1194506‑26‑7, Fruquintinib: The Latest News | ANQING CHICO PHARMACEUTICAL CO., LTD.

Abstract

Fruquintinib (CAS 1194506‑26‑7) is an orally active, highly selective VEGFR‑1/2/3 inhibitor developed by Hutchison China MediTech (Chi‑Med) with Lilly/Takeda collaboration. Initially approved in China in September 2018 for metastatic colorectal cancer (mCRC), it has since gained FDA approval in November 2023 and EU/other regions in mid‑2024. Sales have shown robust growth, rising from approximately $33.7 million in 2020 to an estimated $300 million in 2024. The drug faces competition from regorafenib and evolving generics. Ongoing combination trials and expanding indications position it for future growth.

Keywords: Fruquintinib; VEGFR inhibitor; metastatic colorectal cancer; global launch; sales; approval timeline; competition; generics.

1. Introduction

Colorectal cancer ranks among the leading causes of cancer mortality globally. VEGF pathway inhibition has revolutionized treatment in advanced disease. Fruquintinib, developed by Chi‑Med and partners, inhibits VEGFR‑1, ‑2, and ‑3, reducing tumor angiogenesis while minimizing off-target effects, with a favorable safety profile.

2. Chemical & Physicochemical Properties

• CAS: 1194506‑26‑7

• Molecular Formula: C₂₁H₁₉N₃O₅; MW: 393.39

• Appearance: White solid

• Density: ~1.302 g/cm³ (predicted)

• Boiling Point: ~600.5 °C (predicted)

• Solubility: Soluble in DMSO (~5 mg/mL), DMF (~2 mg/mL); aqueous: 0.9 μg/mL (pH 6.8) to 129.9 μg/mL (pH 1)

3. Research & Development

Chi‑Med discovered and led development. Key trials include:

• FRESCO (China, Phase III): Led to first approval (China, Sep 4 2018) .

• FRESCO‑2 (global MRCT): Confirmed OS/PFS benefit vs placebo, supporting global submissions.

Chi‑Med partnered with Lilly (China) and Takeda (ex‑China) under major licensing deals in 2020–2023.

4. Regulatory Approval Timeline

• China (NMPA): Approved Sept 4 2018.

• Macau: Jan 2022.

• FDA (USA): Approved Nov 8 2023.

• EU: June 2024; Switzerland Aug 2024; Canada/Japan/UK Sep 2024; Argentina/Australia/Singapore Oct 2024.

5. Market Performance & Speculative Sales Estimates

*2024 H1 sales: $130.5 M (ex‑China) (hutch-med.com) and $61.0 M in China. Assuming H2 matches, full-year projected ~$240 M ex‑China.

Total global sales (2023) reached ~$122.6 M, with 2024 on track for around $360 M.

6. Competition & Generics

• Regorafenib: A third-line VEGFR TKI with peak sales around $556 M in 2021. Fruquintinib is positioned as a more selective, potentially better‑tolerated alternative.

• Biosimilars/Generics: Some Chinese copies under development; long‑term impact unclear.

7. Ongoing Research & Combination Use

Chi‑Med and Innovent filed an NDA in China for fruquintinib + sintilimab in renal cell carcinoma (RCC) (FRUSICA‑2) . Other trials include combinations with paclitaxel, PD‑1 inhibitors, in gastric, HCC, lung cancer, etc. .

8. Outlook & Forecast

Analysts estimate peak global sales around $3.3 billion (24% China share) . Continued geographic expansion, indication extension, and market uptake underpin the positive trajectory.

References

1. Approval timeline and Phase III trials

2. Chemical & solubility data

3. China sales 2020–2022

4. US FDA approval and launch

5. Sales in 2023 & H1 2024

6. Competition context

7. Peak sales forecast

8. Combination NDA update

Active Pharmaceutical Ingredient

1194506-26-7,Fruquintinib,(chemical grade, purity ≥99.0%) are currently supplied by our company. [Own compliance factory, fully support factory audit] For details, you can call the bottom line to get the latest price of the product!

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