Nanjing Delova Biotech Co Ltd, a China-based commercial-stage biotechnology company, on Monday reported positive results from two pivotal Phase 3 clinical trials evaluating QP-6211, a long-acting ropivacaine injection, for the management of postoperative pain following hemorrhoidectomy or bunionectomy surgery.

The company claims that QP-6211 is the first and only long-acting ropivacaine with two positive Phase 3 data demonstrating superior and sustained postoperative pain relief through the critical 72-hour postoperative period.

QP-6211 is an investigational, novel, extended-released formulation of ropivacaine, designed to provide prolonged postoperative local analgesia via infiltration, and potentially via peripheral nerve block or fascial plane block. Ropivacaine is an amide local anesthetic, which differs from bupivacaine due to its high safety threshold for cardiotoxicity and greater selectivity for blocking A-delta and C pain fibers relative to A-alpha motor fibers.

QP-6211 uses Delova's proprietary Cryslova technology platform, composed of a dilutable, aqueous (oil-free), injectable suspension containing ropivacaine. Following administration, ropivacaine is released continuously and uniformly for at least 5 days, with consistent pharmacokinetic performance across different surgical models.

According to Delova, as a next-generation long-acting local anesthetic, QP-6211 has the potential to become the best-in-class non-opioid option for postoperative pain.