Core Viewpoint - The report discusses the development and market potential of HDAC/PI3Kα dual-target inhibitors, highlighting their mechanisms, current market status, and future prospects in the pharmaceutical industry. Group 1: Mechanism and Importance - PI3K is a crucial enzyme in the PI3K-Akt-mTOR signaling pathway, which is significant in cancer, immune response, and thrombosis control [3][4] - HDACs play a vital role in gene expression regulation and chromatin structure modification, with abnormal acetylation levels linked to cancer and immune diseases [4][5] - The combination of HDAC and PI3K inhibitors shows synergistic anti-tumor effects, enhancing therapeutic efficacy against various cancers [5][6] Group 2: Market Status - As of June 30, 2025, only BEBT-908 has been approved for market, while several PI3K inhibitors have been approved in China, including Duvelisib and Lymphocil [7][8] - The approved HDAC inhibitors in China include Vorinostat and Entinostat, with specific indications for various cancers [8] Group 3: Research and Development - Ongoing clinical trials for PI3K and HDAC inhibitors include drugs like Aibestatin and Puyisitan, targeting relapsed or refractory diffuse large B-cell lymphoma [9][10] - The report outlines the current R&D status of these inhibitors, indicating a growing pipeline in the oncology sector [10][11] Group 4: Industry Analysis - The report provides a comprehensive analysis of the economic, policy, social, and technological environments affecting the HDAC/PI3Kα dual-target inhibitor industry in China [10][11] - It also discusses the competitive landscape, market structure, and future trends in the industry, emphasizing the importance of multi-target pharmacology [5][6][10]

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]