China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) announced the establishment of a licensing agreement with US firm Acrotech Biopharma, Inc., granting the latter exclusive distribution rights to its efbemalenograstim alfa (F-627) in the United States. The drug 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. Acrotech will pay Yifan Pharma up to USD 236.5 million in a licensing fee, alongside double-digit tiered commission fees on net sales.
F-627: Development and Clinical Trials
F-627, a potential first-in-class rhG-CSF developed via the proprietary Di-Kine bimolecular technology platform, features long-lasting and potent biological characteristics. The drug, with 04 and 05 studies concluded in the US and Europe, has completed Phase I, II, and III clinical trials in China, with all pre-set clinical goals having been reached.
Market Filings and Previous Licensing Deals
Market filings for F-627 were accepted for review by the US FDA, European Medicine Agency (EMA), and the National Medical Products Administration (NMPA) in March 2021, September 2021, and February 2022 respectively. Yifan Pharma struck a slew of licensing deals in relation to F-627. The company handed commercialization rights in mainland China to Chia Tai Tianqing in an RMB 210 million (USD 29.75 million) deal in August 2021, distributions rights in Greece and Cyprus to KALTEQ S.A. in a USD 6.6 million deal in January 2022, Germany distribution rights to Apogepha in a USD 38.9 million deal in February 2022, Brazil distribution rights to LIBBS FARMACÊUTICA LTDA in March this year, with a USD 6.7 million price tag, and finally, Switzerland distribution rights to Apogepha Arzneimittel GmbH one month later via a deal worth USD 6.97 million.-Fineline Info & Tech
