Conbercept

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Conbercept
Clinical data
Trade namesLumitin
Routes of
administration		Intravitreal Injection
Identifiers
CAS Number
DrugBank
UNII
E number{{#property:P628}}
CompTox Dashboard (EPA)
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Chemical and physical data
Molar mass142 KDa

Conbercept, sold under the commercial name Lumitin, is a novel vascular endothelial growth factor (VEGF) inhibitor used to treat neovascular age-related macular degeneration (AMD)[1][2] and diabetic macular edema (DME).[3] The anti-VEGF was approved for the treatment of neovascular AMD by the China State FDA (CFDA) in December 2013.[4][5] As of December 2020, conbercept is undergoing phase III clinical trials through the U.S. Food and Drug Administration's PANDA-1 and PANDA-2 development programs.[6][7]

Conbercept was developed by Chengdu Kanghong Biotech Company in the People's Republic of China and is marketed under the name Lumitin.[3][8]

Medical uses

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It is used for the treatment of neovascular age-related macular degeneration (nAMD),[1][4][8] choroidal neovascularization secondary to pathologic myopia (pmCNV),[9][10] diabetic macular edema (DME).[3][11] The medication is given through intravitreal injection (IVT).[3][1]

Contraindications

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Conbercept is contraindicated in patients with known hypersensitivity to the active ingredient,[6] in patients with ocular or periocular infections,[12] and in patients with active intraocular inflammation.[6]

Adverse effects

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Common adverse effects of the eye formulation include eye pain, transient intraocular pressure (IOP) increase and conjunctival hemorrhage.[13][14]

Mechanism of action

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Conbercept is a soluble receptor decoy that binds specifically to VEGF-B, placental growth factor (PlGF), and various isoforms of VEGF-A.[1][4][15] Conbercept has a VEGF-R2 kinase insert domain receptor (KDR) Ig-like region 4 (KDRd4) which improves the three-dimensional structure and efficiency of dimer formation, thereby increasing the binding capacity of conbercept to VEGF.[16]

Composition

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Conbercept is a recombinant fusion protein composed of VEGFR-1 (second domain) and VEGFR-2 (third and fourth domains) regions fused to the Fc portion of human IgG1 immunoglobulin.[4][17]

History

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Chengdu Kanghong Pharmaceutical Group, a medical company based in Sichuan, started the development of conbercept in 2005.[18] In 2012, the drug was included on the World Health Organization's Drug Information 67th List of Recommended International Nonproprietary Names,[19] which was the first Chinese innovator biotech drug to be recognized on the list.[20]

In November 2013, the Chinese Food and Drug Administration approved conbercept for the treatment of AMD.[21] By 2014, conbercept was marketed for treatment of wAMD in China.[22] In 2016, Phase III clinical trials of conbercept were authorized by the U.S. Food and Drug Administration.[23]

In 2017, Kanghong Pharmaceutical Group partnered with Syneos Health to process Phase III clinical trials simultaneously in more than 30 countries around the world with an investment of $228 million.[24] In 2020, conbercept was approved for use in Mongolia.[25]

Clinical trials in China

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  • Conbercept is the only anti-VEGF drug confirmed by randomized controlled trials (RCT) to sustain visual improvements with 3+Q3M regimens (PHOENIX study)[26]
  • Conbercept significantly improves visual acuity and anatomical outcomes in patient with PCV (AURORA Study).[27]
  • Conbercept provides significantly visual acuity improvement in DME patients (SAILING study).[28][29]

Society and culture

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  • In 2013, the CFDA approved conbercept for the treatment of neovascular age-related macular degeneration (nAMD)[30]
  • In 2017, the CFDA approved it for the treatment of pathologic myopia associated choroidal neovascularization (pmCNV) [31]
  • In 2019, the CFDA approved it for the treatment of diabetic macular edema (DME)[28]

Economic

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  • Conbercept has been shown to be a cost-effective wAMD treatment option in China. Compared to two similar anti-VEGF intravitreal drugs, ranibizumab and aflibercept, conbercept has been shown to be the most cost-effective option for treatment of wAMD in China.[32]
  • In 2017, the national basic medical insurance in China began covering conbercept.[33]

References

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  6. ^ a b c Clinical trial number NCT03577899 for "A Multicenter, Double-Masked, Randomized, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Conbercept Intravitreal Injection in Subjects With Neovascular Age-Related Macular Degeneration (AMD) (PANDA-1)" at ClinicalTrials.gov
  7. ^ Clinical trial number NCT03630952 for "A Multicenter, Double-Masked, Randomized, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Conbercept Intravitreal Injection in Subjects With Neovascular Age-Related Macular Degeneration (AMD) (PANDA-2)" at ClinicalTrials.gov
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  23. ^ Clinical trial number NCT03108352 for "Conbercept Ophthalmic Injection for Patients With Macular Edema Caused by Branch Retinal Vein Occlusion (BRAVE)" at ClinicalTrials.gov
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  29. ^ Clinical trial number NCT02194634 for "Safety and Efficacy Study of Conbercept in Diabetic Macular Edema (DME) (Sailing)" at ClinicalTrials.gov
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  • Conbercept, Drug Information Portal. U.S. National Library of Medicine.
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