China Healthcare | Asia Pacific 11th Round of National Drug VBP Around the Corner Key Takeaways Drug selection criteria aims to balance pricing against clinical practice considerations: Among the 75 drugs proposed, 14 drugs will be further evaluated ( Exhibit 1 ), including: 1) five whose generic products have narrower indications approved than the originators' drugs. The reported volume for these drugs may be limited to the scope of commonly-approved indications; 2) nine generics are considered to have rel ...

Core Viewpoint - Gyre Therapeutics reported a net income of $3.7 million for Q1 2025 and reaffirmed its full-year revenue guidance of $118 to $128 million, indicating a strategic focus on expanding its market presence and product portfolio in the organ fibrosis treatment space [1][12]. Financial Performance - Revenues for Q1 2025 were $22.1 million, down from $27.2 million in Q1 2024, primarily due to a $5.2 million decline in ETUARY sales, which was anticipated following a one-time marketing campaign in early 2024 [12][18]. - The company reported a decrease in income from operations to $2.3 million from $8.1 million year-over-year, attributed to lower revenues [18]. - Non-GAAP adjusted net income for Q1 2025 was $2.9 million, down from $8.2 million in the same period last year, reflecting the decline in revenue and a slight increase in operating expenses [18][28]. Business Highlights - The launch of avatrombopag in March 2025 is expected to enhance Gyre's presence in hepatology and hematology, targeting thrombocytopenia in adults with chronic liver disease [5][6]. - ETUARY (pirfenidone) generated $21.7 million in sales during Q1 2025, maintaining its position as the market leader for idiopathic pulmonary fibrosis (IPF) in China, despite a year-over-year sales decline [3][12]. - Nintedanib is on track for commercial launch in May 2025, aimed at treating multiple forms of fibrosing interstitial lung disease, which is anticipated to support revenue growth in the second half of 2025 [4][12]. Pipeline Development - Gyre received NMPA approval to initiate a clinical trial of pirfenidone for radiation-induced lung injury (RILI), marking its entry into oncology supportive care, with plans for an adaptive Phase 2/3 trial in the second half of 2025 [6][7]. - The company is also advancing F573, a caspase inhibitor for acute liver failure, with a Phase 2 clinical trial completion expected by the end of 2026 [8][12]. - F230, a selective endothelin receptor agonist for pulmonary arterial hypertension, is set to begin a Phase 1 trial in Q2 2025 [9]. Corporate Updates - In March 2025, Gyre appointed Ping Zhang as Executive Chairman of the Board of Directors, indicating a strategic leadership change [11]. Cash Position - As of March 31, 2025, Gyre held $51.3 million in cash, cash equivalents, and deposits, which the company believes will be sufficient to fund its operating and capital requirements for the next 12 months [12][18].