▎WuXi AppTec Content Team Report

Today (October 12), the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China announced that the marketing application for brolucizumab injection submitted by Novartis has been accepted, with the specific indications yet to be disclosed.Public information shows,Brolucizumab (brolucizumab) isNext-Generation Retinal Disease Treatment Drugs Targeting VEGF Inhibition, which has previously been approved internationally for the treatment of wet age-related macular degeneration (wAMD, also known as nAMD) and diabetic macular edema (DME). In China, the product's first marketing application was accepted in August last year, and this is the product's second marketing application in China.

Screenshot source:CDE Official Website

Brolucizumab was developed by Novartis.Full VEGF-A InhibitorIt is a novel humanized single-chain antibody fragment with a molecular weight of only 26kDa, high affinity, strong tissue penetration, and minimal systemic side effects.According to the introduction in the public data released by Novartis earlier, compared with existing treatment methods,BrolucizumabCan absorb intraretinal fluid/subretinal fluid earlier, requiring injection only once every 3 months after the loading period., has certain advantages in continuously improving anatomical structure, fornAMD (neovascular age-related macular degeneration) and DME (diabetic macular edema) and other fundus diseasesThe patient showed better control of effusion.

ClothZiv-afliberceptIt has been approved in dozens of countries worldwide for the treatment of nAMD and DME.In China, Brolucizumab has not yet received formal approval from the NMPA. However, according to publicly available information from Novartis, it was previously approved for urgent clinical use in designated medical institutions within the Greater Bay Area under the "Hong Kong-Macao Medicine and Device Access" policy.

According to the official website of the Chinese Clinical Trial Registry and Information Disclosure Platform, Novartis has completed at least three Phase III clinical studies of brolucizumab in China, including:

1) A 96-week international multi-center (including China) Phase 3 study, inPatients with Proliferative Diabetic RetinopathyEfficacy and Safety of Brolucizumab 6mg Compared to Panretinal Photocoagulation (CONDOR);

2) A Phase 3 clinical study in China comparing brolucizumab with the control drugChinese patients with neovascular age-related macular degenerationEfficacy and safety in China;

3) A Phase 3 clinical study in China,Chinese adult patients with vision impairment due to diabetic macular edemaEvaluate the efficacy and safety of Buziuzumab.

Based on the progress of clinical research and the registration classification for marketing application (Category 3.1 refers to biologics that are produced overseas, already marketed overseas, but not yet marketed in China), it can be inferred that，The two marketing applications successively submitted by Brolucizumab in China target the indications respectively.DME andnAMD。

From the clinical data, previously, the global multicenter HAWK & HARRIER trials enrolled nearly 3000 nAMD patients.LinBed ResearchThe 1-year results showed:BrolucizumabThe effect of the control group at Week 12 can be achieved by the test group at Week 4, along with the presence of intraretinal fluid/subretinal fluid,Retinal Pigment Epithelium (RPE)The proportion of patients receiving infusion is lower than that of the control group.A decrease of up to 41%; For patients with persistent effusion,BrolucizumabGroupAt 24 weeks, the proportion of patients achieving a visual acuity benefit of more than 15 letters was 61% higher than in the control group.; More than half ofBrolucizumabPatients in the group were able to maintain a treatment interval of once every 12 weeks (q12w) until week 52 after the loading period, and among those who first achieved q12w., over 80% of patients can successfully achieve continuous q12W interval treatment subsequently.。

In addition,BrolucizumabThe pivotal Phase 3 study KITE for the treatment of DME patients has also met its primary endpoint and key secondary endpoints, with 6mg showing superiority compared to the control drug.BrolucizumabAt Year 1 (Week 52) Best Corrected Visual Acuity (BCVA）Achieved non-inferiority in the average change.

We look forward to the smooth progress of subsequent clinical studies of Brolucizumab, which will benefit more patients as soon as possible.

[2] ARVO Major Release - Brolucizumab PDR Global Phase III Trial Results: Significant Superiority in Vision Maintenance Compared to Traditional PRP Therapy. Retrieved May 9, 2024, from https://mp.weixin.qq.com/s/MOlJqU43s_fgQ-1HTBCDHg

[3] Innovative Ophthalmic Drug Brolucizumab Completes First Batch of Injections at Public Hospitals in China, Benefiting More Patients with Eye DiseasesP Therapy. Retrieved May 22, 2024, from https://mp.weixin.qq.com/s/vW6UOvLffZW_Ria5kklj4A