一、行业概述 免疫检查点抑制剂是一类通过阻断免疫检查点蛋白来增强免疫系统对癌细胞攻击能力的药物。免疫检查 点是免疫系统中的调节机制，用于防止免疫反应过度而损伤正常细胞。常见的免疫检查点分子主要有 PD-1、PD-L1、CTLA-4和LAG-3等。肿瘤细胞常利用这些检查点来逃避免疫系统的攻击。而免疫检查 点抑制剂通过阻断这些检查点，使免疫系统能够持续攻击癌细胞。 免疫检查点抑制剂分类 二、行业发展历程 内容概况：近年来，中国免疫检查点抑制剂行业呈现出快速发展的态势，已成为生物医药领域的热点之 一。2024年，中国免疫检查点抑制剂行业市场规模约为527.34亿元，同比增长44.14%。这一显著扩张的 核心驱动力在于免疫检查点抑制剂的创新治疗机制——其通过阻断PD-1/PD-L1等免疫检查点通路，重 新激活人体免疫系统精准识别并攻击肿瘤细胞，为传统治疗手段有限的癌症患者提供了革命性的治疗新 选择。正是基于这种突破性的治疗价值，免疫检查点抑制剂在临床应用中快速渗透，推动市场需求持续 攀升。 中国免疫检查点抑制剂行业经历了起步、快速发展和成熟扩展三个阶段。2011年，科技部等部门将免疫 抑制剂研发纳入国家高新技术领域， ...

Core Viewpoint - Genprex, Inc. has received patent allowances for its lead drug candidate, Reqorsa® Gene Therapy, in combination with immune checkpoint inhibitors, enhancing its intellectual property portfolio for oncology treatments [1][2][3] Intellectual Property Developments - The U.S. Patent and Trademark Office and the European Patent Office have issued Notices of Allowance for patents covering the use of Reqorsa in combination with PD-L1 and PD-1 antibodies, respectively, with both patents set to expire in 2037 at the earliest [1][3] - Genprex has also secured patents for Reqorsa in combination with PD-L1 antibodies in Korea and is pursuing additional patent applications in Europe, Canada, Brazil, China, and Israel [3] Clinical Trial Information - The Acclaim-3 study is a Phase 1/2 clinical trial evaluating Reqorsa in combination with Genentech's Tecentriq® for patients with extensive stage small cell lung cancer (ES-SCLC) [5] - The Acclaim-3 trial has received FDA Fast Track Designation and Orphan Drug Designation, indicating its potential significance in treating this patient population [5] Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing a non-viral Oncoprex® Delivery System for its gene therapies [6] - The company's lead product candidate, Reqorsa, is being evaluated in clinical trials for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), both of which have received FDA Fast Track Designation [6]

Core Viewpoint - The study presents a novel CXCR4 partial agonist, TFF2-MSA, which enhances the efficacy of cancer immunotherapy by targeting immunosuppressive neutrophils and cancer-driven granulopoiesis, particularly in gastric cancer [2][3][8]. Group 1: Research Findings - TFF2-MSA is identified as a CXCR4 partial agonist that sensitizes gastric cancer mouse models to anti-PD-1 therapy [6]. - TFF2-MSA reduces immunosuppressive neutrophils and cancer-driven granulocyte production [6]. - The combination of TFF2-MSA with anti-PD-1 therapy induces a robust anti-tumor CD8+ T cell response [6]. - In gastric cancer patients, decreased levels of TFF2 are associated with an increase in polymorphonuclear myeloid-derived suppressor cells (PMN-MDSC) [6][5]. Group 2: Mechanism of Action - The study demonstrates that TFF2-MSA, when fused with mouse serum albumin (MSA), shows improved stability and effectively inhibits primary tumor growth and distal metastasis in gastric cancer mouse models [4]. - TFF2-MSA selectively reduces Hdc-GFP+ CXCR4high immunosuppressive neutrophils, enhancing the tumor-killing ability of CD8+ T cells mediated by anti-PD-1 [4]. - Unlike CXCR4 antagonists, TFF2-MSA also inhibits bone marrow granulocyte production, contributing to its therapeutic benefits [4]. Group 3: Implications for Cancer Therapy - The research proposes a new strategy that utilizes CXCR4 partial agonism to restore tumor sensitivity to immune checkpoint inhibitors [8].

Core Insights - The article discusses the advancements in cancer immunotherapy, particularly focusing on PD-1 inhibitors, which have shown significant effectiveness in treating late-stage cancer patients, leading to clinical cures in some cases [2][3] - It emphasizes the importance of educating patients about their treatment options, as over 4 million new cancer diagnoses occur annually in China, with increasing life expectancy potentially raising this number [3] - Immunotherapy is identified as the third revolution in cancer treatment, following chemotherapy and targeted therapy, with various types of immunotherapies available, including CAR-T therapy and cancer vaccines [3][4] Group 1: Immunotherapy Developments - PD-1 inhibitors are highlighted as the most effective anti-cancer drugs currently available, with over 10 companies offering these products in China [2] - Immunotherapy is described as a complex and diverse treatment method, making it challenging for the general public to understand [2] - The article mentions the potential of new therapies such as CAR-T, which has transformed the treatment landscape for blood cancers like leukemia and lymphoma [3] Group 2: Patient Outcomes and Education - Early-stage cancer survival rates are notably high, with breast cancer stage 1 survival rates approaching 100%, and stage 2 at 90%, while stage 3 still maintains a 70% survival rate [3] - The article aims to bridge the information gap regarding cancer immunotherapy, providing patients with knowledge about their treatment choices and instilling hope for long-term coexistence with cancer [3][4] - The role of gut microbiota in enhancing treatment efficacy is emerging as a significant area of research, indicating a holistic approach to cancer therapy [4]

Core Viewpoint - China Biologic Products (01177.HK) announced preliminary data from a Phase II clinical study of TQB2868, a PD-1/TGF-β dual-function fusion protein, in combination with Anlotinib and AG chemotherapy for first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) at the 2025 ASCO annual meeting [1][2] Group 1: Clinical Study Results - The TQB2868-ALTN-II-01 study evaluated the efficacy and safety of TQB2868 combined with Anlotinib and AG chemotherapy (Gemcitabine + Albumin-bound Paclitaxel) in mPDAC patients [1] - As of January 2025, 40 patients with stage IV mPDAC were enrolled, with 36 being evaluable; the objective response rate (ORR) was 63.9%, significantly higher than the historical data for AG chemotherapy (23%-36%) [1] - The disease control rate (DCR) reached 100%, compared to 62.3% for AG chemotherapy, and the 6-month progression-free survival (PFS) rate was 86%, double that of AG chemotherapy (43.2%) [1] - The median overall survival (OS) has not yet been reached, but it is expected to exceed one year [1] Group 2: Safety Profile - The safety profile of the TQB2868 combination therapy was favorable, with a rate of grade 3 or higher adverse reactions at 52.5%, lower than the 68.1%-77% range reported for AG chemotherapy [1] Group 3: Future Developments - The company is in communication with the Chinese National Medical Products Administration (NMPA) regarding the registration of a Phase III clinical trial for the TQB2868 combination therapy [2] - This combination therapy is anticipated to become the first-line treatment for pancreatic cancer using immune checkpoint inhibitors, potentially leading to significant improvements in overall survival and quality of life for patients [2]