金融界5月30日消息，上证指数低开低走，中华交易服务香港生物科技指数 (中华香港生物科技， CESHKB)下跌0.48%，报6455.02点，成交额124.56亿元。 数据统计显示，中华交易服务香港生物科技指数近一个月上涨9.43%，近三个月上涨20.05%，年至今上 涨44.75%。 据了解，"中华交易服务香港生物科技指数由中华证券交易服务有限公司(中华交易服务)委托中证指数 有限公司(中证指数)进行编制，指数编制方案由中华交易服务以及中证指数共同确定。中华交易服务香 港生物科技指数(中华香港生物科技)为证券价格指数，旨在反映于香港上市的生物科技公司的整体表 现"该指数以2014年12月12日为基日，以2000.0点为基点。 从中华交易服务香港生物科技指数持仓的市场板块来看，香港证券交易所占比100.00%。 从中华交易服务香港生物科技指数持仓样本的行业来看，医药卫生占比100.00%。 本文源自：金融界 从指数持仓来看，中华交易服务香港生物科技指数十大权重分别为：信达生物（11.61%）、百济神州 （10.06%）、药明生物（9.62%）、中国生物制药（9.37%）、康方生物（9.26%）、三生制药 （6 ...

SKB378/HBM9378/WIN378是公司与和铂医药共同开发的项目，双方平分全球权利。 SKB378/HBM9378/WIN378是一种新型的重组全人源单克隆抗体(mAb)，能有效结合TSLP配体，通过阻 断TSLP与TSLP受体的相互作用，抑制TSLP介导的信号通路。TSLP是一种经充分验证的细胞因子，在 包括哮喘和慢性阻塞性肺疾病(COPD)在内的多种免疫疾病的发生和进展中起关键作用，抑制TSLP在多 种炎症表型中已显示出获益。SKB378/HBM9378/WIN378经过改良，达到延长半衰期及抑制作用因子的 效果，并以皮下注射方式给药。 于2025年1月，有关SKB378/HBM9378/WIN378用于治疗慢性阻塞性肺疾病的IND申请获国家药品监督 管理局(NMPA)批准。公司亦已完成于中国健康受试者中开展的用于治疗中度及重度哮喘的一期临床试 验。我们的合作夥伴Windward Bio正准备二期试验。 格隆汇5月23日丨科伦博泰生物-B(06990.HK)宣布，根据该公告披露之许可协议条款，公司已自 Windward Bio收到首付款，包括：(i)现金付款，该款项于2025年2月收到，及(ii) ...

Investment Rating - The report initiates coverage with a "Buy" rating for the company [4][20]. Core Views - The company is recognized as a leading ADC platform in China, with a focus on drug pipeline value realization and key inflection points approaching [4][11]. - The core product, Lukanosatuzumab, is the second TROP2 ADC approved globally and is expected to generate significant sales in both domestic and international markets [19][42]. - The company is transitioning from a biotech firm to a comprehensive biopharmaceutical platform, with potential operational breakeven in two years [19][20]. Financial Overview - Revenue projections for 2023 to 2027 are as follows: - 2023: 1,540 million RMB - 2024: 1,933 million RMB - 2025: 2,038 million RMB - 2026: 3,004 million RMB - 2027: 4,300 million RMB - The expected CAGR for revenue from 2025 to 2027 is 45%, with product sales CAGR reaching 82% [7][20]. Product Pipeline - The company has developed approximately 20 drug candidates across three major platforms: ADC, large molecules, and small molecule targeted drugs [11][21]. - The ADC pipeline includes 11 candidates, with one approved and others in various stages of clinical development [11][27]. - The company has established significant collaborations with Merck, involving over 10 billion USD in total transaction value [11][36]. Market Potential - The global ADC market is projected to grow from 13.2 billion USD in 2024 to 115.1 billion USD by 2032, with a CAGR of 35% [21][24]. - The TROP2 ADC market in China is expected to reach 3.4 billion RMB by 2032, with a CAGR of 91.8% [42][49]. Competitive Landscape - The competitive environment for TROP2 ADCs is moderate, with opportunities for Lukanosatuzumab to gain market share against existing products [49][50]. - The company’s unique molecular design and clinical data provide a competitive edge in the ADC space [42][49].

