The Zhitong Finance App learned that Shanghai Securities released a research report saying that on March 19, the US FDA announced approval for the launch of Tryvio, a new molecular physical drug developed by Idorsia. Tryvio is an endothelin receptor antagonist used to treat high blood pressure that is still insufficiently controlled when combined with other antihypertensive drugs. Notably, Tryvio is the first oral antihypertensive therapy approved to work through a new treatment route in nearly 30 years.
According to the “China Cardiovascular Health and Disease Report 2022”, the prevalence of cardiovascular disease in China continues to rise. It is estimated that there are currently 330 million patients, including 13 million people with stroke, 11.39 million with coronary heart disease, 8.9 million with heart failure, and 245 million with high blood pressure. According to Farber's omni-channel data, among overall medical institutions, the cardiovascular system drug market will exceed 100 billion yuan in 2022.
Recommended attention: Hengrui Pharmaceutical (600276.SH), Cinda Biotech (01801), Xinlitai (002294.SZ), CSPC Group (01093), etc.
The main views of Shanghai Securities are as follows:
New mechanism oral antihypertensive drug Tryvio approved
On March 19, 2024, the US FDA announced approval for the marketing of Tryvio, a new molecular physical drug developed by Idorsia. Tryvio is an endothelin receptor antagonist used to treat high blood pressure that is still insufficiently controlled when combined with other antihypertensive drugs. Tryvio is currently the first and only endothelin receptor antagonist. It is the first oral antihypertensive therapy approved to work through a new treatment route in more than 30 years.
The active ingredient in Tryvio is Aprocitentan, which inhibits the binding of endothelin-1 (ET-1) to endothelin receptor A (ETA) and endothelin receptor B (ETB) receptors. ET-1 and its receptors are highly expressed in vascular endothelium and vascular smooth muscle cells, and play an important role in regulating hemodynamic dynamic balance.
ET-1 is a peptide containing 21 amino acids that can irreversibly bind to its receptors and is currently the strongest and longest lasting vasoconstrictor. In hypertension, ET-1 can also cause endothelial dysfunction, vascular hypertrophy and remodeling, sympathetic activation, and increased aldosterone synthesis. Due to the interaction between endothelin and endothelin receptors, it may be one of the reasons why current medications are unable to control blood pressure.
Earlier, news updates about Aprocitentan were published on the website of the Ministry of Science and Technology, and related results were published in “Lancet”. Previous studies have shown that endothelin signaling pathways that control vasoconstriction are abnormally activated in patients with intractable hypertension. Clinical studies have shown that aprocitentan can significantly reduce diastolic and systolic blood pressure in test patients, especially in patients with intractable hypertension, and the duration of treatment for more than 48 weeks. The most common adverse reaction in patients is mild to moderate fluid retention in the body, and most are manageable.
Novo Nordisk expands cardiovascular drug pipeline, PCSK9 is gaining momentum
Recently, Novo Nordisk announced that it will acquire Cardior Pharmaceuticals at a price of 1.03 billion euros to further expand the cardiovascular drug pipeline. Cardior focuses on a mid-term clinical trial program for heart failure. The two companies have already reached a relevant acquisition agreement. Cardior, founded in 2016, is a clinical-stage biomedical company that develops RNA-based therapies aimed at preventing, repairing and reversing heart disease, according to the Pharmaceutical Economic Daily.
In the cardiovascular drug market, the new drug field that has received more attention is still focused on the bio-targeted drug PCSK9 inhibitors in the lipid-lowering drug market. In August 2023, two new PCSK9 inhibitor drugs were approved for marketing, namely tolecimab developed independently by Cinda Biotech and Novartis's Inxlan sodium injection. Tolecimab is a monoclonal antibody that is used once every 2 or 4 weeks.
Inkslan sodium injection is the world's first and only small interfering RNA (siRNA) drug to reduce LDL-C. It can block the synthesis of PCSK9 protein at the source, and also has certain advantages in the administration cycle. Patients receive booster injections three months after the first dose, and only need to inject twice a year thereafter. Currently, Hengrui Pharmaceutical and Junshi Biotech's PCSK9 monoclonal antibodies have all applied for listing.
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