EirGenix, Inc. (6589.TT) announced on 28th of April that it has completed the 
phase 1 clinical trial (EGC101) of its second breast cancer biosimilar EG1206A 
in Europe. Comparing EG1206A to Roche's Perjeta® US and EU, results of the 
clinical data analysis show that the main test indicators have met the 
pharmacokinetics bioequivalence standard. EG1206A is a biosimilar drug of the 
second-generation HER2-positive antibody drug Perjeta® (pertuzumab). EG1206A 
has a unique binding mechanism for HER2 receptors which can produce a dual 
blockade effect. In combination with the first-generation HER2-positive 
antibody drug Trastuzumab, Pertuzumab has a synergistic effect in the treatment 
of early-stage HER2-positive breast cancer and metastatic breast cancer.

The success of EG1206A's phase 1 clinical trial is an important milestone for 
EirGenix and its development of biosimilar drug products for the treatment of 
HER2-positive breast cancer. Following the product launch of its first 
biosimilar drug EG12014 (trastuzumab biosimilar), EG1206A will soon begin its 
multi-country, multi-center global phase 3 clinical trials. After the 
initiation of the phase 3 clinical trials, it is expected that the evaluation 
of the primary end point indicators will be completed within two (2) years. 
Concurrently, EirGenix has been negotiating with global pharmaceutical 
companies for licensing marketing rights of EG1206A to further fast-track the 
launch of the biosimilar into the global market. Such achievements in 
EirGenix's product development bring great excitement to the future of Taiwan's 
biotechnology industry.

1. About EG1206A (pertuzumab biosimilar)

EG1206A is a biosimilar drug of the second-generation HER2-positive antibody 
drug Perjeta® (pertuzumab). The clinical combination of trastuzumab and 
pertuzumab has a synergistic effect in the treatment of early-stage 
HER2-positive breast cancer and metastatic breast cancer. Patients with 
HER2-positive breast cancer account for approximately 20-30% of new breast 
cancer cases per year. The dual-drug therapy can help to prolong the survival 
period of breast cancer patients and is a standard treatment strategy 
recommended by many international treatment guidelines. According to 2022 sales 
data by Roche (developer of the originator drug Perjeta®), global sales of 
Perjeta® (pertuzumab) reached 4.087 billion Swiss Francs (4.56 billion U.S. 
Dollars). By the time the patent of Perjeta® expires in 2026, it is expected 
that global sales will reach 6 billion U.S Dollars (approx. 180 billion New 
Taiwan Dollars). In 2021, "Taiwan's National Health Insurance" paid 1.02 
billion New Taiwan Dollars for Perjeta® (pertuzumab) products. EirGenix's 
EG1206A currently ranks amongst the top globally for most advanced developments 
of pertuzumab biosimilars. Once EirGenix's products are launched onto the 
market, HER2-positive breast cancer patients will be provided with more 
accessible and affordable treatment options.

2. About EirGenix, Inc.

EirGenix has used its reverse engineering technology to develop several 
biosimilar drug products, including 5 antibody products for the treatment of 
HER2-positive breast cancer. With the continued advancement of EirGenix's 
product line for HER2-positive breast cancer, there is great optimism in the 
future development of the international market. In addition to EirGenix's 
product development, EirGenix will begin production in Q3 2023 at the newly 
completed second production line of its Zhubei Commercial Production Facility. 
The completion of the second production line brings EirGenix's total production 
capacity to 25,500 L. Through the company's innovation and hard work, EirGenix 
has quickly risen to one of the fastest growing biopharmaceutical companies in 
Taiwan.

Website:  www.eirgenix.com 


SOURCE: EirGenix