Group 1 - Company announced the sale of a large transferable certificate of deposit from Industrial Bank to Tongwei for a consideration of 52.8325 million RMB on March 21, 2025 [1] - On May 8, 2025, the company purchased a large transferable certificate of deposit from Industrial Bank for 53.0363 million RMB [1] - The total unpaid principal amount of financial products held by the company at Industrial Bank is 250 million RMB, which includes a 70 million RMB large transferable certificate of deposit and a 130 million RMB structured deposit [1] Group 2 - On May 8, 2025, the company entered into a structured deposit agreement with Zheshang Bank, agreeing to subscribe to two structured deposits, each with a principal amount of 200 million RMB [1] - The total unpaid principal amount of financial products held by the company at Zheshang Bank is 550 million RMB, including two structured deposits of 75 million RMB each and the two new structured deposits of 200 million RMB each [1] Group 3 - On May 8, 2025, the company entered into a structured deposit agreement with China Merchants Bank, agreeing to subscribe to a structured deposit with a principal amount of 100 million RMB [2] - The total unpaid principal amount of financial products held by the company at China Merchants Bank is 300 million RMB, which includes a 200 million RMB structured deposit and the new 100 million RMB structured deposit [2] Group 4 - On May 8, 2025, the company entered into a structured deposit agreement with CITIC Bank, agreeing to subscribe to a structured deposit with a principal amount of 250 million RMB [2] - The total unpaid principal amount of financial products held by the company at CITIC Bank is 400 million RMB, which includes a 150 million RMB large transferable certificate of deposit and the new 250 million RMB structured deposit [2]

Investment Rating - The report assigns a "Buy" rating for Kelun Biotech, marking its first coverage with a target price of 300 HKD [1]. Core Insights - Kelun Biotech is transitioning towards an integrated model of research and sales, with its core product, SKB264 (Lukangshatuo monoclonal antibody), having received approval for two indications in China [6][18]. - The company has a robust pipeline with over 30 products in development, including 11 ADC (Antibody-Drug Conjugate) candidates that are in clinical stages [11][18]. - The partnership with MSD has led to 12 global Phase III studies for SKB264, enhancing its clinical and commercial potential [7][32]. Summary by Sections Major Data - The company operates in the pharmaceutical industry, with a total market capitalization of 63.32 billion CNY and a debt-to-asset ratio of 22.48% [1]. Financial Performance - In 2024, the company reported a revenue of 1.933 billion CNY, a year-on-year increase of 25.5%, while net losses narrowed to 267 million CNY, a 53.5% improvement from the previous year [6][16]. - The gross margin is projected to improve from 49.3% in 2023 to 80.2% by 2027, indicating a positive trend in profitability [5]. Product Pipeline - The core product SKB264 has been approved for treating 3L TNBC and 3L EGFR mutation NSCLC, with additional applications pending for 2L EGFR mutation NSCLC expected to be approved in 2025 [30][29]. - The company has established a strong ADC platform and is actively pursuing global collaborations to maximize the potential of its pipeline [11][18]. Strategic Positioning - Kelun Biotech aims to become a comprehensive pharmaceutical company through innovation, global partnerships, and self-sales capabilities, with a focus on expanding its commercial team and enhancing market access [18][6]. - The management team comprises experienced professionals from both domestic and international pharmaceutical sectors, which is expected to drive the company's long-term growth [14].

