Core Viewpoint - The announcement by Kintor Pharmaceutical regarding the clinical trial results of Shu Rui Ji Ao Lun Sai injection (CT041) for advanced gastric and gastroesophageal junction adenocarcinoma has been accepted for oral presentation at the 2025 American Society of Clinical Oncology (ASCO) annual meeting [1] Group 1: Product Overview - Shu Rui Ji Ao Lun Sai injection is a potential first-in-class autologous CAR-T cell therapy targeting Claudin18.2 protein, primarily for treating Claudin18.2 positive solid tumors, including gastric and gastroesophageal junction adenocarcinoma, as well as pancreatic cancer [2] - The ongoing trials include multiple studies in China, such as a confirmatory Phase II trial for advanced gastric/gastroesophageal junction adenocarcinoma (CT041-ST-01) and a Phase I trial for pancreatic cancer (CT041-ST-05) [2] Group 2: Regulatory Designations - In February 2025, Shu Rui Ji Ao Lun Sai injection received breakthrough therapy designation from the National Medical Products Administration of China for advanced gastric/gastroesophageal junction adenocarcinoma that has failed at least two lines of prior treatment [2] - In January 2022, the product was granted "Regenerative Medicine Advanced Therapy" designation by the FDA for treating advanced gastric/gastroesophageal junction adenocarcinoma [2] - In 2020, it was designated as an "orphan drug" by the FDA for the same indications [2]

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 | --- | --- | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...

Group 1 - Kintor Pharmaceutical Co., Ltd. experienced the largest decline with a drop of 6.72% [1] - Other notable decliners include Kowloon Warehouse Group and Goldwind Technology, which fell by 4.11% and 3.89% respectively [1] - Several companies, including Nongfu Spring, Hisense Home Appliances, New Energy, Pacific Shipping, WuXi AppTec, Tigermed, Jitu Express, Western Cement, Modern Animal Husbandry, Longyuan Power, Kedi-B, and Helen's, all saw declines exceeding 3% [1] Group 2 - Canggang Railway followed closely with a decrease of 5.16% [3] - Other companies such as Jiumaojiu and Kanglong Chemical experienced declines of 4.44% and 4.42% respectively [3]

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 ...

Investment Rating - The report does not specify a clear investment rating for the company [1]. Core Insights - The company reported a revenue of 6.34 million yuan for the first half of 2024, with a net loss of 350 million yuan, which is a reduction of 50 million yuan compared to a net loss of 400 million yuan in the first half of 2023 [2]. - As of June 30, 2024, the company had cash and cash equivalents amounting to 1.65 billion yuan [2]. - The core product, CT053 (赛恺泽), was approved for market launch on March 1, 2024, and has received 52 orders from Huadong Medicine as of the end of July 2024 [2]. - The company plans to submit a New Drug Application (NDA) for CT041 in the first half of 2025, following the completion of patient enrollment in a confirmatory Phase II clinical trial [2]. - The company expects revenues to grow significantly, projecting 100 million yuan in 2024, 300 million yuan in 2025, and 700 million yuan in 2026 [3][10]. Financial Summary - Revenue projections for 2024-2026 are as follows: 1 billion yuan in 2024, 3 billion yuan in 2025, and 7 billion yuan in 2026 [9][10]. - The expected growth rates for revenue are 200% from 2024 to 2025 and 133.33% from 2025 to 2026 [4]. - The net profit attributable to the parent company is projected to be -747.79 million yuan in 2024, -657.51 million yuan in 2025, and -523.17 million yuan in 2026 [4]. - The earnings per share (EPS) are expected to improve from -1.31 yuan in 2024 to -0.33 yuan in 2026 [4].

