公 司 研 究 医药生物/生物制品 科伦博泰生物-B 公司 2024H1 业绩优异，与默沙东再添新合作 （06990.HK） 2024 年 08 月 21 日 余汝意（分析师） yuruyi@kysec.cn 证书编号：S0790523070002 ——公司信息更新报告 投资评级：买入（维持） 开 源 证 券 证 券 研 究 报 告 公司信息更新报告 | --- | --- | |--------------------|---------------| | 日期 | 2024/8/20 | | 当前股价(港元) | 168.30 | | 一年最高最低(港元) | 195.00/62.000 | | 总市值(亿港元) | 375.05 | | 流通市值(亿港元) | 219.25 | | 总股本(亿股) | 2.23 | | 流通港股(亿股) | 1.30 | | 近 3 个月换手率(%) | 20.34 | 股价走势图 科伦博泰生物-B 恒生指数 -40% 0% 40% 80% 120% 160% 2023-08 2023-12 2024-04 数据来源：聚源 相关研究报告 《ADC 领域龙头 Biotec ...

Investment Rating - The report maintains a "Buy" rating for the company [2][3]. Core Insights - The company achieved revenue of 1.383 billion RMB in the first half of 2024, representing a year-on-year increase of 32.3%, primarily driven by licensing and collaboration agreements, including a milestone payment of 90 million USD from MSD [2]. - The core product SKB264 has made significant progress in clinical trials, with its first NDA submission for lung cancer and multiple ongoing studies across various indications [2]. - The company is optimizing its collaboration with MSD, which has initiated 10 global Phase III clinical studies for SKB264 and has exercised exclusive rights for the new dual-antibody ADC product SKB571 [2]. - Four products are expected to be approved and commercialized between the second half of 2024 and the first half of 2025, with a dedicated commercialization team focusing on domestic hospitals and leading physicians [2]. - The revenue forecast for the company has been adjusted upwards, with expected total revenues of 1.993 billion RMB, 2.026 billion RMB, and 3.085 billion RMB for 2024, 2025, and 2026 respectively [2]. Financial Forecasts - The company reported a gross profit of 1.077 billion RMB in the first half of 2024, a year-on-year increase of 59.4%, and a profit of 310 million RMB, with an adjusted profit of 386 million RMB, reflecting a significant increase of 1068.0% year-on-year [2]. - Research and development expenses for the first half of 2024 were 652 million RMB, up 33.0% year-on-year [2]. - The company held cash and financial assets totaling 2.885 billion RMB as of June 30, 2024 [2]. - The projected net profit for the company is expected to be -138 million RMB, -618 million RMB, and -133 million RMB for 2024, 2025, and 2026 respectively [3].

Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected price increase of over 15% in the next 6-12 months [7]. Core Insights - The company reported a revenue of 1.383 billion, a year-on-year increase of 32.2%, and a gross profit of 1.077 billion, up 59.4% [2][3]. - The NDA for sac-TMT's new indication for lung cancer has been accepted, with commercialization imminent [3]. - The company has received multiple milestone payments from MSD, totaling approximately 64.1 million, contributing to a strong cash position of 2.885 billion [3]. - Revenue forecasts for 2024, 2025, and 2026 are adjusted to 1.682 billion, 1.550 billion, and 2.400 billion respectively [3]. Financial Performance - Revenue growth rates are projected at 9.19% for 2024, -7.85% for 2025, and 54.84% for 2026 [5]. - The company is expected to incur net losses of 466 million in 2024, 389 million in 2025, and is projected to achieve a profit of 138 million in 2026 [5]. - The diluted earnings per share are forecasted to improve from -2.09 in 2024 to 0.62 in 2026 [5]. Clinical Development - MSD has initiated ten international Phase III clinical trials for sac-TMT, covering multiple cancer indications [3]. - The company is advancing two Phase III registration studies for sac-TMT in breast cancer and NSCLC [3]. Cash Position and Funding - The company raised approximately 541 million HKD through a placement in May 2024, enhancing its cash reserves [3]. - As of mid-2024, the company holds cash and equivalents of about 2.885 billion, ensuring stable operations [3].

