High incidence of cardiovascular disease drives growth in biologics market size. YB1 continues to write a new chapter in the thrombolysis track?

Health is an eternal pursuit for humankind and a topic that cannot be ignored in everyday life. In addition to the traditional perception of cancer, labelled as a "terminal illness", cardiovascular disease is the number one human health killer. According to statistics, cardiovascular disease is currently the number one cause of death worldwide.

Cardiovascular disease is the collective term for cardiovascular and cerebrovascular diseases and refers to ischaemic or haemorrhagic diseases of the heart, brain, and tissues caused by hyperlipidaemia, blood viscosity, atherosclerosis, and hypertension. To date, there are approximately 330 million patients with cardiovascular disease in China.

In China, the mortality rate of cardiovascular disease has been at the top in recent years, with a large population base of cardiovascular and cerebrovascular patients and a high mortality rate, and now there is a trend of low age, rapid growth in low-income groups and individual aggregation, which is one of the significant medical and health problems in China. The high incidence of the disease has led to continuous growth in market demand, and the development of the cardiovascular disease treatment field has also led to a constant expansion of the domestic and international biologics market size.

The global biologics market is expected to exceed US$450 billion in three years as it continues to grow.

Biologics are a subset of sugars, proteins, nucleic acids or complex combinations and can be made from biological sources. With the development of biotechnology in recent years, biologics have been used more often to prevent and treat diseases such as cardiovascular, tumour and autoimmune, and digestive and metabolic disorders and have shown better therapeutic effects and even irreplaceable effects.

To Looked at the global pharmaceuticals market, the global pharmaceuticals market size has maintained steady growth in the past, with the market size increasing from US$110.5 billion in 2015 to US$1,324.5 billion in 2019, at a CAGR of 4.63%, under the influence of factors such as economic development and improved living standards and increased social spending on healthcare. The global pharmaceuticals market size is expected to reach US$1,639.5 billion by 2024.

(Source: Frost & Sullivan)

The global pharmaceutical market is currently divided into two main categories of drugs: chemical drugs and biological drugs. The worldwide market for natural drugs is growing faster than chemical drugs despite their smaller size.

Data from public sources show that the compound growth rate of globalised drugs from 2015 to 2019 is only 3.63%, while the compound growth rate of global biologics in the same period is 8.75%, and the global biologics market size grows from US$ 204.8 billion in 2015 to US$ 286.4 billion in 2019. The global biologics market size is expected to grow to US$ 456.7 billion by 2024.

The advancing Chinese biologics market - fast growth in size and high growth potential

The Chinese pharmaceutical market had grown from RMB 1,220.7 billion in 2015 to RMB 1,633 billion in 2019, a CAGR of over 7%, higher than the global pharmaceutical market's CAGR of 4.63% over the same period, as economic and healthcare demand grows. The industry-specific tracking report estimates that China's pharmaceutical market size will reach RMB 2,228.8 billion by 2024.

It is worth noting that, unlike the international market, China's pharmaceutical market drugs are mainly composed of chemical, Chinese and biological drugs. Biologics are still a relatively small part of the Chinese pharmaceutical market. However, given their therapeutic advantages in critical therapeutic areas such as cardiovascular disease, cancer, digestive tract, and metabolism, they proliferate and have high growth potential.

Statistics from public sources show that the market size of biologics in China has grown from 145.3 billion yuan in 2015 to 312 billion yuan in 2019, with a compound annual growth rate of about 21.06%, far exceeding the growth rate of the global biologics market. By 2024, the market size of biologics in China is expected to grow to RMB 712.5 billion.

Thrombolysis in the treatment of acute pulmonary embolism - A paradigm for the treatment of cardiovascular disease

In an earlier article, we introduced cardiovascular diseases such as myocardial infarction and stroke, which are deadly and disabling "killers", but today we want to learn about acute pulmonary embolism and how to treat it.

Pulmonary embolism (PE) is a general term for a group of diseases or clinical syndromes caused by the obstruction of the pulmonary arteries or their branches by various types of emboli, including pulmonary thromboembolism (PTE), fat embolism syndrome, amniotic fluid embolism, air embolism and tumour embolism. Of these, PTE is the most common type of PE, and most of its thromboembolic originate from lower limb deep vein thrombosis (DVT), with PTE and DVT collectively referred to as venous thromboembolism (VTE).

Acute pulmonary embolism is a clinical and pathophysiological syndrome caused by an endogenous or exogenous embolus blocking the main trunk or branches of the pulmonary artery, obstructing the pulmonary circulation. Due to the lack of specificity in the clinical presentation of this disease, it is easily confused with other conditions and therefore has a high rate of misdiagnosis, resulting in many patients with acute pulmonary embolism not receiving timely treatment.

