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 ...

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 ...

M N 6 Jun 2024 CMB International Global Markets | Equity Research | Company Update Kelun-Biotech (6990 HK) Data release at ASCO further confirmed SKB264’s potential  Promising efficacy of SKB264+A167 in 1L NSCLC. SKB264 (Q3W)+A167 Target Price HK$246.13 (PD-L1)’s 15.4 months of mPFS in 1L NSCLC was much better than the SoC – (Previous TP HK$200.77) 9.0 months mPFS of Keytruda+chemo in KEYNOTE189 and 9.7 months mPFS Up/Downside 35.8% of tislelizumab+chemo in RATIONALE304. SKB264’s Ph3 dose of Q2W could Curr ...

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 ...

浦银国际研究 行业追踪 | 医药行业 ASCO 2024：重点公司简要点评（一） 阳景 浦 首席医药分析师 5 月 23日下午（美国东部时间），一年一度的美国肿瘤年会（ASCO）披 Jing_yang@spdbi.com 银 露了此次大会投稿接收的摘要内容。对于备受关注的康方生物（9926.HK， (852) 2808 6434 国 际 “买入”评级）AK112 三期 HARMONi-A 数据（EGFR 突变 NSCLC），我 们认为 ORR和 mPFS数字略低于预期，不过首次披露的 PFS获益 HR好 胡泽宇 CFA 于已上市药物（尤其是在 T790M突变细分人群），若后续 OS数据优秀， 医药分析师 公司股价有望迎来反弹。此外，科伦博泰（未覆盖）SKB264 三期 3L+ ryan_hu@spdbi.com TNBC 数据优异，有同类最佳的潜力；二期 1L NSCLC 数据好于国外同类 (852) 2808 6446 竞争对手。 2024年5月24日  康方生物（9926.HK；评级“买入”）AK112三期EGFR突变 NSCLC适 行 应症 mPFS和 ORR数字略低于预期，但首次披露的 PFS获益 ...

证券研究报告 医药生物 首次覆盖报告 2024年05月13日 科伦博泰生物-B（6990.HK） 买入 ——国内 ADC+出海先驱，国际化持续提速 （首次覆盖） 投资要点： 证券分析师 ➢ 国际化平台创新药企，打造ADC领域旗舰地位。四川科伦博泰生物是科伦药业控股子公司，成 刘闯 立于2016年，2023年7月在港交所正式上市，并于2024年3月纳入港股通成分。公司专注 S1350524030002 于生物技术药物及创新小分子药物的研发、生产、商业化及国际合作。通过优势研发平台打造丰 liuchuang@huayuanstock.com 富且全面的ADC创新管线，并与国际巨头药企达成战略合作，进军国际市场。 ➢ “OptiDC”研发平台助力公司 ADC 管线持续扩容，默沙东积极推进国际化进展。目前公司呈 市场表现： 现以ADC药物为核心，单抗、双抗、创新靶点小分子药物等热点领域并进的研发格局。目前公 科伦博泰生物-B 恒生指数 司已有 4 款的 ADC 药物进入临床阶段，覆盖 ADC 核心靶点 TROP2，HER2，CLDN18.2， 223% Nectin-4。此外，公司还有多款的临床前ADC药物储备。公司 ...

