Core Viewpoint - The long-term follow-up results of the CAR-T cell product Zevor-cel (CT053) for treating relapsed/refractory multiple myeloma were presented at the 22nd International Myeloma Society Annual Meeting [1] Group 1: Product Information - Zevor-cel is an autologous CAR-T cell product targeting BCMA, specifically designed for the treatment of multiple myeloma (MM) [1] - The product received approval from the National Medical Products Administration on February 23, 2024, for adult patients with relapsed or refractory multiple myeloma who have progressed after at least three lines of treatment [1] - Zevor-cel was granted Regenerative Medicine Advanced Therapy (RMAT) and orphan drug designation by the FDA in 2019 [1] Group 2: Clinical Trial Updates - The updated results of the Phase I clinical trial were presented under the title "Long term Follow-up of Zevor-cel in Patients with Relapsed/Refractory Multiple Myeloma" at the IMS annual meeting on September 17, 2025 [1]

Core Insights - The long-term follow-up results of the CAR-T cell product Zevor-cel (赛恺泽®) for treating relapsed/refractory multiple myeloma were presented at the 22nd International Myeloma Society (IMS) annual meeting [1] - Zevor-cel is an autologous CAR-T cell therapy targeting BCMA, approved by the National Medical Products Administration (NMPA) in China for adult patients with relapsed or refractory multiple myeloma who have undergone at least three lines of treatment [1] - The product received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and orphan drug status in 2019, indicating its potential significance in treating rare diseases [1] Company Overview - 科济药业-B (02171) is focused on developing innovative therapies for hematological malignancies, with Zevor-cel being a key product in its pipeline [1] - The company aims to address unmet medical needs in the treatment of multiple myeloma, a challenging condition with limited effective therapies available [1] Clinical Development - The Phase I clinical trial results of Zevor-cel were updated and showcased at the IMS annual meeting, highlighting the ongoing commitment to research and development in the field of CAR-T therapies [1] - The long-term follow-up data is crucial for understanding the efficacy and safety profile of Zevor-cel in a real-world patient population [1]

Core Viewpoint - The long-term follow-up results of the CAR-T cell therapy product Zevor-cel for treating relapsed/refractory multiple myeloma have been presented at the 22nd International Myeloma Society (IMS) Annual Meeting [1] Group 1: Product Information - Zevor-cel (CT053) is a fully human anti-BCMA CAR-T cell product designed for the treatment of multiple myeloma (MM) [1] - The National Medical Products Administration approved Zevor-cel for marketing on February 23, 2024, for adult patients with relapsed or refractory multiple myeloma who have progressed after at least three lines of treatment [1] - The product has received the Regenerative Medicine Advanced Therapy (RMAT) designation and orphan drug status from the FDA in 2019 [1] Group 2: Clinical Trial Updates - The updated results of the Phase I clinical trial were presented on September 17, 2025, at the IMS Annual Meeting, focusing on long-term follow-up of patients treated with Zevor-cel [1] - The presentation was titled "Long term Follow-up of Zevor-cel in Patients with Relapsed/Refractory Multiple Myeloma" [1]

Core Insights - The company Kintor Pharmaceutical announced the long-term follow-up results of its CAR-T cell product, Zevor-cel, at the 22nd International Myeloma Society (IMS) annual meeting [1] Group 1 - The long-term follow-up results of the Phase I clinical trial for Zevor-cel were presented in a poster session at the IMS annual meeting [1] - The presentation was titled "Long term Follow-up of Zevor-cel in Patients with Relapsed/Refractory Multiple Myeloma" [1]

Core Viewpoint - The long-term follow-up results of the CAR-T cell product Zevor-cel (赛恺泽®) for treating relapsed/refractory multiple myeloma were presented at the 22nd International Myeloma Society Annual Meeting [1] Group 1: Product Information - Zevor-cel is an autologous CAR-T cell product targeting BCMA, specifically designed for the treatment of multiple myeloma (MM) [1] - The product received approval from the National Medical Products Administration on February 23, 2024, for use in adult patients with relapsed or refractory multiple myeloma who have progressed after at least three lines of treatment [1] - Zevor-cel was granted Regenerative Medicine Advanced Therapy (RMAT) and orphan drug designation by the FDA in 2019 [1] Group 2: Clinical Trial Updates - The updated results of the Phase I clinical trial were presented on September 17, 2025, at the IMS annual meeting, focusing on long-term follow-up for patients treated with Zevor-cel [1] - The presentation was titled "Long term Follow-up of Zevor-cel in Patients with Relapsed/Refractory Multiple Myeloma" [1]

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） 賽愷澤®是一種用於治療多發性骨髓瘤(MM)的全人抗自體BCMA CAR-T細胞產 品。國家藥品監督管理局於2024年2月23日批准賽愷澤®新藥上市申請，用於治 療復發或難治性多發性骨髓瘤成人患者，既往經過至少3線治療後進展（至少使用 過一種蛋白酶體抑制劑及免疫調節劑）。澤沃基奧侖賽注射液於2019年獲得美國 FDA的再生醫學先進療法(RMAT)及孤兒藥稱號。 1 關於本公司 科濟藥業是一家生物製藥公司，專注於開發創新CAR-T細胞療法，以滿足未滿足 的臨床需求，包括但不限於血液惡性腫瘤、實體瘤及自身免疫性疾病。科濟藥業 建立了從靶點發現、臨床前研究、產品臨床開發到商業規模生產的CAR-T細胞研 究與開發的端到端能力。科濟藥業通過 ...

