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7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8月6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 | 本月底法定/註冊股本總額： USD 50 ...

Core Insights - The article emphasizes the need to resolve the contradiction between the high costs of CAR-T therapy and the payment system, which relies on both technological cost reduction and the expansion of research pipelines to access a broader patient market [1] - The focus is on the potential market growth in the solid tumor sector, which could significantly alter the CAR-T market landscape [1] Industry Trends - The global CAR-T research initially focused on hematological tumors, with existing products targeting CD19 and BCMA, covering conditions like non-Hodgkin lymphoma (NHL) and multiple myeloma (MM). The research is now expanding towards solid tumors, with the proportion of clinical trials for solid tumors expected to rise from 15% in 2020 to 30% by 2025 [2][3] - The incidence of solid tumors is significantly higher than that of hematological cancers, indicating a potential exponential growth in the patient population. This growth can help distribute costs through economies of scale and enhance market competitiveness [2] Patient Population Insights - In China, the annual incidence rates for NHL and MM are 6.97 and 1-2 per 100,000 respectively, with approximately 40,000 new cases of DLBCL and 14,000-28,000 new cases of MM each year [2] - For solid tumors, the annual incidence of gastric cancer is between 10-20 per 100,000, with 140,000-280,000 new cases annually, and liver cancer has a similar incidence rate with a potential treatable population of 98,000-196,000 patients per year [3] Technical Challenges - Solid tumors present unique challenges for CAR-T therapies, including tumor microenvironment suppression, antigen heterogeneity, infiltration barriers, and T cell exhaustion [4] Domestic Trends - In China, all six approved CAR-T therapies target hematological tumors, but the proportion of clinical trials for solid tumors is expected to reach 42% by 2024. Key drivers for this shift include technological advancements, policy support, and a large patient base for solid tumors [5] Company Pipeline Analysis - Companies are focusing on expanding their CAR-T pipelines to include solid tumors, with several firms reporting promising clinical trial results and plans for future submissions [6][10][15][20][23][35] - For instance, Kexing Biopharm's Claudin18.2 CAR-T for gastric cancer has shown a 22% objective response rate in Phase II trials, while another company, Yuanqi Bio, reported a 56.5% response rate for GPC3 CAR-T in liver cancer [5][10] Market Potential - The potential market for CAR-T therapies in solid tumors is vast, with estimates suggesting that the annual patient population for gastric and liver cancers alone could reach between 126,000 and 280,000, far exceeding the total for hematological cancers [3][5]

（於開曼群島註冊成立的有限公司） （股份代號：2171） 董事會會議召開日期 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」）董事會（「董事會」）茲通告謹定於2025年8月14日（星期四）舉行董事會會議， 以考慮及通過本集團截至2025年6月30日止六個月的中期業績，以及處理其他事 項。 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 於本公告日期，本公司董事會包括執行董事李宗海博士、王華茂博士及蔣華博 士；非執行董事郭炳森先生、郭華清先生及謝榕剛先生；獨立非執行董事顏光美 博士、趙向可女士及周文博士。 承董事會命 科濟藥業控股有限公司 董事長 李宗海博士 香港，2025年8月1日 ...

Core Insights - The report maintains a positive outlook on small molecule drug conjugates (SMDCs) and related companies, highlighting their potential in cancer treatment due to their ability to enhance efficacy while reducing toxicity [1][5][17] - The report emphasizes the clinical advantages of SMDCs, including better tumor penetration, reduced toxicity to normal cells, and easier control over synthesis and costs compared to antibody-drug conjugates (ADCs) [5][11][12] - The report identifies domestic biopharmaceutical companies, particularly Affinivax, as leaders in the SMDC space, showcasing significant advancements in innovative cancer drug development [5][12][17] Industry Overview - The pharmaceutical and biotechnology sector has shown a relative price-to-earnings (P/E) ratio of 51.14 as of July 25, 2025, which is significantly higher than its historical low of 24.38, indicating a premium valuation compared to the broader market [19] - The report notes that the healthcare sector's valuation is 279% higher than the Shanghai Composite Index, reflecting strong investor interest and confidence in the industry [19] - Recent market performance indicates a 1.90% increase in the pharmaceutical and biotechnology sector from July 21 to July 25, 2025, ranking it 16th among 27 sub-industries [26][29] Company Focus - The report suggests monitoring companies involved in the SMDC space, including Affinivax, and those collaborating with them, such as Innovent Biologics and others, which are expected to benefit from the growing interest in innovative cancer therapies [5][17][18] - Specific companies highlighted for their innovative drug development capabilities include Innovent Biologics, Shunyi Pharmaceutical, and others, which are positioned to capitalize on the advancements in SMDC technology [5][18]

