Find Fruquintinib manufacturers, exporters & distributors on PharmaCompass

PharmaCompass

Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

0

USDMF

US DMFs Filed

0

CEP/COS

CEP/COS Certifications

0

JDMF

JDMFs Filed

0

EU WC

EU WC

0

VMF

NDC API

0INTERMEDIATES

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

0

Others

FINISHED DOSAGE FORMULATIONS

0

Europe

Europe

0

Australia

Australia

0

South Africa

South Africa

0

Listed Dossiers

Listed Dossiers

FDF Dossiers

DRUG PRODUCT COMPOSITIONS

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

PATENTS & EXCLUSIVITIES

0

Health Canada Patents

API REF. PRICE (USD/KG)

GLOBAL SALES INFORMATION

Regulatory FDF Prices

NA

API/FDF Prices: Book a Demo to
explore the features and consider
upgrading later

MARKET PLACE

0

API

0

FDF

DIGITAL CONTENT

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

Chemistry

Click the arrow to open the dropdown
read-moreClick the button for full data set
Also known as: 1194506-26-7, Hmpl-013, Hmpl013, Fruquintinib [who-dd], Fruquintinib(hmpl-013), 6-(6,7-dimethoxyquinazolin-4-yl)oxy-n,2-dimethyl-1-benzofuran-3-carboxamide
Molecular Formula
C21H19N3O5
Molecular Weight
393.4  g/mol
InChI Key
BALLNEJQLSTPIO-UHFFFAOYSA-N
FDA UNII
49DXG3M5ZW

Fruquintinib
Fruquintinib is an orally available, small molecule inhibitor of vascular endothelial growth factor receptors (VEGFRs), with potential anti-angiogenic and antineoplastic activities. Upon oral administration, fruquintinib inhibits VEGF-induced phosphorylation of VEGFRs 1, 2, and 3 which may result in the inhibition of migration, proliferation and survival of endothelial cells, microvessel formation, the inhibition of tumor cell proliferation, and tumor cell death. Expression of VEGFRs may be upregulated in a variety of tumor cell types.
1 2D Structure

Fruquintinib

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
6-(6,7-dimethoxyquinazolin-4-yl)oxy-N,2-dimethyl-1-benzofuran-3-carboxamide
2.1.2 InChI
InChI=1S/C21H19N3O5/c1-11-19(20(25)22-2)13-6-5-12(7-16(13)28-11)29-21-14-8-17(26-3)18(27-4)9-15(14)23-10-24-21/h5-10H,1-4H3,(H,22,25)
2.1.3 InChI Key
BALLNEJQLSTPIO-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC1=C(C2=C(O1)C=C(C=C2)OC3=NC=NC4=CC(=C(C=C43)OC)OC)C(=O)NC
2.2 Other Identifiers
2.2.1 UNII
49DXG3M5ZW
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Hmpl-013

2.3.2 Depositor-Supplied Synonyms

1. 1194506-26-7

2. Hmpl-013

3. Hmpl013

4. Fruquintinib [who-dd]

5. Fruquintinib(hmpl-013)

6. 6-(6,7-dimethoxyquinazolin-4-yl)oxy-n,2-dimethyl-1-benzofuran-3-carboxamide

7. Fruquintinib [usan]

8. 49dxg3m5zw

9. 6-(6,7-dimethoxyquinazolin-4-yloxy)-n,2-dimethylbenzofuran-3-carboxamide

10. 3-benzofurancarboxamide, 6-((6,7-dimethoxy-4-quinazolinyl)oxy)-n,2-dimethyl-

11. 6-[(6,7-dimethoxyquinazolin-4-yl)oxy]-n,2-dimethyl-1-benzofuran-3-carboxamide

