In the fast-paced world of pharmaceutical advancements, Reteplase stands out as a beacon of hope for patients suffering from acute ischemic stroke (AIS). We, Unibest, are excited to share with you the remarkable benefits and opportunities that Reteplase brings to the global market.

First approved in Europe and the United States in 1996, Reteplase has been a significant advancement in thrombolytic therapy. Since its launch in China in early 2000, it has consistently demonstrated its efficacy in treating acute myocardial infarction, with annual sales reaching an impressive 20 million USD.

Clinical Advantages: Reteplase vs. Alteplase

Recent clinical studies have shown that Reteplase isn't just keeping pace with the standard thrombolytic agent, Alteplase – it's surpassing it. Here's why:

The RAISE Study: Compelling Evidence of Superiority

The RAISE study (NCT05295173), a phase 3, multicenter, prospective, open-label, noninferiority, randomized trial with blinded end-point assessment, provides compelling evidence for Reteplase's efficacy. Conducted across 62 sites in China, this landmark study compared Reteplase to Alteplase in patients with acute ischemic stroke eligible for intravenous thrombolysis within 4.5 hours after symptom onset (Read the detailed report here)

Key findings from the RAISE study include:

1/ Superior Functional Outcomes: 79.5% of patients in the Reteplase group achieved an excellent functional outcome, compared to 70.4% in the Alteplase group (risk ratio, 1.13; 95% CI, 1.05 to 1.21; P<0.001 for noninferiority and P=0.002 for superiority).

Distribution of Modified Rankin Scale Scores at 90 Days.

2/ Comparable Safety Profile: The incidence of symptomatic intracranial hemorrhage within 36 hours was similar between the two groups (2.4% for Reteplase vs. 2.0% for Alteplase; risk ratio, 1.21; 95% CI, 0.54 to 2.75).

3/ Increased Efficacy with Manageable Risk: While the incidence of any intracranial hemorrhage at 90 days was higher with Reteplase (7.7% vs. 4.9%; risk ratio, 1.59; 95% CI, 1.00 to 2.51), the superior efficacy in functional outcomes suggests a favorable benefit-risk profile.

These results demonstrate that Reteplase is not only non-inferior but superior to Alteplase in achieving excellent functional outcomes in acute ischemic stroke patients, with a manageable safety profile.

Additional Advantages of Reteplase

1/ Superior Efficacy: Reteplase's unique molecular structure allows for better clot penetration, enhancing both thrombolytic effect and speed. Phase III confirmatory clinical trial results for AIS treatment show that intravenous thrombolysis with reteplase is superior to alteplase in patients within 4.5h of AIS onset, with a manageable safety profile.

2/ Faster Onset: Clinical data shows higher vessel patency rates and earlier recanalization times with Reteplase. This rapid action is crucial for salvaging near-necrotic myocardium and protecting cardiac function.

3/ Convenient Administration: Reteplase features a simple double-bolus intravenous administration with fixed dosing. This not only saves precious time in critical AIS treatment but also reduces the risk of dosing calculation errors.

4/ Good Accessibility: With its competitive pricing (47% less than Alteplase and 62% less than Tenecteplase), sufficient production capacity, and quality assurance, Reteplase can reach more remote hospitals, breaking the monopoly of imported drugs and improving accessibility in underserved areas.

5/ Adjuvant Therapy Advantages: Adjuvant therapy involving heparin and reteplase is commonly used in the treatment of acute myocardial infarction (AMI) and other thrombotic conditions. This combination aims to enhance thrombolysis and improve patient outcomes by preventing reocclusion and maintaining patency of the affected arteries. For example, clinical studies have demonstrated that reteplase combined with low molecular weight heparin (LMWH) like enoxaparin is effective in improving patency rates and reducing complications in ST-Elevation Myocardial Infarction patients.

Technology and Supply Chain Assurance

Behind Reteplase's clinical success is a robust technological foundation. Advanced production processes ensure consistent product quality, while stable raw material sources and ample production capacity support global market demand. With an annual production capacity of 120,000 units in a 500 L stainless steel tank, we're ready to meet worldwide needs.

The Opportunity: A Global Partnership

For the first time, this state-of-the-art Reteplase product is venturing beyond China's borders. Unibest, as the commissioned promoter, is seeking global partners to bring this life-saving treatment to patients worldwide.

By partnering with us, you'll gain:

1/ Access to a clinically superior thrombolytic agent

2/ A product with a proven track record in one of the world's largest pharmaceutical markets

3/ A reliable supply chain with significant production capacity

4/ The opportunity to improve stroke treatment outcomes in your market

5/ A curated and growing pipeline, including heparin as an example, for you to choose from.

We invite pharmaceutical companies, distributors, and healthcare providers to join us in this groundbreaking venture. Together, we can revolutionize stroke treatment and improve patient outcomes globally.

Don't miss this opportunity to be at the forefront of thrombolytic therapy. Contact Unibest today to discuss how we can bring Reteplase to your market and make a real difference in the lives of stroke patients worldwide.

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