China Economic Net, May 26th (Reporter Zhu Guowang) On May 26th, Professor Qin Shukui from Jinling Hospital in Nanjing issued the first prescription for Icaritin soft capsules developed by Beijing Shengnuoji Pharmaceutical Technology Co., Ltd. in Jiangsu Province. During the same period, several hospitals across the country, including the Cancer Hospital affiliated with the Chinese Academy of Medical Sciences, the Third Affiliated Hospital of the Naval Medical University, and the Second People's Hospital of Anhui Province, issued their first prescriptions in Beijing, Shanghai, Anhui, and other regions. This marks the official benefit of icariin soft capsules, an original small molecule immunomodulatory agent with global independent intellectual property rights and a first-class original new drug in the world, to Chinese liver cancer patients.
Epimedium extract is a monomeric compound extracted, isolated, and purified from the natural medicinal plant Epimedium (content>98%). Its research and development has lasted for more than ten years and has received support from the Ministry of Science and Technology's "Eleventh Five Year Plan", "Twelfth Five Year Plan", "Thirteenth Five Year Plan", "Major New Drug Creation" and other major scientific and technological projects.
In a multicenter, randomized, double-blind, double simulated phase III study led by the Cancer Hospital of the Chinese Academy of Medical Sciences, Academician Sun Yan of the Chinese Academy of Engineering, and Professor Qin Shukui of Nanjing Jinling Hospital, with the participation of 28 research centers nationwide, icariin soft capsules were used as first-line treatment for unresectable advanced hepatocellular carcinoma. Compared with the control group of huperzine, the enriched population with poorer prognosis showed sustained significant survival benefits and better safety and quality of life.
Based on the research results, icariin soft capsules were included in the priority review and approval of the National Medical Products Administration (NMPA), and were approved for marketing in January 2022. They are used for unresectable hepatocellular carcinoma that is not suitable for or patients who refuse standard treatment and have not received systemic treatment in the past. The patient's peripheral blood complex markers meet at least two of the following detection indicators: AFP ¡Ý 400 ng/mL; TNF-¦Á<2.5 pg/mL£» IFN-¦Ã¡Ý7.0 pg/mL¡£ This is the first drug in the field of liver cancer worldwide to use clinical research results of peripheral blood complex biomarkers to screen and enrich populations as the main approval basis. This approval injects new energy into the treatment of unresectable advanced hepatocellular carcinoma in China, bringing new hope to patients.
Professor Qin Shukui stated, "The recently updated CSCO Liver Cancer Diagnosis and Treatment Guidelines (2022 Edition) officially include icariin soft capsules in the recommended first-line treatment list for advanced liver cancer (recommended by Level I experts). The "Diagnosis and Treatment Guidelines for Primary Liver Cancer (2022 Edition)" released by the National Health Commission also recommends the use of icariin soft capsules. It can be said that icariin soft capsules have been widely recognized by experts and scholars in the field of liver cancer
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