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 ...

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 ...

Financial Performance - The company reported a revenue of RMB 1,540,493 thousand for the year ended December 31, 2023, representing a 91.6% increase compared to RMB 803,933 thousand in 2022[4]. - Gross profit for the same period was RMB 759,185 thousand, up 44.0% from RMB 527,105 thousand in the previous year[4]. - The adjusted annual loss decreased by 24.4% to RMB 450,788 thousand from RMB 596,288 thousand year-over-year[4]. - The company incurred a total operating loss of RMB 383,383 thousand in 2023, compared to an operating loss of RMB 418,550 thousand in 2022, indicating an improvement in operational efficiency[18]. - The company’s basic and diluted loss per share improved to RMB 2.84 in 2023 from RMB 5.74 in 2022[18]. - The company reported a net increase in cash and cash equivalents of RMB 1,416,423 thousand for the year, compared to an increase of RMB 10,455 thousand in the previous year[26]. - The company reported a foreign exchange gain of RMB 16,085 thousand in 2023, a recovery from a loss of RMB 31,944 thousand in 2022[35]. - The company reported a total of RMB 67,449 thousand in notes payable as of December 31, 2023, compared to RMB 27,777 thousand in 2022, an increase of 143.5%[45]. - The annual loss decreased by 6.8% to RMB 574.1 million for the year ended December 31, 2023, from RMB 616.1 million for the year ended December 31, 2022[134]. - The company reported a significant increase in user data, with a 25% growth in patient enrollment for clinical trials compared to the previous year[181]. Research and Development - Research and development expenses increased by 21.9% to RMB 1,030,966 thousand from RMB 845,984 thousand[4]. - The company plans to continue investing in research and development, with a focus on innovative drug development and commercialization[32]. - The company is developing at least 10 non-core clinical stage assets in its pipeline as of the announcement date[52]. - The company has advanced over ten candidate drugs into clinical development, enhancing its technical knowledge and streamlining its drug discovery workflows[100]. - The company is focusing on chronic diseases related to aging, aiming to provide solutions for autoimmune and metabolic diseases through innovative drug candidates[153]. - The company is exploring PROTAC technology to induce target protein degradation, aiming to enhance the therapeutic value of generated PROTAC molecules[155]. - The company has allocated $50 million for research and development of its new PROTAC technology aimed at targeted protein degradation[181]. Clinical Trials and Product Development - SKB264 (MK-2870) received breakthrough therapy designation for treating unresectable locally advanced, recurrent, or metastatic TNBC, with a reported overall response rate (ORR) of 42.4% in a recent study[5][6]. - The company initiated a pivotal Phase 3 trial for SKB264 (MK-2870) in first-line treatment of unresectable locally advanced, recurrent, or metastatic PD-L1 negative TNBC[6]. - A166 achieved its primary endpoint in a pivotal Phase 2 trial for 3L+ advanced HER2+ breast cancer, with an NDA submitted to the National Medical Products Administration in May 2023[8]. - The company is conducting a Phase 1 clinical trial for SKB315 targeting advanced solid tumors, with global Phase 1/2 studies ongoing[8]. - A400, a second-generation selective RET inhibitor, demonstrated an ORR of 80.8% in first-line and 69.7% in second-line advanced RET+ NSCLC, receiving orphan drug designation from the FDA[9]. - The company completed patient enrollment for the Phase 2 trial of A223 in moderate to severe RA patients and is conducting a Phase 2 trial for severe AA patients in China[11]. - The company plans to submit IND applications for several preclinical assets in 2024, primarily focusing on ADC and ADC-derived assets[61]. - The company is advancing multiple clinical development strategies for SKB264, exploring its use as monotherapy and in combination with other therapies for various advanced solid tumors[65]. - A223's target indications have expanded to include AA, with ongoing Phase 2 trials in China[88]. - A400's NDA for RET+NSCLC is planned for submission in 2024 following successful clinical consultations[83]. Financial Position and Assets - The company achieved a cash and financial assets balance of RMB 2,528,342 thousand as of December 31, 2023, a significant increase from RMB 119,221 thousand in 2022[4]. - Total assets increased to RMB 2,399,751 thousand in 2023 from a negative RMB 3,174,216 thousand in 2022, showing a significant recovery[22]. - Cash and cash equivalents rose dramatically to RMB 1,528,774 thousand in 2023 from RMB 92,960 thousand in 2022, indicating improved liquidity[26]. - Total liabilities decreased significantly, with current liabilities dropping to RMB 1,110,004 thousand in 2023 from RMB 4,167,361 thousand in 2022[22]. - The company’s equity total reached RMB 2,329,497 thousand in 2023, recovering from a deficit of RMB 3,226,186 thousand in 2022[23]. - The company has no significant investments, acquisitions, or disposals as of December 31, 2023[142]. - The company has no contingent liabilities or asset pledges as of December 31, 2023[145][144]. Strategic Partnerships and Collaborations - The company received a non-refundable upfront payment of $175 million (approximately RMB 1,205.5 million) from Merck for exclusive licensing and collaboration agreements related to multiple ADC assets[12]. - Merck triggered milestone payments totaling $75 million (approximately RMB 532.9 million) for clinical milestones achieved in the development of SKB264 (MK-2870) and other assets[13]. - The company has entered into a licensing agreement with Public Discovery for the first targeted ADC, with milestone payments and royalties expected upon commercialization[106]. - The strategic partnerships with global companies validate the company's R&D and business development capabilities, driving continuous innovation and long-term growth[60]. - The company is actively seeking new collaboration opportunities globally to maximize the commercial value of its pipeline and strengthen its technology platform[157]. Market Presence and Future Plans - The company successfully listed on the Hong Kong Stock Exchange, raising net proceeds of approximately HKD 1,258.9 million (approximately RMB 1,155.7 million)[16]. - The company plans to expand its market presence by entering two new international markets by the end of 2024[181]. - The company aims to enhance its end-to-end drug development capabilities and expand its global footprint while deepening strategic partnerships to maximize the value of its product pipeline[149]. - The commercialization team is projected to expand to approximately 500 members by the end of 2024, focusing on oncology and preparing for product launches[156]. - The company is exploring potential mergers and acquisitions to enhance its product pipeline and market reach[181]. Regulatory and Compliance - The company received a high-tech enterprise certificate on October 16, 2023, allowing it to enjoy a preferential income tax rate of 15% from 2020 to 2025[36]. - The company’s ADC development facility passed the GMP compliance inspection in October 2023, marking a significant milestone in its regulatory compliance efforts[38]. - The audit committee, consisting of three independent non-executive directors, reviewed the annual financial performance for the year ending December 31, 2023, and confirmed compliance with applicable accounting standards and regulations[166]. - The company has adopted corporate governance codes and has been compliant since its listing on July 11, 2023, with a commitment to maintaining high standards of governance[159].

