SAN DIEGO - Gyre Therapeutics, a commercial-stage biotechnology company, announced today that its subsidiary Gyre Pharmaceuticals has received approval from China's National Medical Products Administration (NMPA) for avatrombopag maleate tablets. This medication is intended for adult patients with thrombocytopenia associated with chronic liver disease who are undergoing elective diagnostics or therapy.
Thrombocytopenia is a prevalent hematologic complication among patients with chronic liver disease and can pose serious threats to health in severe cases. The approval marks a significant step for Gyre Therapeutics in its efforts to extend its product range for rare diseases and to establish a stronger foothold in the market for treatments targeting chronic liver disease.
Avatrombopag maleate, an oral thrombopoietin receptor agonist, was first approved by the U.S. Food and Drug Administration (FDA) in May 2018 for the treatment of thrombocytopenia in adults with chronic liver disease. Its use was later expanded to include treatment for immune thrombocytopenia in June 2019.
Gyre Therapeutics, headquartered in San Diego, CA, primarily focuses on developing and commercializing treatments for NASH-associated fibrosis and has a diversified pipeline of therapies in the People's Republic of China. The company acquired avatrombopag through a transfer agreement with Nanjing Healthnice Pharmaceutical Technology Co., Ltd. in June 2021.
The CEO of Gyre Therapeutics, Han Ying, Ph.D., expressed eagerness to launch avatrombopag in China and provide a new treatment option for patients suffering from this challenging condition.
In other recent news, Gyre Therapeutics has been making significant strides in its operations. The biotech firm has received approval from China's drug regulator to commence clinical trials for its pulmonary arterial hypertension (PAH) medication, F230. This development marks a crucial step in addressing PAH, a severe and life-threatening disorder. The drug has shown potential in preclinical studies, demonstrating significant reductions in several key PAH severity indicators.
In addition to this, Gyre Therapeutics is set to be included in the Russell 2000® and Russell 3000® Indexes as of June 28, 2024, a development that is expected to increase its visibility in the investment community. The company's inclusion in these indexes is a significant milestone, as these indexes are commonly used by investment managers and institutional investors for creating index funds and benchmarking active investment strategies.
These are just some of the recent developments for Gyre Therapeutics. As the company continues to advance its clinical development strategies, it is important to note that positive clinical trial results may not necessarily predict future outcomes and that economic and industrial conditions can affect the company's progress. Regardless, these recent developments mark significant steps forward for Gyre Therapeutics.
InvestingPro Insights
As Gyre Therapeutics celebrates the approval of avatrombopag maleate tablets in China, the company's financial health and market performance provide additional context for investors. Gyre's market capitalization stands at a robust 1030 million USD, indicating a significant presence in the biotechnology sector. The approval could potentially bolster Gyre's market position and contribute to revenue growth, which was reported at 10.75% over the last twelve months as of Q1 2024.
Despite not being profitable over the last twelve months, Gyre Therapeutics has demonstrated a substantial return over the past year with a 78.9% increase, an InvestingPro Tip that may interest investors looking for growth potential in the biotech industry. Additionally, Gyre operates with a moderate level of debt and has liquid assets that exceed its short-term obligations, suggesting a stable financial footing as it expands its product offerings.
Investors considering Gyre should note the company's high valuation multiples, with a Price / Book multiple of 18.15 as of the last twelve months leading up to Q1 2024. This could indicate expectations of future growth or a premium being placed on the company's assets and market position. With these insights, investors are encouraged to explore further by visiting https://www.investing.com/pro/GYRE, where they can discover an additional 9 InvestingPro Tips to help inform their investment decisions. Don't forget to use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
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