Partnership will expedite storage, distribution channels and hospital access for amubarvimab/romlusevimab combination in China

The amubarvimab/romlusevimab combination is the first SARS-CoV-2 target-specific treatment discovered and approved locally in Chinaevaluated in a randomized, double-blind, placebo-controlled trial

The amubarvimab/romlusevimab combination was marketed in China on July 7, 2022

DURHAM, North Carolina and BEIJING, July 19, 2022 /PRNewswire/ — Brii Biosciences Limited (“Organic Briior the “Company”, stock code: 2137.HK), a multinational corporation developing innovative therapies for diseases with significant unmet medical needs and significant public health burdens, announced today that TSB Therapeutics (beijing) Co., Ltd. (“TSB Therapeutics”), a majority-owned joint venture of the Company, is joining forces with China Resources Pharmaceutical Commercial Group Co., Ltd. (“CR Pharma Comm”) to advance storage, distribution and hospital access for the Company’s long-acting neutralizing monoclonal antibody (mAb) therapy, the amubarvimab/romlusevimab combination. Both parties are working together to ensure a timely supply of medicines that supports efforts to prevent and control the COVID-19 pandemic by China. The collaboration will also explore other new partnership opportunities to enable expanded access to combination therapy in China.

On December 8, 2021the National Medical Products Administration (NMPA) of China approved the amubarvimab/romlusevimab combination for the treatment of adults and pediatric patients (aged 12 to 17 years weighing at least 40 kg) with mild and normal type of COVID-19 at high risk of progression to severe disease, including hospitalization or death. The indication for pediatric patients (12-17 years weighing at least 40 kg) is subject to conditional approval. On March 15, 2022the National Health Commission of China added amubarvimab/romlusevimab to its COVID-19 diagnosis and treatment guidelines (9th pilot edition) for the treatment of COVID-19. On July 7, 2022the amubarvimab/romlusevimab combination was marketed in China.

“As the COVID-19 pandemic continues to impact the health of communities around the world, we are proud to bring the amubarvimab/romlusevimab combination to patients who urgently need it by Chinaand pleased with the 27-month timeline that has allowed us to expedite this important work,” said Rogers Luo, President and CEO, Greater China of Organic Brii, and CEO of TSB Therapeutics. “In 2019, Brii Bio entered into a strategic partnership with China Resources Group to jointly build an integrated life science industry chain. CR Pharma Comm is a large-scale pharmaceutical distribution company owned by China Resources Pharmaceutical Group, which has an extensive drug marketing and distribution network. distribution network. This solid and strategic partnership and this unique operational model allow Organic Brii to rapidly expand access to our amubarvimab/romlusevimab combination to help more patients with COVID-19 in Chinaand we look forward to exploring deeper collaborative efforts with China Resources Pharmaceutical Group down the line for the long-term benefit of patients and the healthcare community. »

“We are delighted that this important combination therapy is now commercially available as part of China Strategy for the prevention and control of the COVID-19 pandemic, enabling treatment to reach more patients quickly and provide significant clinical benefits to those who need it. Brii Bio’s the successful development of this combination therapy highlights the scientific innovation and infectious disease expertise stemming from the China the biotech space,” said Hong Mu, Chairman of CR Pharma Comm. “China Resources Group is a state-owned company that for 83 years has faced profound health risks and challenges, including those seen with the COVID-19 pandemic. CR Pharma Comm will work with our affiliates across the country to fight the frontline, actively respond to the national strategy, strongly support the government to storage for emergency useprovide enough pharmaceuticals and medical equipment to medical institutions for pandemic prevention and control, ensure people’s safety with timely medicine, and put CR Pharma Comm’s mission and commitment into practice.

On July 9, 2022through the joint efforts of Organic Brii and CR Pharma Comm, the first batch of the combination therapy was successfully delivered to Third People’s Hospital in Shenzhen, and the first patient received a dose. May to December 2021, Organic Brii donated nearly 3,000 doses of the amubarvimab/romlusevimab combination for emergency use in 22 hospitals in 21 cities as part of its commitment to ensure humanitarian access and help curb outbreaks of the pandemic. Nearly 1,000 patients received the combination therapy treatment. These real-world data provide important clinical application and safety data in China. Subsidiaries of CR Pharma Comm have been instrumental in delivering drugs to hospitals for the clinical treatment of patients.