Group 1: Hong Kong Stock Market Highlights - Yunfeng Financial (00376) surged over 21% as the company plans to strategically invest in digital currency and AI sectors [1] - China Merchants Securities (06099) opened nearly 15% higher and is currently up over 4% after receiving approval for a virtual asset license [1] - GDS Holdings (09698) rose over 7% as its Southern GDS data center REIT concluded public investor fundraising ahead of schedule [1] - Hillstone Technology (01478) increased nearly 6% with positive earnings expectations, and Citigroup anticipates a favorable market reaction [1] - Sunny Optical Technology (02382) briefly rose over 3% and is currently up over 1% as its lithography equipment successfully entered Shanghai, indicating a shift to mass production [1] - Kintor Pharmaceutical (02171) saw an early gain of over 3% after achieving positive results in the European patent opposition process [1] - Bilibili (09626) rose over 5% as HSBC expressed optimism about its gaming and advertising business, with new games planned for 2025 [1] - Solar stocks experienced a decline, with institutions citing electricity prices affecting the stable profitability of new energy projects [1] Group 2: U.S. Stock Market Highlights - The U.S. nuclear sector saw gains, with NuScale Power (SMR.US) up 12.38% and Oklo Inc (OKLO.US) up 11.29%, following comments from the U.S. Energy Secretary about a nuclear revival [3] - Autodesk (ADSK.US) rebounded 5.05% after a period of decline, expressing confidence in its cloud and AI business strategies [3] - Sonnet BioTherapeutics (SONN.US) surged 86.46% due to a merger announcement, forming a cryptocurrency financial company valued at $888 million [3] - Quantum stocks rose, with D-Wave Quantum (QBTS.US) up 6.89% and Quantum Computing (QUBT.US) up 8.66% [3] - Hims & Hers Health (HIMS.US) increased 8.64% as it plans to enter the Canadian market with a generic drug following the expiration of a patent [4] - Rocket Lab (RKLB.US) rose 10.71% after Citigroup raised its target price, noting a significant increase in global space technology investments [4] - Nvidia-related stocks mostly strengthened as Jensen Huang made his third visit to China this year [5] - Cryptocurrency stocks collectively rose, with Bitcoin surpassing $120,000, driven by upcoming legislative reviews in the U.S. [5] - Tesla (TSLA.US) gained 1.08% amid investor speculation regarding a stake in xAI [5] - Netflix (NFLX.US) rose 1.35% ahead of its upcoming earnings report, with analysts projecting significant revenue growth [6]

Policy Changes - The National Healthcare Security Administration has released the "2025 Basic Medical Insurance Directory and Commercial Insurance Innovative Drug Directory Adjustment Application Guidelines," marking the inclusion of commercial health insurance innovative drug directory in the adjustment plan, indicating a more significant role for commercial health insurance in the multi-level medical security system [1] Regulatory Developments - The National Medical Products Administration's Deputy Director Lei Ping conducted a survey in Hunan to understand the registration management and innovation of medical devices, emphasizing the need for safety and clinical demand-driven innovation [2] - The Guangdong Provincial Drug Administration has revoked the registration certificates of 15 pharmacists due to violations, while Inner Mongolia and Xinjiang are also investigating potential fraudulent practices related to pharmacists' registrations [3] Drug Approvals and Developments - Xuantai Pharmaceutical announced that its application for Enzalutamide tablets has received temporary approval from the FDA, targeting castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer [3] - Shenji Changhua's gene therapy SNUG01 for ALS has received orphan drug designation from the FDA [4] - Laimei Pharmaceutical's generic drug Mabalosavir tablets have received ethical approval to enter the bioequivalence testing phase [5] - Keji Pharmaceutical has submitted a new drug application for its CAR-T cell product targeting Claudin18.2 for advanced gastric/esophageal junction adenocarcinoma [6] Market Activities - Yinuo Micro Pharmaceuticals has had its IPO application accepted by the Hong Kong Stock Exchange, focusing on new oncolytic virus therapies and exosome therapies [7] - Innovent Biologics raised approximately HKD 4.3098 billion through a share placement, with 90% of the proceeds allocated for global R&D of its innovative pipeline [8] Strategic Partnerships - Rongchang Biologics has licensed its drug Taitasip to Vor Biopharma for global development outside Greater China, receiving an upfront payment of USD 125 million and potential milestone payments totaling up to USD 4.105 billion [9] Company Operations - Boya Biological announced that its plasma collection station has obtained a business license from the local market supervision authority [10] Shareholder Actions - A major shareholder of Aomei Medical, Chen Haohua, plans to reduce his stake by up to 3% through block trades and centralized bidding over the next three months [10]

