I.    Date of sanction: February 4, 2026
II.    Object of sanction: Mr./Ms. XX Hsu, the responsible person for the act of Caliway Biopharmaceuticals Co., Ltd.
III.    Legal basis for the sanction: Subparagraph 2, Paragraph 3, Article 36, Subparagraph 4, Paragraph 1, Article 178, and Article 179 of the Securities and Exchange Act, and Subparagraph 8, Article 7 of the Securities and Exchange Act Enforcement Rules.
IV.    Facts and reasons: On September 5, 2025, Caliway Biopharmaceuticals Co., Ltd. had decided to optimize the expression of the Phase III clinical trial subject self-assessment scale (PR-AFRS) for the new drug CBL-514 and to postpone the projected Phase III clinical trial enrollment period from the third quarter of 2025 to the second quarter of 2026; however, it did not announce the updated explanation regarding the projected enrollment schedule on the Market Observation Post System until September 18, 2025. This constitutes a violation of Article 36, Paragraph 3, Subparagraph 2 of the Securities and Exchange Act and Article 7, Subparagraph 8 of the Enforcement Rules of the Securities and Exchange Act.
V.    Sanction imposed: Pursuant to Subparagraph 4, Paragraph 1, Article 178 of the Securities and Exchange Act, a fine of NT$240,000 is imposed on the responsible person for the conduct in relation to the foregoing violation by the company.
Contact Unit:    Corporate Finance Division, Securities and Futures Bureau
Tel.: (02)2774-7295
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