12. 6-((6,7-dimethoxyquinazolin-4-yl)oxy)-n,2-dimethylbenzofuran-3-carboxamide

13. Unii-49dxg3m5zw

14. Elunate

15. Fruquintinib [inn]

16. Fruquintinib; Hmpl-013

17. Fruquintinib (hmpl-013)

18. Schembl947183

19. Gtpl9428

20. Hmpl 013

21. Chembl4303214

22. Bcp15692

23. Ex-a2262

24. Nsc801000

25. Nsc829498

26. S5667

27. Who 10348

28. 6-[(6,7-dimethoxy-4-quinazolinyl)oxy]-n,2-dimethyl-3-benzofurancarboxamide

29. Akos026750586

30. Zinc114898570

31. Ccg-268573

32. Cs-5558

33. Db11679

34. Nsc-801000

35. Nsc-829498

36. Sb17123

37. Ncgc00481603-01

38. As-73141

39. Hmpl-013;hmpl013;hmpl 013

40. Hy-19912

41. B5864

42. A14393

43. C71641

44. A898991

45. Q27259271

46. B2693-470819

2.4 Create Date
2009-12-15
3 Chemical and Physical Properties
Molecular Weight 393.4 g/mol
Molecular Formula C21H19N3O5
XLogP33.4
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count7
Rotatable Bond Count5
Exact Mass393.13247072 g/mol
Monoisotopic Mass393.13247072 g/mol
Topological Polar Surface Area95.7 Ų
Heavy Atom Count29
Formal Charge0
Complexity579
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Treatment of colorectal carcinoma


API SUPPLIERS

read-more
read-more

01

Dr. Reddy's Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Flag India
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Dr Reddy Company Banner

02

Egis Pharmaceuticals PLC

Hungary

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Flag Hungary
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Egis Pharmaceuticals

03

Beijing Sjar Technology Developmen...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

IFT FIRST
Not Confirmed
arrow

04

Macleods Pharmaceuticals Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

IFT FIRST
Not Confirmed
arrow

05

Lee Fine Chem

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

IFT FIRST
Not Confirmed
arrow

06

Sichuan Qingmu Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

IFT FIRST
Not Confirmed
arrow

07

Country

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

IFT FIRST
Not Confirmed
arrow

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

arrow
IFT FIRST
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
blank

08

Asymchem Laboratories

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

IFT FIRST
Not Confirmed
arrow

Asymchem Laboratories

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

arrow
IFT FIRST
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC KDMF arrow-down VMF Others AUDIT
blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

API Reference Price

read-more
read-more
[{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1701801000,"product":"FRUQUINTINIB (6-METHOXY-2-METHYLBENZOFURAN-3-CARBOXYLIC ACID)","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"CHENGDU","customer":"DR REDDY'S LABORATORIES","customerCountry":"INDIA","quantity":"0.90","actualQuantity":"0.9","unit":"KGS","unitRateFc":"5800","totalValueFC":"5273.7","currency":"USD","unitRateINR":"487780","date":"06-Dec-2023","totalValueINR":"439002","totalValueInUsd":"5273.7","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"9097497","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"CHENGDU","supplierAddress":"XIANGFUQIAO, NO. 866 MOGANSHAN ROAD, HANGZHOU 310011, ZHEJIANG PROVINCE, CHINA China China","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"}]
06-Dec-2023
06-Dec-2023
KGS
overview
Loading...

Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API/FDF Prices: Book a Demo to explore the features and consider upgrading later

API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

Upgrade, download data, analyse, strategize, subscribe with us contact

Drugs in Development

read-more
read-more

Details:

HMPL-013 (fruquintinib) in combination with IBI308 (sintilimab) is currently being evaluated for the treatment of advanced renal cell carcinoma.


Lead Product(s): Fruquintinib,Sintilimab

Therapeutic Area: Oncology Brand Name: HMPL-013

Study Phase: Phase II/ Phase IIIProduct Type: Other Small Molecule

Sponsor: Hutchmed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 18, 2025

blank

01

IFT FIRST
Not Confirmed
IFT FIRST
Not Confirmed

Details : HMPL-013 (fruquintinib) in combination with IBI308 (sintilimab) is currently being evaluated for the treatment of advanced renal cell carcinoma.

Product Name : HMPL-013

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

March 18, 2025

blank

Details:

Elunate (fruquintinib) a VEGFR 1/2/3 inhibitor and Tyvyt (sintilimab) has been granted conditional approval in China for the treatment of patients with advanced endometrial cancer.


Lead Product(s): Fruquintinib,Sintilimab

Therapeutic Area: Oncology Brand Name: Elunate

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Innovent Biologics

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 03, 2024

blank

02

Hutchmed

Hong Kong
arrow
IFT FIRST
Not Confirmed

Hutchmed

Hong Kong
arrow
IFT FIRST
Not Confirmed

Details : Elunate (fruquintinib) a VEGFR 1/2/3 inhibitor and Tyvyt (sintilimab) has been granted conditional approval in China for the treatment of patients with advanced endometrial cancer.

