报告发布方：中金企信国际咨询 项目可行性报告&商业计划书专业权威编制服务机构（符合发改委印发项目可行性研究报告编制要求）-中金企信国际咨询：集13年项目编制服务经验为各 类项目立项、投融资、商业合作、贷款、批地、并购&合作、投资决策、产业规划、境外投资、战略规划、风险评估等提供项目可行性报告&商业计划书编 制、设计、规划、咨询等一站式解决方案。助力项目实施落地、提升项目单位申报项目的通过效率。 （1）HDAC/PI3Kα双靶向抑制剂作用机制介绍： PI3K（Thephosphatidylinositol3-kinase）是一类高度保守的酶家族，是胞内PI3K-Akt-mTOR信号通路的重要组成部分。PI3K-Akt-mTOR信号通路中信号转导 的很多成员分子，都是癌症、免疫及控制血栓形成等过程中的关键药物靶点。PI3K本身具有丝氨酸/苏氨酸（Ser/Thr）激酶的活性，也具有磷脂酰肌醇激酶 的活性。PI3K可分为3类，其结构与功能各异。其中研究最广泛的为I类PI3K,此类PI3K为异源二聚体，由一个调节亚基和一个催化亚基组成。 当接受来自酪氨酸激酶和G蛋白偶联受体的信号后，PI3K的p85调节亚基即被募集到临 ...

Core Insights - Lymphoma is the 10th most common cancer globally and has a rapidly increasing incidence rate, with approximately 100,000 new cases reported annually in China, over 50% of which are in individuals aged 60 and above [1] - The Chinese government has made significant advancements in the diagnosis, classification, staging, and treatment of lymphoma, including the implementation of quality control measures for cancer treatment [1][4] - The approval of innovative drugs, such as tanzimab and lenalidomide for treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL), marks a significant step forward in lymphoma treatment in China [2][3] Group 1: Disease Statistics and Trends - Lymphoma is one of the fastest-growing malignant tumors, with a notable increase in younger patients [1] - DLBCL accounts for 30%-40% of adult non-Hodgkin lymphoma (NHL) cases in Western countries and 35%-50% in China, with a median onset age of 50-70 years [3] Group 2: Government Initiatives and Guidelines - The National Cancer Center has initiated pilot projects for standardized diagnosis and treatment quality control for lymphoma, with 60 institutions selected for this purpose in 2023 [1] - The "Healthy China Action - Cancer Prevention and Control Action Implementation Plan (2023-2030)" aims to enhance cancer prevention and control systems, improve early diagnosis and treatment capabilities, and increase the overall five-year survival rate for cancer to 46.6% by 2030 [4] Group 3: Drug Development and Market Impact - The conditional approval of tanzimab for relapsed or refractory follicular lymphoma and its combination with lenalidomide for DLBCL patients represents a significant advancement in treatment options [2] - Clinical studies indicate that tanzimab combined with lenalidomide shows promising efficacy, with an overall response rate (ORR) of 57.5% and a complete response (CR) rate of 41.3% in global studies, and an ORR of 73.1% in Chinese patients [3]

Core Insights - Lymphoma is the 10th most common cancer globally and has the fastest-growing incidence rate among malignant tumors, with approximately 100,000 new cases annually in China, over 50% of which are in individuals aged 60 and above [1][2] - The Chinese government has made significant progress in lymphoma diagnosis, treatment guidelines, and quality control measures, including the establishment of pilot programs for standardized treatment [1][4] - The approval of innovative drugs, such as tanzimab and lenalidomide for treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL), marks a significant advancement in lymphoma treatment options [2][3] Industry Developments - The National Medical Products Administration conditionally approved tanzimab for adult patients with relapsed or refractory follicular lymphoma in November 2022, and its combination therapy for DLBCL was approved in May 2023 [2][3] - Clinical studies show promising results for tanzimab, with an overall response rate (ORR) of 57.5% and a complete response (CR) rate of 41.3% in global studies, while Chinese patients showed an ORR of 73.1% [3] - The 2023 "Healthy China Action - Cancer Prevention and Control Implementation Plan" aims to enhance cancer prevention and treatment capabilities, targeting a 5-year survival rate of 46.6% by 2030 [4][5]