致：香港交易及結算所有限公司 公司名稱: 四川科倫博泰生物醫藥股份有限公司 (於中華人民共和國註冊成立的股份有限公司) 呈交日期: 2025年9月3日 I. 法定/註冊股本變動 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年8月31日 狀態: 新提交 | 3. 股份分類 | 普通股 | 股份類別 | 其他類別 (請註明) | 於香港聯交所上市 (註1) | 否 | | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | N/A | 說明 | 非上市外資股 | | | FF301 第 1 頁 共 11 頁 v 1.1.1 FF301 | | 法定/註冊股份數目 | | 面值 | | 法定/註冊股本 | | --- | --- | --- | --- | --- | --- | | 上月底結存 | | 4,642,190 RMB | | 1 RMB | 4,642,190 | | 增加 / 減少 (-) | | | | RMB | | | 本月底結存 | | 4,642,190 RMB | | 1 RMB | ...

证券研究报告 医药生物 | 生物制品 港股|公司点评报告 hyzqdatemark 2025 年 09 月 02 日 证券分析师 刘闯 SAC：S1350524030002 liuchuang@huayuanstock.com 市场表现： | 基本数据 | 2025 | 年 | 09 月 | 01 | 日 | | --- | --- | --- | --- | --- | --- | | 收盘价（港元） | | | | 486.00 | | | 一年内最高/最低（港 | | | 498.20/152.00 | | | | 元） | | | | | | | 总市值（百万港元） | | | 113,328.38 | | | | 流通市值（百万港元） | | | | 79,106.21 | | | 资产负债率（%） | | | | 15.77 | | | 资料来源：聚源数据 | | | | | | 科伦博泰生物-B(06990.HK) 投资评级： 买入（维持） ——商业化势头可观，潜力管线稳步推进 投资要点： | 盈利预测与估值（人民币） | | | | | | | --- | --- | --- | --- | ...

Group 1 - The biotechnology sector in the Hong Kong stock market experienced a significant decline, with several companies reporting substantial drops in their stock prices [1] - Notable declines include Clover Biopharmaceuticals, which fell by 14.13%, and Beigene, which dropped by 8.33% [2] - Other companies such as Innovent Biologics and WuXi Biologics also saw declines exceeding 5%, indicating a broader trend of negative performance in the sector [1][2] Group 2 - The following companies reported specific percentage declines: Clover Biopharmaceuticals (-14.13%), Beigene (-8.33%), and Innovent Biologics (-6.50%) [2] - Additional companies with notable declines include Kintor Pharmaceutical (-6.38%), CanSino Biologics (-5.98%), and Zai Lab (-5.50%) [2] - The overall trend suggests a challenging environment for biotechnology stocks in the Hong Kong market [1]

Summary of Key Points Core Viewpoint - The report highlights the top short-selling stocks in the Hong Kong market, indicating significant investor sentiment and potential market movements for these companies [1][2]. Short Selling Ratios - AIA Group Ltd (友邦保险-R) and JD Health (京东健康-R) both have a short-selling ratio of 100.00%, indicating complete short interest [1][2]. - JD Group (京东集团-SWR) follows with a short-selling ratio of 87.80% [1][2]. Short Selling Amounts - Alibaba Group (阿里巴巴-SW) leads in short-selling amount with 19.21 billion, followed by Tencent Holdings (腾讯控股) at 18.81 billion and Sanofi (三生制药) at 14.30 billion [1][2]. - Other notable companies include Meituan (美团-W) with 13.13 billion and BYD Company (比亚迪股份) with 12.05 billion [2]. Deviation Values - The top three stocks with the highest deviation values are Hong Kong Exchanges and Clearing (香港交易所-R) at 40.73%, AIA Group (友邦保险-R) at 37.99%, and JD Group (京东集团-SWR) at 36.59% [1][2]. - This deviation indicates a significant difference between current short-selling ratios and their historical averages [2]. Additional Insights - The report provides a detailed table of the top ten stocks by short-selling amounts, ratios, and deviation values, showcasing the current market sentiment towards these companies [2].

