Investment Rating - The report assigns a "Buy" rating to Zai Lab's H shares/ADS, with a 12-month DCF-based target price of HK$41.24/US$52.91, indicating an upside potential of 43.2% for the US shares and 39.8% for the HK shares [6][7]. Core Insights - Zai Lab management reiterated FY25 guidance, expecting total sales between US$560 million and US$590 million, with cash profitability anticipated in Q4 [5][6]. - The company has received FDA approval for the pivotal trial design for ZL-1310, which includes a sample size of 300-400 patients and an option for accelerated approval [6][7]. - Strong phase 3 data for bemarituzumab is expected within the next three months, with three key readouts anticipated [5][6]. Summary by Sections FY25 Guidance and Financial Outlook - Management observed a recovery in efgar sales in Q2 after a soft Q1, with confidence in achieving FY25 sales guidance [5]. - Gross Profit Margin (GPM) is expected to improve, with a target to reduce GPM by two-thirds by 2027 compared to 2024 [5]. Drug Development Updates - Positive feedback was received for SUL-DUR, with larger sales expected in 2026 [5]. - KarXT is on track for approval by the end of 2025 or early 2026, with recruitment for key commercial positions ongoing [5]. FDA and Business Development - The FDA has approved the pivotal trial design for ZL-1310, allowing for conditional approval based on interim data [6]. - Management indicated no immediate financing plans, stating sufficient resources to support the pivotal trial [6].
高盛：再鼎医药_2025 年中国医疗企业日 —— 关键要点