On the 18th, EirGenix held an investor conference, sharing several positive updates. Chairman Lee-Cheng Liu stated that the company’s first-generation biosimilar for breast cancer, Trastuzumab (EG12014), is on track to receive FDA approval for the U.S. market by the end of this year. In addition, a higher-dosage version will be launched globally next year, potentially doubling the market size compared to the lower-dosage version. The company’s second-generation biosimilar for breast cancer, Pertuzumab (EG1206A), is expected to finalize its licensing agreements by the end of the year, with total licensing revenue projected to exceed USD 70 million, surpassing the first generation’s earnings.
Regarding the recent passing of the BIO SECURE Act by the U.S. House of Representatives, EirGenix CEO Chih-Jung Chang noted that the legislation has significantly increased the number of inquiries for partnerships. As of September this year, EirGenix has seen a 108.1% year-on-year growth in proposal value, with potential collaboration opportunities estimated at over USD 1 billion.
Lee-Cheng Liu highlighted that EirGenix’s flagship product, Trastuzumab (EG12014), has already been approved for sale in Taiwan and the EU. The U.S. FDA is expected to conduct an on-site inspection of the company’s manufacturing partner between late October and early November, with approval for the U.S. market anticipated by the end of this year.
He further explained that the currently marketed Trastuzumab (EG12014) is available in a low-dosage form of 150 mg. A higher-dosage 420 mg version, developed in collaboration with Formosa Laboratories, has already completed three batches of consistency tests. The company plans to submit a marketing application to Taiwan’s Food and Drug Administration (TFDA) by the end of the year, targeting a launch in Taiwan next year. Beyond Taiwan, EirGenix’s licensing partner Sandoz is also expected to complete three batches of the 420 mg version in Q3 and Q4 this year, with submissions to the FDA and the European Medicines Agency (EMA) planned for Q3 2025. The higher-dosage product is expected to capture a larger market share in Europe and the U.S., with a sales ratio of 2:1 compared to the 150 mg product.
In addition to Trastuzumab, EirGenix is heavily focused on the development of its second-generation biosimilar for breast cancer, Pertuzumab (EG1206A). Licensing agreements are expected to be finalized by the end of this year, with total licensing revenue exceeding USD 70 million. However, due to International Financial Reporting Standards (IFRS) regulations, the revenue will be recognized in stages and will not contribute to a single fiscal year.
Regarding the passing of the BIO SECURE Act by the U.S. House of Representatives, Chih-Jung Chang explained that international surveys indicate that 16% of biotech companies in the U.S. are considering shifting orders due to the legislation. Additionally, outside of the U.S., 17% of biotech companies are planning to shift orders as a result of the “chilling effect” caused by the Act. Since the beginning of this year, EirGenix has seen a significant increase in inquiries, with the value of proposed collaborations rising by 108.1% year-on-year as of September. The company estimates that these potential partnerships could be worth over USD 1 billion.
Resource (mandarin): 台康法說會釋利多 美生物安全法潛在訂單上看10億美元
