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Nuvectis cites China approval of ciprocopan for PNH, with FDA update due by year-end

🇺🇸 Nuvectis Pharma, Inc. (NVCT) · Wed 04 Nov 2026

The US company says its oral Factor B inhibitor won Chinese approval in July and that FDA discussions on a US route for PNH are continuing.

Nuvectis Pharma reported third-quarter 2026 results on 4 November, highlighting the approval in China of ciprocopan (NXP100), an oral Factor B inhibitor, for paroxysmal nocturnal haemoglobinuria (PNH). The approval came in July and covers patients who have not previously been treated with complement inhibitors.

On the US side, the company says discussions with the FDA about a regulatory path for PNH are ongoing. It expects to provide an update by the end of the year, alongside US investigational new drug applications (INDs) for NXP100 and NXP200.

Nuvectis also reported that NXP200 has received Breakthrough Therapy Designation from China's Center for Drug Evaluation (CDE) for BRAF V600-mutant high-grade glioma. The company did not provide further detail in the information available.

On finances, Nuvectis said cash of about $140 million is sufficient to fund operations into the second half of 2029.

What it means for your team

  • The Chinese approval is the first regulatory milestone cited for ciprocopan; its restriction to complement-inhibitor-naive PNH patients defines the current label population.
  • US plans remain unconfirmed: the FDA path for PNH is still under discussion, with an update and two INDs promised by year-end.
  • Teams tracking complement therapies should watch for the FDA update, which will indicate what US development requirements apply to an oral Factor B inhibitor.
  • The CDE Breakthrough Therapy Designation for NXP200 in BRAF V600-mutant high-grade glioma signals expedited-review interest in China for that indication.

Company's press release (SEC filing): Nuvectis Pharma, Inc. ↗

Article written by VigiEye from the official source (Nuvectis Pharma, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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