Domestically Marketed COVID-19 Treatments Pfizer’s “Paxrovid” and Merck’s “Lagebrio”
As COVID-19 began to spread, the development of treatments for the virus, which had been multiplying like crazy, appears to have come to an end. Dozens of companies once developed treatments for COVID-19, but now only a few companies continue to develop treatments.
Even companies that were trying to complete the development of treatments for Covid-19 seem to lose development momentum and eventually give up.
According to the pharmaceutical industry, on the 4th, three companies announced plans to stop developing COVID-19 treatments in the past three months. It has been confirmed that BL and Aptabio will be discontinued. Shinpoong Pharmaceutical has not officially announced the suspension of development, but the industry believes it has essentially given up.
On the 2nd, BL received approval and was conducting a phase 2 clinical trial of “BLS-H01” targeting 100 coronavirus patients in 2022, but clinical progress was not easy due to difficulties in recruiting patients due to the pandemic. For this reason, BL decided to voluntarily suspend Phase 2 clinical trials and changed its development direction to develop BLS-H01 as a treatment for pneumonia.
Last month, Aptabio voluntarily stopped the Phase 2 clinical trial in the United States for “Isuzynaxib” (APX-115), which had been approved by the US FDA in 2021. Aptabio abandoned the clinical trial because it was determined that it would not It was no longer possible to conduct clinical trials on hospitalized patients due to the rapid decline in the number of hospitalized patients due to the expansion of vaccinations and the decrease in COVID-19 patients.
Aptabio confirmed that APX-115 has an effect on improving lung function in the interim analysis of COVID-19 clinical trials and plans to use it for future development.
In October last year, key results from the global phase 3 clinical trial for Shinpoong Pharmaceutical’s “Pyramax Tablet” were released. In this clinical trial, the primary efficacy endpoint of suppression of severity rate in symptomatic adult patients was not met. The clinical trial failed because it did not produce the desired results.
Shinpoong Pharmaceutical announced that detailed efficacy and safety analyses, including subgroup analysis, are currently underway and that future development directions will be determined based on these results. Although there appears to be hope of producing significant results through further analysis, the industry believes that commercialization will in fact be difficult due to the clinical study alone.
Even for companies that have been successful in COVID-19 clinical trials, the situation is not easy. The cases of Ildong Pharmaceutical and Hyundai Bio are representative examples.
The two companies have completed clinical trials for COVID-19 treatments and have applied for emergency use approval from the Ministry of Food and Drug Safety and are waiting for the results of the preliminary examination, but the results are not conclusive. Since almost a year has already passed since the application was submitted, it is considered that the emergency use approval has been approved.
This means that the strategy of pharmaceutical companies attempting to enter the market even late as latecomers is destined to be disrupted.
Even in Korea there are doubts about the delay in the approval of the products developed by the two companies. Ildong Pharmaceutical’s “Zokova” has already been marketed in Japan and is the most widely used COVID-19 treatment. Hyundai Bio’s “Zefty” has also been shown through clinical trials to be more effective than existing treatments.
That means it’s no longer easy for companies that have been successful in clinical trials to make profits domestically on COVID-19 treatments.
Companies currently conducting clinical trials for COVID-19 treatments at home or abroad include Ubiologics, Celid, iGene and GeneOne Life Science. These companies are continuing their development efforts with the aim of selling to foreign markets such as developing countries rather than domestically, but it seems that it will not be easy to develop sales channels due to the global pandemic.
When another pandemic occurs in the future, experience developing COVID-19 treatments should be useful in developing follow-up products, but it should not be easy to convert that development experience into immediate profits.
2024-01-03 21:32:35
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