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How 2 FDA citations complicate Hengrui, Elevar's push for liver cancer combo approval
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Fusion42 · 28 July 2026 · Fusion42 review
Hengrui Pharmaceuticals and Elevar Therapeutics face a second FDA Form 483 citation at a finished drug manufacturing facility in Lianyungang, complicating their fourth attempt to win approval for camrelizumab and rivoceranib, a liver cancer combination already rejected three times. The second citation arrived late in the review cycle and was not mentioned in the July CRL, but must be resolved before approval is possible.
This Wire brief sits within Fusion42's coverage of Biotech.
◆ ◆ The Wire takeaway
Your manufacturing partner just hit a second FDA citation you didn't know about until the rejection letter landed. You now have one shot to fix both plants before resubmission, and the FDA won't wait for real-time remediation—you submit when you're clean, not when you're close.
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1 source · 28 Jul 2026
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