格隆汇5月28日丨科济药业-B(02171.HK)宣布，舒瑞基奥仑赛注射液(产品编号：CT041，一款靶向 Claudin18.2蛋白的自体CAR-T细胞治疗候选产品)已被国家药品监督管理局药品审评中心纳入优先审 评，用于治疗Claudin18.2表达阳性、至少二线治疗失败的晚期胃╱食管胃结合部腺癌的患者。 舒瑞基奥仑赛注射液是一款潜在全球同类首创的、靶向Claudin18.2蛋白的自体CAR-T细胞治疗候选产 品，用于治疗Claudin18.2阳性实体瘤，主要治疗胃╱食管胃结合部腺癌及胰腺癌。已开展的试验包括在 中国开展的研究者发起的临床试验(CT041-CG4006, NCT03874897)，在中国开展的针对晚期胃╱食管胃 结合部腺癌的确证性II期临床试验(CT041-ST-01, NCT04581473)，在中国开展的针对胰腺癌辅助治疗的 Ib期临床试验(CT041-ST-05, NCT05911217)，在中国开展的用于胃╱食管胃结合部腺癌患者术後辅助治 疗後巩固治疗的研究者发起的临床试验(CT041-CG4010，NCT06857786)以及在北美开展的针对晚期胃 癌或胰腺癌的1b/2期临床试验( ...