Product Development and Approvals - The company has achieved significant breakthroughs with three products approved by NMPA for five indications, including the first domestically approved ADC with global intellectual property rights, and the first PD-L1 monoclonal antibody for nasopharyngeal carcinoma treatment[11]. - As of now, two products have submitted NDA for three indications, and seven ADC and novel conjugate drug projects have received clinical approval, with nearly 20 innovative projects in clinical stages[11]. - The company has established three proprietary technology platforms for ADC, mAb, and bsAb to support drug development, while accelerating the development of ADC drugs and expanding new conjugate drug assets[12]. - The NDA for the company's core product, A166 (HER2 ADC), has been accepted by the National Medical Products Administration for treating HER2+ unresectable or metastatic breast cancer patients who have received at least one prior anti-HER2 therapy[30]. - Sac-TMT is the first TROP2 ADC drug globally approved for the treatment of specific adult patients with advanced or metastatic TNBC[19]. - The company is conducting two Phase 3 registration studies for sac-TMT, comparing it with pembrolizumab in PD-L1 positive and negative locally advanced or metastatic NSCLC patients[27]. - The combination of Tagoli monoclonal antibody with chemotherapy showed a median PFS of 7.9 months in a Phase 3 study for recurrent or metastatic nasopharyngeal carcinoma, with a hazard ratio of 0.47[32]. - The overall response rate (ORR) for the Tagoli combination therapy was 81.7%, compared to 74.5% for the control group[32]. - The median duration of response (DoR) for the Tagoli combination therapy was 11.7 months, nearly double that of the control group at 5.8 months[32]. - The NDA for Sac-TMT to treat EGFR mutation-positive NSCLC after progression on EGFR-TKI therapy was accepted by the NMPA in October 2024, with priority review status[59]. Financial Performance - Revenue for 2024 reached RMB 1,933,045,000, a 25.5% increase from RMB 1,540,493,000 in 2023[17]. - Gross profit for 2024 was RMB 1,273,657,000, representing a 67.8% increase from RMB 759,185,000 in 2023[17]. - Research and development expenses increased by 17.0% to RMB (1,206,134,000) in 2024 from RMB (1,030,966,000) in 2023[17]. - The annual loss for 2024 decreased by 53.5% to RMB (266,766,000) compared to RMB (574,134,000) in 2023[17]. - Adjusted annual loss improved by 73.7% to RMB (118,481,000) in 2024 from RMB (450,788,000) in 2023[17]. - Cash and financial assets increased by 21.6% to RMB 3,075,651,000 as of December 31, 2024, up from RMB 2,528,342,000 in 2023[17]. - Total equity rose by 42.0% to RMB 3,308,661,000 in 2024 from RMB 2,329,497,000 in 2023[17]. - Other net income for the year ended December 31, 2024, was RMB 139.8 million, an increase of RMB 50.0 million from RMB 89.8 million for the year ended December 31, 2023, primarily due to increased government subsidies[127]. - Administrative expenses for the year ended December 31, 2024, were RMB 163.3 million, a decrease of 10% from RMB 181.9 million for the year ended December 31, 2023, mainly due to no listing expenses incurred in 2024[130]. Clinical Trials and Research - The company is exploring sac-TMT as a monotherapy and in combination with other therapies for various solid tumors, including gastric and colorectal cancers[27]. - The company has initiated multiple global Phase 2 basket studies for sac-TMT in various solid tumors, which are currently ongoing[27]. - Early clinical data for SKB315 (CLDN18.2 ADC) shows promising efficacy and acceptable safety in gastric cancer with high CLDN18.2 expression[30]. - SKB410, a new Nectin-4 ADC, has shown encouraging Phase 1 clinical data and is currently undergoing global Phase 1/2 clinical trials initiated by Merck[30]. - The overall response rate (ORR) for Tagolisumab in a Phase 2 clinical study was 26.5%, with a median duration of response (DoR) of 12.4 months and overall survival (OS) of 16.2 months[35]. - The company is actively exploring Sac-TMT for various solid tumors, including GC, EC, CC, OC, UC, CRPC, and HNSCC[60]. - The company has established 33 clinical trial centers for A400/EP0031 in the US, Europe, and the UAE, which received FDA fast track designation and is currently in Phase 2 clinical development[44]. - The