Trastuzumab biosimilar (EirGenix)

TAIPEI, Nov. 22, 2023 /PRNewswire/ -- EirGenix Inc. (6589. TT) announced today that its trastuzumab biosimilar medicine (EG12014) which their commercial partner Sandoz plans to commercialise (150 mg, for intravenous use) had received a marketing authorization from the European Commission (EC). The marketing authorization in the EU will cover the treatment of human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers, which are the same indications approved by the EC for the reference biologic, Herceptin®. Sandoz AG and EirGenix signed a license agreement in April 2019. Under this agreement, EirGenix Inc. will remain responsible for the development and manufacturing of trastuzumab while Sandoz will hold the rights to commercialize the medicine upon approval in the global market (excluding Taiwan, China, Russia, and some Asian countries). Breast and gastric cancers are among the most frequently occurring in Europe, and combined, are responsible for nearly 200,000 deaths annually. Biosimilars have enormous potential to improve cancer care by substantially increasing access to these critical medicines. The impact of both breast and gastric cancer in Europe is significant. Each year, over 355,000 women are diagnosed with breast cancer, and with 92,000 deaths per year, it is the number one cause of cancer death among women. Gastric cancer is the sixth most common of all cancer types and with 107,000 deaths annually it is the fourth most common cause of cancer-related death in Europe. In up to 20% of breast cancers and up to 30% of gastric cancers diagnosed, a HER2 protein overexpression (or HER2 gene amplification) is detected resulting in an uncontrollable growth and division of cells. HER2 cancers are particularly aggressive cancer types that respond well to targeted treatment. The authorisation of EG12014 in Europe expands access to a vital, high-quality treatment for breast and gastric cancers helping to ease the burden of these diseases on patients and delivering important savings for healthcare systems to ensure sustainability. EirGenix's trastuzumab biosimilar drug (EG12014) (150 mg lyophilized powder for injection) also received market approval by TFDA in June. The application of the health insurance pricing was approved by the National Health Insurance Administration under the Ministry of Health and Welfare in mid-September, paving the way for the formal launch of the product in Taiwan. EirGenix develops a series of HER2-positive breast cancer product combinations, including the second-generation HER2-positive targeted antibody drug Perjeta® (Pertuzumab), which are continuously advancing into the Phase III clinical trial. With the successful market introduction of the products, further market expansion and strengthening of the product's international competitive advantage will be realized. Website: SOURCE EirGenix

TAIPEI, May 2, 2023 /PRNewswire/ -- 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 Roch'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: SOURCE EirGenix