AstraZeneca (NASDAQ: AZN), a leading UK pharmaceutical company, is reportedly under the spotlight in Shenzhen, China, with an investigation involving five current and former employees, as per a report by Bloomberg. The probe is said to center on potential breaches of data privacy regulations and the unauthorized importation of drugs that have not been approved for use in China. While AstraZeneca has acknowledged the investigation in a communication to FiercePharma.com, it has clarified that no employees have been formally arrested as of yet.
The individuals in question, all Chinese nationals, are associated with AstraZeneca’s oncology division. There is speculation that the investigation into the unapproved drugs may pertain to the combination therapy of Imfinzi (durvalumab), a programmed death-ligand 1 (PD-L1) inhibitor, and Imjudo (tremelimumab), a cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor. This treatment protocol was approved by the U.S. FDA in 2022 for liver cancer but has not yet been made available in China.
It’s worth noting that this is not AstraZeneca’s first encounter with regulatory issues in Shenzhen. In 2022, the company itself reported certain employees to the authorities for manipulating genetic test results of cancer patients to fraudulently claim funds from the Basic Medical Insurance (BMI) scheme.- Flcube.com
