迪哲医药：深度报告：深耕恶性肿瘤，源头创新构建全球竞争力

Investment Rating - The investment rating for the company is "Buy" [8] Core Views - The company focuses on innovative treatments for malignant tumors, aiming to build global competitiveness through source innovation [9] - The company has two commercialized products, with significant advantages in efficacy and safety compared to domestic competitors, which are expected to drive rapid revenue growth [10] - The company has a strong pipeline of innovative drugs, with several products in clinical stages, indicating a robust growth potential [10] Company Overview - The company, DIZHE Pharmaceutical, was established in October 2017 and went public on the Shanghai Stock Exchange's Sci-Tech Innovation Board in December 2021. It specializes in researching, developing, and commercializing new therapies for malignant tumors [5][10] - The company has launched two innovative products: Shuwotai (Shuwotai) approved by NMPA in August 2023 and Gaoruizhe (Goliqixin) expected to be approved in June 2024 [5][21] Financial Performance - In the first three quarters of 2024, the company achieved revenue of 338 million CNY, a year-on-year increase of 743.97%, with Q3 alone generating 135 million CNY, up 236.39% year-on-year [17] - The net profit attributable to the parent company for the first three quarters of 2024 was -558 million CNY, a year-on-year increase of 32.63% [40] Product Pipeline - The company has a diverse pipeline with several products in clinical trials, all enjoying complete global rights and adopting a global synchronous development model [26][51] - Shuwotai is the only drug approved for targeting EGFR Exon20ins mutations in NSCLC, showing a 61% objective response rate (ORR) in clinical trials [46][54] - Gaoruizhe is the first and only drug targeting the JAK-STAT pathway for treating PTCL, with a 44.3% ORR in clinical trials [22][21] Research and Development - The company maintains high R&D expenditure, which has been the largest component of its operating costs, indicating a commitment to innovation [42] - The company has established a comprehensive R&D platform that covers all stages of drug development, enhancing its ability to successfully launch first-in-class drugs [24][51]