Breaking a million! The surge in thrombolysis-ready population in golden hour window as competitive cardiovascular disease track awaits breakout.

Throughout the development trend of the global biopharmaceutical industry, cardiovascular and cerebrovascular diseases undoubtedly have a considerable market. As the patient population is large and the incidence continues to rise, a large number of unmet medical needs make the development of new interventional therapy, thrombolytic therapy and other sub-sectors highly imaginative, especially thrombolytic therapy has become more common in clinical applications in recent years and is becoming a famous R&D competition track.

Cardiovascular disease is the collective term for cardiovascular and cerebrovascular diseases and refers to ischaemic or haemorrhagic diseases of the heart, brain and body tissues caused by hyperlipidaemia, thick blood, atherosclerosis and hypertension.

According to the analysis of the China Cardiovascular Disease Report 2020, the prevalence of cardiovascular disease in China is on a continuous rise due to factors such as an ageing population, unhealthy diet and lack of exercise.

Currently, China has approximately 330 million cardiovascular patients, and the mortality rate of cardiovascular diseases is the highest in the world. The population base of cardiovascular patients is large, the mortality rate is high, and there is a trend toward early aging, rapid growth in low-income groups, and individual aggregation, all of which contribute to one of China's major medical and health problems.

Public information shows that the market size of the cardiovascular and cerebrovascular disease treatment area in 2019 is approximately RMB 212.2 billion, accounting for approximately 12.99% of the overall size of the Chinese pharmaceutical market.

The market size of cardiovascular diseases grew from RMB158.8 billion in 2015 to RMB212.2 billion in 2019, at a CAGR of 7.51%. The size of China's cardiovascular and cerebrovascular disease market is expected to grow to $247.7 billion by 2024. Statistics show that the size of China's cardiovascular and cerebrovascular disease market continues to grow significantly.

Thrombolytic therapy in the field of acute ST-segment elevation myocardial infarction

Acute ST-segment elevation myocardial infarction (STEMI) is one of the most common cardiovascular diseases in China. It refers to an acute myocardial infarction with typical ischaemic chest pain lasting more than 20 minutes and an ECG with typical acute ST-segment elevation.

Usually, acute ST-segment elevation myocardial infarction is caused by acute occlusive thrombosis due to coronary plaque damage, which leads to massive myocardial necrosis due to prolonged blood supply obstruction, thereby endangering the patient's life.

If patients can receive effective reperfusion therapy early, especially within 3 hours of coronary occlusion, it can save large areas of dead myocardium, reduce the size of the infarct and protect the ventricles.

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Reperfusion therapy: This refers to the reopening of a wholly occluded vessel and the reperfusion of ischaemic tissue through thrombolytic drugs, interventional therapy or surgery, and is an essential method of interventional therapy.

According to the Guidelines for the Diagnosis and Treatment of Acute ST-segment Elevation Myocardial Infarction and the Guidelines for the Rapid Treatment of Acute Coronary Syndromes, acute ST-segment elevation myocardial infarction is currently treated by both PCI surgery and thrombolysis.

At present, only hospitals in the more developed cities can perform PCI, while small and medium-sized cities and rural areas are unable to perform PCI due to a lack of medical resources, so the number of patients who can undergo PCI for reperfusion therapy is still limited.

The specific advantages of thrombolysis over PCI are that it is relatively inexpensive and less traumatic for the patient, and that it is more accessible in our current medical situation.

The number of patients with acute ST-segment elevation myocardial infarction treated by thrombolysis in urban and rural areas accounted for approximately 27% and 49% of all patients with acute ST-segment elevation myocardial infarction treated by reperfusion, respectively, in 2019. the number of patients who could be treated by thrombolysis in China was approximately 141,200 in 2019.

Of course, as the structure of healthcare resources continues to be optimised and awareness of the benefits of thrombolysis for acute ST-segment elevation myocardial infarction increases, the proportion of patients treated with reperfusion by thrombolysis will increase further in the future, with approximately 219,600 people expected to be treated by thrombolysis in China by 2024.

