AstraZeneca's (AZN.US) AZD0780 film-coated tablets approved for clinical trials in China, intended for the treatment of abnormal lipid levels

On September 11, the China National Medical Products Administration's Center for Drug Evaluation (CDE) officially announced that AstraZeneca's (AZN.US) AZD0780 film-coated tablets had been granted a clinical trial implicit approval, which is intended for the treatment of abnormal lipid metabolism in patients with LDL-C who do not meet the standard treatment.

According to public information, AZD0780 is an oral PCSK9 small molecule inhibitor. According to AstraZeneca's Phase I clinical study data released in May this year, when AZD0780 is used in combination with rosuvastatin, it can reduce LDL-C levels in patients by nearly 80%. The product is currently in Phase II clinical trials in the international market, and this is the first time it has been approved for clinical trials in China.

Source: CDE's website

The analysis showed that in patients with untreated hypercholesterolemia, AZD0780 showed a significant 52% decrease in LDL-C levels based on rosuvastatin treatment, with a total LDL-C decrease of 78% compared to baseline. In addition, preliminary data comparing drug intake with fasting showed that AZD0780 has flexibility in terms of intake. AZD0780 also showed good tolerance.