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Chemistry

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NDC API

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01

ASC 2024
Not Confirmed
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ASC 2024
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INCLISIRAN

NDC Package Code : 70596-1002

Start Marketing Date : 2021-12-27

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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01

EUROAPI

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

Flag France
Digital Content Digital Content

Inclisiran

About the Company : EUROAPI is the market leader in small molecule APIs with projected sales of about €1 billion in 2022. With around 200 APIs, it has one of the largest portfolios in the market. Th...

EUROAPI is the market leader in small molecule APIs with projected sales of about €1 billion in 2022. With around 200 APIs, it has one of the largest portfolios in the market. Thanks to its excellent R&D skills and six manufacturing facilities across Europe, EUROAPI guarantees API manufacturing of the highest quality to its clients in over 80 countries. Its strong innovation and R&D skills helps it to speed the development of more complex molecule segments through CDMO operations. It also offers experience in supply, regulation and quality. EUROAPI employs 3,350 people and is listed on Euronext.
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02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothRibobay has expertise in oligonucleotides from siRNA, Antisense Oligonucleotides, miRNAs, and aptamers & Oligonucleotides CXOs.

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Digital Content Digital Content

Inclisiran

About the Company : Anhui Ribobay Pharmaceutical Co., Ltd., known as Ribobay, was established in August 2021 as a fully owned subsidiary of General Biol. Situated in the Quanjiao industry Zone in Chuz...

Anhui Ribobay Pharmaceutical Co., Ltd., known as Ribobay, was established in August 2021 as a fully owned subsidiary of General Biol. Situated in the Quanjiao industry Zone in Chuzhou, within the Nanjing metropolitan area, Ribobay Pharmaceutical specializes in the therapeutic oligonucleotides CXO field. This strategic focus aligns with General Biol's broader expansion plans for its CXO business, making Ribobay a crucial component of the company's ventures in this domain.
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03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

Flag India
Digital Content Digital Content

Inclisiran

About the Company : Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically...

Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integrated company, we focus on developing high-quality formulations based on in-house-produced actives. With GMP-certified facilities and partnerships with contract manufacturers, we excel in formulation development for injectables, lyophilized injectables, complex generics, and oral peptide delivery systems, ensuring affordable, top-quality medicines.
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Drugs in Development

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  • Development Update

Details:

Leqvio (inclisiran), approved in over 80 countries, is the first and only approved Small interfering RNA therapy with a successful synthesis of the antisense strand of this drug.


Lead Product(s): Inclisiran

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 09, 2024

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EnPlusOne Biosciences

Country
arrow
ASC 2024
Not Confirmed

EnPlusOne Biosciences

Country
arrow
ASC 2024
Not Confirmed

Details : Leqvio (inclisiran), approved in over 80 countries, is the first and only approved Small interfering RNA therapy with a successful synthesis of the antisense strand of this drug.

Brand Name : Leqvio

Molecule Type : Large molecule

Upfront Cash : Not Applicable

July 09, 2024

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Details:

Leqvio (inclisiran), the first and only approved small interfering RNA (siRNA) therapy to lower LDL-C, gains expanded approval for the treatment of adults with high LDL-C and who are at increased risk of heart disease.


Lead Product(s): Inclisiran

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 06, 2024

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02

ASC 2024
Not Confirmed
ASC 2024
Not Confirmed

Details : Leqvio (inclisiran), the first and only approved small interfering RNA (siRNA) therapy to lower LDL-C, gains expanded approval for the treatment of adults with high LDL-C and who are at increased risk of heart disease.

Brand Name : Leqvio

Molecule Type : Large molecule

Upfront Cash : Not Applicable

April 06, 2024

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Details:

Leqvio (Inclisiran) is the first and only small interfering RNA (siRNA) therapy to lower LDL-C. It is approved in over 80 countries, including the US, EU and China.


Lead Product(s): Inclisiran

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 28, 2023

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03

ASC 2024
Not Confirmed
ASC 2024
Not Confirmed

Details : Leqvio (Inclisiran) is the first and only small interfering RNA (siRNA) therapy to lower LDL-C. It is approved in over 80 countries, including the US, EU and China.

Brand Name : Leqvio

Molecule Type : Large molecule

Upfront Cash : Not Applicable

August 28, 2023

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Details:

Leqvio (inclisiran), the first and only approved small interfering RNA (siRNA) therapy to lower LDL-C, gains expanded approval for the treatment of adults with high LDL-C and who are at increased risk of heart disease.