Investment Rating - The report maintains a "Recommended" investment rating for the pharmaceutical industry as of September 15, 2025 [1] Core Insights - The trend of Chinese innovative drugs going overseas continues, with a focus on selective opportunities. The report highlights that the global pharmaceutical transaction volume reached 456 deals in the first half of 2025, a 32% year-on-year increase, with upfront payments totaling $11.8 billion, a 136% surge, and total transaction value hitting $130.4 billion, up 58% year-on-year [2] - The report emphasizes the promising clinical data from Chinese innovative drugs presented at the World Lung Cancer Conference, particularly in the ADC (Antibody-Drug Conjugate) field, showcasing significant efficacy advantages [3] - The report discusses the potential of small nucleic acid drugs and innovative delivery systems, indicating new market opportunities arising from strategic collaborations between Chinese companies and multinational corporations [4] - The CXO (Contract Research Organization) sector is expected to gradually recover, with a notable increase in orders anticipated in the third quarter of 2025, driven by improved innovation environments and funding from license-out transactions [5] - The 2025 medical insurance negotiation and commercial insurance innovative drug directory work has commenced, with a focus on orphan drugs and breakthrough treatment varieties [6] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry underperformed the CSI 300 index by 1.75% in the past week, with a recent one-month increase of 3.32%, lagging behind the CSI 300 by 5.81% [22][26] - The medical device sector showed the highest weekly increase of 2.23%, while the chemical pharmaceutical sector experienced a decline of 2.57% [31] 2. Pharmaceutical Sector Trends and Valuation - The pharmaceutical industry index's current PE (TTM) stands at 40.60, above the five-year historical average of 31.60 [46] - The report notes that the pharmaceutical sector has shown a 15.06% increase over the past three months, outperforming the CSI 300 by 16.11% [43] 3. Recent Research Achievements - The report outlines recent research achievements by the Huaxin pharmaceutical team, including various in-depth and commentary reports on innovative drug developments and market trends [50] 4. Recent Industry Policies and News - The report details recent policy updates from the National Healthcare Security Administration regarding the 2025 drug directory adjustments and the approval of new drug applications [52][55]

Core Insights - FTSE Russell updated its FTSE Global Equity Index Series, including several Hong Kong stocks in the FTSE China Small Cap Index, effective after market close on September 19 [1] - The inclusion of stocks like Ninebot Holdings (09636) reflects international capital market recognition of their future growth potential and long-term investment value [1] - This adjustment is expected to attract additional capital inflows, enhance liquidity in the secondary market, and increase global market visibility for the companies involved [1] Company Impact - Ninebot Holdings (09636) and others included in the index are likely to benefit from increased attention and credibility in the global capital markets due to the endorsement by a well-known index [1] - The inclusion in the FTSE Russell indices signifies a positive outlook for these companies, potentially leading to a rise in stock prices and investor interest [1] - The FTSE Russell indices are widely used by global institutional and retail investors, with approximately $20 trillion in assets benchmarked to these indices, indicating significant market influence [1]

Core Viewpoint - The inclusion of stocks such as 九方智投控股 (09636) and others in the FTSE Global Equity Index Series reflects international capital market recognition of their future development potential and long-term investment value [1] Group 1: Index Inclusion - 九方智投控股 (09636), 和誉-B (02256), 第四范式 (06682), 科济药业-B (02171), and 顺丰同城 (09699) have been added to the FTSE China Small Cap Index, effective after market close on September 19 [1] - The FTSE Russell is a leading player in the global index industry, providing benchmarks, analytics, and data solutions widely used by institutional and retail investors [1] Group 2: Market Impact - The inclusion in the FTSE Russell Global Equity Index Series is expected to bring more potential incremental capital inflows to the companies' stocks, enhancing liquidity in the secondary market [1] - The endorsement from a globally recognized index is likely to increase the companies' visibility and recognition in the global capital markets, aiding in the realization of their long-term investment value [1]

截至月份: 2025年8月31日 狀態: 新提交 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9月4日 I. 法定/註冊股本變動 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 III.已發行股份及/或庫存股份變動詳情 | 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 ...