呋喹替尼海外持续放量，国内有望获批新的适应症。呋喹替尼是美国10 年来获批的第一款也是唯一一款针对3 线mCRC 的小分子靶向药，已经写入NCCN 指南。欧盟、瑞士、加拿大、英国、澳大利亚、阿根廷、新加坡和日本最近也陆续获批上市。今年前三季度，武田实现呋喹替尼海外净销售额2 亿美金，公司也会收到首个商业里程碑付款2 千万美金。国际化进度不断推进，其它国家的上市申请审批也在进行中。Key investment points
Incident: Sevotinib successfully renewed the national medical insurance drug catalogue in accordance with current terms.
The price of sevolitinib has not been reduced in health insurance negotiations this year, and the US is about to declare it for listing. Sevotinib's overseas phase II clinical registration target for second-line EGFRM+ MET-driven NSCLC has reached the pre-set target, showing high and clinically significant ORR data, and has the best potential in its class. It is expected to be listed in the US before the end of 2024. The domestic EGFR TKI refractory NSCLC (SACHI study) for treating second-line MET-amplification is expected to complete patient enrollment in 2024H2; domestic Phase II clinical enrollment for third-line gastric cancer with MET amplification is being registered.
Fruquintinib continues to be released overseas, and it is expected that new indications will be approved domestically. Fruquintinib is the first and only small-molecule targeted drug against 3-line mCRC approved in the US in 10 years, and has been included in the NCCN guidelines. The European Union, Switzerland, Canada, the United Kingdom, Australia, Argentina, Singapore, and Japan have also recently been approved for listing. In the first three quarters of this year, Takeda achieved net overseas sales of 0.2 billion US dollars for fruquintinib, and the company also received its first commercial milestone payment of 20 million US dollars. The progress of internationalization continues to advance, and approval of listing applications from other countries is also ongoing.
Overseas clinical trials of solepinib, potentially the best-in-class Syk inhibitor, have started. The number of ITP patients in China is expected to exceed 0.3 million in 2027. 67% of patients will enter the second line of treatment. Innovative treatments are limited, and the competition pattern is good. The Chinese registered phase III clinical results of solepinib for line 2 ITP were impressive. 75% of patients in the baseline had frontline TPO drugs, and the sustained response rate was as high as 48%. This year's ASH conference updated long-term treatment data, and the results were impressive: the long-term sustained response rate was 59.8%, which is expected to be a new treatment option for ITP patients. The review of domestic listing applications is currently suspended. Recently, new data is being prepared. Management stated that this is a normal process of rolling submission, and the review will continue for about 3 months after the new data is submitted. US dose optimization phase I clinical trials are progressing normally.
Profit forecast and investment rating: Considering overseas sales volume of fruquintinib and the upcoming overseas production of sevolitinib. We maintain total revenue of $6.65, 8.08, and 969 million dollars in 2024-2026.
Profitability is expected in 2025. The company's catalysts continued to be realized, overseas markets opened up, growth certainty was high, and the “buy” rating was maintained.
Risk warning: Product registration approval progress falls short of expectations; competition intensifies; commercialization falls short of expectations.
