Dizal Pharmaceutical(SH:688192) Guohai Securities·2024-06-20 11:00Investment Rating - The report initiates coverage with a "Buy" rating for the company [5]. Core Insights - The company, established in 2017, is a globally competitive innovative biopharmaceutical firm focusing on the research, development, and commercialization of therapies for malignant tumors and immune diseases [8][18]. - The company has a robust pipeline of innovative small molecule products, with all products enjoying complete global rights and developed in a synchronized global manner [18]. - The company is expected to achieve revenue of 458 million, 1.049 billion, and 1.646 billion yuan for the years 2024, 2025, and 2026 respectively, with a projected net profit of -74.9 million, -42.7 million, and 1.7 million yuan [5]. Company Overview - The company has successfully commercialized its product, Shuwotini, which has been approved for use in China [11]. - The company’s chief scientist, Dr. Zeng Qingbei, has over 20 years of experience in new drug design and development, previously holding significant positions at AstraZeneca and other major pharmaceutical companies [10][23]. - The management team is experienced, with key members having extensive backgrounds in drug development and management from leading pharmaceutical companies [23]. Financial Performance - In 2023, the company reported a net loss attributable to shareholders of 1.108 billion yuan, a significant increase compared to the previous three years, primarily due to high R&D expenditures [25]. - The R&D expenses for 2023 were 805 million yuan, reflecting a year-on-year increase of approximately 21% as the company accelerates its R&D progress [26]. Product Pipeline - The company has six small molecule products in various stages of global clinical development, with two leading products, Shuwotini and Golixitini, in critical clinical trial phases [14][18]. - Shuwotini has been approved in China for the treatment of EGFR Ex20ins mutation-positive advanced non-small cell lung cancer (NSCLC) [16][29]. - The company’s pipeline includes multiple indications for its products, with a focus on significant diseases such as malignant tumors and hematological malignancies [18]. Market Potential - The report highlights a significant unmet medical need for effective treatments for patients with EGFR Ex20ins mutations, which account for approximately 9-10% of NSCLC cases [17][29]. - The company’s products are positioned to capture market share in a growing patient population, with projections indicating increasing numbers of new NSCLC cases in the coming years [42].