PR100062

TAIPEI, May 8, 2023 /PRNewswire=KYODO JBN/ --

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