Main points of investment
With the commercial listing of COVID-19 neutralizing antibody, it has entered the commercial stage: in July, the long-acting ambavirin / romisovir combination therapy was successfully commercialized, marking the company's transition from the clinical stage to the commercial stage. In the same month, live virus data showed that combination therapy remained neutralized against mainstream mutants of Omicron BA.4/5 and BA.2.12.1 subtypes in most parts of the world. At present, the United States FDA is reviewing the application for emergency use authorization of the combination therapy.
The HBV project is progressing smoothly, with the introduction of VIR-3434 to further strengthen the combination therapy strategy: in February, the phase 2 MRCT of BRII-179 (therapeutic vaccine) and BRII-835 (siRNA) completed the enrollment of 90 patients in the Asia-Pacific region. The company is expected to release medium-term top-line data by the end of this year. If the results are positive, the company is expected to start critical clinical communication with CDE in 2023.
The 2a/2b phase clinical of BRII-179 combined with PEG-IFN- α + NRTI is recruiting patients in China. The company expects the enrollment of the first part of the Phase 2 study to be completed in Q4 in 2022 and the release of medium-term top-line data in the first half of 2023. In July, the company introduced subcutaneous injection of HBV neutralizing monoclonal antibody VIR-3434, further enriching the company's HBV combination therapy strategy. The company expects to apply to CDE for a pre-IND meeting for phase 1 of VIR-3434 by the end of 2022. In addition, in terms of partners, Vir expects to receive further data from the Phase 2 study of VIR-2218 (BRII-835) and PEG-IFN- α by the end of 2022.
HIV, MDR/XDR (multiple drug resistance / extensive drug resistance) and PPD/MDD (postpartum depression / severe depression) are all expected to obtain early clinical data, including competitive data, phase 1 data, etc., in the second half of 2022.
Plenty of cash on hand: research and development expenditure increased to 260 million yuan in the first half of the year, up from 160 million yuan in the same period of the year.
The net loss in the first half of the year increased to 370 million yuan from 300 million yuan in the same period last year. As of June 30, the company had about 3.22 billion yuan in cash and bank deposits, which is abundant relative to the company's expenses.
Risk tips: product research and development progress and post-market sales are not as expected, market competition intensifies, policy risk.