The board of directors (the “Board”) of Hansoh Pharmaceutical Group Company Limited (the“Company” and together with its subsidiaries, the“Group”) is pleased to announce that two new indications of Ameile, an innovative drug of the Group, have been successfully added to the new National Reimbursement Drug List (2025 Version) (the “2025 NRDL”), and all indications of Saint Luolai and Hengmu, innovative drugs of the Group, have been renewed in the 2025 NRDL. The new NRDL will be officially implemented on January 1, 2026.
1. Two new indications of Aumolertinib Mesylate Tablets (trade name: Ameile 阿美乐®), approved in March and April 2025, have been added to the 2025 NRDL:
• For the treatment of adult patients with stage II to IIIB non-small cell lung cancer (“NSCLC”) whose tumors have epidermal growth factor receptor (“EGFR”) exon 19 deletions or exon 21 L858R mutations, and who have undergone tumor resection.
• For the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or after platinum-based chemoradiotherapy, and have EGFR exon 19 deletions or exon 21 (L858R) substitute mutations.
2．Both two indications of Pegmolesatide Injection (trade name: Saint Luolai 圣罗莱®) have been renewed in the 2025 NRDL: used to treat anemia in chronic kidney disease, including:
1) Adult patients who have not received erythropoiesis-stimulating agent (ESA) and are not on dialysis;
2) Adult dialysis patients who are receiving short-acting erythropoietin treatment and on dialysis.
3. Tenofovir Amibufenamide Tablets (trade name: Hengmu 恒沐®) has been renewed in the 2025 NRDL, for adult patients with chronic hepatitis B. Additionally, the Group’s innovative drugs Flumatinib Mesylate Tablets (trade name: Hansoh Xinfu 豪森昕福®), PEG-Loxenatide for Injection (trade name: Fulaimei 孚来美®), Inebilizumab Injection (trade name: XINYUE 昕越®) for NMOSD, Aumolertinib Mesylate Tablets (trade name: Ameile 阿美乐®) for the treatment of first-line and second-line NSCLC, all of which are currently within the NRDL agreement period, with the agreement valid until December 31, 2026; Morinidazole Sodium Chloride for Injection (trade name: Mailingda 迈灵达®) has been included in category B of general list of the NRDL.
About Hansoh Pharma
Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise headquartered in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, anti-infectives, central nervous system (CNS), metabolism and autoimmunity. Hansoh Pharma has launched 7 innovative drugs that generate product sales in China, with the revenue from innovative drugs and collaborative products exceeding 80%, forming a rich product pipeline. The company has consistently ranked among the top 100 global pharmaceutical companies and is recognized as one of the top 3 pharmaceutical R&D enterprises in China, and is designated as a National Key High-Tech Enterprise and a National Technology Innovation Demonstration Enterprise. Hansoh Pharma was listed on the Hong Kong Stock Exchange in June 2019 (stock code: 03692.HK).
Statements
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Forward-Looking Statements
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