Product Name : Elunate

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

December 03, 2024

blank

Details:

Fruzaqla (fruquintinib) is the first and only selective inhibitor of all three VEGF receptor kinases approved for previously treated mCRC regardless of biomarker status.


Lead Product(s): Fruquintinib

Therapeutic Area: Oncology Brand Name: Elunate

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 21, 2024

blank

03

Hutchmed

Hong Kong
arrow
IFT FIRST
Not Confirmed

Hutchmed

Hong Kong
arrow
IFT FIRST
Not Confirmed

Details : Fruzaqla (fruquintinib) is the first and only selective inhibitor of all three VEGF receptor kinases approved for previously treated mCRC regardless of biomarker status.

Product Name : Elunate

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

November 21, 2024

blank

Details:

Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong and Macau, and markets under the Fruzaqla brand name.


Lead Product(s): Fruquintinib

Therapeutic Area: Oncology Brand Name: Elunate

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Takeda Pharmaceutical

Deal Size: $1,130.0 million Upfront Cash: $400.0 million

Deal Type: Licensing Agreement October 31, 2024

blank

04

Hutchmed

Hong Kong
arrow
IFT FIRST
Not Confirmed

Hutchmed

Hong Kong
arrow
IFT FIRST
Not Confirmed

Lead Product(s) : Fruquintinib

Therapeutic Area : Oncology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Takeda Pharmaceutical

Deal Size : $1,130.0 million

Deal Type : Licensing Agreement

Details : Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong and Macau, and markets under the Fruzaqla brand name.

Product Name : Elunate

Product Type : Other Small Molecule

Upfront Cash : $400.0 million

October 31, 2024

blank

Details:

Fruzaqla (fruquintinib) is the first and only selective inhibitor of all three VEGF receptor kinases approved for previously treated mCRC regardless of biomarker status.


Lead Product(s): Fruquintinib

Therapeutic Area: Oncology Brand Name: Fruzaqla

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 24, 2024

blank

05

IFT FIRST
Not Confirmed
IFT FIRST
Not Confirmed

Details : Fruzaqla (fruquintinib) is the first and only selective inhibitor of all three VEGF receptor kinases approved for previously treated mCRC regardless of biomarker status.

Product Name : Fruzaqla

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

September 24, 2024

blank

Details:

HMPL-013 (fruquintinib) is the first and only selective inhibitor of all three VEGF receptor kinases which is being evaluated for the treatment of gastroesophageal junction adenocarcinoma.


Lead Product(s): Fruquintinib,Paclitaxel

Therapeutic Area: Oncology Brand Name: Elunate

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 29, 2024

blank

06

Hutchmed

Hong Kong
arrow
IFT FIRST
Not Confirmed

Hutchmed

Hong Kong
arrow
IFT FIRST
Not Confirmed

Details : HMPL-013 (fruquintinib) is the first and only selective inhibitor of all three VEGF receptor kinases which is being evaluated for the treatment of gastroesophageal junction adenocarcinoma.

Product Name : Elunate

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

August 29, 2024

blank

Details:

Fruzaqla (fruquintinib) is the first and only selective inhibitor of all three VEGF receptor kinases approved for previously treated mCRC regardless of biomarker status.


Lead Product(s): Fruquintinib

Therapeutic Area: Oncology Brand Name: Fruzaqla

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 21, 2024

blank

07

IFT FIRST
Not Confirmed
IFT FIRST
Not Confirmed

Details : Fruzaqla (fruquintinib) is the first and only selective inhibitor of all three VEGF receptor kinases approved for previously treated mCRC regardless of biomarker status.

Product Name : Fruzaqla

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

June 21, 2024

blank

Details:

Fruzaqla (fruquintinib) is a selective oral VEGFR inhibitor, playing a pivotal role in blocking tumor angiogenesis. It is being investigated in combination with sintilimab for endometrial cancer.


