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• Time of issue:2023-01-03 13:16
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(Summary description)Epimedium is a plant that can be used as a whole herb for medicinal purposes. In traditional Chinese medicine, it is mainly used to treat impotence and premature ejaculation, backache and leg pain, numbness of limbs, hemiplegia, neurasthenia, forgetfulness, tinnitus, and dizziness.     On May 19, 2021, at the annual meeting of the American Society of Clinical Oncology (ASCO), my country's self-developed small-molecule immunogen drug, icariin (alcoradine) first-line treatment of advanced hepatocellular carcinoma Phase III research results were released for the first time .   In June, the international cancer academic journal "Cancer Science" (Cancer Science) published online, the phase II clinical trial of the natural small molecule drug Acradine (First-in-class, icariin) immunomodulatory treatment of advanced hepatocellular carcinoma result. The study was led by Academician Sun Yan and Professor Qin Shukui, famous oncologists in my country, and was completed in cooperation with clinical research centers of many hospitals across the country.   Acradine is a small-molecule drug produced by enzymatic hydrolysis of Epimedium extract isolated from the traditional Chinese medicine Epimedium. It has multi-target anti-inflammatory and anti-tumor immunomodulatory biological activities. / Phase II trials have obtained preliminary verification of safety and efficacy. Acradine (SNG-162, common name is icariin) is an active drug monomer extracted, separated and purified from Epimedium. It is considered to be another major breakthrough in the modernization of traditional Chinese medicine after artemisinin.   Since September 2017, a total of 283 patients with advanced hepatocellular carcinoma have been included in the study, of which 71 patients had a positive comprehensive biomarker score and were associated with advanced Barcelona stage (BCLC stage C), HBV infection and thrombocytopenia and other risks or 33 patients were treated with icariin; 38 patients were treated with cinobufacin. The median follow-up time was 8.1 months (cut-off date: December 30, 2020), and the valid research data was as of November 2, 2020. It showed that in the enriched population of compound biomarkers, it was found The median survival (mOS) was significantly better than that of the control group treated with cinobufacin, which were 13.5 months and 6.8 months, respectively, indicating that alkoladine can indeed significantly reduce the risk of death in patients with advanced liver cancer, reaching 57%, which has a significant Survival advantage, which is very valuable.   On the other hand, the advantages of Acradine are also reflected in the relatively good safety data. The incidence of drug-related adverse reactions of grade 3 and above is only 15%, which is consistent with the safety data of the past phase I and II clinical trials. Lading has good security.   Analysis conclusion: The small-molecule immunomodulator icariin can significantly improve the overall survival rate of patients with unfavorable comprehensive biomarker score-positive enriched hepatitis B virus (HBV)-associated advanced liver cancer with a favorable safety profile. At present, the drug has submitted an application for early marketing to the State Food and Drug Administration, which has been accepted and included in priority approval.