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 ...

科伦博泰[Ta生ble物_S -to Bck（Na 6m 9eR 9p 0tT .y Hpe K] ） 公司研究/公司点评 里程碑收入持续兑现，SKB264 上市在即备战商业化 [T投 ab资 le_评 R级 an： k]买 入（维持） 主要观点： 报告日期： 2024-04-02 ⚫ 事件 2024年3 月28日，科伦博泰生物发布 2023 年全年业绩公告，公司 [收Ta盘bl价e_（Ba港se元D）at a] 156.2 实现营收15.40亿元，同比91.62%，其中来自合作伙伴默沙东的许可 近12月最高/最低（港元） 177.90/60.60 及合作协议收入为15.32亿元；全年归母净利润-5.74亿元，同比减亏 总股本（百万股） 219 6.81%，调整后年度亏损 4.51 亿元。经营性现金流净额 0.60 亿元， 流通H股（百万股） 127 首次回正。截至报告期末，公司现金及等价物等25.28亿元。 流通股比例（%） 57.99% 总市值（亿港元） 342 ⚫ 点评 流通市值（亿港元） 198 ✓ 里程碑收入持续兑现，公司财务状况健康 [[公TTaa司bbllee价__CC格hhaa与rrtt]]恒 ...

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 ...

27 Mar 2024 CMB International Global Markets | Equity Research | Company Update Kelun-Biotech (6990 HK) Intense data release to further validate the global potential of SKB264 Kelun-Biotech recorded RMB1.54bn revenue in FY23, primarily from licensing and collaboration agreements with MSD. In Mar 2023, SKB received around RMB1.21bn upfront payment from MSD for out-licensing certain pre-clinical ADC assets, a portion of which was recognized in FY23. Additionally, Kelun-Biotech received RMB215mn milestone paym ...

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） - - - ...