Lead Product(s): Fruquintinib,Sintilimab

Therapeutic Area: Oncology Brand Name: Elunate

Study Phase: Phase II/ Phase IIIProduct Type: Other Small Molecule

Sponsor: HengRui

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 13, 2024

blank

08

Hutchmed

Hong Kong
arrow
IFT FIRST
Not Confirmed

Hutchmed

Hong Kong
arrow
IFT FIRST
Not Confirmed

Details : Fruzaqla (fruquintinib) is a selective oral VEGFR inhibitor, playing a pivotal role in blocking tumor angiogenesis. It is being investigated in combination with sintilimab for endometrial cancer.

Product Name : Elunate

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

May 13, 2024

blank

Details:

FRUZAQLA (fruquintinib) 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.


Lead Product(s): Fruquintinib

Therapeutic Area: Oncology Brand Name: Fruzaqla

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 26, 2024

blank

09

IFT FIRST
Not Confirmed
IFT FIRST
Not Confirmed

Details : FRUZAQLA (fruquintinib) 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.

Product Name : Fruzaqla

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

April 26, 2024

blank

Details:

Elunate (fruquintinib) is a selective oral inhibitor of VEGF receptors. It is approved in Hong Kong for the treatment of metastatic colorectal cancer.


Lead Product(s): Fruquintinib

Therapeutic Area: Oncology Brand Name: Elunate

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 29, 2024

blank

10

Hutchmed

Hong Kong
arrow
IFT FIRST
Not Confirmed

Hutchmed

Hong Kong
arrow
IFT FIRST
Not Confirmed

Details : Elunate (fruquintinib) is a selective oral inhibitor of VEGF receptors. It is approved in Hong Kong for the treatment of metastatic colorectal cancer.

Product Name : Elunate

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

January 29, 2024

blank
click full view
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

FDA Orange Book

read-more
read-more

01

CRS
Not Confirmed
arrow
arrow
CRS
Not Confirmed

FRUQUINTINIB

Brand Name : FRUZAQLA

Dosage Form : CAPSULE;ORAL

Dosage Strength : 1MG

Approval Date : 2023-11-08

Application Number : 217564

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

blank

02

CRS
Not Confirmed
arrow
arrow
CRS
Not Confirmed

FRUQUINTINIB

Brand Name : FRUZAQLA

Dosage Form : CAPSULE;ORAL

Dosage Strength : 5MG

Approval Date : 2023-11-08

Application Number : 217564

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Canada

read-more
read-more

01

CRS
Not Confirmed
arrow
arrow
CRS
Not Confirmed

FRUQUINTINIB

Brand Name : FRUZAQLA

Dosage Form : CAPSULE

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number : 2551454

Regulatory Info :

Registration Country : Canada

blank

02

CRS
Not Confirmed
arrow
arrow
CRS
Not Confirmed

FRUQUINTINIB

Brand Name : FRUZAQLA

Dosage Form : CAPSULE

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number : 2551462

Regulatory Info :