Financial Performance - For the fiscal year ending December 31, 2024, the company's revenue was approximately RMB 394 million, primarily from the sales of CAR-T product, CARSGEN-CT053, calculated at ex-factory prices[16] - The company's gross profit for the year ended December 31, 2024, was approximately RMB 14.7 million, demonstrating strong cost competitiveness due to stable production of plasmids and vectors[17] - The net loss for the year ended December 31, 2024, was approximately RMB 798 million, an increase of about RMB 50 million compared to the net loss of approximately RMB 748 million for the year ended December 31, 2023[18] - The company reported an operating loss of RMB 808 million for the year ended December 31, 2024, compared to RMB 768 million for the year ended December 31, 2023[68] - Adjusted net loss for the year ended December 31, 2024, was RMB 789 million, compared to RMB 733 million for the year ended December 31, 2023[71] - The company reported a net loss per share of RMB (1.44) for the year ended December 31, 2024, compared to RMB (1.34) for the previous year[72] - Cash and bank balances as of December 31, 2024, were approximately RMB 1,479 million, a decrease of about RMB 371 million from approximately RMB 1,850 million as of December 31, 2023[19] - The company generated a net cash outflow from operating activities of RMB (409.69) million in 2024, compared to RMB (454.94) million in 2023[79] Research and Development - The company achieved significant progress in the development of CARSGEN-CT041, which has shown a significant reduction in disease progression and mortality risk in a Phase II clinical trial for advanced gastric cancer[11] - The company is focusing on developing universal CAR-T products targeting hematological malignancies, solid tumors, and autoimmune diseases to improve patient accessibility[12] - The company is actively expanding its pipeline in hematologic malignancies, including CT071, which targets GPRC5D and shows promising potential in early clinical trials[29] - The company is also advancing its solid tumor pipeline, with CT041 completing patient enrollment in a confirmatory Phase II clinical trial for advanced gastric cancer/gastroesophageal junction adenocarcinoma, achieving statistically significant improvement in progression-free survival (PFS)[29] - The company has developed a comprehensive R&D platform covering the entire CAR-T development cycle, including target discovery, vector design, manufacturing, quality assurance, and quality control[57] - The proprietary THANK-uCAR® technology aims to enhance patient accessibility by reducing costs and improving the durability of universal CAR-T cells, with modifications to eliminate TCR and HLA-I surface expression[58] - The company has initiated a clinical trial for CT0590, a universal CAR-T cell candidate targeting BCMA, to evaluate its safety and efficacy in treating R/R MM[52] Regulatory Approvals and Milestones - In February 2024, CARSGEN-CT053 was approved by the NMPA for treating adult patients with relapsed or refractory multiple myeloma after at least three prior therapies[10] - The CAR-T product "Sykazhu" received NMPA approval for marketing in China on February 23, 2024, for the treatment of relapsed or refractory multiple myeloma[21] - The company plans to submit a New Drug Application for CARSGEN-CT041 to the NMPA in the first half of 2025, aiming to be the first CAR-T therapy approved for solid tumors globally[11] - The company plans to submit a New Drug Application (NDA) for Shurui Jioulongsan Injection to the NMPA in China in the first half of 2025[40] Clinical Trials and Results - The company reported that 2 out of 5 patients in the Phase I trial of CT0590 achieved stringent complete response, with a duration of response lasting at least 20 months[12] - The clinical trial for "Shurujike" has achieved significant improvement in progression-free survival compared to the control group, leading to its breakthrough designation by NMPA[22] - The total response rate (ORR) for patients treated with Zevorcabtagene Autoleucel (Zevorcabtagene Autoleucel) was 92.2% (94/102), with a very good partial response (VGPR) or better rate of 91.2% (93/102), and a complete response (CR)/stringent complete response (sCR) rate of 71.6% (73/102) in the LUMMICAR-1 study[36] - The primary endpoint of the confirmatory Phase II trial (CT041-ST-01) for Shurui Jioulongsan Injection has been achieved, showing statistically significant improvement in progression-free survival (PFS) compared to the control group[40] Strategic Partnerships and Collaborations - The company has established a commercial team in collaboration with Huadong Medicine to promote "Sykazhu," with 154 valid orders received as of December 31, 2024[21] - The company aims to build an open ecosystem through strategic partnerships to drive value creation and expand development opportunities[28] - The company entered into an agreement with Zhuhai Softbank Xinchuan to invest RMB 80 million for an 8% stake in Youkaize, focusing on universal CAR-T cell therapy for blood malignancies in mainland China[55] Market and Competitive Landscape - The global CAR-T cell therapy market is expected to grow further due to rising cancer incidence and the approval of more CAR-T therapies[66] - The company aims to develop innovative CAR-T therapies to meet unmet medical needs, particularly for solid tumors[66] - The company may require additional capital to meet operational cash needs, which may not be obtainable on acceptable terms[132] Governance and Management - The management team includes experienced professionals with backgrounds in biochemistry, pathology, and investment management, enhancing the company's strategic direction[101][106] - The board of directors includes independent members with extensive academic and industry experience, contributing to robust governance and oversight[111][112] - The company has established a remuneration committee to determine the compensation policy for directors and senior management based on their experience and qualifications[189] Intellectual Property and Compliance - As of December 31, 2024, the company holds over 300 patents, including 129 global patents, with an increase of 26 granted patents and 27 patent applications since January 1, 2024[62] - The company has established compliance policies to ensure adherence to applicable laws and regulations[153] - The independent auditor has confirmed that there are no issues regarding the disclosed continuing connected transactions[181] Future Outlook and Challenges - The company has incurred significant net losses and operating cash outflows since its inception, with expectations of continued losses in the foreseeable future[132] - The clinical development process for biopharmaceutical products is lengthy and costly, with uncertain outcomes, and early research results may not predict future trial results[135] - The company may face significant liabilities from product liability claims or lawsuits, and insurance coverage may be insufficient to protect against all potential liabilities[140]

智通财经APP讯，科济药业-B(02171)发布公告，舒瑞基奥仑赛注射液(产品编号：CT041，一款靶向 Claudin18.2蛋白的自体CAR-T细胞治疗候选产品)在中国开展的针对晚期胃癌╱食管胃结合部腺癌的确 证性II期临床试验(CT041-ST-01, NCT04581473)的研究结果摘要已被2025年美国临床肿瘤学会(ASCO)年 会接受进行口头报告。摘要和进一步信息将于美国东部时间2025年5月22日后公布。 舒瑞基奥仑赛注射液是一款潜在全球同类首创的、靶向Claudin18.2蛋白的自体 CAR-T细胞治疗候选产 品，用于治疗Claudin18.2阳性实体瘤，主要治疗胃癌╱食管胃结合部腺癌及胰腺癌。已开展的试验包括 在中国开展的研究者发起的临床试验(CT041-CG4006, NCT03874897)，在中国开展的针对晚期胃癌╱食 管胃结合部腺癌的确证性II期临床试验(CT041-ST-01, NCT04581473)，在中国开展的针对胰腺癌辅助治 疗的I期临床试验(CT041-ST-05, NCT05911217)，在中国开展的用于胃癌╱食管胃结合部腺癌患者术后辅 助治疗后巩固治疗的研究者发起 ...