四川科倫博泰生物醫藥股份有限公司 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. （於中華人民共和國註冊成立的股份有限公司） 股份代號：6990 2023 中期報告 目錄 2 公司資料 4 財務及業務摘要 7 管理層討論與分析 33 企業管治及其他資料 48 中期財務資料的審閱報告 49 綜合損益表 50 綜合損益及其他全面收益表 51 綜合財務狀況表 53 綜合權益變動表 55 簡明綜合現金流量表 56 未經審計中期財務報告附註 71 釋義 公司資料 | --- | --- | |-----------------------|-----------------------------------------------| | | | | | | | 董事會 | 審核委員會 | | 董事長兼非執行董事 | 李越冬博士 （主席） | | | 涂文偉博士 | | 劉革新先生 （董事長） | 金錦萍博士 | | 執行董事 | 薪酬委員會 | | 葛均友博士 | 鄭強博士 （主席） | | 王晶翼博士 | 劉思川先生 | | 非執行董事 | 金錦萍博士 | | 劉 ...

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，並明確表示概不就因本公告全部或任何部分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2023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2023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2022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，本公告所用詞彙與本公司日期為2023年6月29日 的招股章程所界定者具有相同涵義。 財務摘要 截至6月30日止六個月 2023年 2022年 同比變動 人民幣千元 人民幣千元 （未經審計）（未經審計） 收入 1,046,226 344,988 203.3% ...