15% from 2020 to 2025[132]. - The company has no contingent liabilities as of June 30, 2024[151]. - The company has no asset pledges as of June 30, 2024[150]. - The company has not proposed any interim dividend for the six months ending June 30, 2024[179].

[Table_Main] 证券研究报告 | 公司点评 科伦博泰生物-B(06990.HK) 2024 年 09 月 08 日 | --- | --- | |----------------------------------------------------------|-------------------------------| | 买入（维持） | 科伦博泰生物 -B(6990.HK) ：开 | | 所属行业：医药生物 / 化学制药 当前价格 ( 港元 ) ： 169.6 | 展十项全球三期，预计多个产品 | | | | | | 国内将获批 | | | | 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 科伦博泰生物-B 恒生指数 -29% 0% 29% 57% 86% 114% 143% 171% | --- | --- | --- | --- | |-------------------------------|------------- ...

科伦博泰生物-B（06990.HK） 与默沙东达成双抗 ADC 合作，sac-TMT 新适应症申请上市 科伦博泰发布 2024 年中期业绩。公司实现收入 13.83 亿元，同比增长 32.2%； 其中包含收到的默沙东合作付款 9000 万美元。实现利润 3.1 亿元，2023 年同期 为亏损 3113 万元，扭亏为盈；实现经调整盈利 3.86 亿元，2023 年同期为 3302 万元。 科伦博泰宣布就芦康沙妥珠单抗递交新适应症上市申请。本次申报适应症为治疗 接受(EGFR-TKI)和含铂化疗治疗后病情出现进展的局部晚期或转移性 EGFR 突变 NSCLC 成人患者，并被拟纳入优先审评审批程序。 科伦博泰与默沙东相关合作项目达成进展。默沙东将就 SKB571 项目行使独家选 择权，并向科伦博泰支付 3750 万美元，且待达致特定开发及销售里程碑后，向科 伦博泰支付进一步里程碑付款，并待 SKB571 商业化后支付按净销售额计算的分 级特许权使用费。科伦博泰将保留在中国内地、香港及澳门开发、使用、制造及商 业化 SKB571 的权利。此外默沙东将向科伦博泰退还 SKB315 项目的开发、使用、 制造及商业化 SK ...

2024 年 08 月 21 日 公司点评 买入/维持 科伦博泰生物-B(06990) 目标价: 238.7 昨收盘:169.9 科伦博泰商业化在即，与默沙东的合作稳步推进 ◼ j (20%) 10% 40% 70% 100% 130% 23/8/2123/11/124/1/1224/3/2424/6/424/8/15 科伦博泰生物-B 恒生指数 事件：2024 年 8 月 19 日，科伦博泰发布 2024 年中期业绩公告：截 至 2024 年 6 月 30 日止六个月，科伦博泰营业收入 13.8 亿元，同比增长 32.2%；毛利 10.8 亿元，同比增长 59.4%；研发投入 6.5 亿元，同比增加 33.0%；调整后净利润 3.9 亿元人民币，同比增长 1086.0%；现金及金融 资产 28.9 亿元，相较于 2023 年底增长 15.9%。 科伦博泰的总收入主要来自许可及合作协议收入 13.8 亿元，以及提 供研发服务收入 481 万元。 科伦博泰商业化在即，sac-TMT 有望成为国产首款 TROP2 ADC 基于科伦博泰管线进度，预期 2024 年下半年或 2025 年上半年在中 国上市四个产品：核 ...

科伦博泰生物 [Table_StockNameRptType] -B（6990.HK） 公司点评 ADC 平台效应持续，即将迈入商业化新纪元 | --- | --- | |------------------------------------------|------------| | [Table_Rank] 投资评级：买入（维持） | | | 报告日期： | | | [Table_BaseData] 收盘价（港元） | 164.1 | | 近 12 月最高/最低（港元） | 195.0/62.0 | | 总股本（百万股） | 223 | | 流通 H 股（百万股） | 130 | | 流通股比例（%） | 58.30% | | 总市值（亿港元） | 365.7 | | 流通市值（亿港元） | 213.8 | | [Table_Chart] 公司价格与恒生指数走势比较 | | -40% -20% 0% 20% 40% 60% 80% 100% 120% 140% 科伦博泰生物-B 恒生指数 [Table_Author] 分析师：谭国超 执业证书号：S0010521120002 电话：055516888 邮 ...