Investment Rating - The report does not specify a clear investment rating for the company [1] Core Insights - The company reported a revenue of 39.43 million HKD for 2024, with a net loss of 798.13 million HKD, which is an increase of 50 million HKD compared to the previous year [7] - The core product, CT053 (赛恺泽), received approval for market launch, with 154 orders received from 华东医药 as of December 31, 2024 [7] - CT041, a CAR-T candidate for advanced gastric cancer, achieved its primary endpoint in a confirmatory Phase II clinical trial and is expected to submit a New Drug Application (NDA) in the first half of 2025 [7] - The company is advancing its universal CAR-T product pipeline, with multiple candidates under development [7] - Revenue projections for 2025-2027 are estimated at 1.5 billion HKD, 4.3 billion HKD, and 8.3 billion HKD respectively, driven by the commercialization of CT053 and CT041 [8][9] Financial Summary - Revenue and growth rates are projected as follows: - 2024A: 39.43 million HKD - 2025E: 149.98 million HKD (growth rate: 280.42%) - 2026E: 429.94 million HKD (growth rate: 186.67%) - 2027E: 829.89 million HKD (growth rate: 93.02%) [2][9] - The net profit attributable to the parent company is projected to improve from a loss of 798.13 million HKD in 2024 to a loss of 402.37 million HKD in 2027 [2][9] - Earnings per share (EPS) is expected to improve from -1.39 HKD in 2024 to -0.70 HKD in 2027 [2][9] - The return on equity (ROE) is projected to shift from -75.53% in 2024 to 67.22% in 2027 [2][9]

