股 票 研 究 [Table_Industry] 医药 证 券 研 究 报 告 锋芒初显,中国 ADC 龙头逐鹿全球市场 ——科伦博泰首次覆盖报告 | --- | --- | --- | --- | |-----------------|-------------------|----------------------------|------------------------------| | [table_Authors] | 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 | jiangzhuxuan029022@gtjas.com | | 登记编号 | S0880514030001 | S0880523080007 | S0880123100004 | 本报告导读: 公司为国内 ADC 药物龙头,核心品种陆续步入收获期。TROP2 ADC SKB264 具备全 球同类最佳潜力,背靠 ...

投资逻辑 国内 TROP2 ADC 领军者,先发优势明显。(1)目前全球仅有三款靶 向 TROP2 的抗体偶联药物(ADC)推进至注册或上市阶段,其中 SKB264 有望成为首款国产上市的 TROP2 ADC。(2)SKB264 围绕乳腺 癌(BC)和肺癌(LC)布局多项适应症:单药 3L+ 治疗三阴性乳 腺癌(TNBC)于 2023 年末递交 NDA,我们预计该药将于 2024 年末 获批上市;另外,单药 2/3L 治疗 EGFRmt NSCLC、单药 1L 治疗 TNBC、 以及单药 2L+治疗 HR+/HER2- mBC 均处于Ⅲ期关键临床,以上三 项适应症有望于 2025/2026/2026 年获批上市并实现商业化放量。 (3)另外 SKB264 还有数项与免疫检查点抑制剂 A167 或 Keytruda 的开发计划,ADC+IO 联用往前线布局潜力较大,市场空间广阔。综 上,公司此款 ADC 在中国市场将是一个数十亿量级的潜在重磅药。 授权默沙东(MSD)打开国际空间,加速推进多项国际临床。(1) 公司与 MSD 分别于 2022、2023 年达成三项涉及 ADC 资产的合作协 议,据公司公告披露, ...

证券研究报告 | 首次覆盖报告 2024年06月23日 科伦博泰生物-B（06990.HK） ADC 征途星辰大海，携手跨国龙头进军国际市场 高屋建瓴率先布局 ADC 前沿技术，OptiDC 平台优势明显。科伦博泰深耕 ADC 买入（首次） 创新分子研发十余年，是国内首批及全球少数建立集成 ADC 开发平台的公司之 股票信息 一。OptiDC 平台基于多样化的 ADC 核心元件库，已通过十多项临床或临床前候 选药物验证、实现超过2000例患者入组。OptiDC平台已获得全球逾40项专利及 行业 生物技术 申请，构成公司核心技术护城河。 6月21日收盘价（港元） 172.80 核心品种进度领先，即将进入商业化阶段。目前公司已向NMPA申报2款ADC候 总市值（百万港元） 38,507.46 选产品SKB264（TROP2 ADC）、A166（HER2 ADC）上市。 总股本（百万股） 222.84 ➢ SKB264：潜在首款国产TROP2 ADC，预计2024年底获批上市。已有4项 其中自由流通股（%） 100.00 适应症被NMPA纳入突破性治疗品种。中度毒性payload、高DAR、自研专 30 日日均成交 ...

Investment Rating - The report assigns a "Buy" rating to the company, with a target price of 187 RMB, equivalent to 206 HKD, and a target market capitalization of 45.9 billion HKD [6][14]. Core Insights - The company is recognized as a leading innovative drug enterprise in the ADC (Antibody-Drug Conjugate) sector, with a robust pipeline that is expected to yield significant value soon. The collaboration with Merck for SKB-264 has a maximum total transaction value of 1.4 billion USD, and there are seven ADC projects in development with a total potential value of nearly 9.5 billion USD [2][11][26]. - The global market for targeted drugs for high-incidence cancers, such as lung cancer and breast cancer, is expanding. The NSCLC (Non-Small Cell Lung Cancer) patient population is projected to grow from 2.04 million in 2023 to 2.46 million by 2030, with a CAGR of 2.7%. The market size for NSCLC targeted drugs is expected to reach 46.3 billion USD in 2023 and continue to grow [3][35]. - The company has a strong pipeline of innovative products, with several expected to enter commercialization in 2024. Key products include SKB-264, A166, and A140, which target various cancers and are anticipated to receive regulatory approval soon [5][12][28]. Summary by Sections 1. Company Overview - The company has a rich technical foundation in ADC development, having established a comprehensive R&D platform, OptiDC, which supports various drug development capabilities [19][23]. - The management team has extensive experience in the pharmaceutical industry, enhancing the company's strategic development and operational efficiency [19][20]. 2. Market Expansion - The report highlights the growing market for targeted therapies in high-incidence cancers, particularly lung and breast cancers, indicating a significant opportunity for the company's products [3][35]. - The breast cancer drug market is projected to grow from 40.6 billion USD to 69.9 billion USD from 2023 to 2030, with a CAGR of 8.1% [4]. 3. Product Pipeline - SKB-264 is positioned as a "Best-in-Class" ADC with multiple indications, expected to be approved in China for TNBC (Triple-Negative Breast Cancer) in 2024. The product is also anticipated to expand into other indications by 2025-2027 [4][12]. - A166 is expected to be the first domestic ADC approved for HER2+ breast cancer in China, with a significant market opportunity [5][12]. 4. Financial Projections - The company forecasts revenues of 1.34 billion RMB in 2024, with a projected growth rate of 15.59% in 2025 and 42.25% in 2026. However, it anticipates net losses in the coming years, with EPS projected at -2.78 RMB in 2024 [6][14].

