SINO BIOPHARM(01177.HK): NDA for Class 2.2 New Drug Ropivacaine Hydrochloride Sustained-Release Solution Accepted, Indicated for Long-Acting Postoperative Analgesia

NewTimeSpace News: On 3 July 2026, Sino Biopharmaceutical Limited (01177.HK) issued a voluntary announcement stating that Beijing Tide Pharmaceutical, its subsidiary, has submitted a New Drug Application (NDA) for self-developed Class 2.2 new drug ropivacaine hydrochloride sustained-release solution to the Center for Drug Evaluation of NMPA, and the application has been accepted. The product is indicated for long-acting postoperative analgesia in adult patients, and it is the world’s first long-acting ropivacaine analgesic drug designed for intra-incision coating administration.

Built on the Group’s proprietary lipid-targeted injectable technology platform, the product is applied before wound suturing. It undergoes phase transformation upon contact with body fluid to form a drug reservoir, enabling sustained and slow drug release over 72 hours. Two pivotal Phase III registration clinical studies revealed that a single administration delivers consistent pain relief for 72 hours following unilateral hip arthroplasty and abdominal surgeries, markedly cutting the dosage and frequency of rescue analgesics required by patients. The product exhibits significantly better therapeutic effects than the positive control and boasts satisfactory overall safety. Compared with bupivacaine of the same category, ropivacaine hydrochloride carries lower cardiac toxicity and delivers more distinct separation of motor and sensory block effects.

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