K-botulinum products are expanding globally

North America, China, and Europe

Hugel's Botulex has a 10% share in China

Medy Tox challenges U.S. with next-generation toxins, analyzing phase 3 results

Hugel Botulex (Letybo)

Domestic botulinum toxin is entering various parts of the world.

 

Feeling limited in the domestic market, developers are targeting the U.S., Europe, and China, which are the largest markets in the world, while expanding their scope to countries such as Australia and the Middle East.

 

◆ Hugel is targeting Europe and North America, and China is expanding its market According to the pharmaceutical industry on the 20th, Hugel won the license for the botulinum toxin drug Letybo developed in Canada on the 16th.

 

It is Hugel's first North American entry.

 

According to Hugel, the Canadian botulinum toxin market is estimated to be worth 180 billion won as of last year.

 

Starting with Southeast Asia, Hugel has attempted to enter Botulinum overseas in earnestly.

 

It is understood that the license registration has been completed in about 40 countries so far.

 

Last year, it applied for permission for Botulinum in the U.S.

 

and Canada to target North America.

 

In particular, the United States is one of the largest botulinum toxin markets worth about 2 trillion won.

 

The U.S.

 

approval, which was originally expected to be approved at the end of March, is expected to take place at the end of this year or early next year.

 

Starting in February, news of Letybo continued in Europe, starting with France.

 

In January, HMA issued a permit recommendation for botulinum.

 

The HMA receives individual decisions in each country after the recommendation for approval, so the date of approval varies.

 

Letybo has obtained product permits from 10 countries, including key European countries such as France, the United Kingdom, Germany, and Italy.

 

◆Daewoong Nabota Launches Third Quarter in Europe.

 

U.S.

 

Sales Close to 300 Billion Daewoong Pharmaceutical's botulinum toxin drug Nabota is doing good performance in the North American market, which was the first to enter.

 

Nabota posted nearly $100 million in sales last year, up 77.3% from the previous year.

 

This is the result of the North American sales of Daewoong Pharmaceutical's U.S.

 

partner Evolus.

 

Nabota's cumulative sales, which were approved by the U.S.

 

in February 2019, amounted to $223.04 million.

 

In the first quarter of this year, Nabota has continued its upward trend, recording $33.23 million (42.5 billion won), up 171.5% from the previous year.

 

Nabota

In the third quarter, Nabota is also set to enter Europe, the second largest market in the world.

 

Evolus, a U.S.

 

partner, will be in charge of sales.

 

Previously, Evolus obtained an item license from the European Commission (EC) in October 2019 under the name Nuceiva.

 

Nuceiva can be sold in 28 countries in the European Union and a total of 31 European countries, including the UK and Switzerland.

 

Daewoong Pharmaceutical recently expanded its scope to Eastern Europe and the Middle East.

 

It has obtained Nabota permission from Saudi Arabia, one of the largest markets in the Middle East, and Ukraine, the representative country of Eastern Europe.

 

Its goal is to expand its market share in the Middle East and Eastern Europe starting with Saudi Arabia and Ukraine.

 

In December last year, Daewoong Pharmaceutical filed an application for permission for Nabota with the NMPA.

 

While Hugel and Daewoong Pharmaceutical are expanding their market to one item developed by themselves, Medy Tox is trying to diversify its products.

 

It was the first in Korea to commercialize botulinum toxin preparations and enter the development of next-generation toxin preparations early.

 

Meditoxin is exported to more than 30 countries around the world under the name Neuronox.

 

However, exports have been decreasing every year since 2019.

 

Overseas exports of Medy Tox, which were 133.3 billion won (including filler products) in 2018, decreased to 120.6 billion won in 2019 and 89.8 billion won in 2020.

 

It recorded 70.6 billion won last year.

 

Neuronox

Newlux, which applied for item permission from the MFDS in May, is a new product that Medy Tox applied the latest process to reduce the possibility of contamination by impurities.

 

Medy Tox is also speeding up its overseas licensing work for Newlux exports.