Core Viewpoint - The article highlights the significant breakthrough of Kanjia Pharmaceutical in expanding CAR-T cell therapy from hematological cancers to solid tumors, with the submission of a new drug application for Shurijiaolun's injection [1][2][5][7]. Group 1: Company Developments - Kanjia Pharmaceutical submitted the new drug application (NDA) for Shurijiaolun's injection to the National Medical Products Administration (NMPA) on June 25, 2023, which was accepted on June 26 [1][3]. - The successful development of Shurijiaolun's injection positions Kanjia Pharmaceutical to potentially become the first company globally to offer CAR-T therapy for solid tumors, specifically targeting Claudin18.2 positive advanced gastric/esophageal junction adenocarcinoma patients [5][8][9]. - The company has seen its stock price surge nearly tenfold from a low of 2.48 HKD to around 25 HKD, driven by research advancements rather than market speculation [3][22]. Group 2: Clinical Trial Results - The NDA submission is based on a Phase II clinical trial (CT041-ST-01) that demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) compared to standard treatments for patients with advanced gastric cancer [9][10]. - The trial results have garnered international attention and recognition, providing a solid evidence base for the NDA application [10][12]. Group 3: Market Potential and Financial Health - The global market for CAR-T therapies is expected to expand significantly, as solid tumors account for approximately 90% of new cancer cases, compared to less than 10% for hematological cancers [11]. - Kanjia Pharmaceutical's financial health is robust, with cash reserves projected to remain above 1.08 billion HKD by the end of 2025, indicating a strong foundation for sustainable growth [12][13]. Group 4: Future Outlook - The company is preparing to build a commercialization team for Shurijiaolun's injection, aiming for a clear path to market and reduced trial costs [14]. - Kanjia Pharmaceutical is also developing universal CAR-T therapies using its THANK-u Plus™ platform, which shows promise in treating various cancers [18]. - The company is expected to leverage its successful commercialization of its first CAR-T product, Zewokaiolun's injection, to enhance the market entry of Shurijiaolun's injection [12][13]. Group 5: Industry Context - The Chinese innovative drug sector is experiencing a favorable environment, with increased investor enthusiasm and a trend of value reassessment among listed companies [16][22]. - Kanjia Pharmaceutical's unique approach contrasts with many peers that rely on overseas business development, as it focuses on self-sustaining growth through successful product commercialization [16].

Investment Rating - The report maintains a "Recommended" rating for the pharmaceutical industry [1] Core Insights - The revaluation of innovative drugs continues, driven by significant transactions and a trend towards differentiation in the market. The value of innovative drugs is increasingly recognized by multinational corporations (MNCs), particularly in the areas of EGFR and PD-1 dual antibodies. The number of pharmaceutical transactions in China increased by 34% year-on-year in Q1 2025, with total transaction value rising by 222% [3] - The upcoming ADA conference presents opportunities for Chinese companies to showcase their research, particularly in the areas of diabetes and weight loss. Notable collaborations and developments in GLP-1 drugs are expected to enhance the market presence of Chinese firms [4] - The gout treatment market shows significant potential, with a projected increase in patients from 170 million in 2020 to 240 million by 2030 in China. New drugs targeting URAT1 are entering critical clinical stages, indicating a strong market opportunity for innovative treatments [5] - Chinese companies are leading breakthroughs in CAR-T technology, with key developments expected in 2025. Recent clinical trials have shown promising results for CAR-T therapies in treating various cancers, indicating a strong future for these innovations [6] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry outperformed the CSI 300 index by 0.25% in the past week, with a weekly increase of 1.13% [17] - Over the past month, the pharmaceutical sector's index rose by 6.48%, surpassing the CSI 300 index by 4.76%, ranking second among all sectors [22] 2. Pharmaceutical Sector Trends and Valuation - The pharmaceutical sector's current PE (TTM) is 34.41, slightly above the five-year historical average of 32.55 [41] 3. Recent Research Achievements - The research team has published several in-depth reports highlighting the growth trends in the blood products industry and the impact of policies on inhalation drug markets [44] 4. Recent Industry Policies and News - Recent policies aim to enhance the pricing and procurement evaluation system in the pharmaceutical sector, promoting a fair and transparent market environment [47] - Notable industry news includes several innovative drugs receiving clinical trial approvals and partnerships between Chinese companies and international firms, indicating a vibrant and evolving market landscape [48][49]

