Conbercept Explained

Tradename:Lumitin
Routes Of Administration:Intravitreal Injection
Cas Number:1227158-72-6
Unii:1P05PW62F3
Molecular Weight:142
Molecular Weight Comment: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.

Conbercept was developed by Chengdu Kanghong Biotech Company in the People’s Republic of China and is marketed under the name Lumitin.[6]

Medical uses

It is used for the treatment of neovascular age-related macular degeneration (nAMD), choroidal neovascularization secondary to pathologic myopia,[7] [8] diabetic macular edema (DME).[9] The medication is given through intravitreal injection (IVT).

Contraindications

Conbercept is contraindicated in patients with known hypersensitivity to the active ingredient, in patients with ocular or periocular infections,[10] and in patients with active intraocular inflammation.

Adverse effects

Common adverse effects of the eye formulation include eye pain, transient intraocular pressure (IOP) increase and conjunctival hemorrhage.[11] [12]

Mechanism of action

Conbercept is a soluble receptor decoy that binds specifically to VEGF-B, placental growth factor (PlGF), and various isoforms of VEGF-A.[13] 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.[14]

Composition

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.[15]

History

Chengdu Kanghong Pharmaceutical Group, a medical company based in Sichuan, started the development of conbercept in 2005.[16] In 2012, the drug was included on the World Health Organization’s Drug Information 67th List of Recommended International Nonproprietary Names,[17] which was the first Chinese innovator biotech drug to be recognized on the list.[18]

In November 2013, the Chinese Food and Drug Administration approved conbercept for the treatment of AMD.[19] By 2014, conbercept was marketed for treatment of wAMD in China.[20] In 2016, Phase III clinical trials of conbercept were authorized by the U.S. Food and Drug Administration.

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.[21] In 2020, conbercept was approved for use in Mongolia.[22]