Financial Performance - The group's revenue for the year ended December 31, 2024, was approximately RMB 394 million, primarily from the product CARSgen®[4] - Gross profit for the same period was approximately RMB 147 million, demonstrating strong cost competitiveness due to stable production of quality plasmids and high batch yields[5] - Net loss for the year was approximately RMB 798 million, an increase of RMB 50 million compared to the previous year's loss of RMB 748 million[6] - Adjusted net loss for the year was approximately RMB 789 million, an increase of RMB 56 million compared to the previous year's adjusted loss of RMB 733 million[6] - The company reported an operating loss of RMB 808 million for the year ended December 31, 2024, compared to RMB 768 million for the previous year, primarily due to R&D and administrative expenses[61] - The net loss for the year ended December 31, 2024, was RMB 798 million, an increase of RMB 50 million from RMB 748 million in the previous year, driven by an increase in other losses[63] - The company reported a net loss of RMB 798,132 thousand for the year ended December 31, 2024, compared to a net loss of RMB 747,794 thousand in 2023, indicating an increase in loss of approximately 6.7%[65] - Adjusted net loss for the same period was RMB 789,043 thousand in 2024, up from RMB 733,336 thousand in 2023, reflecting a rise of about 7.6%[65] Cash Flow and Financial Position - Cash and bank balances as of December 31, 2024, were approximately RMB 1,479 million, a decrease of RMB 371 million from RMB 1,850 million as of December 31, 2023[7] - The company expects cash and cash equivalents to remain above RMB 1,080 million by the end of 2025, ensuring sufficient cash flow until 2028[7] - The company’s cash and cash equivalents at the end of 2024 were RMB 1,479,058 thousand, down from RMB 1,849,752 thousand at the end of 2023, representing a decrease of about 20%[73] - The net cash from financing activities for the year ended December 31, 2024, was RMB 185 million, primarily due to net bank borrowings of RMB 840 million and payment for ordinary share repurchases of RMB 500 million[77] - The total borrowings as of December 31, 2024, were RMB 890 million, an increase of RMB 860 million from RMB 30 million as of December 31, 2023[80] - The debt-to-equity ratio as of December 31, 2024, was 15.75%, compared to 4.73% as of December 31, 2023[81] Research and Development - The company is advancing its proprietary THANK-uCAR® platform to develop differentiated allogeneic CAR-T cell products, with a new platform called THANK-u Plus™[13] - The clinical trial for CT041, targeting Claudin18.2 for advanced gastric cancer, has achieved significant improvements in progression-free survival (PFS)[11] - The pipeline includes CT041, which has completed patient enrollment in a confirmatory Phase II trial for advanced gastric and gastroesophageal junction cancer, achieving statistically significant improvement in progression-free survival (PFS)[19] - The company is actively expanding CAR-T applications in solid tumors, with ongoing clinical trials for pancreatic cancer and hepatocellular carcinoma[19] - The company aims to address unmet clinical needs in hematological malignancies and solid tumors through innovative CAR-T therapies[16] - The company is committed to addressing challenges in CAR-T therapy, including high production costs and limited efficacy against solid tumors, through ongoing research and development efforts[48] Product Development and Commercialization - CARSgen® received approval from the National Medical Products Administration (NMPA) on February 23, 2024, for treating relapsed or refractory multiple myeloma in adults[10] - The company has signed a collaboration agreement with East China Pharmaceutical for the commercialization of CARSgen® in mainland China, with over 200 medical institutions covered[10] - The company achieved a significant milestone in 2024 with the approval and launch of its first product, CT053 (赛愷澤®), for the treatment of relapsed or refractory multiple myeloma (R/R MM) in adult patients who have undergone at least three lines of therapy[17] - The commercialization of CT053 in collaboration with Huadong Medicine is progressing smoothly in mainland China[17] - The approval of the new drug ZEVORCABTAGENE AUTOLEUCEL (赛愷泽®) by NMPA on February 23, 2024, marks the company's first product commercialization in mainland China, with a total milestone payment potential of up to RMB 1,025 million[24] - The collaboration with Huadong Medicine aims to maximize the commercialization success of ZEVORCABTAGENE AUTOLEUCEL in mainland China, leveraging their extensive sales network[25] Clinical Trials and Results - CT071, targeting GPRC5D, shows promising potential in early clinical trials for treating R/R MM and R/R primary plasma cell leukemia[19] - Claudin18.2-CAR T cell therapy achieved complete response in a metastatic gastric cancer patient after two doses, maintaining partial response for 8 months[33] - Two cases of metastatic pancreatic cancer treated with CT041 CAR T cell therapy after standard treatment failure were reported, highlighting its potential efficacy[33] - The LUMMICAR-1 study reported an overall response rate (ORR) of 92.2% (94/102) and a complete response (CR) rate of 71.6% (73/102) among patients treated with ZEVORCABTAGENE AUTOLEUCEL[26] - The objective response rate (ORR) and disease control rate (DCR) for patients with GC/GEJ treated with CT041 were reported at 54.9% (28/51) and 96.1% (49/51), respectively[31] Manufacturing and Production - The company has established GMP-compliant production capabilities to support vertical integration in CAR-T manufacturing, which is expected to significantly reduce costs and improve profit margins[55] - The CARcelerate® platform reduces CAR-T cell manufacturing time to approximately 30 hours, resulting in younger CAR-T cells with potentially enhanced tumor-killing capabilities[55] - The company has developed a patented innovative preconditioning regimen for CT041, which includes a low dose of albumin-bound paclitaxel in addition to traditional chemotherapy agents[29] - The company is exploring innovative technologies to enhance drug target availability, including the LADAR™ technology, which allows precise control of immune cell action against cancer cells[53] Strategic Initiatives and Future Outlook - The company plans to continue expanding its production capacity in China and the U.S. to support clinical trials and future commercialization[60] - The company plans to continue expanding in both Chinese and global markets through self-development, mergers, and acquisitions, supported by various financing channels[92] - The company’s mission is to become a leader in the biopharmaceutical field, providing innovative and differentiated cell therapies globally[16] - The company is focused on strategic resource integration and innovation collaboration to adapt to global industry dynamics and market demands[17] Governance and Compliance - The board of directors has decided not to declare a final dividend for the year ending December 31, 2024[134] - The audit committee has reviewed and approved the accounting principles and practices adopted by the group, confirming compliance with applicable standards[132] - The company has not identified any significant litigation or arbitration as of December 31, 2024[128] - The annual general meeting is scheduled for May 22, 2025[135]

一般声明 特别声明 国元国际控股有限公司 香港中环康乐广场 8 号交易广场三期 17 楼 电话：(852)37696888 传真：(852)37696999 服务热线：400-888-1313 公司网址：http://www.gyzq.com.hk 证 券 研 究 报 告 请务必阅读免责条款 | --- | --- | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...

