Ryzneuta approved for use in China

Chinese pharmaceutical companies Evive Biotech, a subsidiary of Yifan Pharma, and Chia Tai Tianqing Nanjing Shunxin, a subsidiary of Sino Biopharm, announced on Tuesday that China's National Medical Products Administration has approved the use of Ryzneuta, a novel treatment for the prevention and treatment of chemotherapy-induced neutropenia.

Chia Tai Tianqing had in 2021 signed a commercial cooperation agreement with Evive, the manufacturer of Ryzneuta, to acquire all intellectual property rights and exclusive commercial rights of the medicine in China.

Neutropenia is a common side effect of chemotherapy drugs and is characterized by low levels of neutrophils, a type of white blood cell with infection-fighting functions. It increases the risk of adverse reactions in cancer patients during chemotherapy.

"As a third generation, long-acting granulocyte colony-stimulating factor drug, Ryzneuta's advantages is its high stability and low immunogenicity. Its approval will provide a new option for neutropenia therapy," said Theresa Tse, executive director and chairwoman of Sino Biopharm.

A new drug application for the medicine has also been filed with the United States Food and Drug Administration and the European Medicines Agency. The companies said that US FDA is expected to conduct on-site GMP inspection of the drug's producer in Beijing in June.