Frontier Biotechnologies Inc(688221) (688221)
Event: the company received the notice of approval of drug clinical trial approved and issued by the State Food and drug administration, and the application for phase I bridging test of fb2001 for anti covid-19 virus drug injection was approved.
The same mechanism drugs have shown excellent therapeutic effects. Fb2001 is a sars-cov-2 protease inhibitor, which shows good pharmacokinetics and safety in experimental animals. The international authoritative journal Science published some preliminary research data: the inhibitory activity IC of fb2001 on covid-19 virus sars-cov-2m is 0.053 ± 0.005 μ M. The in vitro antiviral activity EC was 0.42 ± 0.08 μ M. It has the activity of highly targeting the main protease of coronavirus. Paxlovid, Pfizer’s new anti covid-19 drug, is also a sars-cov-2 protease inhibitor. The analysis of medium-term data shows that compared with placebo, Patients treated within three days of symptom onset (primary endpoint) had an 89% lower risk of covid-19 virus-19-related hospitalization or death from any cause; 0.8% of patients treated with paxlovid were hospitalized within 28 days after randomization (3 / 389, no death), while 7.0% of patients treated with placebo were hospitalized or died (27 / 385, 7 subsequent deaths), P
<0.0001，疗效优异。
FB2001在中国同机制药物中进度最快， 全球及中国在研同类品种少，竞争格局良好。 全球有 3个 SARS-CoV-2抑制剂上市， 3个处于 III 期或 II/III 期临床， 2个 II 期临床， 1个 I 期临床。但 3 个已经上市和 1 个处于 III 期临床的药物是老药新用，目前来看治疗 COVID-19 的效果尚不能确定。全球进度最快的就是辉瑞的处于 III 期临床的 PAXLOVID，正在美国申请 EUA。 公司的 FB2001是中国同机制在研新药中进度最快的， 除此之外， 尚有 3 家公司处于临床前研究阶段。
疫情波动常态化， 抗 COVID-19 药物成为刚需品种， 中国仍有市场空间。 中国 2021年1 月 1日-2021年 12月 12日，共新增确诊的 COVID-19 患者 1.3万人，这一部分人是 COVID-19 药物的直接使用者。且国家可能对于 COVID-19 药物还有战略储备。因此中国 COVID-19 药物仍有市场空间。
盈利预测。 我们预计 2021-2023年收入分别为 7000万元、 1.4亿元、 2.4亿元，归母净利润分别为-2.0亿元、 -1.7亿元和-1.0亿元， EPS 分别为-0.55元、 -0.47元、 -0.28 元。
风险提示： 艾可宁市场推广不及预期；研发进展不及预期