Registration Country : Canada

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Digital Content read-more

Create Content with PharmaCompass, ask us

DATA COMPILATION #PharmaFlow

read-more
read-more
FDA okays 50 new drugs in 2024; BMS’ Cobenfy, Lilly’s Kisunla lead pack of breakthrough therapies
In 2024, the biopharma industry continued to advance on its robust trajectory of innovation. Though the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) approved fewer drugs, there was a significant increase in medical breakthroughs.While the CDER approved 50 new drugs in 2024, as compared to 55 in 2023, the CBER granted 14 biologics approvals in 2024, down from 20 in 2023.The European Medicines Agency (EMA) approved 34 new therapies, up from 32 in 2023, while Health Canada granted 28 approvals, down from 38 in 2023.The year saw long-awaited treatments being approved in areas such as schizophrenia and Alzheimer’s disease in the second half (H2) of 2024. In H1 2024, drugs to treat metabolic dysfunction-associated steatohepatitis (MASH) and chronic obstructive pulmonary disease (COPD) had been granted FDA approvals.As the year drew to a close, FDA began approving drugs at a feverish pace, with 29 of the CDER’s 50 approvals coming in H2.Like most years, the landscape of drug approvals was dominated by oncology, with 15 of the 50 drugs (30 percent) approved targeting various forms of cancer. This was followed by dermatology and non-malignant hematology, each accounting for 12 percent of approvals. Notably, small molecules continued to dominate the market, making up for 64 percent of the new drug approvals, while 32 percent were proteins, including monoclonal and bi-specific antibodies. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available)Karuna-BMS’ schizophrenia drug, Lilly’s Alzheimer’s med, Neurocrine’s Crenessity dominate list of pathbreaking approvals in H2Out of the 50 new drugs approved in 2024, CDER identified 24 (48 percent) as first-in-class, showcasing novel mechanisms of action. The most anticipated approval of 2024 was Karuna and Bristol Myers Squibb’s Cobenfy, a groundbreaking treatment for schizophrenia. This fixed-dose combination of xanomeline and trospium chloride represents the first novel mechanism of action in decades for this debilitating psychiatric condition. Analysts forecast peak annual sales of over US$ 3.3 billion for Cobenfy. Eli Lilly’s Alzheimer’s drug Kisunla (donanemab) became the third amyloid-targeting antibody to gain FDA approval. Unlike its predecessors, Kisunla offers a unique limited-duration treatment regimen, allowing patients to discontinue therapy once amyloid levels in the brain drop below a certain threshold. Priced at approximately US$ 32,000 per year, it is positioned as a cost-effective alternative to existing treatments. Analysts estimate peak sales of US$ 2.4 billion for Kisunla.Crenessity (crinecerfont), developed by Neurocrine Biosciences, became the first FDA-approved treatment in decades for classic congenital adrenal hyperplasia (genetic conditions that affect the adrenal glands). Similarly, Vertex’s triple combination therapy of deutivacaftor, tezacaftor & vanzacaftor (Alyftrek) for cystic fibrosis represents a significant advancement in genetic disease treatment. Analysts forecast peak sales exceeding US$ 8.3 billion, underscoring the therapy’s potential to transform patient care.Meanwhile, Bridgebio’s Attruby (acoramidis hydrochloride) emerged as a promising treatment for cardiac amyloidosis, a life-threatening condition. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Roche’s Itovebi, Checkpoint’s Unloxcyt clinch FDA approvals in H2 2024; forecast to achieve blockbuster statusThe dominance of cancer drug approvals reflects the ongoing focus on targeted therapies, immuno-oncology, and precision medicine to improve outcomes for patients with hard-to-treat cancers.Among the year’s notable FDA approvals was Genentech’s Itovebi (inavolisib), another targeted therapy that treats hormone receptor-positive (HR+), HER2-negative breast cancer. Itovebi is a PI3Kα inhibitor designed specifically for patients with PIK3CA mutations, a common driver of resistance to endocrine therapy in breast cancer. It demonstrated a more tolerable safety profile. Roche projects Itovebi’s peak (annual) sales to reach CHF 2 billion (US$ 2.3 billion).Checkpoint Therapeutics’ Unloxcyt (cosibelimab) joined the crowded checkpoint inhibitor market as the eleventh PD-1/PD-L1-targeting monoclonal antibody approved by the FDA. It was granted approval for cutaneous squamous cell carcinoma (cSCC), an aggressive form of skin cancer with high recurrence rates. As compared to other checkpoint inhibitors, like Keytruda (pembrolizumab) and Opdivo (nivolumab), Unloxcyt is likely to offer an advantage in immune activation.FDA also approved Astellas’ Vyloy (zolbetuximab), a first-in-class monoclonal antibody for metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma. Analysts forecast peak sales of approximately US$ 850 million for Vyloy.Syndax Pharmaceuticals’ Revuforj (revumenib) was approved by FDA to treat a type of acute leukemia in both adults and children. This approval introduces a novel class of medications known as menin inhibitors. These agents are currently in clinical development for the treatment of genetically defined subsets of acute leukemia. These inhibitors function by preventing the activation of cancer growth-related proteins. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Potential blockbusters Lilly’s Ebglyss, Galderma’s Nemluvio lead advances in dermatologyEli Lilly’s Ebglyss (lebrikizumab) garnered significant attention. Approved by FDA for moderate-to-severe atopic dermatitis, this monoclonal antibody introduces a less burdensome dosing regimen compared to its competitors, with maintenance therapy required only once a month. This feature positions it as a potential contender to Dupixent (dupilumab), a market leader in atopic dermatitis. Ebglyss sales are forecast to reach US$ 1.9 billion by 2030.Galderma’s Nemluvio (nemolizumab) secured FDA approval for two indications in 2024 — prurigo nodularis (a chronic disorder of the skin) and moderate-to-severe atopic dermatitis in patients aged 12 years and older. As the first humanized IgG2 monoclonal antibody targeting the IL-31 receptor, Nemluvio directly inhibits the key driver of itch and inflammation in both these conditions. With its unique mechanism and broad dermatology potential, analysts forecast peak sales of approximately US$ 1.66 billion. Ebglyss and Nemluvio underscore the growing importance of biologics in dermatological care.Botanix Pharmaceuticals also made strides in dermatology by clinching an FDA approval for Sofdra (sofpironium) in June. The drug has been okayed for the treatment of primary axillary hyperhidrosis, a condition characterized by excessive sweating.Ascendis Pharma’s Yorvipath (palopegteriparatide), a therapy approved by FDA to treat hypoparathyroidism, is forecast to achieve blockbuster sales of US$ 1.8 billion by 2030, highlighting its potential to transform endocrine care. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Our viewOverall, 2024 was defined by its breakthrough drug approvals. The year also saw significant reduction in complete response letters (CRLs) — they dropped from 43 in 2023 to just 29 in 2024. This suggests improved industry preparedness and alignment with regulatory expectations.The new year began with the approval of Datroway (datopotamab deruxtecan) from AstraZeneca and Daiichi Sankyo, marking a significant advancement in oncology. Several other promising new drugs are coming up for FDA approval this year, such as J&J’s nipocalimab, Vertex Pharmaceuticals’ suzetrigine, Elevar Therapeutics’ rivoceranib/camrelizumab, Sanofi’s fitusiran and GSK’s gepotidacin. Hopefully, the momentum of breakthrough approvals will continue through 2025, political headwinds in the US notwithstanding. 