With the commercialization of the amubarvimab/romlusevimab combination, the Company will actively cooperate with its commercial partners, make every effort to improve accessibility and advance drug storage at all levels, in order to respond quickly to the sudden epidemic. of COVID-19 and to protect populations. Lives.

About the Amubarvimab/Romlusevimab combination

Amubarvimab and Romlusevimab are non-competitive SARS-CoV-2 neutralizing monoclonal antibodies derived from convalescent COVID-19 patients developed in collaboration with the 3rd Hôpital Populaire de Shenzhen and Tsinghua University. They have been specifically designed to reduce the risk of antibody-dependent enhancement and extend plasma half-lives for a potentially longer lasting therapeutic effect.

Based on the final results of the ACTIV-2 Phase 3 clinical trial sponsored by the US National Institutes of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID) with 837 enrolled outpatients, the amubarvimab/romlusevimab demonstrates statistically significant efficacy of 80% reduction in hospitalizations and deaths with fewer deaths over 28 days in the treatment arm (0) compared to placebo (9), and improved safety outcomes compared to versus placebo in non-hospitalized COVID-19 patients at high risk of clinical progression to severe disease. Similar efficacy rates were seen in participants initiating treatment early (0-5 days) and late (6-10 days), after symptom onset, providing much-needed clinical evidence in COVID-19 patients who were late for treatment.

Live virus test data, together with pseudovirus test data from several independent laboratories, demonstrated that the amubarvimab/romlusevimab combination retains activity against major SARS-CoV-2 variants of concern, including commonly identified variants following, B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), B.1.429 (Epsilon), B.1.617.2 (Delta), AY.4.2 (Delta Plus), C .37 (Lambda), B.1.621 (Mu), B.1.1.529-BA.1 (Omicron) and BA.1.1 and BA.2 (sub-variants of Omicron). Further testing, including live virus testing, is underway to confirm neutralizing activity against BA.4/5 and BA.2.12.1.

About Organic Brii

Brii Biosciences Limited (“Organic Brii“, stock code: 2137.HK) is a biotechnology company based in China and United States committed to advancing therapies for important infectious diseases, such as hepatitis B, COVID-19, human immunodeficiency virus (HIV) infection, multidrug-resistant (MDR) or extensive Gram-negative infections drug-resistant (XDR), and other diseases, such as central nervous system (CNS) diseases, which pose a heavy public health burden China and around the world. For more information, visit www.briibio.com.

About TSB Therapeutics

TSB therapy (beijing) Co., Ltd. (“TSB Therapeutics”) is a holding company of Organic Brii. TSB Therapeutics was jointly established in beijing in May 2020 by Organic Briithe 3rd People’s Hospital of Shenzhen and Tsinghua University. The Company is committed to developing the amubarvimab/romlusevimab combination. TSB Therapeutics has exclusive development and commercialization rights to the amubarvimab/romlusevimab combination in Greater China.

About CR Pharma Comm

China Resources Pharmaceutical Commercial Group Co., Ltd. (“CR Pharma Comm”) is a large-scale pharmaceutical distribution company wholly owned by China Resources Pharmaceutical Group and is one of the activities of China Resources Pharmaceutical Group’s Healthcare business segment. CR Pharma Comm is principally engaged in the marketing, distribution and delivery of pharmaceutical products and the provision of pharmaceutical supply chain solutions, mainly covering chemical pharmaceuticals, chemical APIs, Chinese specialty pharmaceuticals, herbal decoctions plants, medical devices, medical consumables, biological products, dietary supplements and others. CR Pharma Comm is one of the first pharmaceutical companies to achieve GSP certification in China and holds the qualifications for the import and export of drugs and medical devices and third party pharmaceutical logistics services. CR Pharma Comm has long-term stable cooperation with nearly 10,000 pharmaceutical manufacturers in China and abroad, and with beijing as a center, has established a sales and marketing network covering 31 provinces and municipalities across Chinamainly serving medical institutions of various levels, pharmaceutical wholesalers and retail pharmacies in China. CR Pharma Comm ranks in the top 3 pharmaceutical trading companies in China in terms of commercial scale. CR Pharma Comm is active in acquiring high-quality domestic pharmaceutical distribution enterprises and has formed a management and control system consisting of the head office, regional branches and commercial branches in a short time and established a network covering the whole country. To date, CR Pharma Comm has more than 350 branches and subsidiaries in 28 provinces (including autonomous regions and municipalities) in Chinaand most of its subsidiaries have regional competitive advantages in the provinces, prefectures and cities where they operate.

SOURCE Brii Biosciences Limited

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