Acceptance of surufatinib China NDA in epNET
Lighthouse | 12 November 2019
Trinity Delta view: Confirmation of the acceptance of the surufatinib China NDA is an important strategic step for Chi-Med. Subject to regulatory approval, Chi-Med could launch its first wholly owned oncology drug in late-2020, commercialising it through its own China Oncology commercial organisation.
Prior to an approval decision, we expect further clinical news flow related to surufatinib in NET during H120, with the interim analysis of the China SANET-p Phase III in pNET and initiation of the US/Europe registration study.
We also anticipate various other clinical, regulatory, and commercial catalysts during 2019 and 2020 that will unlock further value. The first is expected to be an imminent NRDL inclusion decision for fruquintinib (Elunate) in 3L CRC. Elunate was approved and launched in China by partner Eli Lilly in H218; NRDL inclusion should significantly boost its market penetration and future revenues.
H120 should also see the first savolitinib regulatory submission, with filing of the China NDA for MET exon 14m/del 1L NSCLC.
We currently value Chi-Med at $5.14bn ($38.55/ADS) or £3.95bn (£5.93/share).
12 November 2019
|Price (US ADS) (UK share)||$22.40|
Hutchison China MediTech is a Hong Kong headquartered biopharma with an established Commercial Platform in China, and a diverse pipeline of first-in-class/best-in-class selective oral tyrosine kinase inhibitors (Innovation Platform). Its pipeline, discovered in-house, is in development for the China and global oncology markets.
+44 (0) 20 3637 5041
Mick Cooper PhD
+44 (0) 20 3637 5042
+44 (0) 20 3637 5043
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