Core Viewpoint - The article discusses the promising results of the CAR-T cell therapy targeting Claudin18.2 (satri-cel) for treating advanced gastric and gastro-oesophageal junction cancer, highlighting its potential as a new standard treatment option for patients who have failed multiple lines of therapy [2][3][20]. Summary by Sections Clinical Trial Overview - The study published in The Lancet presents the results of a randomized, open-label, phase 2 trial comparing satri-cel to physician's choice treatment for previously treated advanced gastric or gastro-oesophageal junction cancer [3]. - The trial involved 156 patients with CLDN18.2 positive tumors who had progressed after at least two lines of treatment [6]. Treatment Groups - Patients were randomly assigned in a 2:1 ratio, with 104 receiving satri-cel and 52 receiving standard treatment [7]. - The satri-cel group received autologous CAR-T cells at a dose of 250 million cells, with a maximum of three infusions [8]. Efficacy Results - The median progression-free survival (PFS) was significantly longer in the satri-cel group at 3.25 months compared to 1.77 months in the TPC group [9]. - The median overall survival (OS) was 7.92 months for the satri-cel group, showing a 44% increase compared to 5.49 months in the TPC group [9]. - The objective response rate (ORR) was 22% in the satri-cel group versus 4% in the TPC group [10]. - Notably, patients with peritoneal metastasis showed significant benefits from satri-cel treatment [10]. Safety Profile - In the satri-cel group, 99% of patients experienced grade 3 or higher treatment-related adverse events, primarily hematological toxicities [15]. - Cytokine release syndrome (CRS) occurred in 95% of patients, with 90% being grade 1-2, indicating manageable side effects [15]. - The TPC group had a 63% incidence of grade 3 or higher treatment-related adverse events [15]. Significance of the Study - This study marks the first successful demonstration of CAR-T cell therapy's efficacy in solid tumors, representing a milestone in cancer treatment [20]. - It provides a new effective treatment option for advanced gastric cancer patients, particularly those with poor prognosis due to peritoneal metastasis [20]. - The results pave the way for further research into CAR-T therapies for other solid tumors and highlight China's innovative capabilities in cancer immunotherapy [20].

Core Viewpoint - The company Kogei Pharmaceutical-B (02171.HK) announced that its CAR-T cell therapy candidate, Shurijiaolun Sai Injection (CT041), has been prioritized for review by the National Medical Products Administration for treating Claudin18.2 positive advanced gastric/esophagogastric junction adenocarcinoma patients who have failed at least two lines of treatment [1][2]. Group 1 - Shurijiaolun Sai Injection is a potentially first-in-class CAR-T cell therapy targeting Claudin18.2 protein, primarily for advanced gastric/esophagogastric junction adenocarcinoma and pancreatic cancer [2]. - Ongoing clinical trials include a researcher-initiated trial in China (CT041-CG4006, NCT03874897), a confirmatory Phase II trial for advanced gastric/esophagogastric junction adenocarcinoma (CT041-ST-01, NCT04581473), a Phase Ib trial for pancreatic cancer (CT041-ST-05, NCT05911217), and a post-operative consolidation therapy trial (CT041-CG4010, NCT06857786) [2]. - In March 2025, the injection received breakthrough therapy designation from the National Medical Products Administration in China for treating Claudin18.2 positive advanced gastric/esophagogastric junction adenocarcinoma after at least two lines of treatment failure [2]. Group 2 - In January 2022, the injection was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA in the United States for treating Claudin18.2 positive advanced gastric/esophagogastric junction adenocarcinoma [2]. - In September 2020, the injection received Orphan Drug designation from the FDA for treating gastric/esophagogastric junction adenocarcinoma [2].