China Accepts New Drug Application for Shionogi’s Naldemedine to Treat Opioid-Induced Constipation
Shionogi & Co., Ltd., a leading Japanese pharmaceutical company headquartered in Osaka, has announced a key regulatory milestone for its gastrointestinal therapeutic, naldemedine tosilate. The New Drug Application (NDA) for naldemedine—a peripherally acting μ-opioid receptor antagonist (PAMORA) designed to alleviate opioid-induced constipation (OIC)—has been officially accepted by Chinese health authorities. This marks a significant step forward in expanding access to an important supportive care treatment for patients experiencing OIC in China.
A Global Therapy Expanding into China
Naldemedine was originally developed by Shionogi to address a common and debilitating side effect of opioid therapy: constipation. Since its initial approvals, the drug has been launched in several international markets, including Japan, the United States, Europe, and Taiwan. In each of these regions, naldemedine has demonstrated consistent effectiveness in improving bowel function among patients suffering from OIC, particularly those undergoing long-term opioid therapy for chronic or cancer-related pain.
With this latest regulatory submission, Shionogi aims to bring the same therapeutic benefits to patients in China—an underserved population where opioid use is rising and effective management of side effects remains a challenge. The NDA acceptance signals that Chinese regulatory authorities have deemed the submission to be sufficiently complete to warrant a comprehensive review, moving naldemedine one step closer to market availability in the region.
Addressing an Unmet Medical Need in Pain Management
In the realm of cancer pain management, opioid analgesics remain indispensable. They offer unmatched efficacy in controlling moderate to severe pain, especially in advanced-stage cancer. However, the use of opioids is frequently complicated by adverse effects, with constipation being among the most prevalent and distressing.
Studies indicate that between 40% and 80% of patients receiving opioid therapy experience constipation¹,². Unlike common forms of constipation, opioid-induced constipation is often resistant to standard laxative treatments due to the direct action of opioids on μ-opioid receptors in the gastrointestinal tract. This leads to delayed gastrointestinal transit, hard stools, bloating, and abdominal discomfort—symptoms that not only cause physical suffering but also significantly deteriorate a patient’s quality of life (QOL)³,⁴.
In China, despite the increasing prescription of opioids for cancer and chronic pain, the options for effectively managing OIC remain quite limited. Current strategies largely rely on empirical approaches such as reducing opioid doses or combining them with laxatives, which may offer incomplete or temporary relief⁵. Consequently, there is a pressing demand for a scientifically validated, mechanism-based therapeutic like naldemedine that can relieve OIC without interfering with the analgesic effects of opioids.
Robust Clinical Evidence Supporting the Application
The NDA submission in China was supported by positive data from a Phase III clinical trial⁶ conducted locally to assess the efficacy and safety of naldemedine in Chinese patients with opioid-induced constipation. Although detailed results from this trial have not yet been publicly disclosed, the data were evidently compelling enough to meet the rigorous criteria set by Chinese regulators for NDA acceptance.
The study was executed under the oversight of Shionogi China Co., Ltd. (SCN), the company’s local subsidiary headquartered in Shanghai. SCN played a critical role in managing the trial operations, regulatory documentation, and submission processes. According to the announcement, once naldemedine is approved for use in China, SCN will handle its sales and distribution through a strategic partnership with Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ), a prominent Chinese pharmaceutical company based in Jiangsu Province.
Under the terms of their exclusive licensing agreement, CTTQ will be responsible for importing and distributing naldemedine throughout mainland China. Shionogi will receive a portion of the revenues based on product sales volumes, reinforcing the company’s broader efforts to expand its global footprint while meeting localized healthcare needs.
Expanding Access and Enhancing Quality of Life
The approval of naldemedine in China has the potential to make a substantial difference in the lives of patients managing pain with opioid medications. Beyond clinical symptom relief, the drug is expected to improve patients’ overall well-being by addressing one of the most burdensome side effects of opioid therapy.
For healthcare providers, naldemedine offers a valuable tool that enables them to optimize pain control without having to compromise treatment efficacy due to gastrointestinal complications. The availability of a targeted, peripherally acting agent like naldemedine aligns with the principles of precision medicine—delivering focused interventions with minimal systemic impact.
This launch also resonates with a growing public health focus on palliative care and symptom management in China. As the country’s cancer burden continues to rise and life expectancy increases, the demand for treatments that support functional independence and comfort is intensifying. Naldemedine could play a key role in this evolving landscape by offering a quality-of-life-enhancing option for patients undergoing opioid therapy, both in cancer and non-cancer contexts.
Shionogi’s Commitment to Global Health and Innovation
Shionogi’s mission is rooted in contributing to a “healthier and more prosperous life” for people around the world. The company’s pipeline includes therapeutics targeting infectious diseases, metabolic disorders, and neurological conditions, among others. With naldemedine, Shionogi has addressed a neglected yet widespread issue in supportive care—underscoring its commitment to developing innovative solutions that elevate the standard of care in both specialized and general medical practice.
According to Dr. Isao Teshirogi, President and CEO of Shionogi, the company will continue to prioritize innovation and access in its drug development strategy. The expansion of naldemedine into China reflects Shionogi’s broader efforts to extend the reach of its therapies to regions where unmet medical needs remain high.
Through collaborations with local partners like CTTQ, Shionogi is ensuring that its products are not only scientifically effective but also commercially viable and logistically scalable in foreign markets. These partnerships enable efficient product distribution, physician education, and patient access, forming a model for responsible globalization in the pharmaceutical industry.
While the NDA acceptance is an important step forward, it is not the end of the regulatory process. The application will now undergo a detailed review by Chinese drug authorities, evaluating the clinical, pharmacological, and manufacturing data to determine whether naldemedine meets the country’s standards for safety and efficacy.
Assuming the review proceeds without significant delays, approval could follow within the next several months, paving the way for a commercial launch in mainland China. Once approved, naldemedine will join a limited but growing list of therapeutics in China specifically designed to treat OIC, offering new hope for patients grappling with the unintended consequences of life-saving opioid therapies.
Shionogi’s progress with naldemedine exemplifies the importance of sustained investment in supportive care innovations—an area often overshadowed by primary disease treatment but critical to holistic, patient-centered medicine.
