On May 9, 2023, Eifan Pharma and EIFan Bio (" EIFan ") jointly announced that Eifan ® (EIFan α injection) has been approved by the National Medical Products Administration (NMPA) for the prevention and treatment of neutropenia in cancer patients after receiving chemotherapy drugs。
Neutropenia (CIN) is a common side effect of chemotherapy drugs used to treat tumors,The symptom is persistently low levels of neutrophils, a type of white blood cell that fights infections, due to the use of chemotherapy drugs,This will increase the risk of adverse reactions such as infection and fever in cancer patients during chemotherapy。Erisol ® is a novel long-acting granulocyte colony-stimulating factor (G-CSF).,It can stimulate the proliferation and differentiation of neutrophil precursors and the release of mature neutrophils,To boost the immune system of cancer patients,Prevent neutropenia in cancer patients as a side effect of chemotherapy,Avoid the resulting dose reduction or delayed administration of chemotherapy drugs,And then affect the effectiveness of cancer treatment。
The management team of Yiyi Biology said, "We are pleased to see that Yirisol ® has been approved for registration and marketing in China, bringing new treatment options to cancer patients in China。Eilisol ® is the first macromolecular biological innovative drug developed by EILbio after more than ten years of self-development,It is the result of the joint persistence and efforts of Yifan Medicine and Yiyi Biology,We look forward to the commercialization partner Zhengda Tianqing with its excellent commercialization resources and capabilities,It can make this new drug benefit more Chinese cancer patients who have urgent needs。The approval of Erisol ® in China also provides valuable experience for the upcoming FDA and EMA field verification and final approval,Enhance confidence,We will also continue to display the spirit of perseverance and teamwork,Carefully prepare for the upcoming GMP on-site verification by FDA and EMA,We will strive to achieve the successful approval of Elisol ® in the United States, Europe and more countries as soon as possible。”
Yiyi Biology is a member unit of Beijing Pharmaceutical Industry Association and a supervisory unit of the association。With cGMP facilities of FDA, EMA and NMPA standards, we are the first biopharmaceutical company to independently complete a global Phase III clinical trial of a new macromolecule I drug and submit a new drug marketing application to FDA and EMA for the same product。
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