Frontier Biotechnologies Inc(688221) (688221)
event. The company received the notice of approval of drug clinical trial approved and issued by the State Drug Administration, and the application for phase I bridging test of fb2001 for anti covid-19 virus drug injection was approved. Viewpoint: covid-19 therapeutic drug has been approved clinically in China, and new drugs are urgently needed in inpatient and critical areas. Fb2001 has great market potential. 1. Fb2001 and Pfizer covid-19 have the same target, and phase I clinical trials have been conducted in the United States. Small molecule drugs have cost advantages. Fb2001 is covid-19 pneumonia virus protease inhibitor, It is a peptide like compound designed and synthesized based on the three-dimensional structure (3CL) of coronavirus main protease. It shows good in vivo pharmacokinetic properties and safety in experimental animals. The experimental results are published in science as a cover article. In April 2021, fb2001 obtained the clinical trial approval issued by FDA. At present, the phase I clinical trial in the United States is progressing in an orderly manner. Frontier Biotechnologies Inc(688221) owns the global rights and interests of fb2001 and will fully promote the clinical application of fb2001 in China and the United States. In addition, fb2001 has obvious cost advantages as a small molecule drug.
2. Covid-19 small molecule drugs in inpatient and severe areas are only approved by redcivir, and fb2001 has great market potential. Delta virus strain led to a surge in the number of hospitalizations in the United States in the third quarter. At the same time, with the recent spread of the new variant Omicron, the data of hospitalized patients in the United States also showed signs of rising again. It can also be seen from the sales of redciway that the sales in the third quarter increased by 132% month on month to US $1.923 billion. Since its listing one year ago, The cumulative sales of redcivir has reached US $7 billion (US $2.8 billion in 2020; US $3.42 billion from 2021 to q34). Gilead's annual sales forecast for redcivir was updated again in October to US $4.5-4.8 billion. At present, only redcivir has been approved for covid-19 small molecule drugs in inpatient and critical areas, and there is an urgent need for targeted new drugs. Fb2001 has great market potential.
3. Many varieties under research.
1) Long acting and injectable combination fb1002:
Maintain the treatment indications, and the phase II clinical trial has entered the second stage in the United States;
Indications for multidrug resistance: the international multicenter phase II clinical trial entered the stage of subject screening in China and the United States;
For the indications of immunotherapy, phase II clinical trial has entered the stage of subject enrollment in China.
2) Fb2001, a new drug under development for anti covid-19 virus small molecule: phase I clinical trial was carried out in the United States and approved in China.
3) New transdermal analgesic patch fb3001: the phase I clinical trial of bridging has been completed in China, and the research and development related work in the next stage is being promoted.
4. Re sort out the investment logic. 1) the scale of AIDS market is large, China's growth rate is fast, and the payment structure is changing. 2) Compared with oral medication, aikonin has obvious advantages in medication frequency, safety, drug interaction and drug resistance, and is relatively needed for hospitalized, surgical and severe patients; 3) There are about 700000 target patients for aikening, which has a large space. Equity incentive has set a high growth target. The combination scheme of aikening and neutralizing antibody is expected to become a heavy variety at the level of one billion US dollars; 4) Covid-19 therapeutic drugs are expected to provide greater elasticity. Profit forecast and valuation. Aikening's new medical insurance is expected to achieve rapid volume and drive the rapid increase of the company's revenue. It is estimated that the revenue from 2021 to 2023 will be 82 million yuan, 306 million yuan and 1009 million yuan respectively, with a year-on-year increase of 75%, 274% and 230% respectively; The net profit attributable to the parent company is - 299 million yuan, - 302 million yuan and - 14 million yuan respectively; EPS is -0.83 yuan, -0.84 yuan and -0.04 yuan respectively; PE is - 21x, - 21x, - 446x respectively. Maintain the "buy" rating.
Risk warning: the sales of aikening is less than the predicted risk; Risk of R & D failure.
