Event
On December 8, 2021, the website of the State Drug Administration announced that it has urgently approved the application for registration of novel coronavirus neutralizing antibody combination therapy drugs ambavirin injection (BRII-196) and romisovir monoclonal antibody injection (BRII-198) of Tengsheng Huachuang Pharmaceutical Technology (Beijing) Co., Ltd. (Tengsheng Bo Pharmaceutical subsidiary). This is the first independent intellectual property right novel coronavirus neutralizing antibody combination therapy approved in China.
Comment
Global multicenter phase 3 data is excellent, COVID-19 hospitalization / death reduced by 80%. On December 5, 2021, the company announced the results of its Phase III clinical trial of ACTIV-2 supported by the National Institutes of Health (NIH). Data from all subjects followed up for 28 days showed that among COVID-19 outpatients with a high risk of disease progression, the risk of hospitalization and death in the medication group was reduced by 80 per cent.
The epidemic is so severe that China is the first to be approved with a new crown neutralizing antibody, and the United States' application for EUA has been accepted. (1) on November 9, 2021, a new variety of Omicron was discovered for the first time in Botswana, and the global epidemic situation is still severe. Vaccines, neutralizing antibodies and small molecular drugs are indispensable means of prevention and treatment of COVID-19 at different levels. (2) according to the official website of the State Drug Administration on December 5, this emergency approval for the combination of the two drugs for the treatment of mild and common novel coronavirus infection in adults and adolescents with severe (including hospitalization or death) high risk factors. Among them, the adolescents (12 Mel 17 years old, weight ≥ 40kg) were conditionally approved. (3) according to the company announcement, the US Food and Drug Administration (FDA) has accepted the company's application for emergency use authorization (EUA) for the above two COVID-19 neutralizing antibody combinations in October 2021.
International top professional team, the field of functional cure of hepatitis B is in the forefront of the world. The company develops in China and the United States, focusing on the field of public health, focusing on two major indications: anti-infectious and central nervous system diseases. The company's hepatitis B function cure combined therapy is in the second clinical stage.
Profit forecast and investment suggestion
We maintain our profit forecast and expect revenue of 240.41 billion yuan in 2022Universe for 23 years (as a matter of caution, we will adjust our profit forecast based on subsequent government orders or market pricing). We believe that the company is an international, R & D-leading, commercially experienced, high-quality innovative biotechnology target, maintaining a "buy" rating.
Risk hint
The risk that the company's new drug research and development (e.g., HBV,HIV, etc.) does not progress as expected.
The risk that the commercialization process of the company's future approved listed products (for example, COVID-19 neutralizing antibody) does not reach the expected level.