和黄医药：聚焦小分子领域，呋喹替尼实现海外商业化

Investment Rating and Valuation - The report initiates coverage with a BUY rating for Hutchmed, with a target price of HK$35.4, implying a 33$650M in 2024E, $810M in 2025E, and$950M in 2026E, with oncology/immunology business contributing $370M,$530M, and $650M respectively [4][10] - Net profit is expected to turn positive in 2025E, with forecasts of -$13M in 2024E, $39M in 2025E, and$120M in 2026E [4][10] Core Products and Commercialization - Fruquintinib (Fruzaqla): Approved by the FDA in November 2023 for metastatic colorectal cancer (mCRC), with overseas sales reaching $15M in 2023 and$131M in 1H24 [4][7] - Savolitinib: Expected to file an NDA with the FDA by the end of 2024 for EGFRm/MET+ NSCLC, potentially becoming the second overseas product [4][7] - Sovleplenib: NDA for second-line immune thrombocytopenia (ITP) accepted by NMPA in January 2024, with peak sales in China estimated at 110M [11] Pipeline and R&D Progress - Hutchmed has 13 oncology drugs in clinical stages, with **HMPL-306 (IDH1/2)** entering Phase III for AML in May 2024 [4][7] - **Tazemetostat**: NDA for third-line follicular lymphoma accepted by NMPA in July 2024, with rights licensed in Greater China [4][7] - **Fruquintinib**: Additional indications under development include gastric cancer, endometrial cancer, and renal cell carcinoma [25][26] Market and Competitive Landscape - Fruquintinib is the first and only highly selective VEGFR inhibitor approved in the US for mCRC, with peak overseas sales potential of 670M [11][24] - In China, Fruquintinib holds a 47% market share in third-line mCRC as of 2Q24, with monthly treatment costs of ¥7,541, lower than Regorafenib's ¥14,488 [35][36] - Regorafenib, a competitor, saw a 15% decline in global sales to €523M in 2023 due to generic competition and Fruquintinib's market entry [38][39] Strategic Partnerships - Hutchmed partnered with Takeda for Fruquintinib's global commercialization (excluding China), receiving $400M upfront and up to$730M in milestone payments [4][12] - AstraZeneca is responsible for Savolitinib's marketing in China and is expected to file an NDA with the FDA by end of 2024 [4][7] - Collaboration with Ipsen for Tazemetostat's development and commercialization in Greater China [17]