6589 Tai康 Biotech: EMA Approves Sandoz's Application for 420mg Dose of Trastuzumab Biosimilar HERWENDA

Disclosure Date: July 13, 2026 Announcement Date: July 12, 2026 Announcement Time: 14:00:10 Company Code: 6589 Company Name: Tai康 Biotech Subject: European Medicines Agency (EMA) Approves Dose Packaging Change Application for EG12014 (Trastuzumab Biosimilar) Submitted by Sandoz, the Company's Licensing Partner Applicable Clause: Clause 10 Event Date: July 9, 2026

Details:

1. Event Date: 07/09/2026

2. Name or Code of the New Drug in Development: Development Code: EG12014 (Trastuzumab Biosimilar) Drug Name: HERWENDA

3. Indications: 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: All development stages required for marketing authorization have been completed.

5. Current Development Stage (Please specify whether the current stage is application submitted/approved/rejected. If rejected, describe risks and mitigation measures. Also include future business direction and cumulative R&D expenditure): (1) Application status/approval status/clinical trial results (including interim analyses)/other major events affecting drug development: The 150mg dose has already been approved and commercially launched in Slovakia. This announcement concerns the EMA's approval of the additional 420mg dose application for HERWENDA. (2) Risks and mitigation measures if not approved by regulatory authorities, clinical trial results not statistically significant, or other major events: Not applicable. (3) Future business direction following regulatory approval, statistically significant clinical results, or other major events: Proceed with preparation for the EU market launch of the 420mg dose. (4) Cumulative R&D expenditure: The company has signed a confidentiality agreement with Sandoz. To protect the interests of the company and investors, this information will not be disclosed.

6. Next Development Stage (Expected completion date and anticipated obligations): (1) Expected completion date: Not applicable (2) Anticipated obligations: None

7. Market Status: Breast and gastric cancers are among the major cancer burdens in Europe, and related treatments have high medical needs and market potential. The reference drug, Herceptin, achieved sales of 1.028 billion Swiss francs (approximately 1.3 billion USD) in 2025, and the biosimilar market is estimated at around 6.9 billion USD. The 420mg dose is the primary packaging format used in the European market. Sandoz has already obtained EU marketing authorization for the 150mg dose. With the approval of the 420mg dose, Sandoz is expected to enter the mainstream market, which will positively impact the company's overall operations.

8. Other Matters to be Disclosed (If the subject is a publicly listed company and this announcement qualifies as a material event under Article 7, Clause 8 of the Enforcement Rules of the Securities and Exchange Act affecting shareholder rights or securities prices): None

9. New drug development involves long timelines, high investment costs, and no guarantee of success, which may expose investors to risks. Investors should carefully assess and make prudent investment decisions.