Core Viewpoint - The article highlights the significant style drift observed in the public fund "Baoying Modern Service Industry Mixed Fund," which has deviated from its stated investment theme, focusing heavily on the pharmaceutical and technology sectors instead of modern services [1][10]. Fund Performance and Holdings - As of the end of Q2 2025, the fund's top ten holdings are predominantly in the pharmaceutical and technology sectors, with a notable concentration in stocks like Kelun-Bio and Tencent Holdings, indicating a high industry concentration [1][2]. - The fund has shown high volatility and elasticity, achieving a return of 64.73% since the beginning of 2025 and 73.28% over the past year, ranking well among peers. However, it has experienced declines in previous years, with losses of 11.91% in 2021, 9.32% in 2022, and 3.7% in 2024, indicating issues with performance sustainability [2][9]. Managerial Strategy and Style Drift - The style drift has been evident since the current fund manager, Yao Yi, took over in January 2023, with the first quarterly report showing a complete focus on healthcare stocks, which accounted for over 50% of the net value [5][7]. - Despite achieving a total return of 46.78% and an annualized return of 15.85% under Yao Yi's management, the strategy has not aligned with the fund's original service-oriented theme, raising concerns about the appropriateness of the investment approach [7][9]. Regulatory and Market Implications - The fund's deviation from its contractual investment behavior raises compliance issues and may lead to unexpected risks for investors due to misinterpretation of the fund's theme [9][10]. - The fund's total size is 295 million yuan, with institutional investors holding 20.29%, indicating some level of external oversight, but individual investors remain the primary stakeholders [9].

Investment Rating - The report maintains an "OUTPERFORM" rating for Sichuan Kelun-Biotech with a target price of HK$519.20 [2][3]. Core Views - The company is expected to see robust growth driven by domestic commercialization and global collaborations, particularly in the ADC (Antibody-Drug Conjugate) sector [7][8]. - The drug Sac-TMT is anticipated to become a significant partner to Keytruda, with potential peak sales reaching USD 15-20 billion [8][13]. - The revenue forecasts for FY25-27 have been revised upwards, with expected revenues of RMB 20.6 billion, RMB 28.0 billion, and RMB 48.3 billion respectively [3][7]. Summary by Sections Financial Projections - Revenue for FY24 is projected at RMB 1.933 billion, increasing to RMB 2.056 billion in FY25, RMB 2.798 billion in FY26, and RMB 4.833 billion in FY27, reflecting growth rates of 25%, 6%, 36%, and 73% respectively [2][3]. - Net profit is expected to improve from a loss of RMB 267 million in FY24 to a profit of RMB 879 million by FY27 [2][3]. Product Pipeline and Market Position - The company has commercialized three products in China and has one product awaiting NDA approval, with over ten products in early clinical stages [7][8]. - The ADC platform is positioned as a leader in the domestic biopharmaceutical sector, with significant collaborations with Merck in the ADC field [7][8]. Clinical Development and Global Expansion - Sac-TMT has initiated 14 overseas clinical trials covering various cancers, with a potential patient population of 200,000 to 300,000 [8][20]. - The drug is expected to show strong sales growth in conjunction with Keytruda, particularly in lung cancer and breast cancer indications [8][13]. Competitive Landscape - Sac-TMT is positioned to become a best-in-class TROP2 ADC, with ongoing clinical trials expected to validate its efficacy against existing therapies [13][35]. - The report highlights the competitive advantages of Sac-TMT over other ADCs in the market, particularly in addressing unmet needs in NSCLC and breast cancer [24][35].

Core Viewpoints - The company's revenue for the first half of 2025 was 950 million yuan, a year-on-year decrease of 31.3%, primarily due to reduced milestone payments from licensing and collaboration agreements compared to the same period in 2024 [1][4] - The core product SKB264 generated revenue of 302 million yuan, with commercialization performance meeting market expectations [1][2] - Merck is actively advancing SKB264 with 14 global multi-center Phase III clinical studies [1][3] Financial Performance - The company reported a loss of 145 million yuan for the first half of 2025, a year-on-year decrease of 146.8%, while the adjusted loss was 69 million yuan, down 118.0% [1][5] - Drug sales revenue reached 310 million yuan, with a gross margin of 69.4% [1][5] - Cash and financial assets amounted to 4.528 billion yuan, a year-on-year increase of 47.2%, providing a solid foundation for long-term development [2][5] Product Development and Pipeline - SKB264 has achieved significant breakthroughs in breast cancer and lung cancer, becoming the first TROP2 ADC drug approved for EGFR mutation non-small cell lung cancer in the third-line treatment [2][3] - The company is pursuing multiple clinical studies covering high-incidence cancers, focusing on combination therapies and frontline treatments [2][3] - Early pipeline products are progressing well, with SKB315's Phase 1b clinical study ongoing and dual-specific ADC product SKB571's Phase II clinical trial set to launch in China [3][4] Future Catalysts - Key catalysts for the second half of 2025 include the expected approval of SKB264 for the 2L EGFR TKI-resistant NSCLC indication and the release of clinical data at academic conferences [4] - Other early ADC pipelines are anticipated to show preliminary clinical results [4] - The company has a robust pipeline with multiple products, including A166 and SKB315, expected to receive regulatory approvals in the near future [4][5]

