Clinical Phase III reached the main end point! Domestic class 1 new drug Akolading is on the market

Yuntian recently, Beijing Shengnoki Pharmaceutical Technology Co., Ltd. announced the latest progress in its core product Acolatin clinical research, the drug compared to the effectiveness of the first-line treatment of patients with advanced hepatocellular carcinoma, safety of forward-looking, randomized control, double-blind double simulation, the national multi-center clinical Phase III trial reached the main endpoint, showing that Acolatin listing is ready.
The main ingredient of akoladine is anhydroicaritin, a flavonoid compound alias dehydrated mascarin, which is naturally found in lamb slugs in small python plants, but the content is very low.
present, the obscenity of sheep slugs is mainly based on masturbation of sheep slugs as raw materials, using enzymatic solution, acid solution, enzymatic acid solution combination method and chemical synthesis legal preparation.
as an extract of Traditional Chinese medicine, Acolatin is the original innovative medicine of our country.
Currently, the drug has been shown to have pharmacological activities including: a. estrogen-like effects; b. regulating immune effects; c. cell-promoting differentiation; d. neuro-protective effects; e. bone protection effects; f. yang effects; g. anti-liver injury and liver fibrosis effects; h. anti-abnormal hyperpluration effects; i. anti-tumor effects; j. anti-tumor effects.
hepatocellular carcinoma (HCC) accounts for 90% of liver primary tumors, with high incidence and high fatality, and is a major human disease.
research shows that acolatin is a potential small molecule target drug in human liver cell cancer cell line, which inhibits tumor growth, inhibits tumor cell vitality and induces apoptosis.
In the mechanism of anti-liver cancer action, Acolatin mainly works through signaling pathfours such as IL-6/STAT3, IGF1/STAT3, MAPK/ERK to inhibit tumor cell proliferation, reduce cell vitality, induce tumor cell apoptosis, and also has immunomodulation function, which can induce immunosuppressive cell differentiation and reduce the level of immunosuppression.
, more than 60% of liver cancer patients showed that STAT3 was highly active, and STAT3 activation also indicated a higher level of malignancy of liver cell carcinoma.
Using liver cell-specific knockout STAT3 mice to study the model of nitrosamine-induced hepatocellular carcinoma showed that the incidence of liver cell carcinoma in liver cell-specific knockout STAT3 mice was 6 times lower than that of the control group, and the tumor volume was small, indicating that STAT3 was closely related to the proliferation and survival of liver cell cancer cells.
can be used in STAT3-related pathfects, which is the key to its fight against liver cancer.
addition, Acolatin is used in the treatment of melanoma, T lymphocytic tumor, renal cell carcinoma, breast cancer, prostate cancer, endometrial cancer and other tumor diseases.
the main path of anti-melanoma is IL-6/JAK/STAT3, the main path of anti-T lymphoma is JAK/STAT3 and PI3K/AKT, and anti-kidney The main path paths for cell carcinoma are JAK/STAT3, the main path path for anti-breast cancer is MAPK/ERK, the main target for anti-prostate cancer is Androgen Receptor (AR) Signal, and the main path path for anti-endometrial cancer is MAPK/ERK.
It is learned that the third phase of clinical research on liver cancer in Akolading was approved by China's Drug Administration (NMPA), led by Sun Yan, a member of the Chinese Academy of Engineering, and Qin Shuxuan of the 81st Hospital affiliated with Nanjing University of Traditional Chinese Medicine, and organized 28 research centers nationwide.
the clinical trial adopted the adaptive rich design of composite biomarkers, and has now entered the group of more than 280 cases of advanced hepatocellular carcinoma.
the available results show that the total survival (OS) period of the main therapeutic endpoint of Acolatin reached the preset benefit boundary value, which had significant survival advantage and good safety and tolerance compared with the control group.
, Acolating preclinical and clinical research has received strong support from the national "11th Five-Year Plan" and "12th Five-Year Plan" major projects.
based on the positive clinical data available, it's only a matter of time for us to get to market.
References: 1. Advance on the structural modification and activities of icaritin derivative,2020；2. Test Method and Pharmacology Activity of Anhydroicaritin, 2015; 3. Acolatin's mechanism for treating hepatocellular carcinoma and other tumors, 2016; 4. Beijing Shengnoki Pharmaceutical Technology Co., Ltd.