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Pufanle (Plerixafor Injection) Approved for Marketing


Recently, the company's subsidiary Hefei Yifan Biopharmaceutical Co., Ltd. has applied for the marketing of Plerixafor Injection (trade name "Pufanle"), and the application was approved by the State Food and Drug Administration of China. The newly-approved Pufanle and the company's existing product Melphalan Tablets are a perfect product portfolio, which will bring good news to non-Hodgkin's lymphoma patients/patients who underwent autologous stem cell transplantation in China.

The Plerixafor R&D project undertaken by Peking University Cancer Hospital as the team leader is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, superiority clinical trial conducted in China, which was launched in December 2016. The last case was grouped in December 2018, and the test results reached the preset goals. On December 9, 2019, the results of the Phase III clinical trial were presented orally at the 61st Annual Meeting of the American Society of Hematology. The test results showed that, when used for hematopoietic stem cell mobilization, the combined use of Plerixafor injection developed by the company and G-CSF was safe and effective, and significantly superior to the use of G-CSF alone, which provides a favorable guarantee for autologous hematopoietic stem cell transplantation of patients with non-Hodgkin's lymphoma. At the same time, the clinical results were also communicated in the form of wall newspaper at the 2019 Annual Meeting of the European Society for Medical Oncology.

The approval of Plerixafor Injection developed by the company further enriched the company's anti-tumor product line and improved its competitiveness in the field of anti-tumor treatment. At the same time, the approval for marketing of the company's Plerixafor Injection will further break the situation where the indication could only be treated with imported original drugs for a long time, and provide more economical treatment options for patients with multiple myeloma and malignant lymphoma who need autologous transplantation of hematopoietic stem cells, thereby benefiting more domestic patients.

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