Impressions: 10914

https://www.pharmacompass.com/radio-compass-blog/fda-okays-50-new-drugs-in-2024-bms-cobenfy-lilly-s-kisunla-lead-pack-of-breakthrough-therapies

#PharmaFlow by PHARMACOMPASS
30 Jan 2025

NEWS #PharmaBuzz

read-more
read-more

Global Sales Information

Do you need Business Intel? Ask us

Annual Reports

read-more
read-more

01

Brand Name : Fruzaqla

Fruquintinib

arrow
CRS
Not Confirmed

Brand Name : Fruzaqla

Japan
arrow
CRS
Not Confirmed

Fruquintinib

Main Therapeutic Indication : Oncology

Currency : USD

2024 Revenue in Millions : 299

2023 Revenue in Millions : 15

Growth (%) : 1,900

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Patents & EXCLUSIVITIES

Check the patents & exclusivity for this product

US Patents

read-more
read-more

01

arrow
CRS
Not Confirmed
arrow
CRS
Not Confirmed

FRUQUINTINIB

US Patent Number : 7829574

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 217564

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-05-09

blank

02

arrow
CRS
Not Confirmed
arrow
CRS
Not Confirmed

FRUQUINTINIB

US Patent Number : 7829574

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 217564

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-05-09

blank

03

arrow
CRS
Not Confirmed
arrow
CRS
Not Confirmed

FRUQUINTINIB

US Patent Number : 11046674

Drug Substance Claim :

Drug Product Claim :

Application Number : 217564

Patent Use Code : U-3753

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2035-09-07

blank

04

arrow
CRS
Not Confirmed
arrow
CRS
Not Confirmed

FRUQUINTINIB

US Patent Number : 11046674

Drug Substance Claim :

Drug Product Claim :

Application Number : 217564

Patent Use Code : U-3753

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2035-09-07

blank

05

arrow
CRS
Not Confirmed
arrow
CRS
Not Confirmed

FRUQUINTINIB

US Patent Number : 10519142

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 217564

Patent Use Code : U-3753

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2035-09-07

blank

06

arrow
CRS
Not Confirmed
arrow
CRS
Not Confirmed

FRUQUINTINIB

US Patent Number : 10519142

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 217564

Patent Use Code : U-3753

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2035-09-07

blank

07

arrow
CRS
Not Confirmed
arrow
CRS
Not Confirmed

FRUQUINTINIB

US Patent Number : 8212033

Drug Substance Claim :

Drug Product Claim :

Application Number : 217564

Patent Use Code : U-3753

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-05-09

blank

08

arrow
CRS
Not Confirmed
arrow
CRS
Not Confirmed

FRUQUINTINIB

US Patent Number : 8212033

Drug Substance Claim :

