FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 公司名稱： 科濟藥業控股有限公司 呈交日期： 2025年10月21日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 | 是 | | | 證券代號 (如上市) | 02171 | 說明 | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | 事件 | 已發行股份（不包括庫存股份）變動 | | | 庫存股份變動 | 每股發行/出售價 (註4) | 已發行股份總數 | | | | 已發 ...

Summary of Key Points from the Conference Call Company and Industry Overview - **Company**: 科济药业 (Kojin Pharmaceutical) - **Industry**: Biotechnology, specifically focusing on CAR-T cell therapy and cancer treatment Core Insights and Arguments - **Clinical Trials and Efficacy**: - The Phase I clinical trial of Shurijiaolun's adjuvant therapy for pancreatic cancer showed preliminary efficacy, with 83.3% of patients experiencing a significant decrease in CA199 levels, although longer follow-up is needed to assess long-term disease-free survival (DFS) and overall survival (OS) [2][3] - CT0,596, a universal CAR-T therapy, demonstrated rapid tumor clearance in relapsed/refractory multiple myeloma, with two patients achieving stringent complete response (SCR) and negative minimal residual disease (MRD) detection [2][4] - The CD041 project for pancreatic cancer indicated that CAR-T therapy may extend DFS for high-risk patients, but final data requires further clinical validation [2][3] - **Technological Developments**: - The Enma LNP technology showed excellent performance in B-cell clearance but faces challenges in T CAR-T expansion time and antibody level recovery [2][9] - The company is exploring CT0,596 for other plasma cell tumor indications, such as amyloidosis affecting organs like the heart, to expand its clinical application and market potential [2][5] - **Market Position and Future Plans**: - The company is optimistic about returning to the Hong Kong Stock Connect, with a significant market cap recovery providing a safety cushion for this transition [2][24] - Plans to submit IND applications for multiple myeloma by the end of the year and to continue expanding the clinical application of its CAR-T therapies [2][4][19] Additional Important Insights - **Patient Data and Safety**: - In the CD041 project, 6 patients were enrolled, with a median follow-up of 6.05 months; only one patient experienced disease recurrence, indicating a positive trend in DFS [3][20] - All patients in the trials experienced mild to moderate cytokine release syndrome (CRS), with one case of grade 3 CRS managed effectively [3] - **Competitive Landscape**: - The pancreatic cancer treatment landscape is becoming competitive with various emerging drugs, including small molecule inhibitors and ADCs, necessitating exploration of combination therapies for improved efficacy [2][15][17] - **Intellectual Property**: - The company has a strong patent portfolio, including European patent grants for GP10 CAR-T and broad coverage for NK cell technology, ensuring comprehensive protection for its technology platforms [2][21] - **Financial and R&D Progress**: - The company has made progress in its funding chain and plans to disclose more data on universal products by the end of the year [2][25] - Focus remains on challenging projects in solid tumors, leveraging a less competitive environment to concentrate resources [2][26] - **Viral Vector Technology**: - Viral vectors are a core technology for the company, enabling self-production and modification for potential future relapses, with ongoing efforts to innovate in this area [2][27]

Core Viewpoint - Kintor Pharmaceutical Co., Ltd. (科济药业-B) shares rose over 9% following the announcement of positive results from a clinical trial for its CAR-T cell therapy targeting pancreatic cancer, which was presented at the ESMO annual meeting [1] Group 1: Clinical Trial Results - Kintor's CAR-T cell product, CT053 (赛恺泽), is undergoing an Ib phase registration clinical trial in China for adjuvant therapy in pancreatic cancer [1] - This trial is the first global study exploring CAR-T cell therapy for adjuvant treatment in solid tumors [1] Group 2: Regulatory Developments - On September 20, the National Healthcare Security Administration (国家医保局) announced the completion of expert review for the first version of the commercial insurance innovative drug catalog [1] - Kintor's CT053, along with four other CAR-T drugs, passed the expert review and is expected to be included in this year's basic medical insurance catalog and commercial insurance innovative drug catalog [1]

Core Viewpoint - Kintor Pharmaceutical Co., Ltd. (02171) experienced a significant stock increase of over 9%, reaching HKD 17.66 with a trading volume of HKD 11.95 million, following the announcement of positive clinical trial results for its CAR-T cell therapy targeting pancreatic cancer [1] Group 1: Clinical Trial Results - Kintor announced that the results of its Phase Ib registration clinical trial for the CAR-T cell product CT053 (Zevoracel) targeting BCMA in the treatment of pancreatic cancer have been presented at the 2025 European Society for Medical Oncology (ESMO) annual meeting [1] - This trial is noted as the first global study exploring CAR-T cell therapy for adjuvant treatment in solid tumors, marking a significant milestone in the field [1] Group 2: Insurance and Reimbursement Developments - On September 20, the National Healthcare Security Administration announced the completion of expert review work for the first version of the commercial insurance innovative drug catalog [1] - Kintor's Zevoracel, along with four other CAR-T drugs, successfully passed the expert review and is expected to be included in this year's basic medical insurance catalog and commercial insurance innovative drug catalog [1]

