BEIJING, China and DURHAM, N.C., United States – November 17, 2021
BEIJING, China and DURHAM, N.C., United States – November 17, 2021 – Brii Biosciences Limited (“Brii Bio” or the “Company”, stock code: 2137.HK) a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burdens, today announced it has received the “R&D Achievement of the Year” Award, sponsored by BayHelix, at the 2021 BioCentury China Healthcare Summit in Shanghai, China. The recognition is for the R&D achievements of Brii Bio’s investigational monoclonal neutralizing antibody combination therapy, BRII-196/BRII-198 (“combination BRII-196/BRII-198”), for the treatment of COVID-19.
"We are truly honored to receive this award from BioCentury and BayHelix, as it recognizes our scientific achievements and our ability to deliver innovative therapeutics to tackle global public health challenges for outpatients with COVID-19,” said Qing Zhu, Ph.D., Senior Vice President, Head of Biopharmaceutical Research of Brii Bio. “We have achieved this milestone working in coordination with our partners, Tsinghua University and the 3rd People’s Hospital of Shenzhen, who discovered these neutralizing antibody leads; the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institute of Health (NIH), who sponsored the global ACTIV-2 trial; and the AIDS Clinical Trial Group (ACTG), who led the ACTIV-2 trial.”
In less than 18 months, Brii Bio progressed combination BRII-196/BRII-198 from discovery to completion of Phase 3 in the global ACTIV-2 trial, in which the combination therapy demonstrated a statistically significant 78% reduction of hospitalization and death and improved safety over placebo in non-hospitalized COVID-19 patients at high risk of clinical progression to severe diseases and death. In October 2021, the Company also initiated and subsequently completed the filing of an emergency use authorization (EUA) application with the U.S. Food and Drug Administration (FDA) for combination BRII-196/BRII-198. In parallel, the company has submitted the Phase 3 interim data to China Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA).
“As we continue to grapple with the global impact of this pandemic, we will work closely with regulatory authorities to bring this potential new treatment as quickly as possible to a broad range of COVID-19 outpatients at high risk of clinical progression" Qing added.
The BioCentury-Bayhelix China Healthcare Awards celebrate outstanding individuals and companies for their achievement and contribution to the local healthcare ecosystem. This year, the awards were presented in six categories: R&D Achievement of the Year; Deal of the Year; Commercial Achievement of the Year; Company of the Year; Person of the Year; and Woman Leader of the Year. R&D Achievement of the Year recognizes one company for a scientific discovery in China with direct impact to drug R&D or a significant achievement in pharmaceutical development milestones.
About BRII-196 and BRII-198
BRII-196 and BRII-198 are non-competing SARS-CoV-2 monoclonal neutralizing antibodies derived from convalesced COVID-19 patients developed in collaboration with Tsinghua University and the 3rd People’s Hospital of Shenzhen. They have been specifically engineered to reduce the risk of antibody-dependent enhancement and prolong the plasma half-lives for potentially more durable treatment effect. Interim results from Phase 3 of the NIH-sponsored ACTIV-2 trial recently demonstrated that combination BRII-196/BRII-198 achieved a statistically significant reduction, 78%, of relative risk in the combined endpoint of hospitalization and death in non-hospitalized COVID-19 patients at high risk of clinical progression. Current in vitro pseudovirus testing data suggests that combination BRII-196/BRII-198 retains activity against major SARS-CoV-2 variants of concern, including the following commonly identified variants, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), B.1.429 (Epsilon), P.1 (Gamma), C.37 (Lambda), and B.1.621 (Mu).
The Phase 2 clinical trial in China was initiated in July 2021 and is being conducted at clinical centers in Beijing Ditan Hospital, Guangzhou Eighth People’s Hospital, and the 3rd People’s Hospital of Shenzhen. In response to the recent emergence of COVID-19 cases in China, including cases caused by the Delta variant, Brii Bio has cooperated with governmental agencies and hospitals to donate nearly 3,000 doses of BRII-196/BRII-198 for emergency use in Guangdong, Yunnan, Jiangsu, Hunan, Henan, Fujian, Gansu, Ningxia, Inner Mongolia, Heilongjiang, Qinghai, Guizhou and Liaoning provinces. More than 800 patients have received the treatment.
About Brii Bio
Brii Biosciences Limited (“Brii Bio”, or the “Company”, stock code: 2137.HK) is a biotechnology company based in China and the United States committed to advancing therapies for significant infectious diseases, such as hepatitis B, human immunodeficiency virus (HIV) infection, multi-drug resistant (MDR) or extensive drug resistant (XDR) gram-negative infections, and other illnesses, such as the central nervous system (CNS) diseases, which have significant public health burdens in China and worldwide. For more information, visit www.briibio.com.
Summer Li (China)
Ben Shannon (U.S.)