Tasly Biopharmaceuticals recently announced it has received approval from China's National Medical Products Administration (NMPA) for a new indication of its self-developed innovative biological drug, recombinant human urokinogen for injection (trade name: Puyouke), for thrombolytic treatment of acute ischemic stroke (AIS). The drug was originally approved in 2011 for acute ST-elevation myocardial infarction, and this expansion into stroke treatment will leverage its high safety profile and specific thrombolytic advantages to provide new treatment options for domestic stroke patients.
As the world's only recombinant human urokinogen product using CHO cell expression, Puyouke builds upon years of experience in myocardial infarction treatment to further expand its clinical application scenarios.
Acute ischemic stroke is one of the leading causes of disability and death among Chinese residents, with approximately 2 million new cases annually, accounting for about 80% of total stroke cases. Current stroke treatment faces challenges including low consultation rates within the therapeutic time window and high bleeding risks following thrombolysis.
Puyouke achieves efficient thrombolysis while significantly reducing bleeding risk by precisely activating plasminogen on the thrombus surface. Research results published in top international journals JAMA and The Lancet Neurology from the PROST and ROST-2 studies demonstrated that Puyouke, while maintaining non-inferiority to control drugs in efficacy, reduced bleeding event incidence by 30%-50% and offers clinical advantages including antiplatelet aggregation, low re-thrombosis rates, and convenient operation.
Since its market launch, the drug has cumulatively treated over 200,000 patients and maintains a leading market share in the myocardial infarction thrombolysis segment.
Beyond Puyouke, Tasly has built a robust R&D pipeline in innovative drugs, covering cardiovascular and metabolic diseases, neuropsychiatric disorders, digestive system conditions, and cell and gene therapy (CGT). The company currently has 31 innovative drugs in development, including the world's first adipose-derived mesenchymal stromal cell injection approved for US IND, PD-L1/VEGF dual antibody B1962 injection, and B1344 injection for metabolic dysfunction-associated steatohepatitis (MASH).
These strategic layouts reflect Tasly's "disease tree" strategy, focusing on areas with high technical barriers and high clinical value while avoiding homogeneous competition. With the approval of Puyouke's stroke indication and multiple biological innovative drugs progressively entering mid-to-late clinical phases, Tasly is forming a dual-wheel development model of "traditional Chinese medicine + biological drugs" in critical care and difficult-to-treat diseases.
Industry analysts note that the company's innovative pipeline value has not been fully recognized by the market. As key products gradually launch, Tasly is expected to welcome a new round of value reassessment and developmental breakthroughs.
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