MedPath

BRII-B

🇭🇰Hong Kong, China
Ownership
-
Established
2021-05-31
Employees
95
Market Cap
-
Website
http://www.briibio.com
Introduction

Tengshengbo Pharmaceutical is a biotechnology company dedicated to developing treatments that can solve major public health challenges. Amidst these challenges, large numbers of patients' medical needs are unmet, choices are limited, and social stigma is severe. Since its establishment in 2018, Tengsheng Pharmaceuticals's mission has been to address public health challenges through groundbreaking scientific innovation and insightful patient insight. Tengshengbo Pharmaceutical's mission is very clear: to develop a functional cure for hepatitis B, Tengsheng Pharmaceutical believes this can have a meaningful impact on patients in China and around the world.

Tengshengbo Pharmaceutical is cooperating with its partners to promote a strong portfolio of HBV drug candidates, strategically positioning itself as a leading company in the HBV field. The product portfolio includes three differentiated drug candidates: elebsiran (a siRNA under development targeting HBV, previously BRII-835), tobevibart (a broadly neutralizing monoclonal antibody under development, formerly BRII-877), and BRII-179 (a vaccine for HBV treatment based on recombinant proteins). These drug candidates are being tested for various combination treatment options, and each combination treatment may be the best treatment plan aimed at improving the functional cure rate of HBV.

Data obtained over the past few years strongly confirm that functional cure for HBV is possible for patients with low HBsAg levels. The combination strategy of Tengshengbo Pharmaceutical combines surface antigen reduction therapy with immunomodulatory therapy to improve the effectiveness of HBV treatment and improve the functional cure rate. Encouraged by the latest data readings and insights, Tengshengbo Pharmaceuticals is advancing all three drug candidates and plans to conduct additional trials by the end of 2024.

Based on recognition of the innovation of Tengshengbo Pharmaceutical's HBV product portfolio, all three HBV drug candidates have been certified as breakthrough therapeutic varieties by the Drug Evaluation Center of the China National Drug Administration. These certifications recognize the potential of these candidate drugs to make substantial progress on existing therapies and will accelerate their clinical development and regulatory review.

While concentrating resources to maximize the impact of HBV clinical programs, Tengshengbo Pharmaceutical is also actively seeking partners to further develop its non-HBV programs, including HIV, MDR/XDR, and CNS programs.

A Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and PEG-IFNα in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)

Phase 2
Active, not recruiting
Conditions
Chronic Hepatitis B Virus (HBV) Infection
Interventions
Drug: BRII-835 (VIR-2218)
Drug: Placebo of BRII-179
Biological: PEG-IFNα
Drug: Placebo of BRII-835
First Posted Date
2024-10-21
Last Posted Date
2025-02-11
Lead Sponsor
Brii Biosciences Limited
Target Recruit Count
180
Registration Number
NCT06650852
Locations
🇨🇳

Investigative Site 86002, Guangzhou, Guangdong, China

🇨🇳

Investigative Site 86006, Shanghai, Shanghai, China

🇨🇳

Investigative Site 86007, Shanghai, Shanghai, China

and more 11 locations

Study to Investigate the Efficacy and Safety of Regimens Containing BRII-179, BRII-835, and PEG-IFNα Treating Chronic Hepatitis B Virus (HBV) Infection (ENRICH)

Phase 2
Active, not recruiting
Conditions
For Treatment of Chronic Hepatitis B Virus Infection
Interventions
Drug: BRII-835 (VIR-2218)
Biological: PEG-IFNα
First Posted Date
2024-07-09
Last Posted Date
2024-12-30
Lead Sponsor
Brii Biosciences Limited
Target Recruit Count
150
Registration Number
NCT06491563
Locations
🇨🇳

Investigative Site 86004, Beijing, Beijing, China

🇨🇳

Investigative Site 86009, Beijing, Beijing, China

🇨🇳

Investigative Site 86015, Xiamen, Fujian, China

and more 9 locations

A Study of BRII-296 in Adults With Severe Postpartum Depression (PPD)

Phase 2
Completed
Conditions
Severe Postpartum Depression
Interventions
First Posted Date
2023-09-28
Last Posted Date
2025-01-27
Lead Sponsor
Brii Biosciences Limited
Target Recruit Count
11
Registration Number
NCT06057012
Locations
🇺🇸

