Core Insights - Beijing Shengnuo Pharmaceutical Technology Co., Ltd. received approval for clinical trials of its product, Icariin Soft Capsule, in combination with AG regimen for treating locally advanced unresectable or metastatic pancreatic cancer [1] Group 1: Clinical Trial Approval - The National Medical Products Administration approved the clinical trial for Icariin Soft Capsule in combination with albumin-bound paclitaxel and gemcitabine for pancreatic cancer treatment [1] - Pancreatic cancer has a low 5-year survival rate of less than 10%, with most patients diagnosed at an advanced stage [1] Group 2: Research Findings - A study from Zhejiang University included 20 newly diagnosed patients with advanced pancreatic ductal adenocarcinoma (PDAC), showing an objective response rate (ORR) of 50% and a disease control rate (DCR) of 90% [1] - The 6-month survival rate was reported at 90%, with 35% of initially unresectable patients becoming resectable after treatment [1] - The results indicate significant potential for Icariin in combination chemotherapy for pancreatic cancer [1] Group 3: Collaborative Research - Shengnuo Pharmaceutical collaborated with Nankai University and Peking University Cancer Hospital to conduct in vitro experiments using organoids from pancreatic cancer patients [2] - The experiments confirmed significant synergistic effects of Icariin with first-line treatments (gemcitabine + albumin-bound paclitaxel) and (albumin-bound paclitaxel + PD-1 antibody) [2] - Icariin was observed to promote T cell migration towards tumor organoids, further validating clinical synergistic results and providing a basis for upcoming clinical trials [2]

Group 1 - The research team from Zhejiang University School of Medicine has presented a groundbreaking study on the treatment of advanced pancreatic cancer using "Epimedium extract soft capsules (Akeladin) + AG (Gemcitabine + Albumin-bound Paclitaxel)" at the 2025 American Society of Clinical Oncology (ASCO) annual meeting, attracting significant attention in the oncology community [1][2] - Pancreatic cancer, known as the "king of cancers," has a 5-year survival rate of less than 10%, with most patients diagnosed at an advanced stage, making surgical intervention impossible. Traditional treatment regimens like FOLFIRINOX and AG are currently the main chemotherapy options, but patient survival rates remain poor [2] - The study is a single-arm, single-center prospective Investigator-Initiated Trial (IIT) involving 20 newly diagnosed patients with advanced pancreatic ductal adenocarcinoma (PDAC), all of whom received 6 cycles of treatment with Epimedium extract soft capsules combined with AG [2][3] Group 2 - As of December 15, 2024, the study has shown promising results, with an objective response rate (ORR) of 50%, a disease control rate (DCR) of 90%, and a 6-month survival rate of 90%. Notably, 35% of initially unresectable patients became resectable after treatment [3] - The safety profile indicated that the incidence of grade ≥3 treatment-related adverse events (TRAEs) was 40%, primarily associated with chemotherapy drugs, with no fatal TRAEs reported. This research provides a new treatment option for advanced PDAC patients and demonstrates significant potential for further studies and the development of other indications [3] - The Epimedium extract soft capsules, developed by Beijing Shengnuo Pharmaceutical Technology Co., Ltd., are a first-in-class immunomodulatory drug derived from traditional Chinese medicine, primarily used for treating advanced hepatocellular carcinoma. The drug has recently received approval for clinical trials in combination therapy for advanced colorectal cancer with specific genetic markers [4]