Clinical trials in China

Society and culture

Legal Status

Economic

External links

Notes and References

  1. Zhang J, Liang Y, Xie J, Li D, Hu Q, Li X, Zheng W, He R . 6 . Conbercept for patients with age-related macular degeneration: a systematic review . BMC Ophthalmology . 18 . 1 . 142 . June 2018 . 29902977 . 6003117 . 10.1186/s12886-018-0807-1 . free .
  2. Lu X, Sun X . Profile of conbercept in the treatment of neovascular age-related macular degeneration . Drug Design, Development and Therapy . 9 . 2311–20 . 2015 . 25960634 . 4410828 . 10.2147/DDDT.S67536 . free .
  3. Cai S, Yang Q, Li X, Zhang Y . The efficacy and safety of aflibercept and conbercept in diabetic macular edema . Drug Design, Development and Therapy . 12 . 3471–3483 . 2018 . 30410308 . 6197825 . 10.2147/DDDT.S177192 . free .
  4. Wang L, Zhang C, Hua R . Clinical effectiveness of ranibizumab and conbercept for neovascular age-related macular degeneration: a meta-analysis . Drug Design, Development and Therapy . 12 . 3625–3633 . 2018 . 30464394 . 6211581 . 10.2147/DDDT.S176021 . free .
  5. Wang Y, Shen M, Cheng J, Sun X, Kaiser PK . The Efficacy of Conbercept in Polypoidal Choroidal Vasculopathy: A Systematic Review . Journal of Ophthalmology . 2020 . 4924053 . 2020 . 32855818 . 7442996 . 10.1155/2020/4924053 . free .
  6. de Oliveira Dias JR, de Andrade GC, Novais EA, Farah ME, Rodrigues EB . Fusion proteins for treatment of retinal diseases: aflibercept, ziv-aflibercept, and conbercept . International Journal of Retina and Vitreous . 2 . 3 . 2016 . 27847621 . 5088480 . 10.1186/s40942-016-0026-y . free .
  7. Zhang Y, Han Q, Ru Y, Bo Q, Wei RH . Anti-VEGF treatment for myopic choroid neovascularization: from molecular characterization to update on clinical application . Drug Design, Development and Therapy . 9 . 3413–21 . 2015 . 26170626 . 4494177 . 10.2147/DDDT.S87920 . free .
  8. Yan M, Huang Z, Lian HY, Song YP, Chen X . Conbercept for treatment of choroidal neovascularization secondary to pathologic myopia . Acta Ophthalmologica . 97 . 5 . e813–e814 . August 2019 . 30187680 . 10.1111/aos.13632 . 52162973 . free .
  9. Sun X, Zhang J, Tian J, Chen S, Zeng F, Yuan G . Comparison of the Efficacy and Safety of Intravitreal Conbercept with Intravitreal Ranibizumab for Treatment of Diabetic Macular Edema: A Meta-Analysis . Journal of Ophthalmology . 2020 . 5809081 . 2020 . 32280526 . 7125465 . 10.1155/2020/5809081 . free .
  10. Web site: EU Clinical Trials Register. Clinical Trials Register.
  11. Li X, Xu G, Wang Y, Xu X, Liu X, Tang S, Zhang F, Zhang J, Tang L, Wu Q, Luo D, Ke X . 6 . Safety and efficacy of conbercept in neovascular age-related macular degeneration: results from a 12-month randomized phase 2 study: AURORA study . Ophthalmology . 121 . 9 . 1740–7 . September 2014 . 24793528 . 10.1016/j.ophtha.2014.03.026 . AURORA Study Group . free .
  12. Cui J, Sun D, Lu H, Dai R, Xing L, Dong H, Wang L, Wei D, Jiang B, Jiao Y, Jablonski MM, Charles S, Gu W, Chen H . 6 . Comparison of effectiveness and safety between conbercept and ranibizumab for treatment of neovascular age-related macular degeneration. A retrospective case-controlled non-inferiority multiple center study . Eye . 32 . 2 . 391–399 . February 2018 . 28937147 . 5805597 . 10.1038/eye.2017.187 . 44026758 . free . (p. 397, Table 2)
  13. Stewart MW . Extended Duration Vascular Endothelial Growth Factor Inhibition in the Eye: Failures, Successes, and Future Possibilities . Pharmaceutics . 10 . 1 . 21 . January 2018 . 29382038 . 5874834 . 10.3390/pharmaceutics10010021 . free .
  14. Sacconi R, Giuffrè C, Corbelli E, Borrelli E, Querques G, Bandello F . Emerging therapies in the management of macular edema: a review . F1000Research . 8 . 1413 . 2019-08-12 . 31448093 . 6694451 . 10.12688/f1000research.19198.1 . free .
  15. Cui C, Lu H . Clinical observations on the use of new anti-VEGF drug, conbercept, in age-related macular degeneration therapy: a meta-analysis . Clinical Interventions in Aging . 13 . 51–62 . 2018 . 29343949 . 5747960 . 10.2147/CIA.S151225 . free .
  16. Web site: China Focus: Innovation boosts development of China's private medical companies. dead. https://web.archive.org/web/20181217115857/http://www.xinhuanet.com/english/2018-12/17/c_137680388.htm . 2018-12-17 . 2021-02-05. www.xinhuanet.com.
  17. Web site: 2012. International Nonproprietary Names for Pharmaceutical Substances (INN). World Health Organization.
  18. Web site: China Focus: Innovation boosts development of China's private medical companies. dead. 2021-02-24. www.xinhuanet.com. https://web.archive.org/web/20181217115857/http://www.xinhuanet.com/english/2018-12/17/c_137680388.htm . 2018-12-17 .
  19. Web site: The Phase 3 Clinical Trial of Conbercept for Exudative AMD. 2021-02-05. Retinal Physician.
  20. Ferro Desideri L, Traverso CE, Nicolò M . An update on conbercept to treat wet age-related macular degeneration . Drugs of Today . 56 . 5 . 311–320 . May 2020 . 32406878 . 10.1358/dot.2020.56.5.3137164 . 218632826 .
  21. Web site: 创新赋能 责任担当 康弘药业高成长性再获认可 每经网. 2021-03-15. www.nbd.com.cn.
  22. Web site: 走进"一带一路"，中国创新药康柏西普在蒙古国获批上市--人民健康网--人民网. 2021-03-15. health.people.com.cn.
  23. Liu K, Song Y, Xu G, Ye J, Wu Z, Liu X, Dong X, Zhang M, Xing Y, Zhu S, Chen X, Shen Y, Huang H, Yu L, Ke Z, Rosenfeld PJ, Kaiser PK, Ying G, Sun X, Xu X . 6 . Conbercept for Treatment of Neovascular Age-related Macular Degeneration: Results of the Randomized Phase 3 PHOENIX Study . American Journal of Ophthalmology . 197 . 156–167 . January 2019 . 30148987 . 10.1016/j.ajo.2018.08.026 . 52100991 .
  24. Qu J, Cheng Y, Li X, Yu L, Ke X . EFFICACY OF INTRAVITREAL INJECTION OF CONBERCEPT IN POLYPOIDAL CHOROIDAL VASCULOPATHY: Subgroup Analysis of the Aurora Study . Retina . 36 . 5 . 926–37 . May 2016 . 26595362 . 10.1097/IAE.0000000000000875 . 23512450 .
  25. Wang H, Guo J, Tao S, Wang X, Liu X, Li T, Wang J, Yang X, Niu T, Liu D . 6 . One-Year Effectiveness Study of Intravitreously Administered Conbercept® Monotherapy in Diabetic Macular Degeneration: A Systematic Review and Meta-Analysis . Diabetes Therapy . 11 . 5 . 1103–1117 . May 2020 . 32236812 . 7192996 . 10.1007/s13300-020-00806-0 .
  26. Web site: The Phase 3 Clinical Trial of Conbercept for Exudative AMD. 2021-02-17. www.retinalphysician.com.
  27. Web site: In-depth company research, Kanghong Pharmaceutical.
  28. Chen R, Wu B . Cost-effectiveness of intravitreal conbercept versus other treatments for wet age-related macular degeneration . Annals of Translational Medicine . 8 . 15 . 939 . August 2020 . 32953739 . 7475432 . 10.21037/atm-20-1334 . free .
  29. Gao L, Liu J, Zhang P, Ma J, Wang H . Clinical outcomes of 1 + PRN and 3 + Q3M regimens of intravitreal conbercept injection for exudative age-related macular degeneration . Scientific Reports . 10 . 1 . 8010 . May 2020 . 32409739 . 10.1038/s41598-020-65000-5 . 7224199 . 2020NatSR..10.8010G . free .

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