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 ...

Investment Rating - The report assigns a "Buy" rating to 康方生物 (9926.HK) [2][3] Core Viewpoints - 康方生物's AK112 Phase III HARMONi-A data for EGFR mutation NSCLC shows slightly lower ORR and mPFS than expected, but the PFS benefit HR is better than approved drugs, especially in the T790M mutation subgroup. If subsequent OS data is strong, the company's stock price is expected to rebound [2][3] - 科伦博泰's SKB264 Phase III data for 3L+ TNBC is excellent, showing potential as a best-in-class treatment. The mPFS is 5.7 months compared to 2.3 months for the chemotherapy control group, with a 69% reduction in the risk of disease progression or death [4] - In the early development stage, 科伦博泰's SKB264 shows promising results in 1L NSCLC, with ORR of 48.6% and mPFS of 15.4 months in one cohort, indicating better efficacy compared to competitors [5] Summary by Sections 康方生物 (9926.HK) - AK112's mPFS is 7.06 months versus 4.8 months for the chemotherapy control group, with an ORR of 50.6% compared to 35.4% for the control [2] - The data shows significant PFS benefits across various subgroups, particularly in T790M mutation patients with an HR of 0.22 [3] 科伦博泰 (6990.HK) - SKB264's Phase III results indicate a mPFS of 5.7 months and an ORR of 43.8%, outperforming previous Phase II data and showing better results than DS-1062 [4] - In the 1L NSCLC trial, SKB264 combined with PD-L1 shows an ORR of 77.6% in one cohort, with a DCR of 100% [5]