ESG Report 2025
In terms of assisting overseas customers in upgrading their pharmaceutical standards, the Group, as a globally leading supplier of antibiotic APIs, not only provides high-quality APIs and intermediates to large pharmaceutical companies in developed countries, but is also committed to helping pharmaceutical companies in developing and less developed countries raise their pharmaceutical manufacturing standards. By providing detailed formulation documentation, attaching samples and working reference standards with shipments, and offering process technology improvement support, the Group helps local formulation manufacturers improve production efficiency and effectively control drug quality and stability. During the Reporting Period, while accompanying visits to overseas customers, technical personnel of The United Laboratories provided on-site technical support to address quality issues encountered by customers in their production processes. The technical personnel gained an in-depth understanding of the root causes of the issues and provided professional advice based on the customer's specific circumstances, helping them optimise quality control processes and improve product quality stability. On-site Technical Support for Overseas Customers The rise of antimicrobial resistance due to antibiotic overuse poses a serious threat to public health. Therefore, the Group actively advocates the rational use of antibiotics. Antibacterial drugs are among the Group's core products. The Group strictly follows the national “Administrative Measures for the Clinical Use of Antimicrobials” and the “Catalogue for Classified Management of the Clinical Use of Antimicrobials”, actively cooperates with efforts to control antibiotic overuse, and is committed to reducing unnecessary antibiotic use. To address the issue of antimicrobial resistance, the Group is developing two Class 1 new drug projects, TUL108 for injection and LB2332, for drug-resistant bacterial and fungal infections. As at the end of the Reporting Period, these projects are in the pre-clinical stage. 8.2.4 Focus on Rare Diseases Under the guidance and support of relevant policies such as the "Drug Registration Management Measures" and "Rare Disease Diagnosis and Treatment Guidelines", the Group has fully leveraged the advantages of its own research system, proactively responded to the national call, conducted in-depth analyses of the market demand for rare diseases, and substantially increased the investment in the research and development of medicines for rare diseases. This aims to improve the clinical treatment landscape in our country. The Group focuses on enhancing the accessibility of innovative therapeutic drugs to rare disease patients with rare diseases so as to benefit more patients. PNH is an acquired hemolytic disease in which a mutation in the PIG-A gene of hematopoietic stem cells leads to the loss of a group of membrane proteins anchored to the cell surface through glycosylphosphatidylinositol (GPI). This results in changes in cellular properties and sensitivity to complement, leading to intravascular hemolysis, potential bone marrow failure, and thrombosis. The incidence rate of PNH in Western countries is (1-2)/million population/year, with a standardised rate of 1.3/million population/year. In our country, the overall incidence rate is around 1/100,000, which is higher than in Europe and America. At present, the treatment for PNH is to inhibit complement C3 or C5 monoclonal antibodies, which can effectively reduce their levels in PNH patients. However, these drugs have defects such as injection pain and infection risk. TUL321 Capsules, an oral small molecule new drug, which is to develop a compound that inhibits the complement pathway through the CFB target to achieve the inhibitory effect on complement in PNH patients. Compared with C3 and C5 monoclonal antibodies that completely inhibit the complement pathway, this drug will be safer and more compliant with medication. In December 2023, Novartis CFB target drug LNP023 became the world's first monotherapy drug approved by the FDA for treating PNH. Therefore, our new drug targeting the same target has an opportunity to be used for the treatment of rare diseases such as PNH in the future. Paroxysmal Nocturnal Hemoglobinuria (PNH) 63 The United Laboratories International Holdings Limited 2025 Environmental, Social and Governance Report
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