Gyre Therapeutics Gains China NMPA Approval for Avatrombopag Maleate Tablets to Treat CLD Thrombocytopenia

SAN DIEGO, July 02, 2024 -- Gyre Therapeutics (Nasdaq: GYRE), a biotechnology company known for its self-sustaining and commercial-stage operations, has received approval from China's National Medical Products Administration (NMPA) for its avatrombopag maleate tablets. This approval is specifically for treating thrombocytopenia (TP) associated with chronic liver disease (CLD) in adult patients undergoing elective diagnostic procedures or therapy. Thrombocytopenia is a common and potentially life-threatening hematologic complication in individuals with chronic liver disease.

Han Ying, Ph.D., CEO of Gyre Therapeutics, expressed the significance of this approval, stating, "The NMPA's approval of avatrombopag maleate tablets is a crucial milestone for Gyre as we continue to expand our portfolio of rare disease treatments and strengthen our commitment to addressing chronic liver disease. We are enthusiastic about launching avatrombopag in China to assist patients suffering from this serious condition."

Gyre Pharmaceuticals, an indirectly controlled subsidiary of Gyre Therapeutics, acquired avatrombopag through a transfer agreement with Nanjing Healthnice Pharmaceutical Technology Co., Ltd. in June 2021. Avatrombopag is an oral thrombopoietin receptor agonist (TPO-RA), initially approved by the U.S. Food and Drug Administration (FDA) in May 2018 for treating adults with CLD-associated TP. The indication was later broadened to include the treatment of immune thrombocytopenia in June 2019.

Gyre Therapeutics, headquartered in San Diego, CA, focuses on the development and commercialization of treatments for various chronic organ diseases. The company’s primary project is F351 (Hydronidone) for addressing NASH-associated fibrosis in the U.S. Gyre’s approach to F351 development is informed by their extensive experience with NASH rodent model mechanistic studies and clinical studies related to CHB-induced liver fibrosis. Additionally, Gyre is advancing a diverse pipeline of treatments in China through its indirect controlling interest in Gyre Pharmaceuticals, including the expansion of ETUARY therapeutics, and development of F573, F528, and F230.

In summary, the NMPA's approval of avatrombopag maleate tablets marks a significant progression for Gyre Therapeutics as it extends its rare disease treatment offerings and reinforces its presence in the chronic liver disease treatment landscape. This development also underscores the potential of avatrombopag to provide crucial therapeutic benefits to patients in China suffering from TP associated with CLD.

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