Over one million acute ischaemic stroke patients to receive thrombolytic therapy

As already described, stroke is one of the most common cardiovascular diseases in China after hypertension. As an acute cerebrovascular disease, stroke mainly includes ischaemic stroke and haemorrhagic stroke, which is a group of diseases caused by the sudden rupture of blood vessels in the brain or the failure of blood to flow into the brain due to blockage of blood vessels, and is characterised by high morbidity, mortality and disability.

Acute ischaemic stroke (AIS) is currently the leading cause of stroke, accounting for about 70.2% of all stroke cases. 2019 will see about 719,500 deaths from AIS in China.

It has also been shown that the rate of death/disability within one year of symptom detection in hospitalised patients with acute ischaemic stroke is between 33.4% and 33.8%.

According to relevant industry reports, about 4,832,000 people suffered from stroke in 2019, of which about 3,392,100 suffered from acute ischaemic stroke.

Due to the increasing population of hypertension, diabetes, hyperlipidaemia and coronary heart disease, the size of the acute ischaemic stroke patient population in China is expected to be about 3,977,100 by 2024 and about 4,342,400 by 2030.

The time window for treating acute ischaemic stroke is critical because of the lack of blood supply to the brain and the resulting brain damage after treatment for acute ischaemic stroke, which leads to functional impairment.

Authoritative data shows that in 2019 only about 16% of all acute ischaemic stroke patients treated in China had access to treatment within 4.5 hours of onset, and about 58% between 4.5 and 6 hours after onset.

Despite increasing awareness of acute ischaemic stroke and the availability of medical resources, it is still difficult for many acute ischaemic stroke patients to reach hospital within a short time of the onset of the disease - a challenge for thrombolytic therapy today.

According to industry tracking report data, the number of patients with acute ischaemic stroke who can receive thrombolytic therapy in China in 2019 is about 1,307,700, and the number of patients who can be suitable for thrombolytic drug treatment within 6 hours after the onset is about 967,700, of which about 758,500 patients can receive thrombolytic therapy between 4.5 hours and 6 hours.

The number of patients with acute ischaemic stroke who can be treated with thrombolysis within six hours is expected to grow to 1,249,600 in 2024, driven by favourable policies such as the future increase in medical resources and the construction of stroke centres.

YB1 combined with thrombolytics enters cardiovascular disease treatment as competitive landscape emerges in thrombolytic drugs market

As the market for thrombolytic therapy continues to expand, the competition in the thrombolytic drugs market is becoming increasingly fierce.

According to Frost & Sullivan's analysis, the market size of thrombolytic drugs in China in 2019 is approximately RMB 2.004 billion. At present, the most significant single product of thrombolytic drugs in China is alteplase (rt-PA), accounting for about 70.23% of the market size of thrombolytic drugs in China, with a sales scale of about RMB 1.407 billion.

The second largest class of thrombolytic drugs is urokinase, accounting for about 14.67% of the market size of China's thrombolytic drugs, with a sales scale of about 294 million yuan. One of the giants in the thrombolytic drug industry, Puyuk, the core product of Tianshi Li, is the third largest thrombolytic drug product in China, accounting for about 12.24% of the market size of thrombolytic drugs in China.

However, the currently marketed thrombolytic drugs recombinant urokinase and rt-PA have a short half-life of 4-8 minutes and do not alleviate the onset of acute thrombosis. Therefore, there is an urgent need for more new drugs or therapies to relieve and treat acute thrombosis effectively.

HK PharmaLysis' self-developed biomolecular drug delivery vehicle YB1 can carry the thrombolytic enzyme rt-PA to accumulate at the thrombus site and be released at a fixed point, solving the problem of its short half-life.

This is a very innovative and cutting-edge attempt in antithrombotic therapy, and the combination with urokinase in the treatment of various thrombotic diseases is an essential direction for the expansion of YB1 technology. DE and YB1-rt-PL, and we hope to make further progress in innovative research and development soon.