Nanjing Delova Announces Statistically Significant and Clinically Meaningful Results From Two Phase 3 Trials of QP-6211 for the Treatment of Postoperative Pain
- Treatment with QP-6211 achieved primary and all key secondary endpoints in both placebo- and active-controlled Phase 3 trials following hemorrhoidectomy or bunionectomy.
- QP-6211 demonstrated statistically significant reductions in postoperative pain and opioid consumption through 72 hours following infiltration compared to both ropivacaine hydrochloride injection and placebo in both Phase 3 trials.
- QP-6211 was generally well tolerated.
- Nanjing Delova has submitted a New Drug Application (NDA) for QP-6211.
NANJING, China, Jan. 5, 2026 /PRNewswire/ -- Nanjing Delova Biotech Co., Ltd. ("Delova") today announced 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.
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 72h postoperative period.
About QP-6211 for Postoperative Pain
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 utilizes 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.
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.
Phase 3 Efficacy Results in Patients Undergoing Hemorrhoidectomy
This pivotal Phase 3 trial was a prospective, randomized, double-blind, placebo- and active-controlled, multicenter clinical trial designed to evaluate the efficacy and safety of single-dose QP-6211 administered via infiltration for postoperative pain control following hemorrhoidectomy in 309 Chinese patients.
Primary and Secondary Outcomes in Phase 3 Trial Following Hemorrhoidectomy
QP-6211 (N=154) | ROP HCl (N=77) | Placebo (N=78) | |||||
Primary: | |||||||
AUC0-72h of NRS | |||||||
Mean % reduction compared to placebo | 58 % | 10 % | -- | ||||
P value vs. placebo | <0.0001 | -- | -- | ||||
P value vs. ROP HCl | <0.0001 | -- | -- | ||||
Secondary: | |||||||
AUC48-72h of NRS | |||||||
Mean % reduction compared to placebo | 55 % | 8 % | -- | ||||
P value vs. placebo | <0.0001 | -- | -- | ||||
P value vs. ROP HCl | <0.0001 | -- | -- | ||||
Total opioid consumption (0-72h) | |||||||
Mean % reduction compared to placebo | 88 % | 38 % | -- | ||||
P value vs. placebo | <0.0001 | -- | -- | ||||
P value vs. ROP HCl | <0.0001 | -- | -- | ||||
No-opioid use (0-72h) | |||||||
Proportion of patients | 83 % | 27 % | 23 % | ||||
Mean difference from placebo | 60 % | 4 % | -- | ||||
P value vs. placebo | <0.0001 | -- | -- | ||||
P value vs. ROP HCl | <0.0001 | -- | -- | ||||
ROP = ropivacaine; AUC = the area under the curve; NRS = the Numerical Rating Scale pain intensity scores. | |||||||
Results of other secondary endpoints in this Phase 3 trial were generally consistent with those of the primary endpoint.
Phase 3 Efficacy Results in Patients Undergoing Bunionectomy
This pivotal Phase 3 trial was a prospective, randomized, double-blind, placebo- and active-controlled, multicenter clinical trial designed to evaluate the efficacy and safety of single-dose QP-6211 administered via infiltration for postoperative pain control following bunionectomy in 185 Chinese patients.
Primary and Secondary Outcomes in Phase 3 Trial Following Bunionectomy
QP-6211 (N=92) | ROP HCl (N=46) | Placebo (N=47) | |||||
Primary: | |||||||
AUC0-72h of NRS | |||||||
Mean % reduction compared to placebo | 49 % | 11 % | -- | ||||
P value vs. placebo | <0.0001 | -- | -- | ||||
P value vs. ROP HCl | <0.0001 | -- | -- | ||||
Secondary: | |||||||
AUC48-72h of NRS | |||||||
Mean % reduction compared to placebo | 51 % | 7 % | -- | ||||
P value vs. placebo | <0.0001 | -- | -- | ||||
P value vs. ROP HCl | <0.0001 | -- | -- | ||||
Total opioid consumption (0-72h) | |||||||
Mean % reduction compared to placebo | 74 % | 26 % | -- | ||||
P value vs. placebo | <0.0001 | -- | -- | ||||
P value vs. ROP HCl | <0.0001 | -- | -- | ||||
No-opioid use (0-72h) | |||||||
Proportion of patients | 75 % | 26 % | 23 % | ||||
Mean difference from placebo | 52 % | 3 % | -- | ||||
P value vs. placebo | <0.0001 | -- | -- | ||||
P value vs. ROP HCl | <0.0001 | -- | -- | ||||
ROP = ropivacaine; AUC = the area under the curve; NRS = the Numerical Rating Scale pain intensity scores. | |||||||
Results of other secondary endpoints in this Phase 3 trial were generally consistent with those of the primary endpoint.
Phase 3 Safety Results
QP-6211 was generally well tolerated in two Phase 3 studies. The majority of adverse events (AEs) were mild to moderate, and there were no serious adverse events (SAEs) related to QP-6211.
- Hemorrhoidectomy Phase 3 trial: The overall AE incidence in the QP-6211 group was similar to that in the placebo group. AEs reported in ≥5% of patients and more frequently than placebo included dyschezia (9.1% vs. 3.8%), fever (6.5% vs. 5.1%), constipation (5.8% vs. 3.8%), and diarrhea (5.2% vs. 1.3%).
- Bunionectomy Phase 3 trial: The overall AE incidence was lower in the QP-6211 group than in the placebo group, with no AEs occurring in ≥5% of patients at a higher frequency than placebo.
About Nanjing Delova Biotech Co., Ltd.
Nanjing Delova Biotech Co., Ltd., headquartered in Nanjing, China, is a commercial-stage biotechnology company focused on the development of novel non-opioid analgesics to address unmet medical needs globally. The company is advancing a series of long-acting analgesics based on its proprietary long-acting technology platform, as well as innovative small-molecule therapies.
Delova's first product, QP001 (meloxicam injection), is approved for the management of moderate-to-severe pain in adults and is marketed as QAMZOVA® in the United States (FDA-approved) and 普坦宁® in China (NMPA-approved).
Delova has submitted a NDA for QP-6211 to the China NMPA.
Investor Relations and Media Contact:
Bin Xu
BD Director
Nanjing Delova Biotech Co., Ltd.
[email protected]
+86 18262593842
SOURCE Nanjing Delova Biotech Co., Ltd.
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