HUTCHMED partner Takeda gets U.S. FDA approval for new colorectal cancer drug

Asian Tech Press (Nov 10) -- HUTCHMED China Ltd (HCM:NASDAQ, 0013.HK), a Chinese pharmaceutical company, announced on Thursday that its partner Takeda has obtained approval from the U.S. Food and Drug Administration (FDA) for the new colorectal cancer drug FRUZAQLA™ (fruquintinib).

FRUZAQLA is an oral targeted therapy for adults with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.

Japan-based Takeda said in a statement that "FRUZAQLA is the first and only selective inhibitor of all three VEGF receptor kinases approved in the U.S. for previously treated mCRC regardless of biomarker status."

In January, HUTCHMED signed an agreement with Takeda granting the latter an exclusive global license to advance the development, commercialization and manufacture of fruquintinib for all indications worldwide (ex-China).

Under the agreement, HUTCHMED received an initial payment of $400 million from Takeda in March this year, with subsequent payments to follow milestones, which will total more than $1.1 billion in subject matter.

This FDA approval of FRUZAQLA will trigger $35 million in milestone payments, as well as royalties based on net sales, HUTCHMED said.

Approved in China in September 2018, fruquintinib was developed and marketed across China under the trade name Elunate® by HUTCHMED in collaboration with Eli Lilly and Company.

Upon launch in the U.S., HUTCHMED plans to bring the drug to European and Japanese markets in 2024.

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