TLC Biosciences' Partner Sandoz Receives EMA Approval for Dose Modification Application of EG12014 (Trastuzumab Biosimilar) 420 mg

1. Date of Event: 115/07/09

2. Name or Code of the New Drug: 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 application have been completed.

5. Current Development Stage (Please specify whether the current stage is application submission/approval/rejection. If rejected, describe risks and countermeasures. Also state future business direction and cumulative R&D expenses): (1) Status of application/approval/rejection, results of clinical trials (including interim analyses), or other significant events affecting drug development: The 150 mg dosage has already completed market access and officially launched in Slovakia. This announcement concerns the EMA's approval of the new 420 mg dosage application for HERWENDA. (2) Risks and countermeasures if not approved by the regulatory authority, clinical trial results lack statistical significance, or other major events occur: Not applicable. (3) Future business direction if approved by the regulatory authority, clinical trial results are statistically significant, or other major events occur: Proceed with preparations for the EU market launch of the 420 mg dosage. (4) Cumulative R&D expenses incurred: Due to a confidentiality agreement between the company and Sandoz, disclosure is withheld to protect the interests of the company and investors.

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 represent a significant cancer burden in Europe, with related therapeutics showing high medical need and market potential. 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. The 420 mg dosage is the primary packaging format used in the European market. Sandoz has already obtained EU marketing authorization for the 150 mg dosage, and upon approval of the 420 mg dosage, it is expected to enter the mainstream market, providing a positive impact on the company's overall operations.

8. Other Matters to be Disclosed (If the subject of the event or resolution 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 a 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 expose investors to risks. Investors are advised to carefully assess and make prudent investment decisions.