Clinical Progress Possible with Alternatives
Low Dependence on Raw Material Procurement
On the 25th, citizens at Seoul Station are watching news related to Russia's invasion of Ukraine. Photo by Moon Honam munonam@
[Asia Economy Reporter Lee Gwan-joo] Amid rising concerns in the domestic industrial sector due to Russia's invasion of Ukraine, the impact on the pharmaceutical and bio industries is expected to be limited. In the case of clinical trials, alternatives are available, and since the proportion of raw material procurement is low, the direct impact is not expected to be significant.
According to the industry on the 25th, some domestic pharmaceutical and bio companies have conducted or planned clinical trials in Ukraine, but currently there are no major issues. SK Bioscience conducted part of the multinational Phase 3 clinical trial of the COVID-19 vaccine candidate 'GBP510' in Ukraine, and the dosing has already been completed. A company official said, "We are at the stage where we only need to receive and analyze serum," adding, "The trial was conducted on 99 subjects in Ukraine without major disruptions, and there are no problems in receiving the serum."
In the case of Chong Kun Dang, in September last year, the Ukrainian Ministry of Health approved the Phase 3 clinical trial plan for 'Napabeltan' (active ingredient Napamostat), which is being developed as a COVID-19 treatment, and Phase 3 trials are also underway in Russia. However, since the number of clinical trial patients per country is not fixed, it is not expected that the clinical trials will be immediately disrupted. A Chong Kun Dang official stated, "Clinical trials are being conducted in eight countries worldwide, so we believe there will be no significant problems."
Shinpoong Pharmaceutical announced on the 14th of this month that it changed the countries for the Phase 3 clinical trial of 'Piramax Tablet,' which is being developed as a COVID-19 treatment. The original plan was to conduct trials in Poland, Russia, Argentina, and Chile, but Russia was excluded and Colombia was added. The company explained, "Considering the current international and political situation in Russia, it was judged difficult to proceed with the clinical trial there, so the clinical trial country was changed to Colombia." Additionally, Shinpoong Pharmaceutical has applied for a Phase 3 clinical trial of Piramax Tablet in the United Kingdom. Since they responded quickly, it is expected that this situation will not have a major impact.
The industry expects the impact of Russia's invasion of Ukraine to be limited. Although some disruptions may occur in clinical trials, alternatives exist such as conducting trials in other countries, and the dependence on raw material procurement is not high. A representative from the Korea Pharmaceutical and Bio-Pharma Manufacturers Association analyzed, "The areas that could be affected are clinical trials and raw material procurement, but raw material procurement is usually heavily dependent on India or China, and the proportion from Russia and Ukraine is small," adding, "Since there are alternatives for clinical trials, the impact is expected to be limited."
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