What Is Anti-VEGF?

A new generation of anti-VEGF fusion protein, China's first biological class I new drug with full independent intellectual property rights, which has been given the international common name of the World Health Organization.

Conbercept, English name "Conbercept". It is a fusion protein resistant to vascular endothelial growth factor. The patent holder is Chengdu Kanghong Biotechnologies Co. Ltd., which can inhibit pathological angiogenesis. ^[1]

Drug Name: COMPAXIP Ophthalmic Injection ^[2]
Alias: Lang Mu
Foreign name: Conbercept Ophthalmic Injection

Whether prescription drugs: prescription
Main indications: For the treatment of wet age-related macular degeneration (AMD)
Dosage form: Injection

Compaq Ingredients

Active ingredient: Conbercept is a recombinant fusion protein produced by the Chinese hamster ovary (CHO) cell expression system Immunoglobulin-like regions 3 and 4 in the human immunoglobulin Fc fragment).
Excipients: citric acid, sucrose, arginine, polysorbate 20, etc. ^[2]

Compaq Specs

10 mg / ml, 0.2 ml / piece ^[2]

Compaq Indications

For the treatment of wet age-related macular degeneration (AMD). ^[2]

Compaq adverse reactions

The most common adverse reactions in the clinical trials of Compaq's ophthalmic injections are: bleeding at the injection site, conjunctival congestion, and increased intraocular pressure. These three adverse reactions are caused by intravitreal injection, and to a lesser extent, most of them Recover without treatment. Other adverse reactions include conjunctivitis, vitreous opacities, decreased visual acuity, anterior chamber flash, eye inflammation, cataracts, and corneal epithelial defects. Very few patients have iridocyclitis, iritis, uveitis, retinal rupture, Occasional adverse reactions such as eye congestion, eye pain, and endophthalmitis. ^[2]

Compaq Dosage

This product should be used in qualified hospitals and ophthalmologists. The hospital should have the relevant equipment and conditions required for the diagnosis and treatment of the disease, and it should be operated by an ophthalmologist qualified doctor trained in intravitreal injection technology.
This product is administered by intravitreal injection. The recommended dosing schedule for this product is: 0.5 mg / eye / time per month (equivalent to an injection volume of 0.05 ml) in the vitreous cavity every month for the first 3 months, and then once every 3 months in the vitreous cavity.
Alternatively, the drug may be administered as needed after the monthly intravitreal cavity administration for the first 3 months. This protocol requires monthly follow-up of the patient, and an ophthalmologist assesses whether the patient needs re-administration due to active disease based on the patient's vision and imaging results. After the initial 3 consecutive doses, the on-demand dose requires more follow-up and inspection than the once every 3 months, but the patient may get better treatment results with a more reasonable dose .
During the treatment, the patient's vision changes should be paid attention to. If there is a significant vision loss, the patient should further receive the injection of this product according to the assessment of the ophthalmologist. The interval between two injections should not be less than 1 month. ^[2]

Compaq Information

Conbercept was reviewed by the 51st International Non-Proprietary Name (INN) Naming Conference of the World Health Organization in 2011, with the English name "Conbercept". It is a fusion protein resistant to vascular endothelial growth factor. The patent holder is Chengdu Kanghong Biotechnologies Co. Ltd., which can inhibit pathological angiogenesis. ^[1] The international non-proprietary name (that is, the "international common name") of FP3 protein (a fusion protein that inhibits angiogenesis) passed through the active proteins of KH902 and KH903, a class 1 new drug of Chengdu Kanghong Pharmaceutical Co., Ltd., is "Compaq "Xipu", commonly known as "Conbercept" in English, and notified the National Pharmacopoeia Committees ^[3] . In 2012, the World Health Organization included "Conbercept" in the 67th Recommended International Non-proprietary Names (Recommended INNs) directory.

Chengdu Kanghong Pharmaceutical is developing Compaqip Ophthalmic Injection (KH902). Compaqop Ophthalmic Injection (KH902) treats a variety of fundus neovascular diseases by blocking the growth of diseased neovascularization by blocking VEGF-mediated signal transmission. These include age-related macular deformity (AMD), diabetic macular edema (DME), pathological myopia (PM), and retinal vein occlusion (RVO).

On December 04, 2013, the official website of the State Food and Drug Administration announced that the State Food and Drug Administration approved the use of Conbercept Ophthalmic Injection for the treatment of wet age-related macular degeneration. Age-related macular degeneration (AMD), also known as age-related macular degeneration, is a aging change in the structure of the macular region of the retina. It is mainly caused by irreversible vision loss or loss caused by retinal pigment epithelial cells and retinal degenerative diseases. The disease is clinically divided into two types: dry (atrophic) AMD and wet (exudative) AMD, which occur more than 45 years of age. The incidence rate increases with age. With the acceleration of the aging process in China, the wet The incidence of AMD-induced blinding eye disease is increasing year by year, and it is one of the main eye diseases of the elderly with reduced vision and blindness. The main pathological manifestation of wet age-related macular degeneration is choroidal neovascularization. Studies have shown that VEGF is an essential inducing factor in both physiological and pathological angiogenesis. If it can inhibit the activity of VEGF, it can effectively control the generation of new blood vessels. The Compaqop Ophthalmic Injection approved by the State Food and Drug Administration is a new class drug for therapeutic biological products. It is a fusion protein of VEGF receptor and human immunoglobulin Fc segment gene recombination. The growth factor VEGF competitively inhibits the binding of VEGF to receptors and prevents the activation of VEGF family receptors, thereby inhibiting endothelial cell proliferation and angiogenesis, and achieving the purpose of treating wet age-related macular degeneration. Compaqop Ophthalmic Injection is China's first self-developed drug to treat the disease, and has positive significance for solving the availability of clinical medicine in China. Compaq's ophthalmic injection is administered by intravitreal injection and should be used in qualified hospitals and ophthalmologists. ^[4]

On December 23, 2013, the official website of the State Food and Drug Administration issued the "GMP Certification Announcement for Drugs (No. 14)" ^[5] . Chengdu Kanghong Biotechnology Co., Ltd. approved on-site inspection and review to comply with the "Good Manufacturing Practices (2010 (Revised annually) "and issued a" GMP Certificate for Drugs ", the scope of certification: Compaqop Ophthalmic Injection (10mg / ml, 0.2ml / piece).

Certificate number ^[5]	Company Name	address	Certification scope	Certification date	Valid until	Issuing authority
CN20130483	Chengdu Kanghong Biological Technology Co., Ltd.	No. 108 West Shu Road, Jinniu District, Chengdu	COMPAXIP Ophthalmic Injection	December 23, 2013	December 22, 2018	State Food and Drug Administration