(Health Korea News / Lee Soon-ho) The clinical trial in the United States for ‘K-CAB (ingredient: tegoprazan),’ a new drug for the treatment of gastroesophageal reflux disease in the potassium-competitive acid secretion inhibitor (P-CAB) series developed by HK inno.N, is nearing its final stages. One of the three clinical trials currently underway in the country has already been confirmed to have been completed, and the remaining two are likely to be completed within the year.
With products already launched or undergoing approval procedures in many countries including Asia and Central and South America, it is becoming apparent that the company will enter the US, the largest pharmaceutical market. In line with this, the company is expanding its raw material supply channels for mass production of finished products and is expediting its preparations to conquer the global market.
According to the international clinical trial registration site Clinical Trials of the National Institutes of Health (NIH) on the 23rd, HK inno.N’s North American partner Braintree Laboratories (hereinafter referred to as Braintree) completed the phase 3 clinical trial of ‘K-Cap (local project name: BLI5100)’ targeting patients with non-erosive esophagitis in April.
The company belatedly updated the changes at the end of July, about three months after the end of the clinical trial. Considering the timing of the end of the clinical trial, it seems likely that the company had already begun data analysis.
Braintree is currently conducting two phase 3 clinical trials, including one phase 3 clinical trial targeting patients with erosive esophagitis in addition to non-erosive esophagitis, and a long-term phase 3 safety clinical trial targeting patients with reflux esophagitis.
Among these, the long-term safety phase 3 clinical trial has completed patient recruitment and is aiming to be completed by the end of this month. The phase 3 clinical trial targeting patients with erosive esophagitis is currently recruiting patients and is expected to be completed within the year.
If all goes according to plan, all three clinical trials of ‘K-Cap’ in the United States will be completed within this year. If no other delays occur, it is expected that applications for US FDA approval will be possible as early as the second half of next year.
Currently, the only P-CAB drug approved in the United States is PHATHOM’s ‘VOQUEZNA (ingredient name: vonoprazan)’. ‘Vokezna’ is the US brand name of Japan’s Takeda Pharmaceutical Company’s P-CAB drug ‘Takecab’. Takeda Pharmaceutical Company separated PHATHOM into a subsidiary in 2019, and three years later, in 2022, ‘Vokezna’ was approved in the US as the first P-CAB drug through PHATHOM.
However, the launch was put on hold due to the discovery of impurities, but the company was able to maintain FDA approval last year when it submitted additional safety data. In addition, in November of the same year, in addition to the initial indication of treating Helicobacter pylori infection, it secured an additional indication for treating erosive esophagitis.
In fact, since the full-scale launch of ‘Bokezna’ began at the end of last year, if Braintree speeds up the commercialization of ‘K-Cap’ in the US, it seems that it will be able to catch up with ‘Bokezna’.
HK inno.N adds Tegoprazan raw material manufacturing plant… Global supply preparations ‘steadily’
Braintree, HK inno.N’s US partner, is a subsidiary of the US pharmaceutical company Sebella, and signed a technology transfer agreement for ‘K-Cap’ with HK inno.N in 2021. Accordingly, Braintree acquired local clinical trials, approval, and distribution rights for ‘K-Cap’. However, the raw materials for ‘K-Cap’ for the US market will be supplied by HK inno.N.
As it is targeting the world’s largest pharmaceutical market, a stable supply of raw materials for ‘K-Cap’ has emerged as an important task for HK inno.N.
Reflecting this, HK inno.N added Pharmacostech, a domestic raw pharmaceutical manufacturing company, as the manufacturer of tegoprazan, the raw material of ‘K-Cap’, to the list of raw pharmaceutical ingredients (DMF) of the Ministry of Food and Drug Safety last month.
Regarding this, an official from HK inno.N said, “Considering future production increases, we have additionally registered the raw materials produced by Pharmacostec on the Ministry of Food and Drug Safety’s DMF list to ensure a stable supply of raw materials.”
Accordingly, HK inno.N’s Tegoprazan raw material supply channels have increased to a total of four. When HK inno.N first received approval for ‘K-Cap’, it received raw materials from only one source, China’s Wisdom Pharmaceutical Co., Ltd., but as market demand exploded, it added Estifarm as a raw material manufacturer in 2021 and began its own production.
The reason why securing raw material supply channels has become important is not only because of the United States. ‘K-Cap’ has already been released and is being sold in China, the Philippines, Indonesia, Mongolia, Singapore, Mexico, Peru, Chile, etc., and clinical trials or approval procedures are underway in dozens of countries in Central and South America, Asia, and the Middle East.
This means that in the future, securing raw materials for Tegoprazan is likely to have a direct impact on the global market supply of ‘K-Cap’. Against this backdrop, there are observations that HK inno.N may further expand its supply channels for raw materials for ‘K-Cap’ than they are now.
An industry insider said, “Currently, ‘K-Cap’ sales are around 120 billion won. HK inno.N aims to enter 100 countries by 2028 and achieve 2 trillion won in sales of ‘K-Cap’ in the global market alone by 2030,” adding, “Considering that the global market conquest has just begun, the amount of raw material needed to supply is likely to increase rapidly.”
He added, “HK inno.N is signing contracts with domestic companies for the production of ‘K-CAP’ raw materials following Wisdom Pharmaceutical,” and “If we continue to expand our raw material supply channels through domestic raw material manufacturers as we are doing now, we can expect to build a win-win relationship where domestic companies can grow together.”
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Source: www.hkn24.com
