EirGenix's World-Class Biopharmaceutical Manufacturing Facility Becomes the 
First of Its Kind in Taiwan to Receive Approval 

EirGenix, Inc. (6589, TT) had undertaken the transfer of drug substance 
manufacturing of a marketed drug from a Japanese pharmaceutical company and has 
since fulfilled all the regulatory requirements necessary to complete the 
manufacturing site transfer. The independently administered Pharmaceutical and 
Medical Devices Agency (PMDA), under Japan's Ministry of Health, Labour, and 
Welfare, carried out its on-site inspection of EirGenix's biopharmaceutical 
manufacturing facility from September 9th to September 12th, 2019. A successful 
inspection and approval from PMDA would authorize EirGenix to sell back the 
manufactured drug substance to its Japanese client to ultimately be sold on the 
Japanese market. On February 3rd, 2020, EirGenix received PMDA's official 
approval in its issued 'GMP Compliance Inspection Result Notification', 
proclaiming EirGenix's compliance with relevant Japanese regulations regarding 
the quality, effectiveness and safety of pharmaceutical manufacturing. The 
approval from PMDA represents a remarkable milestone for both EirGenix and 
Taiwan, as EirGenix's facility becomes the first GMP biopharmaceutical 
manufacturing facility in Taiwan to receive the authority's approval. EirGenix 
now stands amongst a small, select group of biopharmaceutical manufacturers in 
Asia that have earned PMDA's approval. Having reached such an astonishing 
achievement has highlighted the rapid growth of EirGenix's contract development 
and manufacturing (CDMO) services to world-class quality standards. The 
exciting news will be sure to stimulate the interest and confidence of both 
Japanese and other international companies in contracting its CDMO service 
needs to EirGenix.

In the past year, EirGenix has experienced substantial growth in its business 
with its 2019 revenue easily surpassing the year prior. Overseas revenue has 
grown the most rapidly with total overseas revenue to domestic revenue ratio 
now reaching a staggering 4 to 1. EirGenix's CDMO business in the Japanese 
market has continually and steadily grown over the years and is the largest 
contributor to overseas revenue. It is without a doubt that EirGenix's revenue 
from its CDMO business will grow even more rapidly in the coming years as even 
more Japanese and other international companies turn their focus towards 
EirGenix as a potential service provider. Passing PMDA's inspection represents 
EirGenix's first international 'stamp of approval' that attests to EirGenix's 
rise in attaining the international standards of other global players.

EirGenix has been providing CDMO services since its establishment in 2013. In 
less than 7 years, the company has seen its operating income grow to a record 
high of 400 million New Taiwan Dollars in 2019, with its gross profit also 
reaching a record high. This year, EirGenix will continue to undertake even 
more contracts entrusted to it by international biotech and pharmaceutical 
companies from all over the world, including Japan, the United States, Mainland 
China, and Europe. In its pioneer years, EirGenix primarily served the local 
Taiwanese market, but quickly expanded its business outside Taiwan to become 
the international CDMO company it is today. Now with the announcement of PMDA's 
authorization for EirGenix to manufacture marketed drug substances in Japan, 
EirGenix further expands its offerings to a more robust service life cycle, 
from early-stage research and development up to commercial manufacturing of 
marketed products. EirGenix's greater one-stop CDMO service offerings are 
certain to provide it with the competitive advantage to compete with other 
international companies on the global market.

Website: www.eirgenix.com