Lead Product(s): Inclisiran

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 10, 2023

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04

ASC 2024
Not Confirmed
ASC 2024
Not Confirmed

Details : Leqvio (inclisiran), the first and only approved small interfering RNA (siRNA) therapy to lower LDL-C, gains expanded approval for the treatment of adults with high LDL-C and who are at increased risk of heart disease.

Brand Name : Leqvio

Molecule Type : Large molecule

Upfront Cash : Not Applicable

July 10, 2023

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Details:

Leqvio is the first and only small interfering RNA (siRNA) therapy to lower LDL-C and is administered with 2 doses a year. Leqvio is important for ASCVD patients who are not reaching recommended LDL-C target levels despite taking other cholesterol-lowering medications.


Lead Product(s): Inclisiran

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 07, 2022

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05

ASC 2024
Not Confirmed
ASC 2024
Not Confirmed

Details : Leqvio is the first and only small interfering RNA (siRNA) therapy to lower LDL-C and is administered with 2 doses a year. Leqvio is important for ASCVD patients who are not reaching recommended LDL-C target levels despite taking other cholesterol-loweri...

Brand Name : Leqvio

Molecule Type : Large molecule

Upfront Cash : Not Applicable

November 07, 2022

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Details:

LEQVIO (inclisiran) injection is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH).


Lead Product(s): Inclisiran

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Novartis Pharmaceuticals Corporation

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership July 26, 2022

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Soleo Health

U.S.A
arrow
ASC 2024
Not Confirmed

Soleo Health

U.S.A
arrow
ASC 2024
Not Confirmed

Details : LEQVIO (inclisiran) injection is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH).

Brand Name : Leqvio

Molecule Type : Large molecule

Upfront Cash : Undisclosed

July 26, 2022

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Details:

The approval of Leqvio (Inclisiran) First siRNA is based on the ability of Leqvio to lower LDL cholesterol up to 52% in patients with Atherosclerotic Cardiovascular Disease.


Lead Product(s): Inclisiran

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 22, 2021

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07

ASC 2024
Not Confirmed
ASC 2024
Not Confirmed

Details : The approval of Leqvio (Inclisiran) First siRNA is based on the ability of Leqvio to lower LDL cholesterol up to 52% in patients with Atherosclerotic Cardiovascular Disease.

Brand Name : Leqvio

Molecule Type : Large molecule

Upfront Cash : Not Applicable

December 22, 2021

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Details:

Treatment emergent adverse events (TEAEs) at the injection site were more frequent with Leqvio, but all were mild or moderate. The effect of Leqvio on cardiovascular morbidity and mortality has not been determined.


Lead Product(s): Inclisiran,Ezetimibe

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Alnylam Pharmaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 08, 2021

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08

ASC 2024
Not Confirmed
ASC 2024
Not Confirmed

Details : Treatment emergent adverse events (TEAEs) at the injection site were more frequent with Leqvio, but all were mild or moderate. The effect of Leqvio on cardiovascular morbidity and mortality has not been determined.

Brand Name : Leqvio

Molecule Type : Large molecule

Upfront Cash : Not Applicable

November 08, 2021

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Details:

Agreement follows positive NICE recommendation and commits to deliver Leqvio® (inclisiran) access via a population health management approach identifying eligible patients across England.


Lead Product(s): Inclisiran,Ezetimibe

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Novartis Pharmaceuticals Corporation

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration September 01, 2021

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NHS England

United Kingdom
arrow
ASC 2024
Not Confirmed

NHS England

United Kingdom
arrow
ASC 2024
Not Confirmed

Details : Agreement follows positive NICE recommendation and commits to deliver Leqvio® (inclisiran) access via a population health management approach identifying eligible patients across England.

Brand Name : Leqvio

Molecule Type : Large molecule

Upfront Cash : Undisclosed

September 01, 2021

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Details:

Separate post hoc analyses of pooled Phase III ORION-9, -10 and -11 data show twice-yearly Leqvio® (inclisiran) consistently reduced LDL-C in patients with atherosclerotic cardiovascular disease with established cerebrovascular disease and polyvascular disease.


Lead Product(s): Inclisiran

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio

Study Phase: Phase IIIProduct Type: Large molecule

Sponsor: Alnylam Pharmaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 31, 2021

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10

ASC 2024
Not Confirmed
ASC 2024
Not Confirmed

Details : Separate post hoc analyses of pooled Phase III ORION-9, -10 and -11 data show twice-yearly Leqvio® (inclisiran) consistently reduced LDL-C in patients with atherosclerotic cardiovascular disease with established cerebrovascular disease and polyvascular ...

Brand Name : Leqvio

Molecule Type : Large molecule

Upfront Cash : Not Applicable

August 31, 2021

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