TaiGen Biotech's Partner Sandoz Submits Marketing Authorization Application for EG12014 (Trastuzumab Biosimilar) in Brazil

Release Date: August 14, 2026 Statement Date: August 13, 2026 Time: 17:35 Company Code: 6589 Company Name: TaiGen Biotech Subject: Our licensing partner, Sandoz, has submitted a marketing authorization application to Brazil’s National Health Surveillance Agency (ANVISA) for the biosimilar EG12014 (trastuzumab biosimilar), 150mg lyophilized injectable formulation. Applicable Clause: Item 10 Factual Date: August 13, 2026 Explanation: 1. Factual Date: 08/13/2026 2. Name or Code of the New Drug Under Development: Development Code: EG12014 (trastuzumab biosimilar) Drug Name: HERWENDA 3. Indication: Treatment of early HER2-positive breast cancer, metastatic breast cancer, and metastatic gastric cancer. (https://www.clinicaltrials.gov/ct2/show/NCT03433313?term=EG12014&draw=2&rank=1) 4. All Planned Development Stages: Submission of marketing authorization application for the biosimilar EG12014 (trastuzumab biosimilar), 150mg lyophilized injectable formulation, to Brazil’s National Health Surveillance Agency (ANVISA). 5. Current Development Stage (Specify whether the current stage is application submitted/approved/not approved; if not approved, describe risks and countermeasures; also state future business direction and cumulative R&D expenditure): (1) Status of application/approval/rejection, results of human trials (including interim analyses), or other major events affecting drug development: Marketing authorization has been granted in the European Union and Taiwan for both 150 mg and 420 mg dosage forms. (2) Risks and countermeasures if not approved by regulatory authorities, clinical trial results fail to achieve statistical significance, or other major events occur: Not applicable. (3) Future business direction if approved by regulatory authorities, clinical trial results achieve statistical significance, or other major events occur: If the 150 mg dosage form is approved in Brazil, it is expected to expand market presence and positively impact the company’s overall operations. (4) Cumulative R&D expenditure incurred: Due to a confidentiality agreement between the company and Sandoz, disclosure is withheld to protect corporate and investor interests. 6. Next Development Stage (expected completion time and anticipated obligations): (1) Expected completion time: The review timeline will follow ANVISA’s regulatory procedures; however, actual review and approval timelines will be determined by ANVISA and confirmed via official notification. (2) Anticipated obligations: None 7. Market Overview: Breast and gastric cancers are major oncological diseases in Brazil, with stable medical demand and market potential for related therapeutics. The submission of EG12014 (trastuzumab biosimilar) to ANVISA will help expand the company’s product footprint in the Latin American market and enhance competitiveness. The reference drug Herceptin achieved sales of 1.028 billion Swiss francs (approximately 1.3 billion USD) in 2025, with the biosimilar market estimated at around 6.9 billion USD. According to estimates by Brazil’s National Cancer Institute, approximately 78,000 new breast cancer cases will occur annually in Brazil between 2026 and 2028, with about 20% being HER2-positive. 8. Other Matters to Be Disclosed (if the subject entity is a publicly listed company and this material information qualifies under Article 7, Paragraph 8 of the Enforcement Rules of the Securities Trading Act as having significant impact on shareholder rights or securities prices): None 9. New drug development involves long timelines, high investment costs, and no guarantee of success, which may pose investment risks. Investors should make careful judgments and invest prudently.