Events. Anti-novel coronavirus 3CL protease inhibitor FB2001 was developed by Frontier Biology in cooperation with Shanghai Institute of Medicine, Chinese Academy of Sciences and Wuhan Institute of virus, Chinese Academy of Sciences. The Drug Evaluation Center of the State Drug Administration approved the company to conduct a key clinical trial of anti-novel coronavirus 3CL protease inhibitor FB2001, an international multicenter, randomized, double-blind, placebo-controlled Ⅱ / Ⅲ phase clinical trial to evaluate the efficacy and safety of FB2001 in COVID-19 's hospitalized patients.
Viewpoint: FB2001 is the first small molecular 3CL protease inhibitor to enter II/III phase in China. New drugs are urgently needed in hospitalization and critically ill fields, and FB2001 has great market potential.
1.FB2001, which has the same target as Pfizer Inc Xinguan drug, is the first small molecular 3CL protease inhibitor in China to enter II/III phase. It has clear mechanism, broad-spectrum antiviral activity, good safety and does not need to be combined with pharmacokinetic enhancers.
1) the mechanism of action is clear: FB2001 is a COVID-19 virus protease inhibitor, a peptide compound designed and synthesized based on the three-dimensional structure (3CL) of coronavirus main protease, and has a clear drug action mechanism. 3CL protease inhibitor can no longer bind to the substrate normally by binding to 3CL protease, thus inhibiting virus replication. 2) it has broad-spectrum antiviral activity: the sequence of 3CL protease is highly conserved, and its inhibitor can show efficient broad-spectrum inhibitory activity against the main epidemic SARS-CoV-2 mutant virus strains Alpha, Beta, Delta and Omicron in preclinical studies. 3) good safety: because 3CL protease has no human homologue, it is safe. 4) No need to be combined with pharmacokinetic enhancers (such as ritonavir, etc.): it can reduce the potential risk of drug interaction due to the use of pharmacokinetic enhancers, so as to meet the needs of COVID-19 inpatients for anti-novel coronavirus drugs with low side effects and low drug interactions.
5) in April 2021, FB2001 obtained the clinical trial approval issued by FDA, and the Phase I clinical trial in the United States is currently in progress in an orderly manner. Frontier Biology has the global rights and interests of FB2001 and will make every effort to promote the clinical application of FB2001 in China and the United States. In addition, as a small molecular drug, FB2001 has obvious cost advantage.
two。 COVID-19 hospitalization and critical areas of small molecular drugs are currently only approved by Redcivir, FB2001 market potential.
According to CDC data in the United States, during the Omicron epidemic from December 2021 to March 2022, the number of hospitalized patients of COVID-19 in the United States exceeded 1.16 million. Of the nearly 1 million COVID-19 deaths in the United States, people over 65 accounted for nearly 680000. At the same time, most of COVID-19 's hospitalized patients in the United States suffer from underlying diseases such as hypertension (56%), metabolic diseases (41%) and cardiovascular diseases (37%), indicating that people with underlying diseases are at higher risk. According to data from the Hong Kong Department of Health, among COVID-19 inpatients in Hong Kong, from December 31, 2021 to April 17, 2022, there were a total of 49149 inpatients in Hong Kong, with an infection hospitalization rate of 4.14%, of which people aged 80 and above had the highest proportion of moderate and severe cases. 8946 people died, of which 73% of the deaths were not vaccinated by COVID-19. In the epidemic situation of COVID-19, the elderly, concomitant underlying diseases, immune deficiency and unvaccinated people have a higher risk of developing into COVID-19 inpatients after infection with the virus, and they are also high-risk groups for progression to critical illness and death.
There is no anti-novel coronavirus small molecule drug approved to treat COVID-19 's hospitalized patients in China; globally, only one injection of Remdesivir has been approved to treat COVID-19 's hospitalized patients in some countries. According to Gilead's financial report, Redcivir has treated about 10 million patients worldwide, used more than 50% of hospitalized patients in the United States, and achieved global sales of US $5.565 billion in 2021. In addition, overseas drug development for COVID-19 's hospitalized patients is also ongoing. On April 11, Veru announced that its COVID-19 drug candidate Sabizabulin performed well in the phase III study. Mid-term analysis showed that Sabizabulin could reduce the mortality of moderate and severe hospitalized patients by 55% (pill 0.0029) with good safety. COVID-19 is in urgent need of targeted new drugs in hospitalization and critical areas, especially in China, and the market potential of FB2001 is great.
Profit forecast and valuation. Aikening's new health insurance is expected to achieve rapid volume, driving the company's revenue to rise rapidly. It is estimated that the income from 2021 to 2023 is 82 million yuan, 306 million yuan and 1.009 billion yuan respectively, an increase of 75%, 274% and 230% respectively over the same period last year; the net profit of returning home is-299 million yuan,-302 million yuan and-14 million yuan respectively; the EPS is-0.83 yuan,-0.84 yuan and-0.04 yuan respectively; and the PE is-17x,-17x and-365x respectively. Maintain a "buy" rating.
Risk hint: Aikening sales are not as good as predicting risk; R & D failure risk.
