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]

Investment Rating - The investment rating for the company is "Buy" (maintained) [2] Core Views - The company has achieved milestone revenues and is preparing for the commercialization of SKB264, which is expected to be launched soon [2][4] - The company reported a revenue of 1.54 billion HKD for the year 2023, representing a year-on-year increase of 91.62% [2] - The company is actively building its domestic commercialization team and has established various departments to support this effort [2][4] Financial Performance - The company reported a net loss attributable to shareholders of 574 million HKD in 2023, a reduction in loss compared to the previous year [2][4] - Operating cash flow was positive at 60 million HKD, and cash and cash equivalents at the end of the reporting period stood at 2.528 billion HKD [2] - The R&D expense ratio was 66.88%, down by 38.35 percentage points year-on-year, indicating improved operational efficiency [2] Revenue and Profit Forecast - Projected revenues for 2024, 2025, and 2026 are 1.332 billion HKD, 1.993 billion HKD, and 2.261 billion HKD, respectively, with expected growth rates of -14%, 50%, and 13% [4] - The forecasted net profit for 2024 is -540 million HKD, with a subsequent expected profit of 5 million HKD in 2025 [4] Pipeline Development - The company’s leading product, SKB264, has received priority review status and is in the final stages of clinical trials for multiple indications, including triple-negative breast cancer [2][3] - The company is advancing multiple ADC and non-ADC products, with several in various stages of clinical trials [3][4]

Investment Rating - The investment rating for the company is "Buy" [1][3][4] Core Insights - The core product SKB264 has submitted a listing application in China and is focused on breast cancer and lung cancer indications, with expected approval in 2024 for the 3L TNBC indication [1][4] - The company reported a significant revenue increase of 92% in 2023, primarily from licensing income, with total revenue of 1.54 billion yuan [1][4] - The company is expanding its global clinical trials for SKB264, with multiple Phase 3 trials initiated by Merck in 2023 and additional trials in 2024 [1][4] Financial Performance - Revenue for 2023 was 1.54 billion yuan, up 92% from the previous year, with a gross profit of 759 million yuan, reflecting a 44% increase [1][2] - The company incurred a net loss of 574 million yuan in 2023, slightly improved from a loss of 616 million yuan in 2022 [2][4] - Research and development expenses increased by 22% to 1.03 billion yuan in 2023, driven by ongoing clinical trials [1][4] Revenue Forecast - Revenue projections for 2024, 2025, and 2026 are 860 million yuan, 984 million yuan, and 1.93 billion yuan, respectively, with expected growth rates of -44%, 14%, and 96% [1][2][4] - The net profit forecast for the same period is expected to be -682 million yuan, -700 million yuan, and -461 million yuan, indicating continued losses but an improvement in the final year [1][2][4] Market Position - The company is building a commercial team to support the launch of its products in China, focusing on high-demand treatment areas such as breast cancer and lung cancer [1][4] - SKB264 is positioned as a key asset in the ADC field, with potential to become a core product in the next generation of immuno-oncology therapies [1][4]

[Table_Main] 证券研究报告 | 公司点评 科伦博泰生物-B(06990.HK) 2024年03月29日 科伦博泰生物-B(6990.HK)： 买入（维持） 所属行业：医疗保健业/药品及生物科技 Trop2 ADC 多项全球三期启 当前价格(港币)：155.00元 动，多个 ADC 进入临床 证券分析师 李霁阳 投资要点 资格编号：S0120523080003 邮箱：lijy7＠tebon.com.cn 业绩：公司2023年3月25日发布年报， 公司2023年收入15.4亿元，增幅达  研究助理 到 91.6%。这一增长主要得益于与默沙东签订的许可及合作协议导致的首付款和 里程碑款的增加。年度亏损减少至2023年的人民币5.74亿元，减少6.8%。研发 开支增加至人民币10.3亿元。Trop2 ADC，HER2 ADC已向CDE递交了NDA申 市场表现 请。公司与默沙东订立三项合作协议，其中SKB264已开展多项全球临床。 科伦博泰生物-B 恒生指数 SKB264 (MK-2870)-trop2 ADC：1）三阴性乳腺癌（TNBC）：CDE已受理既往 206%  171% 接受过至少2种系统治疗 ...