[Table_Title] 【广发医药&海外】科伦博泰生物-B （06990.HK） SKB264 加速推进，在研管线进展顺利 [Table_Summary] 核心观点：*如无特别说明，报告使用货币均为人民币。 ⚫ 公司发布 2024 年中期业绩公告：2024 上半年实现收入 13.83 亿元 （yoy +32.2%），主要来自许可及合作协议相关收入以及提供研发服务 收入；期内利润 3.10 亿元，同比扭亏为盈；调整后期内利润 3.86 亿 元，同比+1068%；在手现金及金融资产 28.85 亿元，同比增长 15.9%。 ⚫ SKB264 有望年内于国内获批，默沙东已开展 10 项全球 III 期。根据 公司 2024 年中期业绩公告，国内：①末线治疗 TNBC 上市申请被 CDE 受理并纳入优先审评审批；一线治疗 TNBC 已启动国内 III 期；②二线 治疗 HR+/HER2-BC 国内 III 期正在入组；③单药治疗经 EGFR TKI 和 含铂化疗失败的 EGFR 突变 NSCLC 的 NDA 已获 CDE 受理并纳入优 先审评审批；④联合 K 药对比 K 药一线治疗 PD-L1 阳性 NSCLC ...

证 券 研 究 报 告 科伦博泰（06990.HK）2024 年中报点评 推荐（首次） 首款产品上市在即，公司即将迎来收获期 目标价：200.4 港元 事项： 2024 年 8 月 19 日，科伦博泰生物公布 2024 年上半年业绩。总收入 13.83 亿 元（+32.2%），其中默沙东里程碑付款 6.41 亿元。上半年实现扭亏为盈，期内 利润 3.10 亿元，2023 年同期亏损为 3113 万元。研发支出 6.52 亿元（+33.0%）， 现金及金融资产 28.85 亿元（+15.9%）。 评论： 已就 4 个产品递交 6 项 NDA，即将进入收获期。自 2023 年 5 月以来，A166 （HER2 单抗）3L 治疗 HER2+ BC 患者、A140（西妥昔单抗生物类似药）治 疗 RAS 野生型 mCRC 和 HNSCC、SKB264（TROP2 ADC）3L 治疗 TNBC 患 者和 3L EGFRmt NSCLC、以及 A167（PD-L1 单抗）1L 治疗 NPC 的 NDA 陆 续获得 CDE 受理。预计 2024 下半年 SKB264 及 A166 获批，2025 年上半年 A167 及 A1 ...

Investment Rating - The investment rating for the company is "Outperform the Market" [3][12]. Core Insights - The company's core product, SKB264, has made significant progress in both domestic and global clinical trials, with applications submitted for various indications and positive data presented at the ASCO annual meeting [1][4]. - The company has a strong cash position, with approximately 2.9 billion yuan in cash and financial assets as of June 30, 2024, and is actively expanding its commercialization team in anticipation of product approvals [1][6]. - The revenue forecast for 2024-2026 has been revised upwards, with expected revenues of 1.648 billion, 1.555 billion, and 2.393 billion yuan, reflecting growth rates of 7.0%, -5.7%, and 53.9% respectively [1][9]. Summary by Sections Clinical Progress - SKB264 has received priority review for the TNBC 3L indication and has had its application for the EGFRm NSCLC 3L indication accepted in August 2024 [1][4]. - Ongoing Phase III trials for multiple indications, including TNBC 1L and HR+/HER2- BC 2L+, are being conducted, with 10 Phase III trials initiated globally by the partner Merck [1][5]. Early Pipeline Development - Merck has exercised its exclusive option for SKB571, paying 37.5 million USD for rights outside Greater China, while another early-stage molecule, SKB518, entered Phase I clinical trials in June 2024 [1][4]. - The company is continuing the development of SKB315 after Merck returned its global rights [1][5]. Financial Performance - In the first half of 2024, the company achieved revenue of 1.383 billion yuan, a 32% increase, with a gross profit of 1.077 billion yuan, up 59% [1][6]. - The net profit for the same period was 310 million yuan, a significant turnaround from a loss of 31 million yuan in the previous year [1][6]. Future Outlook - The commercialization team is expected to expand as products like SKB264, A166, and A167 are anticipated to receive approval in the latter half of 2024 and early 2025 [1][6]. - The upward revision of profit forecasts reflects the company's reliance on collaboration income, with net profits projected to be -296 million, -558 million, and -247 million yuan for 2024-2026 [1][9].

