China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) announced the transfer of exclusive distribution rights in Germany to its efbemalenograstim alfa (F-627), to Apogepha Arzneimittel GmbH. The German firm will pay Yifan Pharma a USD 400,000 upfront payment, up to USD 1 million development milestone payment, and up to USD 37.5 million in a sales milestone payment.
Previous Distribution Agreements
Previously, F-627 was handed to another company for distribution rights in Greece and Cyprus.
F-627: Development and Clinical Trials
F-627 is an in-house developed long-acting recombinant human granulocyte colony-stimulating factor (rhGCSF)-Fc fusion protein for the prevention and treatment of neutropenia during chemotherapy in cancer patients. The drug concluded Phase III clinical study (04 study) in the US in January 2018, having reached its pre-set primary efficacy endpoint. As of July 2020, Yifan Pharma had completed the neutralizing antibody detection related to immunogenicity in the 05 trial, and F-627 had completed the clinical trials carried out at home and abroad, all of which reached the preset goal of clinical trials. On March 30, 2021, a market filing for the drug was made in the US, which was accepted for review on May 27 of the same year. Another market filing was made in China in February of this year.-Fineline Info & Tech