Group 1 - The company achieved a revenue of 950 million yuan in H1 2025, a year-on-year decrease of 31.3%, primarily due to high milestone payments recognized in the same period of 2024 [1] - The net loss attributable to the parent company was 145 million yuan, with an adjusted net loss of 69 million yuan [1] - The pharmaceutical sales revenue reached 309.8 million yuan, with sac-TMT accounting for 97.6% of total pharmaceutical sales, indicating successful commercialization progress [1][2] Group 2 - The sales revenue from sac-TMT is mainly derived from second-line triple-negative breast cancer and third-line EGFR mutation NSCLC, with the second-line EGFR mutation NSCLC indication expected to be approved in China soon, potentially driving stronger annual sales growth [2] - Sac-TMT's two approved indications will participate in the 2025 medical insurance negotiations, with expectations for accelerated sales growth after entering the insurance directory in 2026 [2] - Multiple clinical data will be disclosed at the ESMO conference in H2 2025, including phase III data for sac-TMT in second-line EGFR mutation NSCLC and phase I data for SKB315 (CLDN18.2 ADC) [2] Group 3 - The company's other core product, HER2 ADC (Bodutuzumab), received NDA acceptance in January 2025 and is expected to be approved for market launch in H2 2025 [3] - The company plans to submit the NDA application for the next-generation RET inhibitor A400 in H2 2025 [3] - The next major product, SKB571/MK-2750 (dual antibody ADC), is set to begin phase II clinical trials in China soon [3]

Group 1 - Company reported a revenue of 950 million yuan for the first half of 2025, a year-on-year decrease of 31.27% [1] - The net profit attributable to the parent company was -145 million yuan, a year-on-year decline of 146.80% [1] - As of the end of the reporting period, the company's cash and cash equivalents amounted to 3.103 billion yuan, an increase of 45.68% year-on-year [1] Group 2 - The commercialization of the first batch of products has begun, with sales of the core product, Lukanosatuzumab, reaching 301 million yuan in the first half of the year [2] - The company’s first ADC product received NMPA approval in November 2024 for treating unresectable locally advanced or metastatic TNBC, marking a significant milestone [2] - Multiple new ADCs are in clinical trials, including SKB315 and SKB410, with promising potential for future sales growth [2] Group 3 - Revenue projections for the company are 2.033 billion yuan, 3.147 billion yuan, and 2.833 billion yuan for 2025 to 2027, with year-on-year growth rates of 5%, 55%, and -10% respectively [3] - The net profit forecasts for the same period are -375 million yuan, 46 million yuan, and -171 million yuan, with year-on-year changes of -41%, 112%, and -470% respectively [3] - The company is viewed positively for its platform-based ADC innovation capabilities and potential for global growth through partnerships with multinational pharmaceutical companies [3]

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company reported a significant sales growth in the first half of 2025, with a total revenue of 950 million yuan, although this represents a year-on-year decline of 31.27%. The net profit attributable to the parent company was -145 million yuan, a decrease of 146.80% year-on-year. However, cash and cash equivalents increased by 45.68% year-on-year to 3.103 billion yuan [4][5] - The commercialization of the first batch of products is on track, with the core product, Lukanosatuzumab, achieving sales of 310 million yuan in the first half of the year. This product is the first domestically approved ADC with global intellectual property rights in China, marking a significant milestone for the company [6][8] - The company has multiple new ADCs entering clinical trials, indicating a robust pipeline and potential for future growth. The expected revenues for 2025 to 2027 are projected to be 2.033 billion yuan, 3.147 billion yuan, and 2.833 billion yuan, respectively, with year-on-year growth rates of 5%, 55%, and -10% [7][8] Financial Summary - For the first half of 2025, the company reported a revenue of 950 million yuan, a net profit of -145 million yuan, and cash and cash equivalents of 3.103 billion yuan [4][5] - The projected financials for 2024 to 2027 include revenues of 1.933 billion yuan, 2.033 billion yuan, 3.147 billion yuan, and 2.833 billion yuan, with net profits of -267 million yuan, -375 million yuan, 46 million yuan, and -171 million yuan, respectively [9][10]