注射用 SHR-A2102 为公司自主研发且具有知识产权的靶向 Nectin-4 的抗体药物偶联物(ADC)，其有效 载荷是拓扑异构酶Ⅰ抑制剂(TOP1i)。多种研究表明 Nectin-4 在肿瘤中的高表达与肿瘤的发展和不良预 后密切相关。目前全球共有 1 款同类产品获批上市，为 Enfortumab vedotin(商品名：Padcev)，经查询 EvaluatePharma 数据库，2024 年该产品全球销售额约为 19.49 亿美元。截至目前，注射用 SHR-A2102 相关项目累计研发投入约 20,547 万元。 阿得贝利单抗注射液是公司自主研发的人源化抗 PD-L1 单克隆抗体，能通过特异性结合 PD-L1 分子从 而阻断导致肿瘤免疫耐受的 PD-1/PD-L1 通路，重新激活免疫系统的抗肿瘤活性，从而达到治疗肿瘤的 目的。公司阿得贝利单抗注射液(商品名：艾瑞利)已于 2023 年 3 月获批上市，获批的适应症为与卡铂 和依托泊苷联合用于广泛期小细胞肺癌患者的一线治疗。国外有同类产品Atezolizumab ( 商 品 名 ： Tecentriq ) 、 Avelumab( 商 品 名 ： Bave ...

Core Viewpoint - Heng Rui Medicine's subsidiary has two products, SHR-A1811 and Abedilizumab, included in the list of proposed breakthrough therapies by the National Medical Products Administration, marking the ninth inclusion for SHR-A1811 [1] Group 1: Market Context - Breast cancer is the second most common malignant tumor globally, with approximately 2.297 million new cases reported in 2022 [1] - In China, breast cancer accounts for 15.6% of all malignant tumors, with around 357,000 new cases and 75,000 deaths in 2022 [2] - Triple-negative breast cancer (TNBC) represents 10%-15% of all breast cancer cases, predominantly affecting younger women and exhibiting high invasiveness and poor prognosis [2] Group 2: Product Information - SHR-A1811 is an injectable drug that targets HER2-positive tumors, approved for use in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received prior systemic therapy [3] - The global sales of similar products, Kadcyla and Enhertu, are projected to reach approximately $6.557 billion in 2024 [3] - The total R&D investment for SHR-A1811 has reached approximately 1.259 billion yuan [3] Group 3: Competitive Landscape - Abedilizumab is a humanized anti-PD-L1 monoclonal antibody, approved for first-line treatment of extensive-stage small cell lung cancer [4] - Similar products like Atezolizumab, Avelumab, and Durvalumab are projected to have a combined global sales of approximately $9.648 billion in 2024 [4] - The total R&D investment for Abedilizumab has reached approximately 901 million yuan [4]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of four drugs, indicating a significant advancement in its oncology pipeline [1][2][3][4] Group 1: Drug Approvals and Clinical Trials - The company and its subsidiaries have been granted clinical trial approval for SHR-8068 injection, Adebali monoclonal antibody injection, Bevacizumab injection, and Apatinib mesylate tablets [1][2][3][4] - SHR-8068 is a fully human anti-CTLA-4 monoclonal antibody aimed at enhancing anti-tumor immune effects, with a cumulative R&D investment of approximately 214 million yuan [1] - Adebali monoclonal antibody injection, a humanized anti-PD-L1 monoclonal antibody, was approved in March 2023 for first-line treatment of extensive-stage small cell lung cancer, with a cumulative R&D investment of about 887 million yuan [2] - Bevacizumab injection, a humanized anti-VEGF monoclonal antibody, was approved in June 2021, with a cumulative R&D investment of around 345 million yuan [3] - Apatinib mesylate tablets have been approved for three indications, with a cumulative R&D investment of approximately 587 million yuan [4] Group 2: Market Potential and Competitors - The global sales of similar products for SHR-8068, including Ipilimumab and Tremelimumab, are projected to be approximately 3.271 billion USD in 2024 [1] - The combined global sales for Adebali's competitors, Atezolizumab, Avelumab, and Durvalumab, are estimated to be around 9.648 billion USD in 2024 [2] - Bevacizumab's global sales are projected to be about 5.655 billion USD in 2024 [3] - The global sales for Apatinib's competitors, including Sorafenib, Sunitinib, and Pazopanib, are expected to total approximately 543 million USD in 2024 [4]

Core Insights - Tempest Therapeutics has received approval from the National Medical Products Administration (NMPA) in China to initiate a pivotal trial for amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab for the treatment of unresectable or metastatic hepatocellular carcinoma (HCC) [1][2][3] Company Overview - Tempest Therapeutics is a clinical-stage biotechnology company focused on developing targeted and immune-mediated therapeutics for cancer treatment [8] - The company is headquartered in Brisbane, California, and has a diverse portfolio of small molecule product candidates [8] Drug Development - Amezalpat is an oral, small molecule, selective PPAR⍺ antagonist that shows promise in treating cancer by targeting tumor cells and modulating the tumor microenvironment [7] - The planned Phase 3 study will be a global, blinded, 1:1 randomized trial comparing amezalpat plus atezolizumab and bevacizumab against a placebo combination for first-line treatment of HCC [3] - The company has received agreement from both the FDA and EMA on the study design and statistical plan for the Phase 3 trial [3] Hepatocellular Carcinoma (HCC) Insights - HCC is an aggressive cancer with over 900,000 new diagnoses globally each year, and it is projected to become the third leading cause of cancer death by 2030 [4] - The highest incidence and mortality rates of HCC are found in East Asia, with increasing rates in Europe and the US [4] - Chronic liver diseases, including hepatitis B and C, NAFLD, NASH, and cirrhosis, account for 90% of HCC cases [5] Clinical Trial Context - The ongoing global randomized Phase 1b/2 study of amezalpat in combination with atezolizumab and bevacizumab has shown clinical superiority in overall survival compared to the standard of care [7] - Early-stage HCC patients face a 70-80% recurrence rate post-surgery, which is associated with poorer prognosis [6]

