First steps towards fruquintinib availability in the US

Lighthouse | 19 December 2022

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  • Start of the rolling new drug application (NDA) for fruquintinib for the treatment of ≥3L refractory metastatic colorectal cancer (mCRC) has been initiated in the US. A rolling submission is possible as fruquintinib was granted Fast Track designation by the FDA in June 2020. This enables HUTCHMED to submit sections of the NDA as they are completed, with the review clock usually starting once the entire application has been filed. HUTCHMED expects to complete the NDA filing during H123. Regulatory submissions to the European EMA and the PMDA in Japan will follow completion of the US filing.
  • Depending on the US review time, this could allow for an FDA decision during H223e if a six-month Priority Review is granted, through to H124e under a 10-month Standard Review. Our forecasts conservatively assume first US fruquintinib sales in 2024e allowing for a Standard Review.
  • The regulatory filing will be supported by data from the pivotal FRESCO-2 study, where fruquintinib demonstrated a 2.6 month overall survival benefit and reduced the risk of death by 34% (Hazard Ratio of 0.66, p<0.001) vs placebo in this heavily pre-treated and refractory population (outlined in our September 2022 Update). The FRESCO-2 trial size and scope (691 patients, >150 sites, 14 countries) was designed to meet FDA requirements for a multi-regional clinical trial. The dossier will also include similarly positive data from the China FRESCO trial, plus the US Phase Ib bridging study.
  • Fruquintinib (Elunate) has been marketed in China for 3L mCRC since 2018 and is one of three commercial products in China that are collectively expected to deliver China revenue of $160-190m in FY22. The China partner is Eli Lilly, but global rights are currently unencumbered. Under the recent strategy review, outlined in our November 2022 Lighthouse, the ex-China commercial opportunity is now primarily focused on partnerships. Given mCRC alone represents a blockbuster opportunity, we believe fruquintinib is a natural candidate for ex-China commercial partnership(s).

Trinity Delta view: Initiation of the rolling regulatory filing for fruquintinib has started as expected, potentially allowing for approval in the US for mCRC in H124e, which could come sooner if Priority Review is granted. A positive decision for fruquintinib would represent the first HUTCHMED asset to receive an ex-China approval. Under the new financially disciplined strategy, which is focused on accelerating the path to profitability, ex-China commercialisation will be primarily achieved through partnerships. The positive FRESCO-2 data and physician commentary suggest potential broad uptake of fruquintinib in advanced mCRC given the survival benefits, lack of off-target toxicity and manageable adverse events. Hence, given the potential in mCRC alone, fruquintinib represents a natural candidate for partnering, in our view. Our HUTCHMED valuation is currently $5.51bn ($31.89 per ADS), £4.6bn and HK$43.1bn (531p or HK$49.83 per share); we intend to revisit our forecasts once further details on the broader strategy, and on specific assets like fruquintinib, become available.


19 December 2022

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Company CodesHCM
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Company description

HUTCHMED is a Hong Kong headquartered biopharma focused on discovering, developing and commercializing innovative targeted therapeutics and immunotherapies to treat cancer and autoimmune diseases. It has a diverse pipeline of first-in-class/best-in-class selective oral TKIs in development for the China and global markets.


Lala Gregorek
+44 (0) 20 3637 5043

Philippa Gardner
+44 (0) 20 3637 5042


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