Annual Report 2025

MANAGEMENT DISCUSSION AND ANALYSIS 15 The United Laboratories International Holdings Limited Annual Report 2025 Progress in Research and Development During the year, the Group made the following major progress in R&D: – In January, the investigational new drug (IND) application for the Phase II clinical trial of UBT251 Injection, a Class I innovative drug , for the indication of chronic kidney disease, received implied approval from China’s National Medical Products Administration (the “NMPA”). – In January, the New Drug Application (NDA) for Semaglutide Injection was accepted by the NMPA. – In March, the IND application for UBT251 Injection, a Class I innovative drug , received clinical trial approval from the U.S. Food and Drug Administration (FDA). – In March, the NDA for Polyvinyl Alcohol Eye Drops (specification: 1.4% (0.4ml:5.6mg)) was approved by the NMPA. – In March, the NDA for Liraglutide Injection （聯邦優利泰 ® , specification: 3ml:18mg (pre-filled)) was approved by the NMPA. – In September, the IND application for the clinical trial of UBT37034 for Injection, a Class I innovative drug , for the indication of overweight or obesity, received implied approval from the NMPA. – In November, the Phase II clinical study of TUL01101 Tablets, a Class I innovative drug , was completed in Chinese adult subjects with moderate to severe atopic dermatitis, achieving its predefined goals. – In December, the NDA for Levofloxacin Eye Drops (specification: 0.488% (5ml:24.4mg)) was approved by the NMPA. – In December, the NDA for Moxifloxacin Hydrochloride Eye Drops (specifications: 0.5% (3ml:15mg), 0.5% (5ml:25mg)) was approved by the NMPA.