Today (March 12, 2026), according to the latest announcement on the CDE website, Yichang Renfu Pharmaceutical's application for marketing authorization of acetaminophen-oxycodone extended-release tablets , a Class 2.2 improved new drug , has been accepted. As a leading company in the domestic anesthesia and analgesia field, Renfu Pharmaceutical's move not only enriches its analgesic product pipeline but also targets unmet clinical needs in the treatment of moderate to severe pain.

Image source: CDE official website

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. Its core competitive advantage lies in its extended-release formulation design—compared to existing immediate-release formulations, this extended-release tablet allows for prolonged administration, reducing the frequency of dosing and significantly improving patient adherence.
With its advantages of " potent analgesia + optimized safety ," the acetaminophen-oxycodone series has shown remarkable market performance. Data shows that the hospital market size for this product reached 405 million yuan in 2024, and the growth rate is projected to exceed 6% in 2025. However, oxycodone is listed in the narcotic drug catalog and is a strictly controlled controlled substance. Long-term use may lead to dependence, and sudden cessation of use can cause withdrawal symptoms. This strict policy control constitutes the main barrier for domestic companies to enter this category, resulting in a relatively small number of companies applying for approval.

Meanwhile, the development of acetaminophen/oxycodone extended-release tablets faces a key challenge: the lack of a reference formulation . Currently, the reference formulation catalog only includes immediate-release tablets of this product, while acetaminophen/oxycodone extended-release tablets are not included in the catalog, and no original drug is marketed in China , making it impossible to apply for approval through the conventional generic drug pathway. According to the relevant provisions of the "Drug Registration Management Measures," for such products without a reference generic pathway, companies can only apply for approval in China through the 2.2 category of dosage form modification.
As of March 2026, three domestic companies have already entered the market for acetaminophen/oxycodone extended-release tablets: Chengdu Yuandong , Shanghai Ideal Pharmaceutical , and Yichang Renfu , which has now submitted its application for production approval . Renfu Pharmaceutical's advantage lies in its strong distribution channels and academic promotion capabilities. In the centralized procurement in December 2024, Renfu's acetaminophen/oxycodone immediate-release formulation was the sole winner, subsequently achieving rapid market expansion and leading the domestic substitution process for this product. This also laid a solid foundation for the application for the extended-release formulation.

It is worth noting that, according to the data protection regulations that have not yet been implemented, the first company to receive approval for acetaminophen/oxycodone extended-release tablets, as an improved new drug, will be granted a 3-year data protection period . This means that the first company to market will enjoy a significant market window advantage.
The acceptance of Humanwell Healthcare's application for production approval of acetaminophen/oxycodone extended-release tablets is not only an important step in the company's own pipeline expansion, but also reflects the research and development trend of psychotropic analgesics in China. For Humanwell Healthcare, if this application is successfully approved, it will further consolidate its leading position in the field of anesthesia and analgesia. For the entire industry, the expansion and breakthroughs of more companies will promote the improvement of the treatment level for moderate to severe pain in China, bringing patients better and more convenient analgesic options.

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