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SAN DIEGO - Gyre Therapeutics (NASDAQ:GYRE), a biotechnology company specializing in organ fibrosis treatments with a market capitalization of $853 million, has received approval from China’s National Medical Products Administration (NMPA) to commence a clinical trial for pirfenidone, targeting a new oncology-related indication. Despite the stock’s recent 27% decline over the past six months, InvestingPro analysis suggests the company maintains strong fundamentals. The trial aims to assess the efficacy of pirfenidone capsules in treating radiation-induced lung injury (RILI) and checkpoint inhibitor pneumonitis (CIP), conditions affecting cancer patients undergoing radiation therapy and immunotherapy.
Radiation therapy, essential for lung cancer treatment, results in RILI in 5% to 25% of patients, which can limit treatment effectiveness due to lung damage. Similarly, CIP, a side effect of immune checkpoint inhibitors, occurs in 13% to 19% of patients and is responsible for about 35% of immune-related adverse event deaths, often leading to treatment discontinuation. No targeted therapies are currently available for these lung injuries.
Pirfenidone, an orally administered drug, inhibits TGF-β signaling and fibroblast proliferation, and has been used in the treatment of idiopathic pulmonary fibrosis (IPF) since its first approval in China in 2011. With the new trial, Gyre aims to explore the drug’s potential in mitigating lung injury progression in cancer patients. The company’s impressive 96% gross profit margin and healthy current ratio of 3.32 demonstrate its operational efficiency and strong financial position, according to InvestingPro data.
The company plans to implement an adaptive Phase 2/3 clinical trial design, merging dose exploration with efficacy confirmation, to efficiently evaluate pirfenidone in this novel indication. The trial is expected to begin in the second half of 2025 at leading academic and oncology centers throughout China.
Gyre Therapeutics, headquartered in San Diego, is primarily engaged in developing and commercializing treatments for fibrosis. In addition to its work on pirfenidone, the company is advancing a broad pipeline through its controlling interest in Gyre Pharmaceuticals, focusing on various therapeutic expansions and development programs.
The company’s forward-looking statements, as per the press release, highlight their research and development plans, including the anticipated initiation of the clinical trial. These statements, however, are subject to risks and uncertainties, including the company’s ability to execute its clinical development strategies, the predictive nature of clinical trial results, regulatory filings and approvals, competition, and economic and industrial conditions.
This article is based on a press release statement from Gyre Therapeutics. For deeper insights into Gyre’s financial health, valuation metrics, and growth potential, InvestingPro offers exclusive access to over 10 additional ProTips and comprehensive financial analysis tools.
In other recent news, Gyre Therapeutics has reported its fourth-quarter revenue at $27.87 million, marking a slight increase from the previous year’s $27.1 million. The company also provided its revenue guidance for 2025, which ranges between $118 million to $128 million, falling short of the $135.7 million analysts had anticipated. This projection assumes the launch of two new products, nintedanib and avatrombopag, in China within the year. Meanwhile, Gyre Therapeutics has advanced its Phase 3 trial for hydronidone, a treatment for liver fibrosis in chronic hepatitis B patients, with patient enrollment completed in October 2024. The trial, conducted across 44 clinical research hospitals in China, aims to assess the drug’s effectiveness over a 52-week period. Gyre’s existing product, ETUARY, continues to perform well, contributing significantly to the company’s 2024 net sales of $105.8 million. Despite the cautious revenue outlook, the CEO expressed confidence in the company’s ability to launch and expand its new products successfully. The company concluded 2024 with $51.2 million in cash and investments.
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