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Recently, Beijing Sheng Nuoji Medical Technology Co.
, Ltd.
received an official notification from the American Society of Clinical Oncology (ASCO) that a global class of innovative small-molecule immunomodulatory drug "Accoridine vs.
Cinobufosin" is the first-line treatment of advanced liver disease.
The effectiveness and safety of multi-center, randomized, double-blind, double-dummy Phase III clinical trials in patients with cell carcinoma have been successfully selected for the 2021 ASCO annual meeting oral report.
The research was led by a well-known oncologist in China, Academician Sun Yan of the Cancer Hospital of the Chinese Academy of Medical Sciences, and Professor Shukui Qin from Nanjing Jinling Hospital, and was carried out in 28 research centers across the country.
This is also another major progress that my country has made in the development of original anti-tumor drugs in the past ten years, following the breakthrough of immune checkpoint inhibitors (including PD-1/PD-L1) leading the global tumor immunotherapy.
As China's independent research and development of small molecule immunogen innovative drugs, the first-line treatment of advanced hepatocellular carcinoma phase III clinical research of Akoladine will make its first appearance at the ASCO conference and announce the results and data to the world.
Acoladine is a single molecule (purity>98%) innovative drug extracted from the traditional Chinese herbal medicine Epimedium, which has immunomodulatory and anti-tumor effects.
A number of preclinical tumor model studies have confirmed that Akoladine mediates IL-6/JAK/STAT3 related inflammation-immune regulatory signaling pathways including T cell factors, and down-regulates alpha-fetoprotein (AFP) and has significant immunomodulatory anti-tumor effects effect.
The published phase II clinical related studies have shown that for patients with advanced hepatocellular carcinoma with poor physical condition and related complex biomarkers, acoradine has a significant overall survival benefit.
The current phase III clinical studies have further verified the clinical benefits and safety of Acoladine for the above types of patients.
Based on the complexity and heterogeneity of advanced hepatocellular carcinoma in China, while fully absorbing the latest achievements in related academic research such as hepatitis B virus infection, while taking into account the limiting factors of the clinical application of driver gene markers in advanced hepatocellular carcinoma, Sheng Nuoji The medical clinical research and development team draws on the successful experience of the international hepatocellular carcinoma ramucirumab phase III clinical REACH-2 study enrichment design, and based on the phase II clinical study of acoradine, applied the composite markers AFP and Th1 cells Factors, a phase III clinical study with a prospective adaptive enrichment design was carried out.
When 283 patients were randomly enrolled, the data of the prospective enrichment population was subjected to a preset interim analysis.
The unblinded results of the Independent Data Monitoring Committee (IDMC) showed that acolamidine can significantly improve the overall survival of patients with hepatitis B virus-related advanced hepatocellular carcinoma in poor physical condition, and has good safety, reaching the preset primary endpoint of clinical trials .
The results of the test showed that the overall survival (OS) of the primary efficacy endpoint of the enriched population of the study reached the preset superior clinical efficacy endpoint, that is, the mOS of the acoradine group in the EFAS population was significantly longer than that of the cinocabine group.
At the same time, the results of the study showed that in patients with highly heterogeneous hepatitis B-related advanced hepatocellular carcinoma, the peripheral blood-enriched complex markers have a good predictability for the clinical efficacy of Akoladine.
The clinical efficacy of Akoladine in the enriched population is significantly better than that of Cinobufosin, and it shows the advantages of safety and tolerability for patients with advanced hepatocellular carcinoma.
The detailed data will be announced by Professor Shukui Qin in an oral report during the ASCO conference.
It is reported that at present, the marketing application (NDA) of Akoladine for the first-line treatment of advanced hepatocellular carcinoma has been formally accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration.
, Ltd.
received an official notification from the American Society of Clinical Oncology (ASCO) that a global class of innovative small-molecule immunomodulatory drug "Accoridine vs.
Cinobufosin" is the first-line treatment of advanced liver disease.
The effectiveness and safety of multi-center, randomized, double-blind, double-dummy Phase III clinical trials in patients with cell carcinoma have been successfully selected for the 2021 ASCO annual meeting oral report.
The research was led by a well-known oncologist in China, Academician Sun Yan of the Cancer Hospital of the Chinese Academy of Medical Sciences, and Professor Shukui Qin from Nanjing Jinling Hospital, and was carried out in 28 research centers across the country.
This is also another major progress that my country has made in the development of original anti-tumor drugs in the past ten years, following the breakthrough of immune checkpoint inhibitors (including PD-1/PD-L1) leading the global tumor immunotherapy.
As China's independent research and development of small molecule immunogen innovative drugs, the first-line treatment of advanced hepatocellular carcinoma phase III clinical research of Akoladine will make its first appearance at the ASCO conference and announce the results and data to the world.
Acoladine is a single molecule (purity>98%) innovative drug extracted from the traditional Chinese herbal medicine Epimedium, which has immunomodulatory and anti-tumor effects.
A number of preclinical tumor model studies have confirmed that Akoladine mediates IL-6/JAK/STAT3 related inflammation-immune regulatory signaling pathways including T cell factors, and down-regulates alpha-fetoprotein (AFP) and has significant immunomodulatory anti-tumor effects effect.
The published phase II clinical related studies have shown that for patients with advanced hepatocellular carcinoma with poor physical condition and related complex biomarkers, acoradine has a significant overall survival benefit.
The current phase III clinical studies have further verified the clinical benefits and safety of Acoladine for the above types of patients.
Based on the complexity and heterogeneity of advanced hepatocellular carcinoma in China, while fully absorbing the latest achievements in related academic research such as hepatitis B virus infection, while taking into account the limiting factors of the clinical application of driver gene markers in advanced hepatocellular carcinoma, Sheng Nuoji The medical clinical research and development team draws on the successful experience of the international hepatocellular carcinoma ramucirumab phase III clinical REACH-2 study enrichment design, and based on the phase II clinical study of acoradine, applied the composite markers AFP and Th1 cells Factors, a phase III clinical study with a prospective adaptive enrichment design was carried out.
When 283 patients were randomly enrolled, the data of the prospective enrichment population was subjected to a preset interim analysis.
The unblinded results of the Independent Data Monitoring Committee (IDMC) showed that acolamidine can significantly improve the overall survival of patients with hepatitis B virus-related advanced hepatocellular carcinoma in poor physical condition, and has good safety, reaching the preset primary endpoint of clinical trials .
The results of the test showed that the overall survival (OS) of the primary efficacy endpoint of the enriched population of the study reached the preset superior clinical efficacy endpoint, that is, the mOS of the acoradine group in the EFAS population was significantly longer than that of the cinocabine group.
At the same time, the results of the study showed that in patients with highly heterogeneous hepatitis B-related advanced hepatocellular carcinoma, the peripheral blood-enriched complex markers have a good predictability for the clinical efficacy of Akoladine.
The clinical efficacy of Akoladine in the enriched population is significantly better than that of Cinobufosin, and it shows the advantages of safety and tolerability for patients with advanced hepatocellular carcinoma.
The detailed data will be announced by Professor Shukui Qin in an oral report during the ASCO conference.
It is reported that at present, the marketing application (NDA) of Akoladine for the first-line treatment of advanced hepatocellular carcinoma has been formally accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration.
