Incident: On February 28, Hutchison Pharmaceutical announced its 2023 annual results, with total revenue of US$840 million (+97%) in 2023 and comprehensive revenue of US$530 million (+223%) from the oncology/immunology business. Fruquintinib market sales reached US$107 million (+22%), surufatinib market sales reached US$43.9 million (+43%), and sevotinib market sales reached US$46.1 million (+19%). The results are in line with expectations. The comprehensive revenue guidance for the oncology/immunology business is $300 million to $400 million for the full year of 2024, mainly due to a 30% to 50% increase in target revenue from already marketed oncology products.
Fruquintinib is expected to be approved for marketing by EMA and PMDA in 2024, and indications such as gastric cancer and endometrial cancer will continue to advance. Fruquintinib was approved by the FDA for marketing on November 9, 2023, and sales reached US$15.1 million for 7 weeks in 2023. Fruquintinib is expected to complete the review of the EMA marketing license application for the treatment of metastatic colorectal cancer in mid-2024, and the review of the PMDA new drug marketing application for the treatment of metastatic colorectal cancer by the end of 2024. In the regulatory review of the indications for second-line gastric cancer of fruquintinib, registration applications for second-line endometrial cancer treatment are expected to be submitted to the National Drug Administration in early 2024, and the top-line results of the renal clear cell carcinoma phase II/III registration study are expected to be announced by the end of 2024.
Sevotinib is expected to communicate the new drug marketing application with the FDA by the end of 2024. Sevotinib is expected to submit marketing applications for first-line and second-line treatment of ME14 jumping mutation non-small cell lung cancer in China in early 2024. Patient recruitment for the SACHI study is expected to be completed by the end of 2024. Is SACHI savotinib and Teresa? The combination therapy was used to treat MET-amplified non-small cell lung cancer patients with advanced disease after treatment with EGFR inhibitors in a critical phase III study in China. Patient recruitment has been completed for the critical global Phase II SAVANNAH study, and it is expected that the US FDA will be communicating with the US FDA about the submission of a possible new drug marketing application by the end of 2024.
Solepinib is expected to launch a dose-exploratory study for the treatment of immune thrombocytopenia in the US/Europe in the middle of the year. Solepinib is a Syk inhibitor developed to treat hematologic malignancies and autoimmune diseases. Solepinib is expected to submit the ESLIM-01 study results for publication and/or publication in mid-2024, and a dose exploration study for the treatment of immune thrombocytopenia in the US/Europe is expected to be initiated in mid-2024.
Profit forecasting and investment advice. With the gradual implementation of various innovative drugs and the expansion of the global market, we expect the company's revenue for 2024-2026 to be US$6.6, 800, and 960 million, respectively, maintaining a “buy” rating.
Risk warning: R&D falls short of expected risks, commercialization falls short of expected risks, market competition increases risks, and drug price reduction risks.