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Only 6 days after obtaining the production license, Yiyibielixue ® (Ebergestine α injection) was shipped in the first batch in the country

      Following the new long-acting granulocyte colony stimulating factor (G-CSF) independently developed by Yiyi Bio, a holding subsidiary of Yifan Pharmaceutical, Yilishu ® (Ebegerstim α injection) was approved by the State Drug Administration on May 6, and obtained the GMP production license from the Beijing Municipal Drug Administration on June 15。The first shipment was made on June 21。At 15:00 on the same day, a cold chain truck full of the third generation of long-term Shengbaiyao Yilishu ®, the first in China, drove out of Beijing Economic and Technological Development Zone, the highland of Beijing biomedical manufacturing, and sent a new treatment option for cancer patients at the first time。

       Erisol ® is approved for the treatment of adult non-myeloid malignants who are treated with myelosuppressive anticancer agents that are predisposed to cause febrile neutropenia to reduce the incidence of infection characterized by febrile neutropenia。According to the drug instructions approved by the State Food and Drug Administration and the results of three Phase III clinical trials conducted in China, Europe and the United States respectively,On some clinically significant indicators,The clinical efficacy of Erisol is better than that of short-acting megasetin and long-acting megasetin (Pefegasetin Neulasta).。For example, in a pivotal Phase III clinical trial completed in China (Trial 1), patients treated with Erisol had a statistically significant difference in neutrophil minimum values over four chemotherapy cycles compared to the original Fegerstim control group。At the same time, the incidence of grade 4 neutropenia, grade 3 and grade 4 neutropenia in the third chemotherapy cycle was lower than that in the original Fegerstim control group, and the difference between groups was statistically significant。

       In two pivotal Phase III clinical trials (Trials 2 and 3) completed in the United States and Europe, Eperisol was injected subcutaneously on day 2 of each chemotherapy cycle (24 hours after the end of chemotherapy), and the clinical efficacy and safety were similar to that of the original long-acting drug (Pefegelstim Neulasta)。It is suggested that Erisol can be administered in a shorter period of time after the end of chemotherapy, so as to reduce the hospitalization time and reduce the treatment cost。

       After 15 years of intensive research and development, Ealishu ® is the first macromolecule Class I new drug approved by Eichi Biotics。The successful completion of the first national shipment of Eilisol ® further demonstrates Eilisol's collaborative capabilities from drug development and production to supply chain integration。Yiyi has a high quality production and quality management system that meets the requirements of international GMP regulations, ensuring the product listing and commercialization process。With our China commercialization partner (Zhengda Tianqing) and its high-quality commercialization team and distribution network resources, Ealishu ® will soon be delivered to more patients and become a new choice for Shengbai treatment。


(2023/6/22 8:40:38 Read 5460 times)

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