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]

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]

Investment Rating - The report maintains a "Buy" rating for the company [1] Core Views - The company recently presented two clinical data sets at the AACR annual meeting, with promising results for lung cancer and initial data for gastric cancer [2] - The company plans to initiate a global Phase III clinical trial for its drug, Lukanosumab, in patients with advanced gastric or gastroesophageal junction adenocarcinoma, which is expected to expand its market presence [2] - Revenue forecasts for 2024-2026 are projected at 11.4 billion, 15.6 billion, and 24.4 billion RMB respectively, driven by the anticipated launch of core products and collaborations with major pharmaceutical companies [2][8] Summary by Sections Clinical Data - The company reported updated efficacy and safety results for Lukanosumab in previously treated advanced non-small cell lung cancer (NSCLC) patients, with a median duration of response (mDoR) of 8.7 months and median overall survival (mOS) of 22.7 months for EGFR mutation patients [2] - For advanced gastric cancer patients, the overall response rate (ORR) was 22.0% with a disease control rate (DCR) of 80.5% [2] Financial Projections - Revenue projections for 2024-2026 are as follows: 11.4 billion RMB in 2024, 15.6 billion RMB in 2025, and 24.4 billion RMB in 2026, reflecting a growth rate of 91.6% in 2023, followed by a decline of 25.8% in 2024, and subsequent growth of 36.1% and 56.7% in 2025 and 2026 respectively [3][9] - The company expects to receive milestone payments from Merck for ongoing collaborations, contributing to revenue growth [8] Product Development - The company is preparing for the market launch of Lukanosumab, which is anticipated to be approved by the end of 2024, with projected revenues from this product of 440 million RMB in 2024, 9.6 billion RMB in 2025, and 18.9 billion RMB in 2026 [8][9]