医药 2025 年 12 月 30 日 基石药业-B（2616.HK） 以临床开发为引擎、稳健迈入研发2.0阶段，创新布局前沿管线及领域 推荐（首次） 股价：5.51 港元 主要数据 | 行业 | 医药 | | --- | --- | | 公司网址 | www.cstonepharma.com | | 大股东/持股 | Wuxi Healthcare Ventures/11.84% | | 总股本(百万股) | 1475.98 | | 流通 A 股(百万股) | 0 | | 流通 B/H 股(百万股) | 1475.98 | | 总市值（亿港元） | 81.3 | | 每股净资产(元) | 0.23 | | 资产负债率(%) | 73.57 | 行情走势图 证券分析师 | 投资咨询资格编号 | | --- | | S1060524030001 | | HEMINXIU894@pingan.com.cn | | 投资咨询资格编号 | | S1060519060002 | | hanmengmeng005@pingan.com.cn | | 叶寅 投资咨询资格编号 | | S1060514100001 | | B ...

该研究设计了一种 基于多肽 接枝聚合物 的纳米机器人 （ peptide-grafted polymer-based nanorobot ） ，它能够在阻断 PD-1/PD-L1 的同时； 通过一个 pH 响应模块原位形成纤维来 破坏癌细胞膜 ，诱导 免疫原性细胞死亡 （ICD） ，释放 损伤相关分子模式 （DAMP） ，招募 T 细胞浸润。从而双管齐下 （解除 刹车+踩下油门） 发挥抗癌作用。 撰文丨王聪 编辑丨王多鱼 排版丨水成文 目前，阻断 PD-1 及其受体 PD-L1 为癌症治疗带来了巨大前景。尽管 PD-1/PD-L1 阻断疗法在临床上对多种类型的癌症的治疗取得了令人振奋的进展，但超过 95% 的 结直肠癌 （CRC） 患者属于错配修复功能正常 （pMMR） 的" 冷肿瘤 "，其对 PD-1/PD-L1 阻断疗法无响应，因为免疫细胞几乎无法浸润到免疫抑制 性的肿瘤微环境 （TME） 中。 诸如化疗、放疗和光热疗法之类的策略有可能通过免疫原性细胞死亡 （ICD） 和损伤相关分子模式 （DAMP） 的释放，将 pMMR 型"冷肿瘤"逆转为"热肿瘤"， 从而重塑肿瘤微环境，使癌细胞对基于 PD-1/PD ...

目前国内除原研外，暂未有类似药获批上市 公司研发的帕博利珠单抗注射液为生物类似药。帕博利珠单抗原研产品(商品名：可瑞达?，Keytruda?) 由默沙东公司开发，是全球首个获批上市的PD-1抑制剂之一，已在全球范围内获批用于包括非小细胞 肺癌、黑色素瘤、头颈部鳞状细胞癌、食管癌、肝癌、胃癌、结直肠癌等在内的数十个重要肿瘤适应 症，临床价值得到广泛认可。 帕博利珠单抗是一种靶向程序性死亡受体-1(PD-1)的人源化单克隆抗体。PD-1 是免疫 T 细胞表面的一 种关键免疫检查点蛋白，肿瘤细胞可通过激活PD-1通路抑制 T 细胞的免疫活性，从而实现免疫逃逸。 帕博利珠单抗通过阻断PD-1与其配体 PD-L1/PD-L2 的结合，恢复 T 细胞的肿瘤杀伤功能，增强人体免 疫系统对抗肿瘤的能力。该药物作为免疫检查点抑制剂，已成为多种晚期恶性肿瘤的标准治疗方案之 一，革新了肿瘤治疗格局。 格隆汇12月16日丨华兰生物(002007.SZ)公布，近日公司参股公司华兰基因工程有限公司(以下简称"基因 公司")收到国家药品监督管理局签发的帕博利珠单抗注射液境内生产药品注册临床试验申请《受理通知 书》(受理号：CXSL2501 ...

