SINO BIOPHARM (01177) announced that Naldemedine, an innovative drug exclusively introduced by its subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd., has received approval from the Guangdong Provincial Medical Products Administration for a prioritized launch in the Guangdong-Hong Kong-Macao Greater Bay Area. The drug is indicated for the treatment of Opioid-Induced Constipation (OIC). In March of this year, the Guangzhou Municipal Health Commission issued a notice promoting ten measures for the deeper implementation of the "Hong Kong and Macao Drug and Medical Device Access" policy, marking a new phase of scaled implementation for the policy. Naldemedine has become one of the first innovative drugs to enter the Greater Bay Area through this new policy framework following its announcement. Naldemedine is the world's first approved oral selective peripheral mu-opioid receptor antagonist. It works by blocking the binding of opioids to mu-receptors within the intestines, directly restoring normal bowel motility and fluid secretion, thereby reversing the pathological process of OIC at its source. A two-week, randomized, double-blind, placebo-controlled Phase III clinical study demonstrated that the median time to the first spontaneous bowel movement (SBM) after the initial dose of Naldemedine was 4.67 hours, significantly faster than the placebo group's 26.58 hours. The SBM response rate in the Naldemedine treatment group was 71.1%, significantly higher than the 34.4% rate in the placebo group, indicating that the 0.2mg dose effectively controls OIC and provides sustained, stable improvement in bowel function. The incidence of pain in patients with advanced cancer ranges from 60% to 80%, with approximately one-third experiencing moderate to severe pain. Opioids are a primary method for managing chronic pain in cancer patients; however, 60% to 90% of patients develop OIC, which severely impacts their quality of life and treatment adherence. Effectively treating OIC while balancing analgesia and adverse effects is a critical challenge in current clinical practice. Existing therapies have significant limitations: laxatives only provide symptomatic relief and are associated with gastrointestinal side effects; while traditional opioid receptor antagonists like naloxone can alleviate constipation by mitigating the gastrointestinal effects of opioids, they may cross the blood-brain barrier and reduce the analgesic efficacy of the opioids. In contrast, Naldemedine selectively acts on intestinal mu-opioid receptors, carries no risk of electrolyte imbalance, is suitable for long-term patient use, and has minimal penetration into the central nervous system, with no observed impact on the analgesic effects of opioids. Beyond the Greater Bay Area, Naldemedine has already received approval for marketing in the United States, the European Union, Japan, Taiwan (China), Macao (China), and Hong Kong (China). It has also been introduced into Hainan Province as a clinically urgently needed drug via the Boao Lecheng International Medical Tourism Pilot Zone policy and is recommended for OIC treatment in guidelines from the American Gastroenterological Association (AGA) and the European Society for Medical Oncology (ESMO). In January 2025, Chia Tai Tianqing entered into an exclusive marketing agreement with Shionogi, securing exclusive promotion rights for Naldemedine in mainland China. In May 2025, the marketing application for Naldemedine was accepted for review by the National Medical Products Administration (NMPA) of China. The approval of Naldemedine in the Greater Bay Area is expected to significantly enhance patient access to the drug. Leveraging its strong commercialization capabilities, the group aims to make this global innovative medicine available to more OIC patients within the country.