March 26, 2024 Source: drugdu 167
Recently, the innovative biologic drug Efbemalenograstim alfa Injection (Chinese trade name "Ryzneuta"), independently developed by Evive Biotech and for which Chia Tai Tianqing has exclusive commercialization rights in China, received the "COMMISSION IMPLEMENTING DECISION" issued by the European Commission, approved for sale in the EU. The decision is based on a positive review by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). So far, Efbemalenograstim alfa Injection has become the first domestic innovative biological drug that has been approved for marketing in China, the United States and the European Union. It has also become the first innovative drug approved by the European Union by a Chinese pharmaceutical company in 2024.
Previously, Chia Tai Tianqing had signed a commercial cooperation agreement with Evive Biotech and obtained all intellectual property rights and exclusive commercialization rights of Yilisu® in China.
Efbemalenograstim alfa Injection is currently the only G-CSF therapeutic drug in the world that has been compared with both long-acting and short-acting original research products in head-to-head clinical studies. It has achieved the preset goals and achieved China, The drug has been approved for marketing in the United States and Europe at the same time. As a non-PEG-modified long-acting G-CSF, it has the advantages of better clinical performance, better safety, and can be administered earlier.
In May 2023, Ryzneuta was approved for marketing by the China National Medical Products Administration for the treatment of adult patients with non-myeloid malignant tumors receiving myelosuppressive anti-cancer drugs that are prone to febrile neutropenia. Reduce the incidence of infection manifested by febrile neutropenia, and successfully enter China's 2023 version of the National Medical Insurance Drug List in December 2023. The clinical application of Ryzneuta provides a new option for the majority of chemotherapy patients to prevent neutropenia, and earlier medication timing also brings more benefits to patients.
According to IQVIA statistics, the global market for G-CSF in the first three quarters of 2023 was US$4.35 billion, including US$1.06 billion in Europe. G-CSF drugs are currently the main whitening drugs in clinical practice. They are urgently needed for cancer patients suffering from neutropenia after receiving anti-cancer drugs. They are also the preferred clinical drugs recommended by ASCO, NCCN and other guidelines.
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