Ryzneuta® (Efbemalenograstim alfa Injection), a novel long-acting granulocyte colony-stimulating factor (G-CSF) and Class 1 innovative drug independently developed by Evive Biotech, a subsidiary of Yifan Pharmaceutical, was approved by SFDA on May 6 and obtained the GMP production license from the Beijing Food and Drug Administration on June 15. The product was first shipped nationwide on June 21. At 15:00, a cold-chain truck fully loaded with  China’s first third-generation long-acting GCSF Ryzneuta®, departed from the Beijing Economic and Technological Development Zone, a highland of biomedical manufacturing in Beijing, sending brand-new treatment options to cancer patients immediately.

Ryzneuta® was approved for the treatment of adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs that are prone to febrile neutropenia to reduce the incidence of infection manifested 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 of Ryzneuta® conducted in China, Europe and the United States, the clinical efficacy of Ryzneuta® is potentially better than short-term (filgrastim) and long-acting (pegfilgrastim, Neulasta) drugs in some clinically meaningful indicators. For example, in the pivotal Phase III clinical trial (Trial 1) completed in China, the depth nadir of the ANC in patients receiving Ryzneuta® in 4 chemotherapy cycles was higher than that of the control group which received filgrastim, and the difference between the two groups is statistically significant. At the same time, the incidence of grade 4 neutropenia and the incidence of grade 3 and 4 neutropenia in the third chemotherapy cycle were lower in patients receiving Ryzneuta® than in those receiving filgrastim in the control group, and the differences between the two groups were statistically significant.

In two global pivotal Phase III clinical trials (Trial 2 and Trial 3) completed in the United States and Europe, Ryzneuta® was injected subcutaneously on the second day of each chemotherapy cycle (24 hours after the end of chemotherapy), and the clinical efficacy and safety is comparable to the original long-acting drug (pefilgrastim, Neulasta), suggesting that Ryzneuta® can be administered in a shorter time after the end of chemotherapy, thereby reducing the hospitalization time and treatment costs.

After 15 years of painstaking in house research and development, Ryzneuta® becomes Evive’s first macromolecular class I new drug approved for marketing. The successful completion of the first national shipment of Ryzneuta® further proves that Evive has the synergy capability from drug research and development, CMC to supply chain. Evive has a high-quality CMC and quality management system that meets the international GMP standards, ensuring the  successful launch and commercialization of products. Leveraging the power of Evive’s Chinese commercialization partner (Chia Tai Tianqing) and its high-quality commercialization team and distribution network resources, Ryzneuta® will be delivered to more patients in the near future, becoming a new choice for G-CSF treatment.