Dizal Pharmaceutical(SH:688192) 智通财经网·2026-01-24 11:51Company Overview - DIZHE Pharmaceutical is a commercial-stage biopharmaceutical company focused on oncology and hematology diseases, with its core product, Shuwozhe®, being the only approved small molecule EGFR TKI for treating EGFR 20 insertion mutation lung cancer globally [2] - Founded in 2017, DIZHE originated from AstraZeneca's Global Oncology Translational Science Center, possessing significant competitive advantages in drug discovery and development [2] - The company has a robust product pipeline, including two approved drugs (Shuwozhe® and Gaoruizhe®), one candidate in the registration clinical stage, three assets in the concept validation stage, and one in early clinical stage [2] Product Information - Shuwozhe® is the first lung cancer drug developed in China to receive both FDA and NMPA breakthrough therapy designations, and it is the only drug recommended by the NCCN guidelines for treating EGFR 20 insertion mutation NSCLC [3] - 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 [3] Financial Performance - Revenue for the fiscal years 2023, 2024, and the nine months ending September 30, 2025, were approximately RMB 91.29 million, RMB 359.90 million, and RMB 586.30 million respectively [4] - Research and development expenses for the same periods were approximately RMB 806 million, RMB 724 million, and RMB 644 million respectively [5] - Gross profit margins for 2023, 2024, and the nine months ending September 30, 2025, were approximately 96.5%, 97.4%, and 95.7% respectively [8] Industry Overview - The global oncology drug market is projected to grow from USD 167 billion in 2020 to USD 262 billion by 2024, with a CAGR of 11.9%, and is expected to reach USD 724.9 billion by 2035 [9] - In China, the oncology drug market is expected to grow from USD 25.8 billion in 2020 to USD 37.2 billion by 2024, with a CAGR of 13.1%, reaching USD 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 [11] - The global NSCLC drug market is anticipated to grow from USD 22.5 billion in 2020 to USD 49.2 billion by 2024, with a CAGR of 21.6%, and is projected to reach USD 97.5 billion by 2035 [11] - The market for EGFR 20 insertion mutation NSCLC is expected to grow from USD 700 million in 2020 to USD 1 billion by 2024, with a CAGR of 9.0%, and is projected to reach USD 8 billion by 2035 [13]