Peijia Medical-B (09996) has announced that the registration application for Shenpuchang™ SeQuent® Please CIS paclitaxel drug-coated intracranial balloon dilatation catheter ("SeQuent® Please CIS" or "the product") has recently been approved by China's National Medical Products Administration.
SeQuent® Please CIS is registered by B. Braun Medical (Suzhou) Co., Ltd. (B. Braun Medical) and is an intracranial paclitaxel drug-coated balloon dilatation catheter developed based on B. Braun Medical's mature drug-coated balloon technology. When performing mechanical dilation of target lesions, the product precisely releases the coated paclitaxel to the diseased vessel wall. As an anti-proliferative drug, it effectively inhibits intimal hyperplasia and reduces the long-term risk of restenosis.
The product is specifically designed for the slender and tortuous anatomical characteristics of intracranial vessels, aiming to provide an innovative "implant-free" treatment option for intracranial vascular diseases. The company's subsidiary, Shanghai Jiaqi Biotechnology Suzhou Co., Ltd., has obtained exclusive distribution rights for SeQuent® Please CIS in mainland China.
The approval of SeQuent® Please CIS by the National Medical Products Administration further expands the group's neurointerventional product portfolio and consolidates the group's product layout in the field of intracranial atherosclerotic stenosis treatment. The group will leverage its established commercialization capabilities in the neurointerventional field to support the market introduction and commercialization process of SeQuent® Please CIS in mainland China.