Recently, Eddie Pharmaceutical disclosed the report for the third quarter of this year, and the report showed that the overall development trend from January to September this year is improving. The new drug independently developed by Eddie Pharmaceutical: anti-Aidi three-in-one compound single-dose preparation ACC008 (ANV+3TC+TDF) (for first-treated patients) has also completed the inspection and quality standards verification work in October this year. With the expected progress, ACC008 (for first-treated patients) is expected to be approved this year.
Eddie Pharmaceutical Ganquan Preparation Production Base
Eddie Pharmaceutical Anti-Ai three-in-one compound single-table preparation ACC008 (for patients treated first) was accepted by the State Food and Drug Administration as early as May this year. This drug is the first anti-Ai three-in-one compound single-table innovative drug preparation in China, which is more convenient to take. The Phase III clinical trial of ACC008 (for medically treated patients) is being carried out smoothly. It is expected that the 48-week clinical trial will be completed from March to April next year, and an application for marketing will be submitted next year.
AIDS has the characteristics of strong infectiousness, long incubation period and high mortality rate. According to the latest data of the "2022 Global AIDS Prevention and Control Progress Report" released by the United Nations Programme for AIDS in Montreal, Canada, , the latest data of the "2022 Global AIDS Prevention and Control Progress Report" show that in 2021, 1.5 million new HIV infections and 650,000 related deaths worldwide, 1 million more than the global target. The global anti-AIDS situation is severe, and it is urgent to innovate and develop anti-AIDS drugs. The ACC008 drug for patients who are initially treated with HIV is another "anti-ami-in" new drug from Eddie Pharmaceutical since the launch of ACC007, a Class 1 innovative drug for AIDS in June 2021. The drug only needs one tablet a day and no longer needs to take other anti-AIDS drugs. It can significantly increase compliance, reduce the burden on infected people to take medication, and will also bring more treatment options to clinicians and patients.
Eddie Pharmaceutical ACC008 (for patients with initial treatment) contains a new structure of non-nucleoside reverse transcriptase inhibitor ACC007. Preclinical studies and clinical research results have shown that compared with existing similar drugs, it can significantly reduce adverse central nervous system reactions; in addition, ACC008 (for patients with initial treatment) also contains tenofovir and lamivudine , which can inhibit HIV virus from different targets, improve the therapeutic effect of a single drug on HIV, and at the same time, it does not produce superposition of toxicity, and has the characteristics of good treatment effect and high safety. ACC008 (for patients who are initially treated) is also very rigorous in terms of manufacturing process. It uses granulation separately for each component to control different moisture content, increase the stability of the compound preparation, and at the same time, coated after tableting, further strengthening the stability of the tablet.
Eddie Pharmaceutical ACC008 (for initially treated patients) is expected to be approved before the end of the year, marking that my country will achieve a major innovative breakthrough in the field of HIV treatment. It will also further improve Eddie Pharmaceutical's "integrated anti-AI diagnosis and treatment" patient service methods and accelerate the internationalization of HIV diagnosis and treatment in my country.