Core Insights - The company Kogei Pharmaceutical-B (02171) announced the results of its clinical trial for the CAR-T cell therapy candidate, Shurui Jiao Lun Sai Injection (CT041), targeting Claudin18.2 for pancreatic cancer, which will be presented at the 2025 ESMO annual meeting [1][2] Group 1: Product Overview - Shurui Jiao 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 pancreatic cancers [2] - Ongoing trials include various phases for different indications, such as advanced gastric/esophageal junction adenocarcinoma and adjuvant therapy for pancreatic cancer [2] Group 2: Regulatory Milestones - On June 25, 2025, the National Medical Products Administration (NMPA) of China accepted the New Drug Application (NDA) for Shurui Jiao Lun Sai Injection for treating Claudin18.2 positive advanced gastric/esophageal junction adenocarcinoma patients who have failed at least second-line treatment [3] - The product received priority review status from the NMPA in May 2025 and was designated as a breakthrough therapy by the NMPA in March 2025 [3] - In January 2022, the product was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA in the United States for treating Claudin18.2 positive advanced gastric/esophageal junction adenocarcinoma [3]

Core Viewpoint - The announcement by Kintor Pharmaceutical regarding the clinical trial results of its CAR-T cell therapy candidate targeting Claudin18.2 for pancreatic cancer has significant implications for the company's future in oncology treatments [1][2]. Group 1: Clinical Trials and Research - The clinical trial CT041-ST-05, focusing on the use of Claudin18.2-targeted CAR-T cells for adjuvant therapy in high-risk pancreatic cancer, was presented at the 2025 ESMO annual meeting [1]. - Multiple clinical trials are underway for the candidate, including studies for advanced gastric/esophageal junction adenocarcinoma and pancreatic cancer, indicating a broad application of the therapy [2]. Group 2: Regulatory Approvals and Designations - The National Medical Products Administration (NMPA) in China accepted the New Drug Application (NDA) for the therapy on June 25, 2025, for treating advanced gastric/esophageal junction adenocarcinoma [3]. - The therapy has received priority review status and breakthrough therapy designation from the NMPA, highlighting its potential significance in treating patients who have failed at least second-line therapy [3]. - In the United States, the therapy was granted Regenerative Medicine Advanced Therapy (RMAT) designation and orphan drug status by the FDA, further emphasizing its innovative nature and potential market impact [3].

香港交易及結算所有限公司、香港聯合交易所有限公司及香港中央結算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。 CARsgen Therapeutics Holdings Limited 科濟藥業控股有限公司 （於開曼群島註冊成立的有限公司） （股份代號：2171） 自願公告 2025年ESMO年會上呈列的 舒瑞基奧侖賽注射液研究成果 本公告由科濟藥業控股有限公司（「本公司」，連同其附屬公司及併表聯屬實體統 稱「本集團」或「科濟藥業」）自願作出，以告知本公司股東及潛在投資者本集團最 新業務更新。 本公司董事會（「董事會」）宣佈，舒瑞基奧侖賽注射液（產品編號：CT041，一種靶 向Claudin18.2的自體CAR-T細胞治療候選產品）在中國開展的針對胰腺癌(PC)輔 助治療的中國Ib期臨床試驗（CT041-ST-05，NCT05911217）研究結果已於2025年 10月19日（星期日）歐洲中部夏令時間(CEST)12:00-12:45在2025年歐洲腫瘤內科 學會(ESMO)年會上進行壁報 ...

致：香港交易及結算所有限公司 公司名稱: 科濟藥業控股有限公司 呈交日期: 2025年10月8日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02171 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 200,000,000,000 | USD | | 0.00000025 | USD | | 50,000 | | 增加 / 減少 (-) | | | | | | | USD | | | | 本月底結存 | | | 200,000,000,000 | USD | | 0.00000025 | USD | | 50,000 | 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年9月30日 狀態: 新提交 本 ...

Major Events - Huiying Holdings (00821) plans to establish a joint venture to provide training, professional consulting services, and high-end conference business in the RWA category [1] - MIRXES-B (02629) intends to set up a joint venture for research, development, and commercialization of early cancer detection and other nucleic acid-based tests in Malaysia [1] - Kintor Pharmaceutical-B (02171) will present updates on the research results of CT0596 at the 2025 ASH annual meeting [1] - Energy & Energy Global (01142) has had its mining license revoked by a Russian subsidiary and plans to appeal further [1] Operating Performance - C&D International Group (01908) reported a cumulative contract sales amount of approximately 71.03 billion yuan for the first nine months, representing a year-on-year increase of about 7.5% [1] - Sa Sa International (00178) recorded a total revenue of 1.031 billion HKD for the second quarter, an annual increase of 8.4% [1] Buybacks/Reductions - Hang Seng Bank (00011) repurchased 200,000 shares for 23.9836 million HKD on October 6 [1] - Tencent Holdings (00700) repurchased 815,000 shares for 550.3 million HKD on October 6 [1] - Mengniu Dairy (02319) repurchased 1 million shares for 14.4099 million HKD on October 6 [1] - HSBC Holdings (00005) repurchased 1.49 million shares for 163 million HKD on October 3 [1]

Core Viewpoint - Hong Kong's biopharmaceutical stocks experienced a significant afternoon rally, indicating positive market sentiment in the sector [1] Company Performance - Yongtai Bio-B surged over 12% [1] - Kexing Pharmaceutical-B increased nearly 10% [1] - Tiansheng Pharmaceutical-B rose over 5% [1] - WuXi AppTec-B and Weisheng Pharmaceutical-B both gained over 3% [1]