The Zhitong Finance App learned that CICC released a research report saying that Hewang Pharmaceutical (00013) announced that SAFFRON Global Phase III study results were released on October 26 at the European Society of Medical Oncology (ESMO) Chairman's Forum. Recently, the company announced that AstraZeneca has submitted a marketing application to the US FDA for this indication. The bank maintained its 2026 and 2027 net profit forecasts of US$78 million and US$66 million respectively, maintaining a “outperforming industry” rating and a target price of HK$28, with 24.1% upside compared to the current stock price.
CICC's main views are as follows:
Studies have shown that compared with platinum-containing dual-drug chemotherapy, sevotinib (orpathys, TAGRISSO), achieved statistically significant and clinically significant improvements in progression-free survival (PFS) and overall survival (OS) in patients with second-line EGFR mutations (EGFRM) and MET overexpressed or amplified (NSCLC).
SAFFRON becomes the first global Phase III study to benefit both PFS and OS in a similar disease
The SAFFRON trial results announced by ESMO showed that in patients with second-line EGFRM, MET overexpressed or amplified NSCLC that progressed after treatment with ositinib, the main endpoints were 7.6 months of median PFS assessed by the Blind Independent Center Review (BICR) compared to chemotherapy, 5.4 months for the control group, and 0.55 for the risk ratio (HR); the median OS for the key secondary endpoints was 17.8 months, the control group was 12.9 months, and the HR was 0.68.
The median treatment time for the sevotinib plus osimitinib regimen was 8.5 months, compared to 3.5 months for the control group. The incidence of grade 3 and above adverse events in the two groups was 64% and 63%, respectively, which was basically the same, showing the good safety and tolerability of combination therapy.
AstraZeneca has submitted an application for the US listing of sevolitinib, and the company is expected to usher in the next commercial growth point
On September 29, the company announced that based on SAFFRON research results, AstraZeneca has submitted a listing application for sevolitinib combined with osimitinib for second-line EGFRM NSCLC in the US. According to the company announcement, about one-third of EGFRM NSCLC patients will develop MET-driven drug resistance after receiving first-line treatment with the third-generation EGFR tyrosine kinase inhibitor (TKI) osimitinib, and there is a large unmet clinical need.
The bank believes that combination therapy is expected to provide a new biomarker-based chemotherapy option for MET-driven EGFR-resistant NSCLC patients. The bank anticipates that savotinib is expected to be approved for listing in the US in 2027, becoming another growth point for the company contributing to global commercialization value after fruquintinib.
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R&D failed, costs exceeded expectations, commercialization fell short of expectations, and external cooperation fell short of expectations.