company is advancing its differentiated HER2 ADC, A166, which is in the NDA registration stage for treating advanced HER2+ solid tumors[65]. - The company is developing over 30 candidate drugs, including its core product sac-TMT, which has been approved for market in China[46]. Strategic Partnerships and Collaborations - In 2024, the company deepened its strategic partnership with Merck, initiating 12 ongoing global Phase III clinical studies for sac-TMT in various cancer types[14]. - The collaboration with Merck includes the development of multiple ADC assets, with 12 ongoing global Phase 3 clinical studies for sac-TMT[40]. - The exclusive option for SKB571/MK-2750 was exercised by Merck, resulting in a payment of $37.5 million to the company, with further milestone payments contingent on specific development and sales milestones[42]. - The company has established a partnership with Ellipses Pharma for the development and commercialization of A400, covering all regions except Greater China, North Korea, South Korea, Singapore, Malaysia, and Thailand[107]. - The collaboration with Windward Bio could yield up to $970 million in upfront and milestone payments, along with tiered royalties based on net sales of SKB378/WIN378[44]. Commercialization and Market Strategy - The company has completed the establishment of a commercial system and formed a mature commercialization team to enhance market influence and brand reputation, focusing on therapeutic areas with medical needs in China such as breast cancer and lung cancer[13]. - The company is preparing to launch multiple products in the Chinese market, including the anticipated launch of Botuzumab in 2025[37]. - The company has established a solid commercialization foundation and market channels, leveraging its major shareholder's extensive experience and industry relationships[47]. - The company is actively exploring new collaboration opportunities globally to maximize the commercial value of its pipeline[169]. - A mature commercialization team has been established to implement strategic marketing and commercialization efforts, focusing on areas with medical needs such as BC, NSCLC, and GI cancers[115]. Research and Development Capabilities - The company has established three core platforms focused on ADC, macromolecule, and small molecule technologies to address medical needs in specific disease areas such as oncology and autoimmune diseases[98]. - The ADC platform, OptiDC™, has accumulated over ten years of development experience and includes a core component library that enables the design of customized ADCs for various therapeutic needs[98]. - The mature macromolecule platform accelerates the development of innovative antibodies through advanced technologies, including monoclonal B cell screening and high-throughput analysis[101]. - The small molecule platform utilizes integrated drug chemistry and computer-aided drug design (CADD) to optimize compounds efficiently during early research stages[101]. - The company has reduced reliance on CROs by establishing internal R&D capabilities, ensuring quality and efficiency in drug development projects[102]. - AI has been integrated into multiple R&D processes, enhancing efficiency in antibody sequence prediction and toxicology mechanism forecasting[103]. - The company is exploring advanced technologies such as PROTAC to tackle challenging protein targets in drug discovery[101]. Governance and Management - The company has a diverse board with members holding significant experience in finance and management, including past roles in major financial institutions[189]. - The management team is composed of professionals with extensive academic and industry experience, enhancing the company's governance and operational efficiency[196]. - The company has a strong focus on independent oversight with multiple independent directors and supervisors in place[193][194][197]. Sustainability and ESG Initiatives - The company has built a comprehensive ESG governance framework, enhancing its ESG accountability and sustainability efforts[45]. - The management team emphasized the importance of sustainability initiatives, targeting a 25% reduction in carbon footprint by 2025[200]. - A comprehensive ESG governance structure has been established, enhancing the company's ESG responsibility capabilities[118].

