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PO Box 309, Ugland House, Grand Cayman, KY1－1104, Cayman Islands
Head Office and Principal Place of Business
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Tengsheng Boyao Biotechnology Co., Ltd. is a biotechnology company headquartered in China and the United States, mainly engaged in infectious disease therapy research and development business. The company's products are used in infectious diseases (such as hepatitis B virus (HBV), human immunodeficiency virus (HIV), multidrug-resistant (MDR) or extensively drug-resistant (XDR) Gram-negative bacteria infections) and other diseases with significant public health burdens, such as central nervous system (CNS) diseases. The company also develops treatments for COVID-19 and others.
Tengsheng Boyao Biotechnology Co., Ltd. is a biotechnology company dedicated to promoting the treatment of major infectious diseases and central nervous system diseases, mainly in China and the United States. Since its establishment in 2017, the company has gradually implemented strategic measures to become a global biopharmaceutical company focusing on the public health industry and integrating strong R & D, business development and commercialization capabilities. We have built an internal team with strong R & D capabilities and transformational medical research capabilities, as well as proprietary candidate product lines that enjoy global rights. The company's internal R & D and external cooperation of twin engines can promote its flexible multinational business model and develop effective treatments for patients.
Our infectious disease programs include the treatment of hepatitis B virus, human immunodeficiency virus and multidrug-resistant or extensively drug-resistant Gram-negative bacteria infections currently in clinical trials, as well as the COVID-19 project approved by BLA in China. For our CNS program, we are currently exploring treatments for and prevention of postpartum depression, as well as treatments for severe depression, two diseases that pose a significant public health burden worldwide. Our pipeline covers all stages of clinical development, including more than 10 innovative candidates for major infectious diseases and mental illness.
Under the guidance of our business strategy, we have achieved several major clinical development milestones during the reporting period.
Based on the unique combination therapy design of RNA interference therapy, the top priority of our HBV project is to achieve functional therapy. In this regard, our clinical development is a leader in China, which is the world's largest HBV market. We launched a Phase 2 MRCT combination study in April 2021, which is a combination of small interfering nucleotide BRII-835 (VIR-2218) based on nucleoside analogue therapy and recombinant therapeutic vaccine BRII-179 (VBI-2601). Patient enrollment was completed in February 2022, and mid-term data are expected in the second half of 2022. We and our partner Vir are also exploring other combination treatments in a number of clinical studies. With a large number of innovative projects, combination strategy and leading edge in clinical research, we are the industry leader in the research and development of HBV functional therapy.
In order to respond quickly to the global emergency needs caused by the COVID-19 epidemic, we use our expertise and research capabilities to help reduce the heavy burden of COVID-19 on public health. In less than two years, we have successfully passed the clinical development and regulatory approval process, demonstrating our team's superb R & D capabilities and efficiency. In December 2021, our internally developed new ambavirin ╱ romisciumab combination therapy was approved by the State Drug Administration of China (SDA) BLA for the treatment of mild and common COVID-19 patients in adults and adolescents with high risk factors for progression (including hospitalization or death). The positive results of the randomized, double-blind, placebo-controlled phase 3 global 2max trial show that this combination therapy reduces the risk of hospitalization and death of COVID-19 outpatients with high risk of clinical progression by 80%, which is statistically significant and is a strong support for us to obtain BLA approval. In March 2022, the National Health Commission of China incorporated the combination therapy of ambavirin monoclonal antibody ╱ and romisovir into the COVID-19 diagnosis and treatment Program (trial version 9) for the treatment of COVID-19. Recently, we have also announced the conclusion of a cooperative relationship with Sinopharm Holdings, a leading pharmaceutical circulation company in China, to promote the drug reserve, channel distribution and regional access of the neutralizing antibody.
During the reporting period, we advanced the self-developed HIV and CNS projects from the preclinical stage to the clinical trial stage. Currently, our BRII-778 and BRII-732 for HIV treatment are in the phase I clinical study, and the data are expected to be released at the relevant scientific conference in the second half of 2022. We developed BRII-296 for the treatment and prevention of PPD and MDD. The phase 1 clinical study of BRII-296 is ongoing and the results of its phase 1 clinical study are expected to be published in the second half of 2022. This project has great potential to become a better choice for patients with PPD and MDD. BRII-297 is a new type of chemical entity that we are developing to treat all kinds of depression.
In addition to the above programs, we also have a Greater China license for the treatment of MDR/XDR Gram-negative infections, TB mycobacteria and NTM program candidates, which are currently under clinical development by our partners Qpex or AN2.
In addition to the progress made in the product pipeline, we successfully listed on the main board of the Stock Exchange on July 13, 2021, raising a total of approximately HK $2.788 billion (about RMB 2.325 billion). Shortly thereafter, on December 6, 2021, we were included in the Hong Kong Stock Connect to enable eligible mainland Chinese investors to trade the Company's shares directly, thereby enhancing the Company's capital market recognition and increasing stock liquidity.
In 2021, as a fast-growing small biotechnology company and newly listed company, our achievements are obvious to all, and we have won many honors for our corporate achievements and clinical performance this year. It includes the "2021 R & D Achievement Award" issued by BioCentury-BayHelix, the "Best New economy listed Company of 2021" award from Sina Finance, the "Best IPO of 2021" award from PharmaDJ&ClinicalTrial and the "Best Investor in Greater China" award from IRMagazine. Huaxia Times, China's central mainstream financial media, also awarded our CEO Dr. ZhiHong ("Dr. Hong") "Industry Leader of the year 2021" award. In addition, Sina Finance has also nominated our Chief Financial Officer and Chief Strategy Officer, Dr. Li Ankang, as the "Best CFO of 2021 Hong Kong and US stocks".