Cenexel CNR, Sherman Oaks, California, United States

🇺🇸

Aventura Clinical Research, LLC, Davie, Florida, United States

🇺🇸

Clinical Research Center of Florida, Boynton Beach, Florida, United States

and more 8 locations

Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients

Phase 2
Active, not recruiting
Conditions
Chronic Hepatitis B Virus Infection
Interventions
Biological: PEG-IFNα
First Posted Date
2023-08-01
Last Posted Date
2024-03-21
Lead Sponsor
Brii Biosciences Limited
Target Recruit Count
75
Registration Number
NCT05970289
Locations
🇹🇭

nvestigative Site 66007, Chiang Mai, Thailand

🇦🇺

Investigative Site 61003, Melbourne, Victoria, Australia

🇦🇺

Investigative Site 61001, Kingswood, New South Wales, Australia

and more 25 locations

A Study of BRII-297 in Healthy Adult Subjects

Phase 1
Completed
Conditions
Postpartum Depression
Interventions
Drug: Placebo
First Posted Date
2023-05-06
Last Posted Date
2024-01-18
Lead Sponsor
Brii Biosciences Limited
Target Recruit Count
41
Registration Number
NCT05845840
Locations
🇦🇺

CMAX, Adelaide, South Australia, Australia

A Study of Human Monoclonal Antibodies, BRII-196 and BRII-198

Phase 2
Completed
Conditions
COVID-19
Interventions
Drug: BRII-196 and BRII-198
Drug: Placebo
First Posted Date
2021-03-08
Last Posted Date
2023-03-03
Lead Sponsor
Brii Biosciences Limited
Target Recruit Count
48
Registration Number
NCT04787211
Locations
🇨🇳

Guangzhou Eighth Hospital, Guangzhou Medical University, Guangzhou, Guangdong, China

🇨🇳

Beijing Ditan Hospital Capital Medical University, Beijing, Beijing, China

🇨🇳

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

and more 3 locations

Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic Hepatitis B Virus (HBV) Infection

Phase 2
Completed
Conditions
Hepatitis B, Chronic
Interventions
Drug: BRII-835 (VIR-2218)
Biological: BRII-179 (VBI-2601) with IFN-α
Biological: BRII-179 (VBI-2601)
First Posted Date
2021-02-11
Last Posted Date
2024-06-18
Lead Sponsor
Brii Biosciences Limited
Target Recruit Count
91
Registration Number
NCT04749368
Locations
🇦🇺

Investigative Site 61004, Herston, Queensland, Australia

🇨🇳

Investigative Site 88601, Kaohsiung, Taiwan, China

🇰🇷

Investigative Site 82003, Seongnam-si, Gyeonggi-do, Korea, Republic of

and more 25 locations

A Phase 1 Study of Human Monoclonal Antibodies, BRII-196 and BRII-198

Phase 1
Completed
Conditions
COVID-19
Interventions
Drug: BRII-196 and BRII-198
Drug: Placebo
First Posted Date
2020-12-31
Last Posted Date
2023-03-03
Lead Sponsor
Brii Biosciences Limited
Target Recruit Count
12
Registration Number
NCT04691180
Locations
🇨🇳

Investigative Site, Beijing, Beijing, China

Study of VIR-2218 in Patients With Chronic Hepatitis B in Mainland China

Phase 2
Completed
Conditions
Hepatitis B, Chronic
Interventions
Drug: Placebo
First Posted Date
2020-08-11
Last Posted Date
2024-08-26
Lead Sponsor
Brii Biosciences Limited
Target Recruit Count
21
Registration Number
NCT04507269
Locations
🇨🇳

Investigative Site, Changchun, Jilin, China

Safety, Tolerability, and Pharmacokinetics Study of Human Monoclonal Antibody BRII-198

Phase 1
Completed
Conditions
COVID-19
Interventions
Drug: Placebo
First Posted Date
2020-07-21
Last Posted Date
2023-03-03
Lead Sponsor
Brii Biosciences Limited
Target Recruit Count
17
Registration Number
NCT04479644
Locations
🇨🇳

Investigative Site, Beijing, Beijing, China

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