Announcement from Aoxiang Pharmaceutical on the cooperation product tofacitinib citrate tablets obtaining overseas marketing approval
Securities code: 603229 Securities abbreviation: Aoxiang Pharmaceutical Announcement number: 2026-003
Zhejiang Aoxiang Pharmaceutical Co., Ltd.
About the cooperative product tofacitinib citrate tablets
Announcement on Obtaining Overseas Marketing Authorization
The company's board of directors and all directors guarantee that the contents of this announcement do not contain any false records, misleading statements or major omissions, and assume legal responsibility for the authenticity, accuracy and completeness of its contents.
Recently, Spirig HealthCare AG, a subsidiary of STADA Arzneimittel AG (hereinafter referred to as "STADA"), a partner of Zhejiang Aoxiang Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company"), received the marketing authorization for tofacitinib citrate tablets approved by the Swiss Medicines Agency. The relevant information is now announced as follows:
1. Basic information about drugs
Drug name: Tofacitinib citrate
Dosage form: tablet
Specifications: 5mg, 10mg
Registration number: 70158
This preparation product is one of the products jointly developed and commercialized by the company and STADA. The company assumes the production task of the preparation product, while the sales work will be carried out by both parties in their respective market areas. The two parties will realize resource sharing, complement each other's advantages, and jointly promote the internationalization process of the company's preparations. The two parties have launched a long-term and comprehensive cooperation on the joint development and global marketing of chemical generic drug preparation products, and signed the "Cooperative Development and Commercialization Strategic Cooperation Agreement" on November 3, 2021. For specific content, please refer to the "Announcement of Aoxiang Pharmaceutical on the Signing of the "Cooperative Development and Commercialization Strategic Cooperation Agreement" with STADA Arzneimittel AG" disclosed by the company on November 5, 2021 (announcement number: 2021-043).
2. Drug related information
Tofacitinib citrate tablets are the world's first approved oral Janus kinase inhibitor and are targeted synthetic disease-modifying antirheumatic drugs. It regulates immune responses by inhibiting the intracellular JAK signaling pathway and is mainly used to treat autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.
The trade name of tofacitinib citrate preparation is Xeljanz, which was developed by Pfizer. It was approved for marketing by the U.S. Food and Drug Administration (FDA) in November 2012, and was approved to enter the Chinese market in March 2017. According to IQVIA database statistics, the global sales of tofacitinib citrate preparations in 2024 will be approximately US$1.168 billion.
Up to now, the company's cumulative R&D investment in this product is approximately RMB 6.96 million.
3. Impact on the company and risk warning
This time, tofacitinib citrate tablets have obtained Swiss marketing authorization, which means that the drug developed and produced by the company meets the regulatory requirements for Swiss drug registration and marketing, and will soon officially enter the Swiss market for sale. This achievement not only laid a solid foundation for the company's business expansion in the Swiss market, but will also have a positive and far-reaching impact on the company's continued expansion into the EU market, further enhancing the company's brand awareness and market share in the European market. This time, the preparation products of the company's cooperation with STADA were approved again, marking another breakthrough in the company's "intermediate + specialty API + preparation" integration strategy. It will further enrich the company's product line, enhance the advantages of integrated production, enhance the company's competitiveness, and promote the company's sustainable, stable and healthy development.
Since pharmaceutical products are characterized by high technology, high risk and high added value, the future production and sales of pharmaceuticals may be affected by factors such as industry policies and market environment changes, and there is a certain degree of uncertainty. Investors are kindly requested to make prudent decisions and pay attention to preventing investment risks.
Announcement is hereby made.
Board of Directors of Zhejiang Aoxiang Pharmaceutical Co., Ltd.
February 6, 2026