Tianxi

Tianxi Cai requested an update on the Nanjing Anji in-licensed assets, inquiring about the company's confidence level, the clinical development pathway for these assets in their respective indications, and the potential for expedited regulatory pathways.

Answer

Tony Marrs, Executive Vice President of Regulatory Affairs and Clinical Operations, expressed excitement about the Nanjing Anji products, noting they are currently in the preclinical stage with packages being prepared for early FDA conversations. He confirmed these would follow a standard NDA process as new drugs, with optimism for expedited pathways, particularly for some oncology products, though FDA engagement has not yet occurred.

Tianxi asked for updates on the Nanjing Anji in-licensed assets, including the company's confidence level, and the anticipated clinical development path for these assets in their respective indications.

Answer

Tony Marrs, EVP of Regulatory Affairs and Clinical Operations, expressed excitement for the Nanjing Anji products, noting they are currently in the preclinical stage. He mentioned that Amphastar is preparing packages for early conversations with the FDA and is optimistic about potential expedited pathways, particularly for oncology products. He confirmed these would follow the standard NDA process as new drugs, with internal teams building and prioritizing these projects.