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 ...

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].

Financial Performance - Revenue for the six months ended June 30, 2023, reached RMB 1,046,226 thousand, a 203.3% increase compared to RMB 344,988 thousand in the same period of 2022[4] - Gross profit for the same period was RMB 675,660 thousand, reflecting a 199.1% increase from RMB 225,889 thousand year-over-year[4] - The company reported a net loss of RMB 31,130 thousand, significantly reduced by 88.5% from a loss of RMB 270,864 thousand in the prior year[4] - The company's cost of sales for the six months ended June 30, 2023, was RMB 370.57 million, an increase of 211.1% from RMB 119.10 million for the same period in 2022[61] - Gross profit increased by 199.1% to RMB 675.66 million for the six months ended June 30, 2023, compared to RMB 225.89 million for the same period in 2022[62] - The gross margin slightly decreased to 64.6% for the six months ended June 30, 2023, from 65.5% for the same period in 2022[62] - Other net income for the six months ended June 30, 2023, was RMB 24.12 million, an increase of RMB 37.38 million compared to a net expense of RMB 13.26 million for the same period in 2022[64] - Administrative expenses for the six months ended June 30, 2023, were RMB 89.42 million, a 109.88% increase from RMB 42.61 million for the same period in 2022[67] - The company reported a loss of RMB 31.13 million for the six months ended June 30, 2023, a decrease of 88.5% from a loss of RMB 270.86 million for the same period in 2022[73] - Cash and cash equivalents increased to RMB 587.26 million as of June 30, 2023, from RMB 93.0 million at the end of 2022, primarily due to B-round financing and payments from Merck[75] Research and Development - Research and development expenses increased to RMB 490,347 thousand, up 42.6% from RMB 343,787 thousand in the previous year[4] - The company has established a strong pipeline of 14 clinical-stage candidates, with 5 in pivotal trials or NDA registration stages as of June 30, 2023[16] - The company is developing over 10 preclinical ADC assets targeting various solid tumors[18] - The company is recognized as a pioneer in developing ADCs, with over ten years of experience and a proprietary ADC platform, OptiDC[14] - The company aims to optimize patient treatment outcomes through a diversified pipeline offering combination therapy options[9] - The company is actively pursuing a multi-strategy clinical development plan for SKB264 as both monotherapy and in combination therapies for various advanced solid tumors[21] - The company is advancing multiple clinical development plans for A166 in various indications, including ongoing Phase 1b trials and a confirmatory Phase 3 trial for advanced HER2+ BC[27] - The company is exploring combination therapies for its immunotherapy assets and ADCs to expand clinical applications across various cancer types[38] Product Development and Clinical Trials - SKB264 received breakthrough therapy designation from the National Medical Products Administration for treating EGFR-TKI resistant NSCLC in January 2023, with the first patient enrolled in a pivotal Phase 3 trial in July 2023[5] - A166 achieved its primary endpoint in a pivotal Phase 2 trial for advanced HER2+ breast cancer, with a New Drug Application submitted in May 2023[7] - The company has initiated a confirmatory Phase 3 trial for A166 as a second-line treatment for advanced HER2+ BC patients in June 2023[13] - A400's Phase 1 clinical trial data was presented at the ASCO annual meeting in June 2023, with a key trial for advanced RET+ NSCLC starting in July 2023[8] - A223 demonstrated a significant ACR20 difference of 35.1% (63.6% vs. 28.6%) and an ACR50 difference of 33.7% (39.4% vs. 5.7%) in moderate to severe RA patients after 12 weeks of treatment[40] - A400, a second-generation selective RET inhibitor, shows promising preliminary results with an overall response rate (ORR) of 74% in first-line and 66.7% in second-line advanced RET+ NSCLC patients[36] Strategic Partnerships and Collaborations - Merck has entered into an exclusive licensing and collaboration agreement with the company to develop up to seven preclinical ADC assets for cancer treatment, with an upfront payment of $175 million received in March 2023[9] - The company signed nine licensing agreements, including three with Merck Sharp & Dohme LLC, with upfront and milestone payments totaling up to $11.8 billion[15] - The company has retained rights to develop and commercialize SKB264 and other TROP2 ADCs in Greater China, while granting Merck exclusive rights outside this region[24] - The company is pursuing flexible strategies to create collaborative licensing and partnership opportunities globally to enhance commercial value[9] Market Presence and Commercialization - The company successfully listed on the Hong Kong Stock Exchange on July 11, 2023, raising approximately HKD 1,258.9 million (about RMB 1,155.7 million) in net proceeds[10] - The company plans to establish a commercial team of approximately 100 people by the end of 2023 to prepare for the marketing and commercialization of strategic products[56] - The company aims to expand its brand influence through collaborations with major hospitals and experts in the oncology field[56] - The company plans to continue expanding its market presence and investing in new product development to enhance its competitive edge[158] Corporate Governance and Compliance - The company is committed to maintaining high standards of corporate governance and has adopted relevant codes and practices[96] - The audit committee has reviewed the unaudited interim financial information for the six months ended June 30, 2023, ensuring compliance with applicable accounting standards[99] - The independent review of the interim financial report concluded that there were no significant issues regarding compliance with International Accounting Standard 34[141] Employee Incentives and Management - The employee incentive plan has granted significant equity stakes to key personnel, indicating a commitment to aligning interests with shareholders[10] - The employee incentive plan was approved in 2016 and revised in 2020 and 2023, focusing on aligning employee interests with the company's long-term development[122] - The employee incentive management committee determines the allocation of incentive shares based on factors such as tenure and performance[129]

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% ...