SBP GROUP (ASX: 01177) has announced that its subsidiary, Beijing Tide Pharmaceutical Co., Ltd., has submitted a new drug application for its self-developed, innovative long-acting anesthetic, Ropivacaine Hydrochloride Extended-Release Solution, to China's Center for Drug Evaluation (CDE), and the application has been accepted for review. This drug is intended for long-term post-operative pain management in adults.
This product is the world's first long-acting ropivacaine analgesic designed for administration by direct application into the surgical incision. Ropivacaine Hydrochloride is the first long-acting amide-type local anesthetic composed purely of the levorotatory isomer. It can achieve surgical anesthesia at high doses and provide sensory blockade (analgesia) at lower doses. It works by blocking sodium ion influx into nerve axons, inhibiting the depolarization of nerve cell membranes, and thereby interrupting the conduction of action potentials to block pain signal transmission. Compared to similar drugs like bupivacaine, Ropivacaine Hydrochloride offers significant clinical advantages, including lower cardiac toxicity and a more pronounced separation between motor and sensory blockade.
The Ropivacaine Hydrochloride Extended-Release Solution is a novel, long-lasting, non-opioid analgesic developed using a proprietary lipid-targeted injectable technology platform. The product employs an innovative application method directly into the incision, administered before wound closure. This method is simple to use, effectively reduces medical procedure time, and significantly enhances clinical convenience. Thanks to its innovative formulation technology, the drug undergoes a phase change upon contact with bodily fluids at the administration site, forming a drug reservoir that enables a slow, continuous release of medication for up to 72 hours. Compared to traditional multi-point infiltration methods, this drug significantly reduces systemic exposure, offering a notable safety advantage.
Results from two pivotal Phase III registration clinical studies demonstrated that in models of somatic pain (unilateral hip replacement surgery) and mixed somatic/visceral pain (abdominal surgery), a single administration of Ropivacaine Hydrochloride Extended-Release Solution provided continuous analgesia for up to 72 hours. It significantly reduced the dosage and frequency of rescue analgesic medications required by patients. The analgesic efficacy was markedly superior to the active comparator drug, with an overall favorable safety profile.
Pharmacokinetic studies revealed the drug's extended-release characteristics, including delayed absorption, lower peak plasma concentration, a longer plateau period for peak concentration, reduced systemic exposure, and a smoother elimination process. These findings further confirm its clinical value in prolonging analgesic duration, enhancing safety, and improving patient compliance.
The acceptance of this new drug application will further enrich the company's portfolio in the long-acting analgesia field and strengthen its strategic positioning in post-operative pain management. This product offers differentiated and complementary benefits to the company's existing marketed products and can be used in clinical combination therapies. This development is expected to help optimize post-operative pain management protocols and continuously reinforce the company's competitive edge and market position in the analgesia sector.