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 ...

Investment Rating - The investment rating for the company is "Buy" with a current price of HKD 168.30 and a fair value of HKD 204.49 [1][2]. Core Insights - The company reported a revenue of RMB 1.383 billion for the first half of 2024, representing a year-over-year increase of 32.2%. The profit for the period was RMB 310 million, marking a turnaround from losses, with an adjusted profit of RMB 386 million, up 1068% year-over-year. The company holds cash and financial assets totaling RMB 2.885 billion, a 15.9% increase from the previous year [2]. - The drug SKB264 is expected to receive domestic approval within the year, with Merck having initiated 10 global Phase III trials. The company has several ongoing clinical trials for various indications, including triple-negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC) [2]. - The company has a robust pipeline of Antibody-Drug Conjugates (ADCs), with A166 having submitted a New Drug Application (NDA) in China, and other candidates in various stages of development [2]. - The financial forecast estimates revenues of RMB 1.655 billion, RMB 1.786 billion, and RMB 2.366 billion for 2024, 2025, and 2026, respectively. The ADC platform is considered globally competitive, and a DCF valuation yields a fair value of HKD 204.49 per share [2]. Financial Summary - For the first half of 2024, the company achieved a revenue of RMB 1.383 billion, with a profit of RMB 310 million, compared to a loss in the previous year. The adjusted profit was RMB 386 million [2]. - The revenue growth rates for the years 2022 to 2026 are projected at 2387.3%, 91.6%, 7.4%, 7.9%, and 32.5%, respectively [2][6]. - The company’s EBITDA is forecasted to be negative in the coming years, with a projected net profit of RMB -728 million in 2024 and improving to RMB -663 million by 2026 [6][7].

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].

Investment Rating - The report maintains an "outperform" rating for Kelun-Biotech (6990 HK) with a target price of HKD 200.10 per share, up 84% from the previous target of HKD 108.61 [14][18]. Core Insights - Kelun-Biotech reported H1 2024 results with revenue of RMB 1.38 billion (+32.2%), gross profit of RMB 1.08 billion (+59.4%), R&D expenditure of RMB 650 million (+33.0%), and a profit of RMB 310 million compared to a loss of RMB 31.13 million in the same period last year [9][18]. - The core product sac-TMT has initiated 10 global registrational trials, with 2 indications having submitted NDA in China. The collaboration with Merck has been optimized, reflecting a dynamic adjustment in the scope of early-stage pipelines [10][18]. - The report highlights significant clinical data from the 2024 ASCO meeting, indicating sac-TMT's potential to provide clinical survival benefits in breast cancer and non-small cell lung cancer [10][18]. Financial Performance - For H1 2024, the company achieved a revenue of RMB 1.38 billion, a gross profit of RMB 1.08 billion, and a profit of RMB 310 million, marking a significant turnaround from a loss in the previous year [9][18]. - The company has a cash and cash equivalents balance of RMB 2.89 billion as of June 30, 2024 [9][18]. Product Pipeline and Development - The core product sac-TMT is expected to be approved in China between H2 2024 and H1 2025, with multiple indications in the pipeline [10][18]. - The report outlines four development strategies for sac-TMT, including first-to-market opportunities and biomarker enrichment strategies [10][18]. - The company has four products currently in the NDA stage, expected to be approved in 2024H2-25H1, including sac-TMT and A166 (HER2 ADC) [13][18]. Collaboration and Partnerships - Merck has exercised its option for SKB571, a bispecific antibody ADC, with a payment of USD 37.5 million, while returning the global rights to SKB315 [13][18]. - The collaboration with Merck is seen as a strategic move to cover a wide range of oncology indications through differentiated ADC pipelines [13][18]. Earnings Forecast and Valuation - Revenue forecasts for 2024-2026 have been adjusted to RMB 1.76 billion, RMB 1.53 billion, and RMB 2.36 billion, reflecting a YoY growth of +14%, -13%, and +54% respectively [14][18]. - The net profit attributable to the parent company is forecasted to be -RMB 230 million, -RMB 1.01 billion, and -RMB 782 million for the same period [14][18].

21 Aug 2024 CMB International Global Markets | Equity Research | Company Update Kelun-Biotech (6990 HK) Innovative bispecific ADC product licensed to MSD Kelun-Biotech recorded RMB1.38bn (+32% YoY) revenue in 1H24, including a total of US$90mn (or RMB641mn) milestone payments from MSD regarding multiple collaborated pipelines. In 1H24, Kelun-Biotech spent RMB652mn on R&D, +33% YoY, mainly driven by an uptick in clinical trials. The company is gearing up for the near-term launch of several key assets in Chin ...

21 Aug 2024 CMB 国际全球市场 | 股票研究 | 公司更新 科伦生物技术 （ 6990 香港 ） 创新的双特异性 ADC 产品授权给 MSD (上一个 TP HK$243.38 HK$246.13) 44.6% 科伦生物技术在上半年录得 13.8 亿元人民币 （ 同比增长 32% ） 的收入 ， 包括总额 从 MSD 支付 9000 万美元 （ 或 6.41 亿元人民币 ） 的里程碑款项 ， 涉及多个 合作管道。上半年 ， 科伦生物在研发上花费了 6.52 亿元人民币 ， + 33% 同比增长 ， 主要是由于临床试验的增加。该公司正在为 近期在中国推出几项关键资产 ， 包括 sac - TMT （ TROP2 ADC ） ， A166 （ HER2 ADC ） ， A167 （ PD - L1 mAb ） 和 A140 （ 西妥昔单抗生物仿制药 ） 在 2H24 或 1H25 。在准备工作中 ， 公司组建了 110 + 的商业团队 计划到 2024 年底将销售人员扩大到约 400 名员工。 因此 ， 在 1H24 ， 该公司记录了 4100 万元人民币的销售费用 (而在 1H23 ） 。科伦生物 ...

Investment Rating - The investment rating for the company is "Buy" (maintained) [3][14]. Core Insights - The company reported excellent performance in H1 2024, with revenue reaching 1.477 billion yuan, a year-on-year increase of 41.19%, and a net profit of 310 million yuan, marking its first profit [6]. - The company has accelerated the clinical progress of its core product SKB264, which has received breakthrough therapy designation for treating locally advanced PD-L1 negative TNBC and is advancing through various clinical trials [6][8]. - A new collaboration with Merck has been established for SKB571, which is expected to enhance the company's global footprint in the ADC sector [7]. Financial Performance Summary - Revenue and Profit: In H1 2024, the company achieved revenue of 1.477 billion yuan, up 41.19% year-on-year, and a net profit of 310 million yuan, marking a turnaround from previous losses [6]. - R&D Investment: R&D expenses for H1 2024 were 652 million yuan, reflecting a 33.0% increase year-on-year [6]. - Future Projections: The company's net profit forecasts for 2024-2026 have been revised to -386 million yuan, -292 million yuan, and -93 million yuan, respectively, indicating improved expectations compared to previous estimates [6]. Product Pipeline and Regulatory Progress - SKB264 is expected to receive approval for its third-line treatment for triple-negative breast cancer in H2 2024, with additional products like A166 and A167 also anticipated to gain approvals in the near future [8]. - The first NDA application for SKB264 was accepted by the CDE in December 2023 and is undergoing priority review, positioning it to be the first domestically approved TROP2 ADC drug in China [6]. Market Position and Valuation - The company's market capitalization is approximately 37.505 billion HKD, with a circulating market value of 21.925 billion HKD [4]. - The stock has shown a significant trading volume with a turnover rate of 20.34% over the past three months [4].