Investment Rating - The investment rating for the company is "Buy" (maintained) [5] Core Views - The company is expected to achieve high growth driven by commercialization and milestone achievements, with smooth progress in overseas markets [5] - The company reported a narrowing net loss of 267 million RMB in 2024, a 53.5% year-on-year reduction, with total revenue of 1.933 billion RMB, reflecting a 25.5% increase [7] - The company is entering a commercialization phase with promising data and backing from Merck, indicating potential for increased global value [7] Financial Performance Summary - Revenue projections for 2025-2027 are 1.963 billion RMB, 3.007 billion RMB, and 5.363 billion RMB respectively, with growth rates of 1.55%, 53.18%, and 78.35% [6][8] - The company is expected to achieve a positive net profit of 877 million RMB by 2027, with a significant increase in earnings per share from -2.40 RMB in 2025 to 3.86 RMB in 2027 [6][8] - The company's reasonable equity value is estimated at 81 billion HKD, based on a DCF method with a perpetual growth rate of 2% and WACC of 8.58% [7]

Investment Rating - The report maintains an "Outperform" rating for Sichuan Kelun-Biotech Biopharmaceutical with a target price of HKD 297.20, reflecting an upward revision of 48.5% from the previous target price of HKD 200.1 [2][22]. Core Insights - The company has entered a phase where R&D collaboration revenue and commercial sales serve as dual growth drivers, with a sales team expanding to 360 members by the end of 2024 [4][15]. - The company reported a revenue of RMB 1.93 billion for 2024, a 25.5% year-over-year increase, with a gross profit of RMB 1.27 billion and a gross margin of 65.9%, up 16.6 percentage points [3][14]. - Regulatory and R&D catalysts are expected to be abundant in 2025, with three NDAs submitted that are likely to be approved within the year, contributing to incremental revenue growth [5][19]. Financial Performance - Revenue forecasts for 2025-2027 have been adjusted to RMB 1.96 billion, RMB 2.98 billion, and RMB 4.47 billion, reflecting year-over-year growth of +1.4%, +52.2%, and +49.9% respectively [21]. - The net profit forecast for 2025-2027 has been revised to -RMB 280 million, RMB 240 million, and RMB 1.02 billion, showing a significant improvement from previous estimates [21]. - As of December 31, 2024, the company had cash and financial assets of RMB 3.08 billion, reflecting a 21.6% year-over-year increase [3][14]. Product Pipeline and Market Potential - The company has three approved products covering five indications, with ongoing clinical trials for SKB264 and other promising molecules in its pipeline [4][16]. - SKB264 has seen steady sales growth since its market launch in November 2024, with peak sales estimated to reach USD 6-7 billion [16]. - A167, the first PD-L1 inhibitor approved for nasopharyngeal carcinoma, holds significant commercial potential due to the high prevalence of the disease in China [17]. Valuation Methodology - The valuation is based on a DCF model with a weighted average cost of capital of 9.4% and a terminal growth rate of 3.5%, leading to a target price of HKD 297.20 per share [22].

Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected relative increase of over 15% compared to the CSI 300 index in the next six months [1][11]. Core Insights - The company's performance aligns with expectations, with the core product, Lukan Satuzumab, anticipated to become a blockbuster drug due to its rapid sales growth potential and multiple approved indications [1][4][5]. - The company reported a revenue of 1.933 billion yuan for 2024, reflecting a year-on-year growth of 25.5%, with a significant reduction in annual losses [3][7]. Financial Summary - Revenue projections for 2025-2027 are estimated at 2.093 billion yuan, 4.046 billion yuan, and 6.451 billion yuan, respectively, with growth rates of 8%, 93%, and 59% [7]. - The company expects to reduce its net losses significantly, with projections of -582 million yuan in 2025, -485 million yuan in 2026, and a profit of 836 million yuan in 2027 [7]. - The diluted earnings per share (EPS) is projected to improve from -1.20 yuan in 2024 to 3.68 yuan in 2027 [7]. Product Development and Market Potential - Lukan Satuzumab has received approval for two indications and is expected to gain a third indication by late 2025, which will enhance its market potential [4][5]. - The company has established a sales team of over 400 personnel, targeting major hospitals and expanding into lower-tier markets, which is expected to drive rapid sales growth [4][5].

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Insights - The company has successfully transitioned to commercialization, with significant revenue growth expected from the drug Lukanosatuzumab, which was approved in China on November 22, 2024. The total revenue for 2024 is projected to be 1.933 billion yuan, representing a year-on-year growth of 25.5% [6] - The company reported a net loss of 267 million yuan for 2024, a reduction of 53.5% compared to the previous year, indicating improved financial performance [6] - The approval of Lukanosatuzumab for two indications in China and ongoing global clinical trials in collaboration with MSD highlight the company's strong pipeline and potential for future growth [6][7] - Financial forecasts have been adjusted, with expected net losses of 707 million yuan in 2025, 492 million yuan in 2026, and a profit of 512 million yuan in 2027, reflecting a positive outlook for the company's profitability trajectory [6] Financial Summary - Total revenue (in million yuan) is projected as follows: 2023: 1,540; 2024: 1,933; 2025: 1,690; 2026: 2,496; 2027: 4,101 [9] - The gross margin is expected to improve from 49.3% in 2023 to 82.0% by 2027, indicating enhanced operational efficiency [9] - The net profit margin is projected to turn positive by 2027, with a net profit margin of 12.5% [9] - The company's earnings per share (EPS) is expected to improve from -2.5 yuan in 2023 to 2.3 yuan in 2027 [9] Pipeline and Catalysts - The company is expected to receive approval for additional indications of Lukanosatuzumab in 2025, including 2L HR+Her2- breast cancer and other first-line indications anticipated for NDA submission in 2026 [8] - A166, another drug in the pipeline, is expected to receive approval for HER2+ breast cancer in the first half of 2025 [8]