Yi Li Shu® Approved in the European Union, Becoming the First Innovative Biological Drug Approved in China, the U.S. and Europe

March 26, 2024  Source: drugdu 82

"/On March 22nd, Yi Li Shu® (Efbemalenograstim Alfa Injection), an innovative biopharmaceutical product developed by EVIVE and exclusively commercialized in China by Chiatai Tianqing, received the "COMMISSION IMPLEMENTATION DECISION" from the European Commission approving its marketing and sales in the European Union. The decision is based on the positive review opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Thus, Efbemalenograstim Alfa Injection has become the first innovative biopharmaceutical in China that has been approved for marketing in China, the United States and the European Union, as well as the first innovative drug approved by a Chinese pharmaceutical company in the European Union in the year 2024.

Previously, Chiatai Tianqing has signed a commercialization cooperation agreement with EVIVE to obtain all intellectual property rights and exclusive commercialization rights of Yi Li Shu® in China.

Efbemalenograstim Alfa Injection is the only drug among the global G-CSF therapeutic drugs that has been compared with both long-acting and short-acting originator products in head-to-head clinical studies, reached the pre-determined target and achieved the simultaneous approval and marketing in China, the U.S., and Europe. As a non-PEG-modified, long-acting G-CSF, it has the advantages of better clinical performance, better safety, and the ability to be administered at an earlier time.

In May 2023, Yi Li Shu® was approved by the State Drug Administration of China for use in adult patients with non-myeloid malignant tumors to reduce the incidence of infections manifested by febrile neutropenia when receiving myelosuppressive anticancer drugs that are prone to cause febrile neutropenia, and was successfully entered into China's 2023 version of the National Health Insurance Drug List in December 2023. The clinical application of Yi Li Shu® provides a new option for the prevention of neutropenia for the majority of chemotherapy patients, and the earlier timing of dosing also brings more benefits to patients.

According to IQVIA statistics, the global market for G-CSF in the first three quarters of 2023 was $4.35 billion, of which $1.06 billion was in Europe. G-CSF drugs are currently the main clinical leukocytochemicals, and they are the first choice for neutropenia in patients with tumors after receiving anticancer drugs, and are also the first choice for clinical use as recommended by ASCO, NCCN and other guidelines.

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