Core Viewpoint - Xinda Biologics (信达生物) demonstrates strong revenue growth and significant improvement in profitability, with a global pipeline entering registration research stages. The company is expected to achieve revenues of 11.788 billion, 15.256 billion, and 20.516 billion yuan from 2025 to 2027, with year-on-year growth rates of 25.11%, 29.43%, and 34.47% respectively. Net profit attributable to shareholders is projected to be 604 million, 1.396 billion, and 3.007 billion yuan, with growth rates of turning profitable, 131.07%, and 115.45% respectively. Earnings per share (EPS) are expected to be 0.35, 0.81, and 1.76 yuan per share for the same period. The company is recognized as a leading innovative drug developer with global R&D and commercialization capabilities, maintaining a "buy" rating [1]. Financial Performance - In the first half of 2025, Xinda Biologics achieved total revenue of 5.953 billion yuan, a year-on-year increase of 50.6%, with profits reaching 834 million yuan, marking a significant turnaround. Non-IFRS profit was 1.213 billion yuan, and Non-IFRS EBITDA was 1.413 billion yuan, indicating a notable enhancement in profitability. The product portfolio has expanded to 16 marketed products, with a synergistic focus on oncology and comprehensive pipelines, and successful commercialization of multiple new drugs [2]. Operational Efficiency - Product revenue in the first half of 2025 reached 5.234 billion yuan, a year-on-year increase of 37.3%. Revenue from licensing fees surged to 666 million yuan due to upfront payments from collaboration with Roche, reflecting a year-on-year increase of 474%. Gross margin stood at 86.0%, up by 3.1 percentage points, while R&D expenses were optimized to 1.009 billion yuan, down by 28%. The sales expense ratio decreased to 39.9%. As of June 30, 2025, cash reserves were approximately 11 billion yuan, providing solid support for global innovation [3]. Pipeline Development - The core pipeline IBI363 (PD-1/IL-2α-bias) has initiated global Phase III clinical trials, with breakthrough data presented at the ASCO annual meeting showing excellent efficacy in cold tumors and IO-resistant populations. A key Phase II study for melanoma has commenced, and the FDA has approved the global Phase III clinical trial for squamous NSCLC (MarsLight-11), with plans to enroll patients from multiple countries [4]. Global Expansion - Significant progress has been made in multiple pipelines, with the CLDN18.2 ADC (IBI343) starting Phase III studies for pancreatic cancer, and HER2 ADC (IBI354) advancing to Phase III clinical trials for ovarian cancer. The foundational product in the metabolic field, Masitide, has two new Phase III studies added, and IBI112 (IL-23p19) for psoriasis is under NDA review, expected to receive approval by the end of 2025. The company has established a global collaboration with Roche for IBI3009 (DLL3 ADC), advancing MRCT clinical studies in Australia, China, and the United States [5].
国联民生:维持信达生物“买入”评级 盈利水平显著改善