Investment Rating - The report assigns a "Buy" rating for the company, with a target price of 225 HKD, compared to the last closing price of 167 HKD [1]. Core Insights - The report highlights that the company is positioned to lead in the ADC (Antibody-Drug Conjugate) market, with a strong pipeline and strategic partnerships, particularly with Merck, aiming for significant growth in the biopharmaceutical sector [1][19]. - The company has developed a comprehensive ADC platform, OptiDC, which supports the development of multiple ADC candidates currently in clinical trials, showcasing its competitive edge in the oncology treatment landscape [19][27]. - The anticipated commercialization of key products, including SKB264 and A166, is expected to drive revenue growth, with projections indicating a turnaround to profitability by 2027 [3][39]. Summary by Sections Company Overview - Founded in 2016, the company focuses on innovative drug development in oncology and immunology, establishing itself as a pioneer in ADC technology with over ten years of experience [16]. - The company successfully went public on the Hong Kong Stock Exchange in July 2023, marking a new chapter in its development [16]. Technology and Pipeline - The company has built a leading ADC development platform, OptiDC, which integrates extensive knowledge of biological targets and proven ADC design expertise [27]. - It has a diverse pipeline with 33 projects targeting various cancers and diseases, including 14 in clinical stages and several nearing NDA submissions [30][39]. Strategic Partnerships - The company has formed significant partnerships, notably with Merck, to enhance its global reach and accelerate the development of its ADC products [35][37]. - The collaboration with Merck includes multiple ADC assets, which is expected to generate substantial overseas revenue [37]. Financial Projections - Revenue forecasts for 2024, 2025, and 2026 are projected at 1.186 billion, 1.684 billion, and 2.621 billion HKD respectively, with a return to profitability expected in 2027 [3][39]. - The report estimates the company's market capitalization could reach 515 billion HKD and 598 billion HKD based on discounted cash flow and sales peak valuation multiples [3].

2024年06月17日 公司深 度研究 公 买入 / 首次 司 科伦博泰生物-B(06990) 研 究 目标价: 225 昨收盘:167 科伦博泰深度报告：ADC 商业化在即，携手默沙东剑指 Biopharma ◼ 走势比较 报告摘要 180% ADC风口之上，科伦博泰平台优势明显 ADC 正在开启广谱抗肿瘤模式，有望引领精准化疗新时代，成为肿 太 140% 瘤治疗格局的改变者。科伦博泰作为先行者，已成功构建OptiDC 研发平 平 100% 台，4 款 ADC 处于临床研究阶段，多款处于临床前研究阶段。其中 洋 60% TROP2 ADC在TNBC和EGFRmt NSCLC上展现出来良好的有效性和安 证 20% 全性，有BIC潜质。 券 股 (20%)11/7/32 9/9/32 8/11/32 7/1/42 7/3/42 6/5/42 势，在同时 AD， C科 工伦 艺博 开泰 发O 、p 制tiD 造C、 和质大 量分 控子 制及 方小 面分 都子 处三 于大 较研 领发 先平 的台 地具 位备协 。未同优 来 份 科 恒伦 生博 指泰 数生物-B 毒素分子的研发将是ADC升级改造的关键环节，相较于没有 ...

Investment Rating - Maintain BUY rating for Kelun-Biotech based on promising data for SKB264 in 1L NSCLC and late-line TNBC, with a target price raised from HK$200.77 to HK$246.13, indicating a 35.8% upside potential from the current price of HK$181.30 [1][3][19] Core Insights - SKB264 combined with A167 shows significant efficacy in 1L NSCLC, achieving a median progression-free survival (mPFS) of 15.4 months, outperforming current standard of care (SoC) treatments [1][12] - The drug demonstrates a favorable safety profile, with less than 1% of patients discontinuing treatment due to adverse events, compared to higher rates in competing therapies [1][12][13] - Strong Phase 3 results in 3L+ TNBC support the drug's approval in China, with an overall response rate (ORR) of 43.8% and mPFS of 5.7 months, which is superior to competitors [1][16] Summary by Sections Efficacy in NSCLC - SKB264+A167 shows promising efficacy in 1L NSCLC, with mPFS of 15.4 months, significantly better than Keytruda+chemo (9.0 months) and tislelizumab+chemo (9.7 months) [1][12] - In Phase 2 trials, cohort 1A (Q3W) had an ORR of 48.6% and cohort 1B (Q2W) had an ORR of 77.6%, indicating strong potential across different PD-L1 expression levels [8][12] Safety Profile - SKB264 exhibits a more tolerable safety profile than competitors, with <1% discontinuation due to treatment-related adverse events (TRAEs), compared to 29% for Dato-DXd and 17% for Trodelvy [1][12][13] - The most common grade ≥3 TRAEs were manageable, with neutropenia rates of 30.0% in cohort 1A and 30.2% in cohort 1B, lower than those seen in competing therapies [11][13] Commercial Potential - The wide indication coverage for SKB264 in NSCLC is expected, with ongoing Phase 3 trials planned in both China and globally, which could significantly enhance its commercial value [1][12][19] - The drug's promising data in late-line TNBC, with a BLA filed in China, positions it favorably against competitors like Trodelvy and Dato-DXd [1][16][19]

