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On April 9, Kanghong Pharmaceutical announced that it would completely stop the global multi-center clinical trial of Conbercept ophthalmic injection
.
As a domestically produced and original Class 1 drug, Conbercept has performed well in the past few years and is a star drug that the industry has placed high hopes on
Domestic original biological class 1 new drug
As a class 1 innovative drug with completely independent intellectual property rights independently developed by Kanghong Biological, Conbercept ophthalmic injection can effectively bind to VEGF in blood vessels and tissues and block the VEGF-mediated promotion of new blood vessel sprouting and growth The signal transmission of retinal disease is a blockbuster domestic drug in the field of treatment of retinal diseases
.
In November 2013, Conbercept was approved for marketing by the State Food and Drug Administration of China, and the approved indication is wet age-related macular degeneration (wAMD).
In 2017 and 2019, Conbercept was approved in China.
Two new indications were approved: for the treatment of visual impairment caused by choroidal neovascularization secondary to pathological myopia (pmCNV), and the treatment of visual impairment caused by diabetic macular edema (DME)
.
As of the end of 2020, Conbercept has accumulated more than 1.
5 million injections in China, and its related clinical studies have been 74, covering more than 13,000 patients.
The safety and effectiveness of domestic patients have been adequate Verification
.
Review of Compaqcept's overseas clinical layout
Based on a large amount of clinical trial data in China, Kanghong Pharmaceutical submitted a clinical application to the US FDA for the first time in 2016
.
In September 016, the US FDA approved the direct development of a phase III clinical trial of Conbercept ophthalmic injection for the treatment of wAMD indications.
In November 2017, Kang Hong hired the professional CRO company INC Research to be responsible for the full implementation of the trial on a global scale
.
In April 2018, Kanghong received a notice from the U.
S.
FDA on the special program review of clinical trials, and agreed to directly enter the global phase III clinical trial of Conbercept
.
In September 2018, the first subject in the United States was enrolled for treatment
.
In 2019, the PANDA trial received clinical registration applications from 17 countries/regions
.
In 2020, all enrolled subjects will continue to receive drug treatment in accordance with the clinical trial protocol
.
In 2021, the project will enter a comprehensive safety observation phase, and the phased database lock for the 36-week primary endpoint will be completed in March; in April, the PANDA Trial Scientific Steering Committee held a special meeting and conducted a mid-term review of the existing data Comment
.
The adverse impact of the epidemic on the overseas clinics of Conbercept
In January 2020, the new crown epidemic broke out one after another at home and abroad
.
As a global public health emergency, the new crown epidemic has caused great difficulties and impacts on Conbercept's overseas clinical research.
Factors including various control measures introduced by various countries have caused a large number of subjects to fall off and lose follow-up.
, Super-windows, the closure of a large number of research centers and visit restrictions have also made on-site clinical quality inspections and audits extremely difficult, and the project implementation has started a comprehensive battle
.
As many as 68 clinical trial centers, more than half of the subjects' visual acuity improved at or below zero from baseline after injection
.
The 68 center analysis is based on all patients with aflibercept and conbercept.
At present, there is no universal assessment and correction method for the epidemic situation, and the significant impact on the PANDA trial cannot be fully evaluated.
The PANDA trial failed to achieve the expected goal.
Considering the clinical benefits of the tested patients, the continued advancement of the PANDA trial has been unable to obtain registration.
The result of value
.
Follow-up
In the recent investor exchange meeting for listed companies, Kanghong Pharmaceutical stated that the two sub-tests 1801 and 1802 of the PANDA trial have now been stopped globally.
The company needs to analyze and investigate the trial, and carefully analyze the data and the reasons behind it.
And continue to communicate with regulatory agencies in various countries to prudently promote follow-up related work
.
