Under the agreement, the Russian company will obtain exclusive rights to registration, promotion, and commercialization of the Armocibart in Russia, Kazakhstan, Belarus, and other countries across the region.
Russian biopharmaceutical company Nanolek and Chinese biopharmaceutical company Suzhou Alphamab Co., Ltd. (“Alphamab”) have entered into a strategic cooperation agreement to commercialize Armocibart, a therapy for the prevention of hemophilia A and hemophilia B, in Russia, the Eurasian Economic Union (EAEU), Azerbaijan, and Uzbekistan.
The agreement was signed at the Russian–Chinese Pharmaceutical Forum in Shanghai. The document was signed by Nanolek CEO Evgeny Barinov and Alphamab's substantial shareholder and board member, Xue Chuanxiao.
Under the terms of the agreement, Nanolek will be granted exclusive rights to register, promote, and commercialize Armocibart in the agreed territories and will also act as the holder of the marketing authorization.
“We are pleased to start a collaboration with Nanolek, a company with substantial experience in entering of the innovative medicines to the Russian and Eurasian markets. We are confident that this partnership will help to make modern approaches of hemophilia prevention more widely accessible to patients,” mentioned Xue Chuanxiao.
Armocibart is a subcutaneous drug intended for the prevention of bleeding in hemophilia A and hemophilia B with or without inhibitors. Subcutaneous administration is more convenient for Inhibitory hemophilia is a condition characterized by the producing of antibodies against coagulation factors VIII (in hemophilia A) or IX (in hemophilia B). These antibodies neutralize the respective factors, reducing the efficacy of factor replacement therapy and making standard hemophilia treatment ineffective.
For Russia, the implementation of a TFPI inhibitor into clinical practice will provide access to a first-in-class therapy for the prevention of bleeding in patients with hemophilia A and B, regardless of the presence of inhibitors to coagulation factors.
Hemophilia is a rare inherited disorder characterized by impaired blood clotting. It is caused by mutations in the genes encoding coagulation factors VIII or IX. The average age of diagnosis is approximately two years.
“According to the Russian registry, there are currently more than 8,500 patients with hemophilia A and B in the country. For many of them, regular therapy is essential to maintain quality of life and prevent serious complications. We consider our collaboration with Alphamab as an important step in developing of our orphan drug portfolio and expanding patient access to modern biotechnological therapies in Russia,” mentioned Evgeniy Barinov.
Armocibart is currently undergoing Phase III clinical trials in patients with hemophilia with and without inhibitors. Completion of the trials in China is planned by middle of 2027.