Yifan Pharmaceutical Co., Ltd (SHE: 002019), a China-based pharmaceutical company, has announced receiving market approval from the National Medical Products Administration (NMPA) for its efbemalenograstim alfa (F-627). This in-house developed long-acting recombinant human granulocyte colony stimulating factor (rhGCSF)-Fc fusion protein is indicated for the prevention and treatment of neutropenia in cancer patients undergoing chemotherapy.
F-627: A Potential First-In-Class rhG-CSF with Di-Kine Bimolecular Technology
F-627 is a potential first-in-class rhG-CSF developed using Yifan’s proprietary Di-Kine bimolecular technology platform, known for its long-lasting and potent biological characteristics. This breakthrough therapy offers a significant advancement in the management of neutropenia, a common side effect of chemotherapy that can lead to severe infections.
Partnership and Commercialization Rights
In August 2021, Yifan Pharma and its subsidiary Evive Biotech Ltd entered into a partnership agreement with Chia Tai Tianqing Pharmaceutical Co., Ltd’s unit Nanjing Shun Xin Pharmaceutical Co., Ltd, a deal valued at RMB 210 million (USD 33.2 million). This agreement grants Shun Xin Pharma exclusive commercialization rights to the product in China. Additionally, Yifan transferred exclusive distribution rights in Germany to Apogepha Arzneimittel GmbH through a USD 38.9 million deal in December last year.
Global Market Filings for F-627
The drug has been filed for marketing in China, the US, and Europe, indicating Yifan Pharmaceutical’s commitment to expanding access to this innovative treatment for cancer patients globally.-Fineline Info & Tech
