Press release
Gyre Therapeutics Announces China’s NMPA Approval of Avatrombopag Maleate Tablets for the Treatment of CLD-Associated Thrombocytopenia
SAN DIEGO, July 02, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a self-sustainable, commercial-stage biotechnology company with
About this update from Gyre Therapeutics, Inc.
[{"type":"text","content":"SAN DIEGO, July 02, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a self-sustainable, commercial-stage biotechnology company with clinical development programs focusing on a variety of chronic organ diseases, today announced that China’s National Medical Products Administration (“NMPA”) has approved Gyre Pharmaceuticals’ (Gyre’s indirectly controlled subsidiary) avatrombopag maleate tablets for the treatment of thrombocytopenia (“TP”) associated with chronic liver disease (“CLD”) in adult patients undergoing elective diagnostics procedures or therapy. TP is the most common hematologic complication in patients with CLD and can be life threatening in severe cases. “The approval of avatrombopag maleate tablets by the NMPA represents an important milestone for Gyre as we expand our rare disease product lines and build our presence in developing treatments for patients with CLD,” said Han Ying, Ph.D., CEO of Gyre Therapeutics. “We are eager to launch avatrombopag in China and provide a treatment for patients suffering from this devastating disease.” Gyre Pharmaceuticals acquired avatrombopag under a transfer agreement with Nanjing Healthnice Pharmaceutical Technology Co., Ltd. (“Nanjing Healthnice”) in June 2021. Avatrombopag is an oral thrombopoietin receptor agonist (“TPO-RA”). Avatrombopag was approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of adults with CLD-associated TP in May 2018, and its indication was subsequently expanded to include the treatment of immune thrombocytopenia in June 2019. About Gyre Therapeutics Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, with a primary focus on the development and commercialization of F351 (Hydronidone) for the treatment of NASH-associated fibrosis in the U.S. Gyre’s development strategy for F351 in NASH is based on the company’s experience in NASH rodent model mechanistic studies and CHB-induced liver fibrosis clinical studies. Gyre is also advancing a diverse pipeline in the PRC through its indirect controlling interest in Gyre Pharmaceuticals, including ETUARY therapeutic expansions, F573, F528, and F230. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which st...