Market Trends and Projections - The prevalence of idiopathic pulmonary fibrosis (IPF) in China increased from 89,002 patients in 2018 to 145,776 patients in 2023, with projections to reach 322,000 patients by 2031, reflecting a CAGR of 10.38%[34] - The total market size for IPF in China grew from $23.9 million in 2018 to $156.8 million in 2023, with expectations to reach $344.9 million by 2027 and $698.6 million by 2031, representing a CAGR of 20.5%[34] - The prevalence of CHB-associated liver fibrosis in the PRC is estimated to be stable between 63.6 million and 66.4 million patients from 2018 to 2023, with a projected market growth from $167.8 million in 2023 to $801.2 million by 2031, reflecting a CAGR of 21.58%[46] - The market for anti-fibrosis drugs for pneumoconiosis is projected to reach $12.1 million by 2027 and $64.1 million by 2031, with a CAGR of 58.1% from 2027 to 2031[39] - The DKD market in China grew from $26.4 billion in 2018 to $40.2 billion in 2023, with expectations to expand to $54.0 billion by 2028 and $60.5 billion by 2031[77] - The prevalence of PAH in China increased from 50,600 patients in 2018 to 60,600 patients in 2023, with projections of 68,600 patients by 2028 and 70,600 patients by 2031[94] - The prevalence of COPD in China rose from 103.5 million patients in 2018 to 107.3 million patients in 2023, with forecasts of 113.1 million patients by 2028 and 116.4 million patients by 2031[97] Product Development and Trials - F351 (hydronidone) is currently in a Phase 3 trial for chronic hepatitis B-associated liver fibrosis, with topline results expected in Q2 2025[21][24] - F573 is in Phase 2 trials for acute liver failure, initiated in March 2023, while F230 is expected to begin Phase 1 trials for pulmonary arterial hypertension in 2025[31][20] - The Phase 3 clinical trial of ETUARY for the treatment of pneumoconiosis has enrolled 172 patients as of December 31, 2024, with a target of 272 patients[41][42] - F351 demonstrated a statistically significant improvement in liver fibrosis score in a Phase 2 trial, with 56.10% of patients in the 270 mg/day group achieving fibrosis regression compared to 25.58% in the placebo group[54] - The Phase 3 trial of F351 is designed to enroll 248 patients, with the primary endpoint being a reduction in liver fibrosis score by at least one stage[57][58] - The Phase 2 clinical trial for F351 in MASH-associated liver fibrosis is expected to be initiated in the first half of 2025, following IND filing[70] - The first stage of the Phase 2 trial for F573 is expected to enroll 16 patients with drug-induced liver injury and 9 patients with chronic hepatitis B, with completion anticipated in December 2024[91] Regulatory and Compliance - F351 received Breakthrough Therapy designation from the Center for Drug Evaluation in China, expediting its review process due to its potential for substantial improvement over existing therapies[25] - The FDA's review process for NDAs typically aims for completion within ten months, with priority review applications targeted for six months[140] - The FDA may require a REMS plan to mitigate serious risks associated with a drug, which can include various risk management tools[142] - The FDA conducts inspections of manufacturing facilities and clinical sites to ensure compliance with GMP and GCP before approving an NDA[141] - The FDA may issue a complete response letter outlining deficiencies in an NDA submission, requiring additional testing or information for reconsideration[144] - Drug manufacturers must register with the FDA and are subject to inspections to ensure compliance with current Good Manufacturing Practices (cGMP)[154][155] Company Strategy and Operations - The company has paused two Phase 3 trials for pirfenidone to prioritize other product candidates, indicating a strategic shift in development focus[17][22] - Gyre Pharmaceuticals plans to start commercializing avatrombopag in China in 2025 after receiving NMPA approval for its use in treating TP associated with CLD[101] - Gyre owns 26 granted patents globally and 20 pending patent applications in China, critical for protecting its core technology and intellectual property[104] - The company has developed a pipeline of pharmaceutical product candidates, including F351, F528, F230, and F573, through in-house R&D and collaboration with GNI Japan[193] - The company has implemented various internal occupational health and safety procedures to maintain a safe work environment, with no material claims or labor disputes reported in 2024[198] - The company actively identifies and monitors environmental, social, and climate-related risks, incorporating these considerations into its business and financial planning[200] Financial Performance - ETUARY (pirfenidone) achieved annual sales of $105.0 million in 2024, down from $112.1 million in 2023, indicating a decline in market share due to competition from new drugs[26][37] - Gyre Pharmaceuticals has achieved sustained profitability, primarily due to increased market demand for ETUARY, with limited competition in the IPF drug market[192] Clinical Insights - The average five-year survival rate for IPF patients is 32%, with a ten-year survival rate dropping to 16%, highlighting the critical need for effective treatments[34] - MASH affects approximately 25% of the global population, with 20% to 30% of MASLD patients developing MASH, indicating a significant market opportunity[60] - F351 was well tolerated in clinical trials, with no serious adverse events reported and treatment-emergent adverse events including headache (25.0%), constipation (16.7%), and somnolence (12.5%) observed[69] Intellectual Property and Acquisitions - Catalyst Biosciences, Inc. acquired assets and intellectual property rights related to the proprietary F351 compound for $35 million, consisting of 6,266,521 shares of common stock and 12,340 shares of Series X Convertible Preferred Stock[121] - Following the business combination, GNI USA owned approximately 85.3% of Gyre's outstanding shares, while minority shareholders held about 12.3% and pre-combination Catalyst stockholders retained approximately 2.5%[123]
Gyre Therapeutics(GYRE) - 2024 Q4 - Annual Report