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Medytox Public Announcement
Medytox Public Announcement We sincerely apologize to all our customers and investors for causing concerns regarding the ‘recent administrative actions by the MFDS (KFDA)’.Medytox, which was established in the year 2000 as a venture biotech company, developed ‘Meditoxin’ as the first botulinum toxin product in Korea and fourth in the word.In 2013, Medytox developed ‘Innotox’, which is the first ever liquid botulinum toxin product. In 2016, Medytox also developed ‘Coretox,’ which reduces the immune response risk by using non animal sourced media in the manufacturing process for the first time in the world. Medytox now exports these 3 products to 60 countries. In addition, Medytox achieved KRW 121.6 billion in exports, which is 60% of total sales, in 2019. We are also anticipating the approval of the license in China this year, which will result in even greater sales. There have been no reports to date of any severe adverse effects for using Meditoxin, which has manufactured 16.9 million vials (100 unit equivalent) from the date of initial launching in the market to 2019.The ‘Meditoxin issue’ was initiated of actions by MFDS based on a report in 2019 to the Korea ACRC (Anti-Corruption & Civil Right Commission) by a former Medytox employee (last name with "A"), who was working for Daewoong pharmaceutical in 2019. The issue arose from prosecution investigation based on a report that Medytox used ingredients without change of permission for some of Meditoxin products which were manufactured from December 2012 to June 2015. Following the above report, the MFDS and prosecution have investigated Medytox several times and currently related hearings are ongoing.On April 17, 2020 the MFDS suspended manufacturing and sales of Meditoxin 50 unit, 100 unit and 150 unit products, based on Article 71 of the Pharmaceutical Act.Medytox's position in regard to such decision by the MFDS is as follow1. Actions of MFDS are based on the article 71 of the Pharmaceutical Act pertains to concerns over current "public health" based on sales and manufacturing. However, the period related to the ‘Meditoxin issues’ was from the manufacturing period of December 2012 to June 2015. Meditoxin products manufactured during such period have all been used a long time ago and no longer exist. Therefore, no harm to public health can currently exist.2. The Meditoxin products that are currently being distributed were manufactured after April 2017. Medytox not only received a conformity decision on the inspection for distributed products which was undertaken in 2016 and 2018 by the MFDS, but also had no issues whatsoever during the MFDS' numerous inspections concerning special observations and random collections for distributed products in terms of efficacy and safety within the shelf life.In this connection, Medytox submitted a request for suspension of execution on the MFDS’s order and for cancellation of the MFDS’s order to the Taejon District Court at 9pm on April, 19 2020.Currently, based on the order by the MFDS, Medytox temporarily has suspended the manufacturing and sales of Meditoxin. In response to the above, Medytox plans to increase revenue by promoting 'Innotox' and 'Coretox', which are advanced new botulinum toxin type A products.As a leading global company in the botulinum toxin industry, Medytox has developed the world's first pre filled syringe botulinum toxin products for maximizing usage convenience. Also the R&D division, comprised of 20% of all employees, will soon develop innovative new bio products.Medytox again offers a sincere apology to its shareholders and customers. Taking this opportunity, Medytox will do our best to prevent this from occurring again in the future by preparing internal verification processes and strengthening a continuous monitoring system.Finally, the recent order of the MFDS is related to the production process of Meditoxin which occurred in the past. We note that this issue is a separate and unrelated issue from the legal disputes with Daewoong Pharmaceutical at the U.S International Trade Commission (ITC) and the civil and criminal cases with respect to the theft of Medytox's botulinum toxin strain and manufacturing process. The truth will start to unfold with the ITC's initial determination on June 5, 2020.
2020.04.20
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Medytox received approval of the world’s first liquid-type BTX ‘INNOTOX® 100 unit’ in domestic market from MFDS
- With the approval, Medytox secured its lineup of various capacities along with 25, 50 units…dominating the premium BTX market in advance - The utilization rate of Medytox’s 2nd plant under cGMP guidelines has increased SEOUL, SOUTH KOREA – January, 2020 – INNOTOX® 100 unit received approval in domestic market manufactured in Medytox’s second plant designed to meet cGMP of US FDA. Medytox Inc., the leading biopharmaceutical company in Korea, said on January 2 that the Ministry of Food and Drug Safety has approved to sell INNOTOX® 100 unit, the world’s first liquid-type botulinum toxin (BTX) A-Type product, in the domestic market. With this approval, Medytox has secured its lineup of various capacities along with the existing 25 and 50 units. Also Medytox has increased the utilization rate of its second plant in Osong, which exclusively manufactures BTX products under U.S. current Good Manufacturing Practice (cGMP) guidelines. INNOTOX® is the world’s first liquid type BTX A-type developed by Medytox in 2014. It enhances safety by eliminating both human serum albumin and animal-derived substances in the manufacturing process. Also INNOTOX® can be used immediately without any dilution process, further improving the convenience of treatment and having the advantage of more accurate treatment capacity calculation. "The sales approval for INNOTOX® 100 unit is significant as it has allowed the company to secure a lineup of various capacities, and help to meet consumer needs better," Medytox CEO Hyunho Jung said. "Clinical trials are underway to secure additional indications for INNOTOX® and accelerate the company's advance to the premium BTX market." The company also plans to unveil a new prefilled syringe-type BTX, Jung said. Meanwhile, Medytox signed a partnership with Allergan, the original manufacturer of Botox, in 2013 to bring BTX to the advanced market. Recently, Allergan initiated phase 3 clinical trials in both US and EU with hopes to get US marketing approval in 2022.
2020.01.03
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