1760 Bailiang Fu Jin Announces Approval of New Indication and Formulation for PBF-1681 Tablet 'Fexenol Film Coated Tablet'

Release Date: July 18, 2026 Statement Date: July 17, 2026 Statement Time: 14:22:23 Company Code: 1760 Company Name: Bailiang Fu Jin Subject: Approval of New Therapeutic Indication and New Formulation for PBF-1681 Tablet 'Fexenol Film Coated Tablet' Applicable Clause: Clause 10 Factual Date: July 17, 2026

Explanation: 1. Factual Date: 07/17/115 2. Name or Code of the New Drug: PBF-1681 Tablet 'Fexenol Film Coated Tablet' 3. Indication: Approved by the Ministry of Health and Welfare for the treatment of iron deficiency anemia in adult chronic kidney disease (CKD) patients not undergoing dialysis. For patients with elevated serum phosphorus levels, this product may assist in controlling serum phosphorus during treatment. 4. All Planned R&D Stages: The company has completed the new drug review and approval process and received official approval. Subsequent steps will include obtaining the drug marketing authorization, product manufacturing, market launch, and commercialization in accordance with relevant regulations. 5. Current R&D Stage: (1) Application submitted / approved / not approved / clinical trial results (including interim analysis) / other significant events affecting drug development: On July 17, 115, the company received approval from the Ministry of Health and Welfare for the new formulation and new indication of PBF-1681 Tablet. The approved product name is 'Fexenol Film Coated Tablet (FEXENOL Film Coated Tablet)'. (2) If not approved by the competent authority, clinical trial results lack statistical significance, or other significant events occur: Not applicable. (3) If approved by the competent authority and clinical trial results are statistically significant, the future business direction (e.g., continued development, licensing, sale): The company will proceed with product manufacturing, market launch, and promotional activities in accordance with the approved content and relevant regulations. (4) Cumulative R&D expenses incurred: Due to marketing strategy considerations and to protect investor interests, this information will not be disclosed at this time. 6. Next R&D Stage: (1) Expected completion time: Approval has been obtained. The market launch timeline will be determined based on the issuance of the drug license, production scheduling, market readiness, and regulatory procedures. (2) Expected obligations: The company will fulfill all regulatory obligations related to product launch and post-marketing requirements. After product sales commence, the company will pay Akebia Therapeutics, Inc. a single-digit percentage of net sales as royalty for formulation patent licensing. 7. Market Overview: Chronic Kidney Disease (CKD) is a global public health issue, posing significant challenges to healthcare systems worldwide due to its rising prevalence, high risk of complications, and substantial medical expenditures. According to statistics from the National Health Insurance Administration, approximately 80,000 to 90,000 patients in Taiwan receive dialysis treatment annually, with dialysis-related medical expenses reaching approximately NT$46 billion in 2024. Additionally, a study published in The Lancet (2008, Wen et al.) estimates Taiwan's CKD prevalence at approximately 11.93%, with over 2 million patients—about one in ten people. Kidneys play a crucial role in regulating phosphorus excretion and promoting red blood cell production. Deteriorating kidney function leads to complications such as hyperphosphatemia and anemia. Approximately 80% of dialysis patients suffer from hyperphosphatemia, while anemia affects about 33% of all CKD patients, with prevalence increasing significantly as kidney function declines: 17% in Stage 1, 20% in Stage 2, 32% in Stage 3, 60% in Stage 4, and 76% in Stage 5. (Source: WCN23-0200) The active ingredient in PBF-1681 Tablet is pharmaceutical-grade ferric citrate coordination complex. This approval for treating iron deficiency anemia in non-dialysis CKD adult patients represents the company's ongoing commitment to CKD therapeutics. According to regulatory approval, in addition to treating iron deficiency anemia, the product may assist in controlling serum phosphorus in patients with elevated levels, offering an additional treatment option for eligible patients. 8. Other Disclosures: The company previously announced on August 27, 114, that it had submitted a new drug application for PBF-1681 Tablet's new formulation and new indication to the Ministry of Health and Welfare. This announcement is made in compliance with material information disclosure regulations regarding the approval outcome. 9. Drug development involves long timelines, high investment costs, and no guarantee of success, which may pose investment risks. Investors should carefully evaluate and make prudent investment decisions. Actual market launch timing, drug pricing, insurance reimbursement, hospital adoption, market acceptance, and sales performance may affect the product's future market development and its actual contribution to the company's financial and operational performance.