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Anqing Chico Pharmaceutical Co., Ltd.
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Anqing Chico Pharmaceutical Co., Ltd.
1194506?26?7, Fruquintinib: The Latest News | ANQING CHICO PHARMACEUTICAL CO., LTD.

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


1194506-26-7,Fruquintinib.pngAbstract

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: C??H??N?O?; 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

Year China Sales (“Elunate”) Ex?China Sales (“Fruzaqla”) Estimated Global Sales
2019 $17.6?M (baseline) $17.6?M
2020 $33.7?M (hsppharma.com) $33.7?M
2021 $71.0?M (hutch-med.com) $71.0?M
2022 $93.5?M (hutch-med.com) $93.5?M
2023 $107.5?M (China) + $15.1?M (US) (hutch-med.com) $122.6?M |  
2024* Estimated $240?M (ex?China) + $122?M (China) | ~$362?M    

*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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  Disclaimer:Products are only available to countries where there is no valid patent protection. Products still covered by patents rights are available exclusively for experimental or registration purpose pursuant to national applicable law, and shall be sold in strict accordance with the laws of the People's Republic of China and the laws of the Buyer's country. All products are not for human use. Buyer is obligated for evaluation of the patent situation in its domestic market and shall be held liable for uses which do not fall within the scope of the experimental or registration use exception and are not permitted by national applicable law.

  References or other information:

  FDA,Wikipedia,Chatgpt,DeepSeek,chemicalbook,lookchem.

  If there is any infringement, please apologize and delete. If there are any errors, welcome to criticize and correct.

  Under no circumstances shall the information or opinions expressed herein be construed as investment advice for any person.

Anqing Chico Pharmaceutical Co., Ltd.
Anqing Chico Pharmaceutical Co., Ltd.
Anqing Chico Pharmaceutical Co., Ltd.
Anqing Chico Pharmaceutical Co., Ltd.

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Anqing Chico Pharmaceutical Co., Ltd.
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