Financial Performance - The group reported revenue of approximately RMB 6 million for the six months ended June 30, 2024, primarily from the sale of CAR-T product, CARSgen's CT053[5]. - The net loss for the six months ended June 30, 2024, was approximately RMB 352 million, a decrease of about RMB 52 million compared to RMB 404 million for the same period in 2023[7]. - Adjusted net loss for the same period was approximately RMB 342 million, down RMB 44 million from RMB 386 million in the prior year[7]. - The company reported an operating loss of RMB 362 million and RMB 409 million for the six months ended June 30, 2024, and 2023, respectively, primarily due to R&D and administrative expenses[35]. - The adjusted net loss for the six months ended June 30, 2024, was RMB 342.368 million, a decrease from RMB 385.726 million for the same period in 2023, representing a reduction of approximately 11.2%[38]. - The adjusted loss per share improved to RMB (0.61) for the six months ended June 30, 2024, compared to RMB (0.70) for the same period in 2023, reflecting a 12.9% improvement[39]. - The company reported a revenue of RMB 6,340 thousand for the six months ended June 30, 2024, with a gross profit of RMB 1,617 thousand[60]. - Total other income for the six months ended June 30, 2024, was RMB 23,062 thousand, a decrease of 44.8% from RMB 41,605 thousand in the same period of 2023[67]. Cash Flow and Liquidity - Cash and bank balances as of June 30, 2024, were approximately RMB 1,653 million, a decrease of about RMB 197 million from RMB 1,850 million as of December 31, 2023[8]. - The company expects to maintain cash and cash equivalents of no less than RMB 1,350 million by the end of 2024, with sufficient cash flow anticipated until 2027[8]. - The company reported a net cash outflow from operating activities of RMB (255.947) million for the six months ended June 30, 2024, compared to RMB (141.815) million for the same period in 2023[47]. - The net cash used in operating activities for the six months ended June 30, 2024, was RMB 256 million, compared to RMB 142 million for the same period in 2023[48]. - The total borrowings as of June 30, 2024, amounted to RMB 129 million, an increase of RMB 126 million from RMB 3 million as of December 31, 2023[52]. - The debt-to-equity ratio as of June 30, 2024, was 14.23%, up 9.50 percentage points from 4.73% as of December 31, 2023[53]. Research and Development - The company focuses on developing innovative CAR-T cell therapies to address unmet medical needs in hematologic malignancies and solid tumors[9]. - The lead R&D focus in hematologic malignancies is on CT071, targeting GPRC5D, which has shown promising preliminary results in clinical trials[10]. - The company is actively expanding CAR-T applications in solid tumors, including ongoing Phase I trials for pancreatic cancer and gastric cancer[10]. - CARSgen's CT041, targeting Claudin18.2, is undergoing clinical trials for gastric cancer, with recent data published in Nature Medicine[3]. - The company is collaborating with Moderna on preclinical research for a Claudin18.2 mRNA product[3]. - The company has established CAR T cell research and development capabilities, covering target discovery, preclinical research, clinical development, and commercial-scale production[62]. - The company is engaged in clinical trials to evaluate the safety and efficacy of its therapies, with a focus on solid tumors and hematological malignancies[39]. Product Pipeline and Commercialization - CT053 has been commercialized in nearly 20 provinces or cities in China, with over 100 medical institutions covered by insurance[2]. - The company has established a clinical production facility in Shanghai and a commercial GMP facility to support global clinical trials and subsequent commercialization of its pipeline products[4]. - The RTP production facility in North Carolina is expected to produce CAR-T products for 700 patients annually, supporting clinical research and early commercialization in the US, Canada, and Europe[4]. - The product pipeline includes several proprietary CAR-T candidates, with LUMMICAR 1 already launched in China for relapsed/refractory multiple myeloma[11]. - The company received NMPA approval for the new drug application of Zekun (CT053) on February 23, 2024, for treating adult patients with relapsed/refractory multiple myeloma (R/R MM) after at least three lines of therapy[12]. - The exclusive commercialization rights for Zekun in mainland China were granted to East China Pharmaceutical, with an upfront payment of RMB 200 million and regulatory milestone payments of RMB 75 million already received[12]. - The company plans to submit a New Drug Application (NDA) for Shurui (CT041) to NMPA in the first half of 2025, following the completion of patient enrollment in a confirmatory Phase II trial[16]. Technology and Innovation - The company has achieved significant progress in technology innovation and product pipeline in both the US and China[2]. - The company has developed the proprietary THANK-uCAR® technology to enhance the accessibility of allogeneic CAR-T cell therapies, aiming to reduce costs and improve patient outcomes[24]. - The CARcelerate® platform has been established to shorten CAR-T cell manufacturing time to approximately 30 hours, enhancing production efficiency and potentially increasing anti-tumor activity[25]. - The CycloCAR® technology has been developed to improve the efficacy of CAR-T cells against solid tumors, showing superior preclinical results compared to traditional CAR-T cells[26]. - The LADARTM technology has been introduced to improve drug target availability, allowing for precise control of immune cell activity against cancer cells[27]. - The company is exploring combination therapies to enhance the clinical performance of CAR-T treatments, including a collaboration with Moderna to investigate the effects of a cancer vaccine[26]. Market and Strategic Outlook - 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 for various indications[33]. - The company aims to develop innovative CAR-T technologies to enhance the efficacy, safety, and affordability of its products, addressing unmet medical needs in cancer treatment[34]. - The company plans to continue expanding in both domestic and global markets through R&D and acquisitions, supported by sufficient bank credit facilities[59]. - Future outlook includes plans for market expansion and potential mergers and acquisitions to enhance growth opportunities[39]. - The company is committed to ongoing research and development of new products and technologies to address unmet medical needs[39]. Corporate Governance and Compliance - The roles of Chairman and CEO are currently held by the same individual, Dr. Li, which the board believes facilitates effective strategic execution[88]. - The audit committee has reviewed and approved the accounting principles adopted by the company, ensuring compliance with relevant standards[94]. - The company has not disclosed any significant events requiring additional disclosure or adjustments after the reporting period[89]. - The company emphasizes the importance of compliance with GMP and regulatory standards in its manufacturing processes[39].