SBP GROUP (01177): Naltrexone sustained-release tablets "peripheral -opioid receptor antagonist" approved for listing in the Greater Bay Area

SBP GROUP (01177) announced that its subsidiary, Zhongda Tianqing Pharmaceutical Group Co., Ltd. (Zhongda Tianqing), has exclusively introduced the innovative drug Naldemedine, which has been approved by the Guangdong Provincial Drug Administration, and is the first to market in the Guangdong-Hong Kong-Macao Greater Bay Area for the treatment of opioid-induced constipation (OIC). In March of this year, the Guangzhou Health Commission issued a notice on the ten measures to promote the further implementation of the "Hong Kong-Macao Drug and Medical Device Cooperation" policy, marking a new stage in the policy exploration from the implementation of the "Hong Kong-Macao Drug and Medical Device Cooperation" on a large scale. Naldemedine became the first innovative drug to enter the Greater Bay Area through the "Hong Kong-Macao Drug and Medical Device Cooperation" after the release of the new policy. Naldemedine is the world's first orally selective peripheral -opioid receptor antagonist approved for marketing. By blocking the binding of opioid drugs to receptors in the intestinal tract, it directly restores normal intestinal motility rhythm and intestinal fluid secretion function, reversing the pathological process of OIC from the root. A phase III clinical study with a 2-week treatment period, randomized, double-blind, placebo-controlled trial showed that the median time to first spontaneous bowel movement (SBM) in OIC patients after initial administration was 4.67 hours, significantly better than the placebo group (26.58 hours, P <0.0001). The SBM response rate in the Naldemedine treatment group was 71.1%, significantly higher than the placebo group (34.4%, P <0.0001), indicating that 0.2 mg of Naldemedine can effectively control OIC and continuously improve intestinal function. Late-stage cancer patients have a pain incidence rate of 60%-80%, with approximately one-third experiencing moderate to severe pain. Opioid drugs are the main method of treating chronic pain in cancer patients, but 60%-90% of patients may experience OIC, severely affecting their quality of life and treatment adherence. Effectively treating OIC and balancing analgesia with side effects is a pressing clinical issue. Current therapies have significant limitations: laxatives only provide symptomatic relief, with gastrointestinal reactions; traditional opioid receptor antagonists such as naloxone may alleviate constipation by reducing the gastrointestinal effects of opioid drugs, but they may weaken the analgesic effect of opioid drugs by crossing the blood-brain barrier. Compared to current therapies, Naldemedine selectively acts on intestinal -opioid receptors, without the risk of electrolyte imbalance, meeting the long-term medication needs of patients, and almost not entering the central nervous system, without affecting the analgesic effect of opioid drugs. In addition to the Greater Bay Area, Naldemedine has been approved for marketing in the United States, the European Union, Japan, Taiwan, Macau, and Hong Kong, as well as being introduced to Hainan Province through the policy of the Boao Lecheng International Medical Tourism Pilot Zone as a clinically urgently needed drug, and has been recommended for the treatment of OIC by the American Gastroenterology Association (AGA) and the European Society for Medical Oncology (ESMO) guidelines. In January 2025, Zhongda Tianqing signed an exclusive marketing agreement with Yakyu Yushi to obtain exclusive marketing rights for Naldemedine in mainland China; in May 2025, the marketing application for Naldemedine was accepted by the China National Medical Products Administration (NMPA). The approval of Naldemedine in the Guangdong-Hong Kong-Macao Greater Bay Area will further enhance the accessibility of the drug. The group will leverage its strong commercial capabilities to promote this global innovative drug to benefit more OIC patients domestically.