Aoxiang Pharmaceutical (603229.SH): The cooperative product Lucotinib tablets obtained overseas marketing approval

Zhitong Financial App News, Aoxiang Pharmaceutical (603229.SH) issued an announcement. Recently, Spirig HealthCare AG, a subsidiary of the company's partner STADA Arzneimittel AG (hereinafter referred to as “STADA”), received approval from the Swiss Drug Administration to market rucotinib tablets.

Rucotinib tablets are a selective inhibitor of Janus kinase (JAK) JAK1/2. It is suitable for treating moderate or high-risk primary myelofibrosis, splenomegaly and related symptoms in adult patients with myelofibrosis secondary to polycythemia vera, and myelofibrosis secondary to primary thrombocytosis, and can also be used to treat glucocorticoid refractory acute/chronic graft-versus-host disease (some indications are limited by local data protection regulations). As the world's first JAK inhibitor approved for marketing, rucotinib tablets can selectively inhibit JAK1/2 kinase activity, block abnormal activation of the JAK-STAT signaling pathway, and inhibit abnormal clonal hematopoietic proliferation and production of inflammatory factors, thereby reducing excessive bone marrow hematopoiesis and improving related clinical symptoms.

The US product name for rucotinib tablets is Jakafi, and the product name in other regions of the world (including China) is Jakavi (Jakavi). It was originally developed by Incyte in the US. Novartis received exclusive commercial rights in markets outside the US. It was approved for listing by the US Food and Drug Administration (FDA) in November 2011, then approved in the European Union, Japan and other regions; it was approved for marketing in China in March 2017. According to IQVIA database statistics, in 2024, global sales of rucotinib tablet preparations were approximately US$4.728 billion.

This time, lucotinib tablets have obtained marketing approval in Switzerland, indicating that the drug developed and produced by the company meets the regulatory requirements for Swiss drug registration and marketing and is about to officially enter the Swiss market for sale. This achievement not only lays a solid foundation for the company's business expansion in the Swiss market, but will also have a positive and profound impact on the company's continued expansion of the EU market, further enhancing the company's brand awareness and market share in the European market. This time, the company's cooperative formulation products with STADA have been approved once again, marking a continuous breakthrough in the company's “intermediates+specialty ingredients+formulations” integrated strategy, which will further enrich the company's product line, enhance the advantages of integrated production, enhance the company's competitiveness, and promote the company's continuous, stable and healthy development.