政府新闻
中国Asieris与美国疾病控制与预防中心达成协议，为自由生活的阿米巴感染提供新药 2025-01-07
Asieris Pharmaceuticals has entered into an investigational medication supply agreement with the US Centers for Disease Control and Prevention that will allow the Chinese pharmaceutical company’s experimental drug for the treatment of free-living ameba infections, which are relatively rare but are often fatal when they occur, to be used in special research cases.
The CDC has submitted an expanded-access investigational new drug application to the US Food and Drug Administration to provide Asieris’ APL-1202 drug for the treatment of laboratory-confirmed or suspected non-keratitis infections caused by FLA, Shanghai-based Asieris said on Monday.
"We are grateful for this opportunity to work with the CDC. This agreement will allow us to quickly provide new treatment options for FLA patients in the US," Asieris Chief Medical Officer Zhang Yun said.
At present there are few medicines available in the US for the treatment of FLA infections, such as amoebic meningoencephalitis which has a mortality rate of up to 90 percent, and no single medicine has been approved for its specific treatment by the FDA.
Although APL-1202 has yet to get the greenlight from the regulator, it can be used under certain conditions as a research drug in the US. The FDA has approved its use in several single-patient emergency-IND applications since 2021. Of the two patients to receive the novel drug, both have made a full recovery.
An IND application for the use of APL-1202 in the treatment of FLA infections was approved by China’s National Medical Products Administration in June last year to ensure the supply of the medicine to Chinese patients.
Source: Yicai Global
