赛沃替尼有望向FDA 递交上市申请。赛沃替尼于2021 年获NMPA 附条件上市，用于治疗MET 外显子14 跳变的局部晚期或转移性NSCLC 患者，成为国内首个获批的选择性MET 抑制剂。目前，由合作方阿斯利康负责赛沃替尼中国市场的销售推广。基于赛沃替尼IIIb 期确证性研究，赛沃替尼用于一线和二线治疗MET 外显子14 跳变NSCLC 的新适应症上市申请于2024 年3 月获NMPA 受理，若成功获批有望拓展至初治患者。此外，SAVANNAH 全球 II 期研究已于2024 年2 月完成患者入组，用于治疗二/三线奥希替尼难治性EGFRm/MET+ NSCLC 患者。若进展顺利，预计合作方阿斯利康有望于2024 年底向FDA 递交上市申请。若成功获批，有望成为公司第二款海外上市的产品。公司正在开展赛沃替尼的七项注册研究，包括三项全球研究和四项中国研究，主要覆盖非小细胞肺癌、胃癌和肾癌。Hutchison Pharmaceuticals is a commercialized pharmaceutical company focused on the discovery, development and commercialization of innovative drugs for oncology and immune diseases.
At present, the company has approved three innovative small-molecule drugs for marketing in China, including fruquintinib (Elute), surufatinib (Suteda), and sevolitinib (voraxa). Among them, furoquintinib has successfully entered the international market and was approved for marketing by the FDA in November 2023. Furthermore, 13 oncology drugs in the company's pipeline are currently in the clinical phase.
Fruquintinib was approved for marketing in the US, and overseas commercialization accelerated. Fruquintinib is a small-molecule VEGFR1, 2, and 3 oral inhibitor developed by the company. It was approved for marketing by NMPA in September 2018 for the treatment of third-line mCRC patients. In overseas markets, Fruzaqla (Fruzaqla) was approved for marketing by the FDA in November 2023, becoming the first and only highly selective inhibitor of three VEGF receptor kinases approved in the US to treat metastatic colorectal cancer. Additionally, fruquintinib was approved for marketing in the European Union in June 2024. In January 2023, the company and Takeda reached a cooperation agreement for fruquintinib. Takeda will be responsible for advancing the development, commercialization and production of fruquintinib globally (excluding mainland China, Hong Kong, and Macau). Chi-Med received a down payment of $0.4 billion, potential milestone payments of up to $0.73 billion, and a share of sales. Overseas sales of furoquintinib were around 15 million US dollars in 2023, and 1H24 sales rapidly increased to 0.131 billion US dollars. We believe that with the overseas approval of fruquintinib, it is expected that sales volume will be further increased.
Sevotinib is expected to submit a marketing application to the FDA. Sevotinib was conditionally marketed by NMPA in 2021 to treat patients with locally advanced or metastatic NSCLC with MET exon 14 transitions, making it the first selective MET inhibitor approved in China. Currently, partner AstraZeneca is responsible for sales and promotion of sevolitinib in the Chinese market. Based on the phase IIIb confirmatory study of sevotinib, the marketing application for new indications of sevotinib for first-line and second-line treatment of MET exon 14 transient NSCLC was accepted by the NMPA in March 2024, and if successfully approved, it is expected to expand to first-time patients. Additionally, the SAVANNAH Global Phase II study completed patient enrollment in February 2024 to treat patients with refractory EGFRM/met+ NSCLC with second-line osimitinib. If things go well, partner AstraZeneca is expected to submit a listing application to the FDA by the end of 2024. If successfully approved, it is expected to become the company's second overseas product. The company is conducting seven registered studies of sevolitinib, including three global studies and four Chinese studies, mainly covering non-small cell lung cancer, stomach cancer, and kidney cancer.
Actively lay out other innovation pipelines. Solepinib is an oral spleen tyrosine kinase (Syk) inhibitor developed in-house by the company. In January of this year, solepinib was accepted by the NMPA for second-line treatment of immune thrombocytopenia (ITP). Furthermore, the company introduced the rights of tazepastat (EZH2 inhibitor) in Greater China in 2021. Currently, tazepastat's new drug marketing application (third-line follicular lymphoma) was accepted by the NMPA in July 2024. Additionally, the company initiated the RAPHEL phase III clinical trial of HMPL-306 (IDH1/2) in May 2024 to treat relapsed/refractory acute myeloid leukemia (AML) patients with IDH1 and/or IDH2 mutations. We believe that as other pipelines enter an advanced stage, it is expected that the company's product portfolio will be further enriched.
The first coverage gives a buy rating. We expect the company's revenue for 2024-2025 to be $0.65 billion, $0.81 billion, and $950 million, respectively, of which the oncology/immunology business revenue will be $0.37 billion, $0.53 billion, and $650 million, respectively, and other business revenue of $0.28 billion, $0.29 billion, and $30 billion, respectively. Furthermore, considering the commercialization volume of the company's core products, we expect the company to be profitable in 2025, and the net profit to mother for 2024-2025 is -0.013 billion US dollars, 0.039 billion US dollars, and 120 million US dollars, respectively. Based on the DCF model, we gave a target price of HK$35.4, corresponding to a 33% increase, and gave a buy rating for the first time.
Risk warning: Overseas commercialization of core products falls short of expectations; industry competition intensifies, commercial product pricing is lower than expected; core pipeline product development progress falls short of expectations.