Financial Performance - Total revenue for 2023 reached RMB 1,540,493 thousand, representing a 91.6% increase compared to RMB 803,933 thousand in 2022[8] - Gross profit for 2023 was RMB 759,185 thousand, up 44.0% from RMB 527,105 thousand in the previous year[8] - The annual loss for 2023 was RMB 574,134 thousand, a decrease of 6.8% from RMB 616,099 thousand in 2022[8] - Adjusted annual loss improved by 24.4% to RMB 450,788 thousand in 2023 from RMB 596,288 thousand in 2022[8] - Cash and financial assets surged to RMB 2,528,342 thousand as of December 31, 2023, compared to RMB 119,221 thousand in 2022[8] - Other net income for the year ended December 31, 2023, was RMB 89.8 million, a significant increase of RMB 94.2 million compared to a loss of RMB 4.4 million for the year ended December 31, 2022, mainly due to increased interest income from bank deposits and financial assets[84] - Administrative expenses for the year ended December 31, 2023, amounted to RMB 181.88 million, an increase of 90.8% from RMB 95.30 million in 2022[86] - R&D expenses for the year ended December 31, 2023, totaled RMB 1,030.97 million, representing a 21.9% increase from RMB 845.98 million in 2022[87] - Financial costs for the year ended December 31, 2023, decreased by 43.3% to RMB 84.3 million from RMB 148.8 million in 2022[88] - The company recorded income tax of RMB 106.4 million for the year ended December 31, 2023, compared to RMB 48.7 million in 2022[89] Research and Development - Research and development expenses increased by 21.9% to RMB 1,030,966 thousand in 2023, compared to RMB 845,984 thousand in 2022[8] - The company aims to accelerate the submission of multiple new drug INDs and enhance its end-to-end drug development capabilities in 2024[6] - The company has established a robust pipeline with over ten clinical-stage candidates, including four in NDA application stage and one in pivotal trial stage[32] - The company is conducting a Phase 3 trial for A167 in combination with chemotherapy as a first-line treatment for recurrent/metastatic nasopharyngeal carcinoma (RM-NPC)[16] - The company is developing multiple oncology assets targeting different subtypes of NSCLC, with plans to submit an NDA application for 3L EGFR-mutant NSCLC in 2024[110] Clinical Trials and Product Development - The core product SKB264 (MK-2870) achieved a 42.4% overall response rate (ORR) and a 76.3% disease control rate (DCR) in a Phase 2 trial for previously treated metastatic triple-negative breast cancer (TNBC) patients[10] - SKB264 (MK-2870) received breakthrough therapy designation for first-line treatment of unresectable locally advanced, recurrent, or metastatic PD-L1 negative TNBC, with a pivotal Phase 3 trial initiated[11] - A166 achieved its primary endpoint in a pivotal Phase 2 trial for third-line advanced HER2+ breast cancer, with an NDA submitted to the National Medical Products Administration (NMPA) in May 2023[14] - A400 demonstrated an ORR of 80.8% and 69.7% for first-line and second-line treatment of RET+ NSCLC, respectively, with DCR exceeding 96% in both cases[16] - SKB264's NDA application for treating 3L+ advanced TNBC was accepted in December 2023, with expectations for approval in 2024[36] Collaborations and Partnerships - The company received multiple payments from Merck and initiated three key Phase 3 clinical trials in 2023, enhancing collaboration on the SKB264 (MK-2870) project[5] - The company entered into three licensing and collaboration agreements with Merck to develop multiple ADC assets for cancer treatment, retaining rights for certain regions[18] - Merck paid a non-refundable upfront payment of $175.0 million (approximately RMB 1,205.5 million) for the exclusive licensing and collaboration agreement for multiple preclinical ADC assets[19] - The company has established strategic partnerships with Ellipses, Harbour BioMed, and Southwest Medical University, enhancing its R&D and business development capabilities[31] Market Presence and Commercialization - The company successfully listed on the Hong Kong Stock Exchange on July 11, 2023, marking the largest healthcare IPO in Hong Kong since 2022[5] - The company has established a mature commercialization team to implement marketing strategies for strategic products, focusing on areas with medical needs in China such as breast cancer, NSCLC, and gastrointestinal cancers[17] - The company aims to create synergistic licensing and collaboration opportunities globally to enhance commercial value in major international markets[78] - The commercialization team is expected to expand to approximately 500 members by the end of 2024 to oversee pre-launch preparations and commercialization efforts[117] Financial Position and Future Outlook - The company has no significant investments or acquisitions during the reporting period, and no major disposals of subsidiaries, associates, or joint ventures[101] - The company may require substantial additional financing to support its operations and expansion, which could impact the development and commercialization of its candidate drugs[154] - The company is exploring strategic investment and acquisition opportunities to promote long-term development, with further announcements to be made as opportunities mature[104] - The company aims to optimize its operational system to become a leading global biopharmaceutical company[106] Governance and Management - The company has a strong management team with diverse backgrounds in finance and investment, enhancing its strategic capabilities[128] - The management team includes professionals with significant experience in investment banking and financial analysis, which supports the company's growth strategy[127] - The company has been expanding its board with experienced professionals, including those with backgrounds in finance and auditing, to strengthen governance[136] - The board's composition reflects a commitment to independent oversight and strategic guidance, essential for long-term success[130] Regulatory and Compliance - The company has established comprehensive internal regulations for environmental protection and has taken effective measures to ensure resource efficiency and waste reduction[153] - The company has not identified any significant non-compliance issues related to environmental protection, health and safety, or employment laws[153] - The company has established a remuneration committee to determine the compensation policies for directors, supervisors, and senior management based on their experience and qualifications[160]

[Table_StockInfo] 买入 2024年 04月 10日 *（维持） 证券研究报告•公司动态跟踪报告 当前价： 145.00港元 科伦博泰生物-B（6990.HK） 医疗保健 目标价： ——港元 AACR 大会发布两项数据，胃癌全球三期临床可期 投资要点 西南证券研究发展中心  事件：公司近日发布公告于美国AACR年会发布两项临床数据。 [分Ta析bl师e_：Au杜th向or阳]  肺癌试验 OS结果亮眼，胃癌临床数据首次公布。公司此次发布两项芦康沙妥珠 执业证号：S1250520030002 单抗（前称 SKB264）2 期临床数据：1）既往接受过治疗的晚期非小细胞肺癌 电话：021-68416017 邮箱：duxy@swsc.com.cn (NSCLC)患者的 2期研究的最新疗效和安全性结果，该项数据系2023年ASCO 大会上披露数据的进一步更新。截至数据截止日期，22 例 EGFR 突变患者的 分析师：王彦迪 mDoR为 8.7个月，mPFS为11.5个月，mOS为 22.7个月。在 21例EGFR野 执业证号：S1250524040001 生型患者中，mDoR为 9.6个月，mPFS ...