It is important to be alert that the clinical presentation of pulmonary embolism can range from asymptomatic, insidious, to haemodynamically unstable, or even sudden death.

Tips: Cardiovascular disease tips: some signs before "sudden death", find these symptoms, please send to the doctor immediately!

The China PEACE prospective myocardial infarction study showed that 94% of myocardial infarction patients in China presented with chest pain or chest discomfort. In comparison, the other most common symptoms were heavy sweating (67.2%), weakness (31%), nausea (30.7%), shortness of breath (29.1%), radiating pain in the shoulder and neck (27.9%), palpitations (22.3%) and stomach discomfort or pain (12.8%). 0.2% of patients had no acute symptoms.

The CAMI registry study analysed 14,854 patients with myocardial infarction and found that persistent chest pain and profuse sweating were the most typical clinical manifestations in Chinese patients with myocardial infarction, with 66.4% of patients experiencing persistent chest pain and 63.7% of patients with profuse sweating. Asymptomatic myocardial infarction was found in 1.2% of men and 1.7% of women. Approximately one-quarter of patients with STEMI presented without typical chest pain (defined as lasting longer than 20 min and not relieved by rest or nitroglycerin); patients without specific chest pain presented late had a low rate of emergency PCI and had a higher mortality rate during hospitalisation.

Compared to common cardiovascular diseases such as stroke (strokes), the number of patients with acute pulmonary embolism is relatively tiny. Data from public sources show that there were approximately 227,700 patients with acute pulmonary embolism in China in 2019, and considering the high rate of misdiagnosis of acute pulmonary embolism, only 5,900 patients with acute pulmonary embolism received thrombolytic therapy in 2019. The relevant follow-up report predicts that 29.88 people will suffer from acute pulmonary embolism in China by 2024.

With the increasing awareness of the dangers of acute pulmonary embolism and the development of medical technology, it is believed that the diagnosis rate of acute pulmonary embolism will continue to increase in the future, and it is expected that the number of patients with acute pulmonary embolism who can receive thrombolytic therapy in China will increase to approximately 15,100 by 2024.

Thrombolytic therapy works by directly or indirectly converting plasma protein fibrinogen into fibrinolytic enzymes, rapidly degrading fibrin and causing clots to dissolve, and it also has a partial anticoagulant effect. In terms of therapeutic effect, thrombolytic therapy can improve the hemodynamic instability of patients with acute pulmonary embolism, rapidly dissolve the clot, restore reperfusion of lung tissue, and rapidly improve the hemodynamic parameters; facilitate the dissolution of venous emboli and potentially reduce the recurrence rate of pulmonary embolism; and prevent the occurrence and development of chronic pulmonary vascular obstruction, thus lowering the incidence of pulmonary embolism.

Current competitive overview of the thrombolytic drugs market at a glance: YB1 taps into the innovative thrombolytic drugs market

Thrombolytic drugs commonly used in clinical practice include Urokinase (UK), streptokinase (SK), alteplase (rt-PA), Puyuk (Pro-UK), ralteplase (r-PA) and tenecteplase (TNK-Tpa).

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 sales scale of about RMB 1.407 billion. The second-largest class of thrombolytic medications is Urokinase, accounting for 14.67% of the market size of thrombolytic drugs in China, with a sales scale of about RMB 294 million. At present, the core product of Tianshi Li, Puyuk, 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 short half-life of recombinant urokinase rt-PA, a commonly used thrombolytic drug on the market today, is only 4-8 minutes and does not relieve the onset of acute thrombosis, a central pain point in traditional thrombolytic drug therapy. "Half-life" refers to the time required to reduce the plasma concentration or the amount of drug in the body by 50%. A drug with a short half-life means that it is eliminated quickly in the body and the blood concentration decreases quickly, making it difficult to achieve the optimal therapeutic effect.

As an innovative biotechnology company, HKopharma Lyso is also actively entering the antithrombotic therapy market and has already established a pipeline of innovative thrombolytic products.

The use of our core technology product, YB1

, a large-molecule drug delivery carrier, in combination with a variety of thrombolytic drugs to treat a variety of thrombotic diseases is the focus of our research and development direction, the specific product pipeline, YB1-rt-PA is the company's first generation of targeted thrombus ablation products, the main feature is carried by YB1, and in the Urokinase is released at the thrombus site to achieve rapid targeted release of thrombolytic drugs. Urokinase is produced in the human body by the kidneys and directly activates fibrinolytic enzymes into fibrinolytic enzymes, the first generation of natural thrombolytic agents derived from urine.

At the same time, the company has also laid out innovative product pipelines for YB1-rt-DE, a YB1-conjugated recombinant fibrinolytic enzyme, and YB1-rt-PL a YB1-conjugated fibrinolytic enzyme, both of which are currently in the R&D design stage.