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益方生物首次覆盖报告:立足未满足需求,专注高门槛靶向药开发

Investment Rating - The report gives a "Buy" rating for the company with a target price of 8.75 RMB [1][3] Core Views - The company focuses on high-barrier targeted drug development in oncology and autoimmune diseases, with a strong R&D team and multiple drugs in clinical trials or already approved [1] - In oncology, the company targets high-difficulty targets and large indications, with one drug already approved and others in late-stage trials [1] - In autoimmune and metabolic diseases, the company has two drugs in development targeting high-prevalence diseases with significant unmet clinical needs [1] Oncology Pipeline - The company's drug Bifatinib, a third-generation EGFR TKI, has been approved for NSCLC and shows superior survival and intracranial efficacy data compared to competitors [1][21] - Gersuresib, a KRAS G12C inhibitor, is expected to be the first approved in China for NSCLC and is also in trials for CRC and pancreatic cancer [1][13] - D-0502, an oral SERD, is the fastest progressing oral SERD in China, currently in Phase III trials [1][14] Autoimmune and Metabolic Pipeline - D-0120, a URAT1 inhibitor, targets hyperuricemia and gout, with a large market and high unmet need [1] - D-2570, a TYK2 inhibitor, targets psoriasis, another large market with significant unmet clinical needs [1] Financial Projections - The company is expected to report net losses of -310 million, -226 million, and -337 million RMB for 2024-2026 [1][2] - Revenue is projected to grow from 149 million RMB in 2024 to 395 million RMB in 2026, with a CAGR of 32.1% [2] Market and Industry Insights - The NSCLC market is large, with EGFR mutations present in about 40% of Chinese NSCLC patients, creating a significant opportunity for EGFR TKIs [15][17] - KRAS G12C mutations are prevalent in multiple cancers, including NSCLC, CRC, and pancreatic cancer, with no approved drugs in China, indicating a significant market opportunity [13][32] - The oral SERD market is growing, with D-0502 leading the development in China, targeting the large ER+ breast cancer market [19][21]