Panion & BF Biotech (PBF) announced on 5 July that it has been notified by the National Medical Products Administration of China that the import case of Nephoxil, a new kidney drug, has been accepted by the authority for registration of its API ferric citrate.

The Company explained that in accordance with the requirements by the Chinese government, chemical APIs are required to apply for the registration along with relevant research data, and therefore ferric citrate, the API of Nephoxil, has applied for registration in accordance with its relevant regulations.

PBF added that under the new regulations introduced in China, both APIs and new pharmaceutical products are required to submit applications and the review time is expected to be at least one year.

In addition to the acceptance of the API for Nephoxil, the approval of is also expected to enter substantive review. After Nephoxil receives the approval from China and goes to market, PBF can then recognise the RMB 100 million milestone payment.