The National Medical Products Administration (NMPA) website indicates that China-based Hansoh Pharmaceutical Group Co., Ltd’s (HKG: 3692) generic version of Japan firm Takeda Pharmaceutical Co., Ltd’s Firazyr (icatibant) has been approved for marketing in China.
Firazyr: Mechanism and Approval History
Firazyr, a selective bradykinin B2 receptor antagonist developed by Shire Pharmaceuticals, competitively binds to bradykinin B2 receptors with high selectivity, thereby reducing edema of the skin, and gastrointestinal and respiratory mucosa caused by the increase of bradykinin in HAE, shortening the onset time of edema, and treating acute hereditary angioedema. The drug, first approved in the US in 2011, was approved for marketing in China in April 2021.
Hereditary Angioedema (HAE) and Treatment Landscape
HAE is a rare genetic disease that is mainly manifested as recurrent swelling of the skin, respiratory tract, and internal organs. When edema occurs in the airway, it can cause laryngeal edema. If the rescue is not timely, the patient can suffocate and die. The disease was included in the first batch of rare disease catalog in 2018 in China, where there is no effective drug for the treatment of acute HAE attacks.
Hansoh’s Clinical Trials and Market Approvals
Hansoh initiated clinical trials for its generic version in 2014, which obtained market approval in the US in March 2020. Meanwhile, Shengnuo Biotech also made a market filing for its product in May 2018 in China.-Fineline Info & Tech
