On 3 July 2026, Sino Biopharmaceutical Limited (Sino Biopharm) announced that the Center for Drug Evaluation of China’s National Medical Products Administration has formally accepted the company’s New Drug Application for ropivacaine hydrochloride sustained-release solution, a national Category 2.2 candidate developed by subsidiary Beijing Tide Pharmaceutical.

The product is positioned as the world’s first long-acting ropivacaine analgesic administered via intra-incisional instillation for postoperative pain control in adults. Built on a proprietary lipid-based targeted injection platform, the formulation transitions into a drug reservoir upon contact with tissue fluid, enabling continuous local release of ropivacaine for up to 72 hours while lowering systemic exposure.

Phase III registrational studies in unilateral hip replacement and abdominal surgery demonstrated that a single administration delivered sustained analgesia across the three-day postoperative window, significantly trimming both the dose and frequency of rescue analgesics versus an active control. Pharmacokinetic data showed delayed absorption, reduced peak serum concentration, an extended plateau phase, and gradual elimination, collectively underscoring improved safety and compliance.

Regulatory acceptance of this NDA expands Sino Biopharm’s long-acting analgesia portfolio and strengthens its postoperative pain management franchise, offering a differentiated, non-opioid option that complements the group’s existing analgesic products.