CDE official website recently disclosed that the marketing application of the Category 1.2 innovative traditional Chinese medicine "Icaritin" of Shenogen Pharma Group/Kangerfu Pharmaceutical would be included in the priority review as scheduled, and its proposed indication was reported to be unresectable hepatocellular carcinoma (HCC) receiving no previous systemic treatment.
Icaritin is accepted as a Category 1 original natural drug with independent intellectual property rights, with anhydroicaritin as its main component. Anhydroicaritin (Cycloicaritin) is a kind of flavonoid compound that naturally exists in Epimedium brevicornum and is chiefly prepared from icariin by enzymolysis, acidolysis, combined enzymolysis and acidolysis and chemical synthesis.
Icaritin is found to be a multi-target immunomodulatory molecule, which comes into play through IL-6/STAT3, IGF1/STAT3, MAPK/ERK and other signaling pathways. In specific, it controls tumor cell proliferation, lowers cell viability, and induces apoptosis of a high volume of tumor cells. Moreover, it performs immune regulation by inducing the differentiation of immunosuppressive cells and bringing down the level of immunosuppression.
On top of that, it has been revealed in studies that Icaritin can intervene in the formation of IKK kinase complex, and inhibit the migration of NF-kB from the cytoplasm to the nucleus via its application to IKKα and IKKβ in the NF-kB signaling pathway, consequently lowering PD-L1 expression of the immune checkpoint ligand molecule. NF-kB is recognized as a key factor in the most important signal transduction pathway of biological immune responses including apoptosis, anti-inflammation and anti-infection, and its activation and migration are subject to regulation by IKK and other complex molecules These findings render significant molecular biological proof for coming study on the anti-inflammatory and immunomodulatory signaling pathway, anti-tumor mechanism and combination therapy of Icaritin, and allow for more innovative ideas and options for clinical research on the unique immunomodulatory and combination therapy of Icaritin in cancer patients.
HCC is regarded as a common malignant tumor with high incidence in China. Statistics display 466,000 new cases and 422,000 deaths every year, causing serious threats to people's lives and health. Quite different from Europe and the United States in a variety of ways, HCC in China has a high degree of heterogeneity, the majority of which are highly associated with hepatitis B virus infection. Furthermore, the patients are usually suggested to be in the middle and late stage at the initial diagnosis, resulting in loss of the opportunity for surgery, difficult treatment, poor prognosis and short survival time. Major causes for this include complex conditions of patients, and underlying liver diseases (including hepatitis, cirrhosis, liver dysfunction and related complications) and immune dysfunction.
For the last few years, survival status of partial patients with advanced HCC improved with the help of molecularly targeted drugs, systemic chemotherapeutics and immune checkpoint inhibitors developed and marketed. Nevertheless, existing targeted therapy, systemic chemotherapy and immunotherapy are less available for a considerable part of patients due to their physical fitness, liver function, and later stage, etc. A lack of standard first-line treatment plans and drugs lead to a huge clinical need to be met.
Icaritin's marketing can't do without the positive results of a prospective, randomized, controlled, double-blind, double-simulation, phase III clinical study of the first-line treatment of patients with advanced HCC compared with Cinobufotalin. Jointly led by renowned oncologists, Academician Sun Yan of the Cancer Hospital of the Chinese Academy of Medical Sciences, and Qin Shukui, Bayi Hospital Affiliated to Nanjing University of Chinese Medicine, the research is designed with a composite biomarke...
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