Investment Rating - The investment rating for the company is "Buy" with a current price of 162.10 CNY and a target value of 190.94 CNY [1]. Core Views - The report highlights the global potential of SKB264, which was showcased at ASCO, indicating its potential to become a Best-in-Class (BIC) treatment [1]. - Two studies presented at ASCO show promising results for SKB264 in treating TNBC and NSCLC, with significant improvements in progression-free survival (PFS) and overall response rates (ORR) compared to chemotherapy [1]. - The company is advancing its global clinical trials for SKB264, including multiple Phase III studies for various cancers [1]. Financial Summary - Revenue projections for the company from 2024 to 2026 are estimated at 12.45 billion CNY, 11.81 billion CNY, and 22.08 billion CNY respectively, indicating a strong growth trajectory despite a projected decline in 2024 and 2025 [1][2]. - The company reported a significant increase in revenue from 804 million CNY in 2022 to 1.54 billion CNY in 2023, reflecting a growth rate of 2,387.3% [3]. - The EBITDA is projected to worsen from -399 million CNY in 2023 to -1.08 billion CNY in 2025, indicating increasing operational challenges [2][3]. Clinical Development - SKB264 is currently undergoing multiple Phase III clinical trials for various indications, including NSCLC and TNBC, with promising early results [1]. - The report notes that SKB264 has been accepted for priority review by the CDE for first-line treatment in PD-L1 positive TNBC [1]. Analyst Team - The report is prepared by a team of analysts from GF Securities, including lead analysts with extensive backgrounds in finance and medicine [4].

2024年05月27日 公司深 度研究 公 买入 / 首次 司 科伦博泰生物-B(06990) 研 究 目标价: 226 昨收盘:167 科伦博泰深度报告：ADC 商业化在即，携手默沙东剑指 Biopharma ◼ 走势比较 报告摘要 180% ADC风口之上，科伦博泰平台优势明显 ADC 正在开启广谱抗肿瘤模式，有望引领精准化疗新时代，成为肿 太 140% 瘤治疗格局的改变者。科伦博泰作为先行者，已成功构建OptiDC 研发平 平 100% 台，4 款 ADC 处于临床研究阶段，多款处于临床前研究阶段。其中 洋 60% TROP2 ADC在TNBC和EGFRmt NSCLC上展现出来良好的有效性和安 证 20% 全性，有BIC潜质。 券 股 (20%)11/7/32 9/9/32 8/11/32 7/1/42 7/3/42 6/5/42 势，在同时 AD， C科 工伦 艺博 开泰 发O 、p 制tiD 造C、 和质大 量分 控子 制及 方小 面分 都子 处三 于大 较研 领发 先平 的台 地具 位备协 。未同优 来 份 科 恒伦 生博 指泰 数生物-B 毒素分子的研发将是ADC升级改造的关键环节，相较于没有 ...

2024年05月27日 公司深 度研究 公 买入 / 首次 司 科伦博泰生物-B(06990) 研 究 目标价: 226 昨收盘:167 科伦博泰深度报告：ADC 商业化在即，携手默沙东剑指 Biopharma ◼ 走势比较 报告摘要 180% ADC风口之上，科伦博泰平台优势明显 ADC 正在开启广谱抗肿瘤模式，有望引领精准化疗新时代，成为肿 太 140% 瘤治疗格局的改变者。科伦博泰作为先行者，已成功构建OptiDC 研发平 平 100% 台，4 款 ADC 处于临床研究阶段，多款处于临床前研究阶段。其中 洋 60% TROP2 ADC在TNBC和EGFRmt NSCLC上展现出来良好的有效性和安 证 20% 全性，有BIC潜质。 券 股 (20%)11/7/32 9/9/32 8/11/32 7/1/42 7/3/42 6/5/42 势，在同时 AD， C科 工伦 艺博 开泰 发O 、p 制tiD 造C、 和质大 量分 控子 制及 方小 面分 都子 处三 于大 较研 领发 先平 的台 地具 位备协 。未同优 来 份 科 恒伦 生博 指泰 数生物-B 毒素分子的研发将是ADC升级改造的关键环节，相较于没有 ...