华兰生物（002007）(002007.SZ)发布公告，近日，公司参股公司华兰基因工程有限公司(以下简称"基因 公司")收到国家药品监督管理局签发的帕博利珠单抗注射液境内生产药品注册临床试验申请《受理通知 书》。 公司研发的帕博利珠单抗注射液为生物类似药。帕博利珠单抗原研产品(商品名：可瑞达，Keytruda)由 默沙东公司开发，是全球首个获批上市的PD-1抑制剂之一，已在全球范围内获批用于包括非小细胞肺 癌、黑色素瘤、头颈部鳞状细胞癌、食管癌、肝癌、胃癌、结直肠癌等在内的数十个重要肿瘤适应症， 临床价值得到广泛认可。 帕博利珠单抗是一种靶向程序性死亡受体-1(PD-1)的人源化单克隆抗体。PD-1是免疫T细胞表面的一种 关键免疫检查点蛋白，肿瘤细胞可通过激活PD-1通路抑制T细胞的免疫活性，从而实现免疫逃逸。帕博 利珠单抗通过阻断PD-1与其配体PD-L1/PD-L2的结合，恢复T细胞的肿瘤杀伤功能，增强人体免疫系统 对抗肿瘤的能力。该药物作为免疫检查点抑制剂，已成为多种晚期恶性肿瘤的标准治疗方案之一，革新 了肿瘤治疗格局。 ...

Core Insights - The study indicates that gut microbiota can predict the efficacy of consolidation immunotherapy and chemoradiotherapy toxicity in lung cancer patients [3][9] - The research highlights the dynamic changes in gut microbiota during treatment and its correlation with progression-free survival (PFS) and treatment-related lung toxicity [5][6] Group 1: Research Findings - The research team utilized 16S rRNA sequencing to track the dynamic changes in gut microbiota of stage III lung cancer patients undergoing concurrent chemoradiotherapy (CRT) and consolidation immune checkpoint inhibitors (ICI) [5] - In traditional CRT, the composition of gut microbiota remained unaffected, whereas in CRT combined with ICI, patients with longer PFS exhibited higher baseline gut microbiota diversity, which decreased during treatment [6][9] - The abundance of Akkermansia muciniphila (Akk) increased post-chemoradiotherapy, correlating with extended distant metastasis-free survival in patients receiving CRT combined with ICI [6][10] Group 2: Clinical Implications - The study suggests that the overall clinical benefit of CRT combined with ICI is significantly greater compared to CRT alone for locally advanced lung cancer patients [9] - The dynamic changes in Akkermansia muciniphila serve as a potential prognostic indicator for patient survival outcomes [10] - Distinct gut microbiota characteristics were observed in patients who developed severe lung toxicity post-treatment, indicating a possible predictive marker for treatment-related pneumonia [6][10]

Core Insights - The Chinese immune checkpoint inhibitor industry is rapidly developing, with a projected market size of approximately 52.734 billion yuan in 2024, representing a year-on-year growth of 44.14% [1][4][8] - The primary driver of this growth is the innovative therapeutic mechanism of immune checkpoint inhibitors, which reactivate the immune system to identify and attack tumor cells, providing revolutionary treatment options for cancer patients with limited traditional therapies [1][4] Industry Overview - Immune checkpoint inhibitors enhance the immune system's ability to attack cancer cells by blocking immune checkpoint proteins, which are used by tumor cells to evade immune responses [2][5] - The industry has evolved through three stages: initiation, rapid development, and mature expansion, with significant policy support and market entry of domestic products since 2018 [3][4] Market Size - The immune checkpoint inhibitor market in China is expected to reach approximately 52.734 billion yuan in 2024, with a significant increase in clinical application driving market demand [1][8] Key Companies - Leading companies in the industry include Junshi Biosciences, Hengrui Medicine, Innovent Biologics, and BeiGene, which collectively hold over half of the market share [8] - Junshi Biosciences' core product, Toripalimab, has been approved for 12 indications and is the first domestic PD-1 inhibitor to receive FDA approval for kidney cancer treatment [9] - Akeso's dual antibody technology has led to significant advancements, with its PD-1/CTLA-4 dual antibody achieving notable efficacy in cervical cancer [11] Industry Development Trends 1. Continuous technological innovation is driving breakthroughs in precision treatment and combination therapies, with dual antibodies and ADCs becoming more prominent [12] 2. Market expansion and the shift of indications towards early-stage treatments are accelerating internationalization, with several domestic products gaining traction in overseas markets [13] 3. Policy and regulatory developments are promoting industry standardization, with support for new biological agents and reforms in medical insurance payment methods [13]

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]