证券研究报告·海外公司点评·药品及生物科技(HS) 科伦博泰生物-B（06990.HK） 科伦博泰 2023 年年报点评：SKB264 海外及 2024 年 03月 27日 国内临床推进超预期，核药赛道前景可期 证券分析师 朱国广 买入（维持） 执业证书：S0600520070004 zhugg@dwzq.com.cn [Table_EPS] 盈利预测与估值 2022A 2023A 2024E 2025E 2026E 股价走势 营业总收入（百万元） 803.93 1,540.49 1,150.00 1,200.00 1,500.00 同比 2,380.36% 91.62% -25.35% 4.35% 25.00% 科伦博泰生物-B 恒生指数 归母净利润（百万元） -616.10 -574.13 -664.01 -874.65 -890.38 156% 136% 同比 30.76% 6.81% -15.65% -31.72% -1.80% 116% 96% 76% EPS-最新摊薄（元/股） -2.81 -2.62 -3.03 -3.99 -4.06 56% 36% 16% P/E（现价&最新摊薄） - - - ...

Investment Rating - The report maintains a "BUY" rating for Kelun-Biotech [2][4][17]. Core Insights - Kelun-Biotech recorded RMB1.54 billion in revenue for FY23, primarily from licensing and collaboration agreements with MSD, with a significant upfront payment of RMB1.21 billion received in March 2023 [2][11]. - The company expects to receive over US$100 million in payments from MSD in FY24, indicating strong future revenue potential [2]. - The net loss for FY23 decreased to RMB574 million from RMB616 million in FY22, showing improvement in financial performance [2][11]. - SKB264 is anticipated to unlock commercial value upon approval in China in the second half of 2024, with ongoing clinical trials expected to validate its global potential [2][3]. - The company is preparing for domestic commercialization by building a commercial team, expected to grow to approximately 500 employees by the end of 2024 [2][4]. Financial Summary - Revenue for FY23 was RMB1.54 billion, a 91.6% increase year-over-year, while FY24 revenue is projected to decline by 40.4% to RMB918 million [3][11]. - R&D expenses increased by 21.9% year-over-year to RMB1.03 billion in FY23, reflecting the company's commitment to advancing its clinical trials [2][11]. - The company had a cash balance of RMB2.53 billion at the end of 2023, providing a solid financial foundation for ongoing operations [2][11]. Clinical Development - SKB264's NDA for 3L+ TNBC has been under review since December 2023, with approval expected in 2H24 [2]. - The company has initiated a Phase 3 trial for SKB264 in 1L TNBC treatment and plans to start pivotal trials in various indications, including NSCLC and HR+/HER2- BC [2][6]. - MSD is actively registering multiple global Phase 3 trials for SKB264, enhancing its development prospects [2][6]. Valuation - The report revises the DCF-based target price from HK$189.25 to HK$200.77, reflecting a potential upside of 25% from the current price of HK$160.60 [4][9].

申万宏源研究 上海市南京东路99号 | +86 21 2329 7818 www.swsresearch.com 简单金融 成就梦想 生物科技 | 公司研究 国内 ADC 领域先行者，核心产品有望走向国际市场 2024年3月25日 科伦博泰生物 (06990:HK) 买入 科伦博泰是一家专注于创新药物研发、制造及商业化的生物医药公司。公司是开发 ADC 药物的先 行者之一，在ADC药物开发方面拥有丰富的经验。公司拥有ADC、大分子及小分子的技术平台， 首次覆盖 目前共有 14 款产品处于临床阶段，核心管线包括 SKB264(TROP2 ADC)、A166(HER2 ADC）、 SKB315(CLDN18.2 ADC)、SKB410 (Nectin-4 ADC)等，其中SKB264和A166的上市申请已被 市场数据：2024年3月22日 收盘价（港元） 163.80 CDE受理。 恒生中国企业指数 5,758 与默沙东达成重磅合作，发掘海外市场潜力。2022年公司与默沙东达成三项研发许可及授权协议， 52周最高/最低价 (港元) 175.00/60.60 总市值（百万港元） 35,904 开发九项ADC产品，包 ...