Drug Product Claim :

Application Number : 217564

Patent Use Code : U-3753

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-05-09

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

US Exclusivities

read-more
read-more

01

arrow
CRS
Not Confirmed
arrow
CRS
Not Confirmed

FRUQUINTINIB

Exclusivity Code : NCE

Exclusivity Expiration Date : 2028-11-08

Application Number : 217564

Product Number : 1

Exclusivity Details :

blank

02

arrow
CRS
Not Confirmed
arrow
CRS
Not Confirmed

FRUQUINTINIB

Exclusivity Code : NCE

Exclusivity Expiration Date : 2028-11-08

Application Number : 217564

Product Number : 2

Exclusivity Details :

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

ABOUT THIS PAGE

Looking for 1194506-26-7 / Fruquintinib API manufacturers, exporters & distributors?

Fruquintinib manufacturers, exporters & distributors 1

22

PharmaCompass offers a list of Fruquintinib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Fruquintinib manufacturer or Fruquintinib supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fruquintinib manufacturer or Fruquintinib supplier.

PharmaCompass also assists you with knowing the Fruquintinib API Price utilized in the formulation of products. Fruquintinib API Price is not always fixed or binding as the Fruquintinib Price is obtained through a variety of data sources. The Fruquintinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Fruquintinib

Synonyms

1194506-26-7, Hmpl-013, Hmpl013, Fruquintinib [who-dd], Fruquintinib(hmpl-013), 6-(6,7-dimethoxyquinazolin-4-yl)oxy-n,2-dimethyl-1-benzofuran-3-carboxamide

Cas Number

1194506-26-7

Unique Ingredient Identifier (UNII)

49DXG3M5ZW

About Fruquintinib

Fruquintinib is an orally available, small molecule inhibitor of vascular endothelial growth factor receptors (VEGFRs), with potential anti-angiogenic and antineoplastic activities. Upon oral administration, fruquintinib inhibits VEGF-induced phosphorylation of VEGFRs 1, 2, and 3 which may result in the inhibition of migration, proliferation and survival of endothelial cells, microvessel formation, the inhibition of tumor cell proliferation, and tumor cell death. Expression of VEGFRs may be upregulated in a variety of tumor cell types.

Fruquintinib Manufacturers

A Fruquintinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fruquintinib, including repackagers and relabelers. The FDA regulates Fruquintinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fruquintinib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Fruquintinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Fruquintinib Suppliers

A Fruquintinib supplier is an individual or a company that provides Fruquintinib active pharmaceutical ingredient (API) or Fruquintinib finished formulations upon request. The Fruquintinib suppliers may include Fruquintinib API manufacturers, exporters, distributors and traders.

click here to find a list of Fruquintinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Fruquintinib KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Fruquintinib Drug Master File in Korea (Fruquintinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fruquintinib. The MFDS reviews the Fruquintinib KDMF as part of the drug registration process and uses the information provided in the Fruquintinib KDMF to evaluate the safety and efficacy of the drug.

After submitting a Fruquintinib KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Fruquintinib API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Fruquintinib suppliers with KDMF on PharmaCompass.

Fruquintinib NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Fruquintinib as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Fruquintinib API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Fruquintinib as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Fruquintinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fruquintinib NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Fruquintinib suppliers with NDC on PharmaCompass.

Fruquintinib GMP

Fruquintinib Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Fruquintinib GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Fruquintinib GMP manufacturer or Fruquintinib GMP API supplier for your needs.

Fruquintinib CoA

A Fruquintinib CoA (Certificate of Analysis) is a formal document that attests to Fruquintinib's compliance with Fruquintinib specifications and serves as a tool for batch-level quality control.

Fruquintinib CoA mostly includes findings from lab analyses of a specific batch. For each Fruquintinib CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Fruquintinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Fruquintinib EP), Fruquintinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fruquintinib USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
Ask Us for Pharmaceutical Supplier and Partner
Ask Us, Find A Supplier / Partner
No Commissions, No Strings Attached, Get Connected for FREE

What are you looking for?

How can we help you?

The request can't be empty

Please read our Privacy Policy carefully

You must agree to the privacy policy

The name can't be empty
The company can't be empty.
The email can't be empty Please enter a valid email.
The mobile can't be empty