Investment Rating - The report assigns a "Buy" rating for the company, Lepu Biopharma (2157.HK), marking its first coverage [1]. Core Insights - The company is entering a harvest period for new drug approvals, having established a comprehensive pipeline in oncology that includes immunotherapy, ADC (Antibody-Drug Conjugate) targeted therapy, and oncolytic virus drugs. The company has multiple ADC drugs and other therapies in clinical stages, with expectations for new drug approvals in the next 3-5 years [3][10]. - The ADC pipeline is characterized by unique features and competitive advantages in various indications, with MRG003 (EGFR ADC) already approved for NPC (nasopharyngeal carcinoma) in China and showing promising results in other indications [4][30]. - The introduction of oncolytic virus therapy CG0070 has shown potential in the bladder cancer market, with successful regulatory progress in the U.S. and ongoing clinical trials in China [5][30]. - Financially, the company has achieved its first profit and positive operating cash flow in the first half of 2025, with steady revenue growth driven by business development and sales [25]. Summary by Sections R&D Coverage and Pipeline - The company focuses on oncology treatment, with a pipeline that includes immunotherapy, ADCs, and oncolytic virus therapies. It has developed a robust ADC technology platform and has multiple products in various stages of clinical development [11][10]. - The pipeline includes 6 ADC drugs and 1 oncolytic virus therapy, with several candidates in pivotal clinical stages, indicating a well-structured development strategy [14][10]. Unique Features of ADCs - MRG003 has been approved for NPC and is in advanced trials for HNSCC (head and neck squamous cell carcinoma) and NSCLC (non-small cell lung cancer), showcasing its broad applicability and competitive edge [30][4]. - Other ADCs in development, such as MRG004A for pancreatic cancer and MRG006A for liver cancer, are also progressing well, with MRG004A entering pivotal trials [30][6]. Financial Performance and Projections - The company reported revenues of 4.66 billion yuan in the first half of 2025, a significant increase from 1.33 billion yuan in the same period of 2024. The net profit for the same period was 290 million yuan, marking a turnaround from a loss of 197 million yuan in the previous year [25][30]. - Revenue projections for 2025, 2026, and 2027 are estimated at 8.8 billion yuan, 10.2 billion yuan, and 14.9 billion yuan, respectively, with expected growth rates of 138%, 16%, and 47% [30].
乐普生物-B（02157）：深度报告：研发布局稳扎稳打，ADC平台进入收获期