Company Overview - Tempest Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing first-in-class targeted and immune-mediated therapeutics for cancer treatment [1][8] - The company is headquartered in Brisbane, California, and has a diverse portfolio of small molecule product candidates [8] Drug Development and Designations - The European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to amezalpat (TPST-1120), an oral, small molecule, selective PPAR⍺ antagonist for hepatocellular carcinoma (HCC) [1][6] - Earlier in the year, the FDA also granted ODD and Fast Track Designation (FTD) to amezalpat for the same indication, highlighting the urgent need for new treatment options [2][6] - Amezalpat has shown positive outcomes in a global randomized Phase 1b/2 clinical study, demonstrating a six-month improvement in median overall survival (OS) with a hazard ratio (HR) of 0.65 when combined with standard-of-care therapies [2][4] Disease Context - Hepatocellular carcinoma (HCC) is an aggressive cancer with over 900,000 new diagnoses globally each year, projected to become the third leading cause of cancer death by 2030 [3] - The majority of HCC cases are linked to chronic liver diseases, with a high recurrence rate of 70-80% even after early-stage diagnosis [3][4] Mechanism of Action - Amezalpat is designed to target tumor cells directly while also modulating immune suppressive cells and angiogenesis within the tumor microenvironment [4] - The drug has shown clinical superiority across multiple study endpoints, including overall survival in both the entire population and key subpopulations compared to standard care [4][6] Regulatory Benefits - The EMA's ODD provides benefits such as potential 10 years of market exclusivity following regulatory approval in the EU, reduced regulatory fees, and a centralized EU approval process [7]

Core Viewpoint - Galmed Pharmaceuticals has initiated a research collaboration with Virginia Commonwealth University to explore the potential of Aramchol in overcoming drug resistance in gastrointestinal cancers, particularly colorectal and hepatocellular cancers, aiming to enhance treatment efficacy against these aggressive tumors [1][5]. Group 1: Collaboration Details - The collaboration involves VCU scientists studying Aramchol in preclinical models, focusing on its ability to prevent or reverse resistance to standard therapies such as targeted kinase inhibitors and chemotherapies [1][2]. - The project is based on recent research highlighting the role of lipid metabolic pathways, specifically Stearoyl-CoA Desaturase 1 (SCD1), in driving drug resistance in GI tumors [2][5]. - Galmed will provide funding and Aramchol materials, while VCU will conduct the studies, leveraging its expertise in cancer biology and drug resistance [7]. Group 2: Market Implications - This partnership marks a strategic expansion for Galmed beyond its historical focus on fibrotic liver diseases into oncology, targeting a significant market with high unmet needs [4][5]. - Aramchol is the most clinically advanced SCD1 inhibitor, with a strong safety profile demonstrated in previous trials, presenting a unique opportunity in cancer treatment [4][5]. - The collaboration aims to generate proof-of-concept data that could lead to further clinical development in oncology, potentially expanding Galmed's pipeline and enhancing its commercial prospects [6][7]. Group 3: Clinical Context - A significant proportion of patients with advanced hepatocellular carcinoma (HCC) do not benefit from current second-line therapies due to drug resistance, with most developing resistance within six months [3][6]. - Targeting lipid metabolism with Aramchol is seen as a promising strategy to overcome resistance to tyrosine kinase inhibitors (TKIs), which are pivotal in treating advanced HCC [6][3]. - The collaboration aims to develop safe drug combinations that can block and circumvent drug resistance in HCC, addressing a critical need in cancer treatment [3][6].

江苏恒瑞医药股份有限公司 关于获得药物临床试验批准通知书的公告 阿得贝利单抗注射液是公司自主研发的人源化抗 PD-L1 单克隆抗体，能通过 特异性结合 PD-L1 分子从而阻断导致肿瘤免疫耐受的 PD-1/PD-L1 通路，重新激 活免疫系统的抗肿瘤活性，从而达到治疗肿瘤的目的。国外有同类产品 Atezolizumab （ 商 品 名 ： Tecentriq ） 、 Avelumab( 商品名： Bavencio) 和 Durvalumab(商品名：Imfinzi)于美国获批上市销售，其中 Atezolizumab 和 Durvalumab 已在中国获批上市。国内有康宁杰瑞/思路迪药业的恩沃利单抗、基 石药业的舒格利单抗和正大天晴药业的贝莫苏拜单抗等同类产品获批上市。公司 阿得贝利单抗注射液（商品名：艾瑞利）已于 2023 年 3 月获批上市，获批的适 应症为与卡铂和依托泊苷联合用于广泛期小细胞肺癌患者的一线治疗。经查询， 2023 年 Atezolizumab、Avelumab 和 Durvalumab 全球销售额合计约为 89.85 亿 美元。截至目前，阿得贝利单抗注射液相关项目累计研发投入约 78,47 ...