Recently, according to the NMPA website, Chengdu Yuandong Biopharmaceutical Co., Ltd.'s improved new drug, acetaminophen oxycodone extended-release tablets , submitted under the Class 2.2 chemical drug category , has been approved for marketing, making it the first company in China to obtain approval for this dosage form.
Acetaminophen/oxycodone extended-release tablets are a potent, centrally acting analgesic composed of the opioid analgesic oxycodone and the nonsteroidal anti-inflammatory drug acetaminophen. The two work synergistically to ensure analgesic efficacy while optimizing medication safety. Compared to domestically marketed acetaminophen/oxycodone immediate-release tablets, its core innovation lies in its dual-layer tablet design —one immediate-release layer and one extended-release layer —achieving long-lasting and stable analgesia, effectively reducing dosing frequency, and significantly improving patient adherence .According to the "China Pain Medicine Development Report," there are over 300 million chronic pain patients in China, and this number continues to grow by 10-20 million annually, indicating a huge and rigid clinical demand for the treatment of moderate to severe pain. While acetaminophen-oxycodone combination therapy is a first-line treatment for moderate to severe pain recommended in domestic and international pain management guidelines, its application in China has long been limited by the industry's pain point of having only one dosage form. According to data from Yaozhi, the hospital market size for acetaminophen-oxycodone reached 341 million yuan in 2025 , indicating broad market potential. The approval of sustained-release formulations will further unleash clinical demand.
It is worth noting that oxycodone is listed in the catalog of narcotic drugs and is a strictly controlled psychotropic drug in China. Long-term use carries the risk of dependence, and sudden cessation of use may trigger withdrawal symptoms. Strict policy regulation has become a core barrier for domestic companies entering this category, resulting in a relatively small number of related applications. Currently, two other domestic companies, Shanghai Ideal Pharmaceutical and Yichang Renfu, have also applied for approval for acetaminophen/oxycodone extended-release tablets, both of which are currently under review and approval. Yuandong Bio's early approval, leveraging its dosage form advantage, allows it to seize market opportunities and become the first company in China to launch this dosage form.
The approval of acetaminophen/oxycodone extended-release tablets is not only a significant milestone for Yuandong Bio in the field of anesthesia and analgesia, but also provides a safer and more convenient treatment option for a wide range of patients with moderate to severe pain. It is expected to disrupt the existing treatment landscape and promote the improvement of pain management in China. How this innovative dosage form will change clinical practice as the product is launched and promoted remains to be seen.

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