科济药业-B以6.72%的跌幅领跌，成为跌幅最大的股票。 九龙仓集团和金风科技也分别录得4.11%和3.89%的跌幅，农夫山泉、海信家电、新特能源、太平洋航 运、药明康德、泰格医药、极兔速递-W、西部水泥、现代牧业、龙源电力、科笛-B和海伦司等跌逾 3%。 证券时报网讯，港股通标的中，部分股票出现了较大幅度的调整。 紧随其后的是沧港铁路，下跌5.16%，而九毛九和康龙化成分别下跌了4.44%和4.42%。 校对：赵燕 ...

科濟藥業控股有限公司 CARSGEN THERAPEUTICS HOLDINGS LIMITED 科濟藥業控股有限公司 CARSGEN THERAPEUTICS HOLDINGS LIMITED （於開曼群島註冊成立的有限公司） 股份代號 : 2171.HK INTERIM REPORT 2024 中期報告 中期報告 2024 | --- | --- | |----------------------------------|-------| | 目錄 \n公司資料 | 2 | | 業務摘要 | 3 | | 財務摘要 | 5 | | 管理層討論及分析 | 6 | | 企業管治及其他資料 | 29 | | 中期簡明綜合損益及其他全面收益表 | 45 | | 中期簡明綜合財務狀況表 | 46 | | 簡明綜合權益變動表 | 47 | | 中期簡明綜合現金流量表 | 48 | | 中期簡明綜合財務資料附註 | 49 | | 前瞻性聲明 | 62 | | 釋義 | 63 | | 詞彙 | 66 | 公司資料 | --- | --- | |---------------------------------------- ...

国泰君安版权所有发送给上海东方财富金融数据服务有限公司.东财接收研报邮箱.ybjieshou@eastmoney.com p1 股 票 研 究 证 券 研 究 报 告 赛恺泽放量可期，CT041 临床进展顺利 科济药业-B(2171) [Table_Industry] 医药 [Table_Invest] 评级： 增持 ——科济药业 2024H1 点评 [当前价格 Table_CurPrice] (港元)： 3.25 股票研究 /[Table_Date] 2024.09.04 | --- | --- | --- | --- | --- | --- | --- | --- | |----------|-----------------------------------|----------------------------|-------|----------------|--------------------------|-------|-------| | | | | | | | | | | | [table_Authors] 丁丹 ( 分析师 ) | 甘坛焕 ( 分析师 ) | | 付子阳 ( | 研 ...

证券研究报告 | 半年报点评 gszqdatemark 2024 09 03 年 月 日 科济药业-B（02171.HK） 赛恺泽商业化推进顺利，同种异体 CAR-T 进入临床研究 科济药业发布 2024 年中期业绩。公司 2024 上半年实现收入 6 百万元，净亏损 为 3.52 亿元，2023 年同期为亏损 4.04 亿元；实现经调整净亏损 3.42 亿元，2023 年同期为亏损 3.86 亿元。 科济药业宣布舒瑞基奥仑塞注射液中国确证性 2 期临床完成入组。该临床试验 旨在评价舒瑞基奥仑赛注射液治疗 Claudin18.2 表达阳性、既往接受过至少 2 种治 疗失败的晚期胃癌╱食管胃结合部腺癌的患者的有效性和安全性。 观点：赛恺泽商业化推进顺利，同种异体 CAR-T 进入临床研究。 收入端为人民币 6 百万元，主要来自赛恺泽®（（泽基基奥仑赛注射液，自体 BCMA CAR-T 细胞产品）。赛恺泽®的主要收入是以出厂价格进行计算而非终端市场价计 算，收益于完成产品出厂交付后确认；此外从华东医药获得里程碑付款人民币 75 百万元。利润端亏损收窄，除获得产品收入外研发开支同比减少。 主要产品推进情况： ➢ 赛 ...