新股消息 | 迪哲医药递表港交所 两款获批药物为舒沃哲®和高瑞哲®

Company Overview - Dize Pharmaceutical Co., Ltd. is a commercial-stage biopharmaceutical company focused on oncology and hematology diseases, with its core product, Shuwozhe®, being the only approved small molecule EGFR tyrosine kinase inhibitor for treating EGFR 20 insertion mutation lung cancer globally [3] - The company was established in 2017, originating from AstraZeneca's global oncology translational science center, and possesses significant competitive advantages, including a strong research heritage and a mature scientific team with experience in drug discovery and development [3] - Dize has a robust product pipeline, including two approved drugs (Shuwozhe® and Gaoruizhe®), one candidate drug in the registration clinical stage, three assets in the concept validation stage, and one asset in the early clinical stage [3] Product Details - Shuwozhe® has been approved in China and the U.S., recognized as the first lung cancer drug developed in China to receive breakthrough therapy designation from both the FDA and the National Medical Products Administration of China [4] - Gaoruizhe® is the first and only approved JAK1 inhibitor for treating relapsed or refractory peripheral T-cell lymphoma, having received fast track and orphan drug designations from the FDA [4] Financial Performance - The company reported revenues of approximately 91.29 million RMB for the fiscal year 2023, projected to increase to 360 million RMB in 2024 and 586 million RMB in 2025 [5][7] - Research and development expenses were approximately 806 million RMB in 2023, decreasing to 724 million RMB in 2024 and 644 million RMB in 2025 [6][7] - The gross profit margin for the company was approximately 96.5% in 2023, 97.4% in 2024, and 95.7% in 2025 [8] Industry Overview - The global oncology drug market is expected to grow from $167 billion in 2020 to $262 billion by 2024, with a compound annual growth rate (CAGR) of 11.9%, and projected to reach $724.9 billion by 2035 [9] - In China, the oncology drug market is anticipated to expand from $25.8 billion in 2020 to $37.2 billion by 2024, with a CAGR of 13.1%, reaching $143.7 billion by 2035 [9] - Non-small cell lung cancer (NSCLC) accounts for approximately 85% of lung cancer cases, with the global incidence expected to rise from about 1.9 million cases in 2020 to 2.9 million by 2035 [12] - The global NSCLC drug market is projected to grow from $22.5 billion in 2020 to $49.2 billion by 2024, with a CAGR of 21.6%, and expected to reach $97.5 billion by 2035 [12]