Investment Rating - Buy (Maintained) [1] Core Views - The company's 2024 H1 revenue reached 1.38 billion yuan, a year-on-year increase of 32.2%, with Merck milestone payments contributing 640 million yuan [2] - Net profit for H1 2024 was 310 million yuan, marking a temporary profitability [2] - Cash and financial assets totaled 2.89 billion yuan, indicating sufficient capital reserves [2] - SKB264, the first domestic Trop2 ADC, is expected to be approved in China in H2 2024 or H1 2025, with potential inclusion in next year's medical insurance negotiations [3] - Multiple products, including A166 (HER2 ADC), SKB315 (CLDN 18.2 ADC), and SKB410 (Nectin-4 ADC), are progressing well and expected to enter the commercialization phase [3] - Merck exercised its option for the global rights (excluding Greater China) of the bispecific ADC product SKB571, paying a $37.5 million upfront fee with additional development and sales milestones [3] Financial Performance and Forecasts - Revenue for 2024E, 2025E, and 2026E is forecasted at 1.602 billion yuan, 1.447 billion yuan, and 2.003 billion yuan, respectively [2] - Net profit attributable to the parent company for 2024E, 2025E, and 2026E is projected at -376.31 million yuan, -921.17 million yuan, and -795.16 million yuan, respectively [2] - EPS for 2024E, 2025E, and 2026E is estimated at -1.69 yuan, -4.13 yuan, and -3.57 yuan, respectively [2] - Operating cash flow for 2024E is forecasted at 2.197 billion yuan, while investment and financing cash flows are expected to be 15.21 million yuan and 689.50 million yuan, respectively [9] Product Pipeline and Clinical Progress - SKB264 has initiated 10 global Phase 3 clinical trials overseas, covering multiple indications in lung cancer, breast cancer, endometrial cancer, cervical cancer, and gastroesophageal adenocarcinoma [3] - A166 (HER2 ADC) has completed NDA submission for its first indication (HER2+ BC, 3L+) and is expected to be launched in H2 2024 or H1 2025 [3] - SKB571, a bispecific ADC targeting lung cancer and gastrointestinal tumors, is expected to submit an IND application soon [3] Valuation and Market Data - The closing price as of the report date was HK$169.40, with a 52-week range of HK$62.00 to HK$195.00 [5] - The P/B ratio is 11.76x, and the market capitalization is HK$22.07 billion [5] - The company's ROE for 2024E, 2025E, and 2026E is forecasted at -19.06%, -85.82%, and -266.03%, respectively [10] Platform and Strategic Developments - The OptiDC platform's value is further validated by Merck's exercise of the option for SKB571, highlighting the company's innovative capabilities in ADC development [3] - The company is transitioning into a commercialization phase with multiple products nearing market entry, supported by a robust pipeline and strategic partnerships [3]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 四川科倫博泰生物醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：6990） 截至2024年6月30日止六個月的中期業績公告 董事會欣然宣佈本集團截至2024年6月30日止六個月的未經審計簡明綜合中期業 績，連同截至2023年6月30日止六個月的比較數字。本公司獨立核數師已根據香 港審閱工作準則第2410號「實體獨立核數師審閱中期財務資料」對中期財務資料進 行審閱。除本公告另有界定外，本公告所用詞彙與招股章程所界定者具有相同涵 義。 | --- | --- | --- | --- | |---------------------------|--------------------------------------------------|-------------------- ...

医药生物/生物制品 公 司 研 究 科伦博泰生物-B （06990.HK） 2024 年 08 月 13 日 投资评级：买入（首次） | --- | --- | |--------------------|---------------| | 日期 | 2024/8/12 | | 当前股价(港元) | 157.00 | | 一年最高最低(港元) | 195.00/62.000 | | 总市值(亿港元) | 349.87 | | 流通市值(亿港元) | 204.53 | | 总股本(亿股) | 2.23 | | 流通港股(亿股) | 1.30 | | 近 3 个月换手率(%) | 20.19 | 股价走势图 科伦博泰生物-B 恒生指数 -50% 0% 50% 100% 150% 200% 2023-08 2023-12 2024-04 数据来源：聚源 开 源 证 券 证 券 研 究 报 告 港股公司首次覆盖报告 ADC 领域龙头 Biotech，携手默沙东拓展全球版图 ——港股公司首次覆盖报告 余汝意（分析师） yuruyi@kysec.cn 证书编号：S0790523070002 科伦博泰是全球领先的 ADC ...

科伦博泰（6990.HK）深度报告 ADC 龙头商业化在即，授权出海展现重磅潜力 2024 年 07 月 28 日 ➢ ADC 龙头企业产品获批在即，海外授权现金充足。科伦博泰是科伦集团旗 下的创新药企业，经过十余年积累已形成行业领先的 ADC 研发平台"OptiDC"， 是国内 ADC 龙头企业。公司管线中包含 10 余款临床阶段候选药物，其中 5 款 已处于关键试验或 NDA 注册阶段，预计年内将有多款产品获批，进入商业化阶 段。同时得益于与默沙东的授权合作，公司 2023 年实现营收 15.4 亿元，截至 2023 年底，现金及现金等价物期末余额为 15.29 亿元，资金充足。 ➢ 国内：SKB264 潜力巨大，多款产品获批商业化在即。公司核心产品 SKB264 是全球研发进度领先 TROP2 ADC。SKB264 适应症潜力广泛，临床试验全面布 局三阴乳腺癌、HR+/HER2-乳腺癌、EGFR 突变型 NSCLC、EGFR 野生型 NSCLC 等领域，已在多个学术会议上发表了亮眼的临床数据。目前，SKB264 已处于的 首发适应症三阴乳腺癌三线已处于 NDA 阶段，预计将于 2024 年获批，未来随 ...

股 票 研 究 [Table_Industry] 医药 证 券 研 究 报 告 锋芒初显,中国 ADC 龙头逐鹿全球市场 ——科伦博泰首次覆盖报告 | --- | --- | --- | --- | |-----------------|-------------------|----------------------------|------------------------------| | [table_Authors] | 丁丹(分析师) | 甘坛焕(分析师) | 姜铸轩(研究助理) | | | 0755-23976735 | 021-38675855 | 021-38674878 | | | dingdan@gtjas.com | gantanhuan028803@gtjas.com | jiangzhuxuan029022@gtjas.com | | 登记编号 | S0880514030001 | S0880523080007 | S0880123100004 | 本报告导读: 公司为国内 ADC 药物龙头,核心品种陆续步入收获期。TROP2 ADC SKB264 具备全 球同类最佳潜力,背靠 ...

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 ...