Investment Rating - The investment rating for the company is "Buy" (maintained) [3][7]. Core Insights - The company has turned a profit in the first half of 2024, with revenue of 1.38 billion yuan, a 32.2% increase from 1.046 billion yuan in the same period of 2023. The net profit reached 310 million yuan, compared to a loss of 31.13 million yuan in the previous year [3][4]. - The revenue composition includes 1.378 billion yuan from licensing and collaboration agreements, and 4.813 million yuan from research services, with significant growth driven by collaboration with Merck [3][4]. - The company has established a new collaboration with Merck for SKB571, receiving a prepayment of 37.5 million USD, and has had the NDA for SKB264 accepted for a new indication [3][4]. Revenue and Financial Performance - The company reported a total revenue of 1.378 billion yuan in 24H1, with a year-on-year growth of 32.2% [3][4]. - The adjusted net profit for the same period was 386 million yuan, indicating a significant turnaround from the previous year's loss [3][4]. - Cash and financial assets stood at 2.89 billion yuan, indicating a strong financial position [3]. Research and Development Progress - The core pipeline SKB264 is progressing well globally, with multiple NDAs accepted and ongoing clinical trials for various indications [4]. - The company is pursuing both large and small molecule research, with several NDAs expected to be approved soon, indicating a balanced approach to short-term and long-term growth [4]. - Merck has initiated 10 Phase III studies covering major indications, which may lead to further expansion of the company's pipeline [4]. Earnings Forecast and Valuation - The company is expected to generate total revenues of 1.739 billion yuan, 1.479 billion yuan, and 2.715 billion yuan for the years 2024, 2025, and 2026 respectively [4]. - The company maintains a rich pipeline of innovative products and is progressing well globally, justifying the "Buy" rating [4].

Investment Rating - The report maintains a "Buy" rating for the company [2][4]. Core Insights - The company exceeded expectations in both licensing revenue and R&D progress, achieving a turnaround in profit for the first half of 2024 with revenue of 1.383 billion yuan, a year-on-year increase of 32.2% [4][5]. - The company has submitted its first NDA for a lung cancer indication, indicating accelerated progress in its R&D pipeline [4][5]. - The collaboration with Merck has been optimized, with the company receiving a $37.5 million upfront payment for the SKB571 project, while retaining rights in Greater China [5]. Revenue and Financial Performance - The company reported a profit of 310 million yuan for 2024H1, marking a significant recovery from losses in 2023H1 [5]. - Revenue forecasts for 2024-2026 have been revised upwards to 1.720 billion, 1.924 billion, and 2.534 billion yuan, respectively, from previous estimates of 1.181 billion, 1.574 billion, and 2.361 billion yuan [5][7]. R&D Pipeline Progress - The core product SKB264 has received CDE approval for its first indication in lung cancer, targeting EGFRm NSCLC after failure of EGFR-TKI and platinum-based chemotherapy [5]. - Multiple potential catalysts are expected, including approvals for various indications in 2024 and 2025, such as 3L+ TNBC and PDL1 monoclonal antibody for nasopharyngeal carcinoma [5]. Market Data - The current stock price is 169.90 HKD, with a market capitalization of 37.861 billion HKD [6]. - The stock has traded within a range of 72.05 to 189.30 HKD over the past 52 weeks [6]. Financial Summary - The company has shown significant revenue growth from 32 million yuan in 2021 to an estimated 1.720 billion yuan in 2024, reflecting a compound annual growth rate of 2387.3% from 2021 to 2022 and 91.6% from 2022 to 2023 [7]. - Gross profit is projected to increase from 12 million yuan in 2021 to 1.093 billion yuan in 2024 [7].