EirGenix’s Second Breast Cancer Biosimilar EG1206A Successfully Reaches Phase 1 Clinical Trial ObjectivesTAIPEI
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.