Brii Biosciences Licenses Novel Antibiotic BRII-693 to Joincare Group for Greater China Market
核心洞察
Brii Biosciences (搜索) has entered into an exclusive licensing agreement with Joincare Group (搜索) for the development and commercialization of BRII-693 in Greater China, addressing the urgent need for novel antibiotics against multidrug-resistant infections.
BRII-693 is a novel synthetic lipopeptide designed to treat critically ill patients with MDR/XDR gram-negative bacterial infections (搜索), particularly carbapenem-resistant Acinetobacter baumannii (搜索) and Pseudomonas aeruginosa (搜索), with enhanced potency and reduced toxicity compared to older polymyxin (搜索) agents.
The drug has demonstrated favorable safety, tolerability, and pharmacokinetic profiles in Phase 1 studies and received IND approval from China's NMPA for a Phase 1 PK bridging study supporting future Phase 3 registrational trials.
Brii Biosciences (搜索) Limited has announced a strategic licensing agreement with Joincare Pharmaceutical Group Industry Co., Ltd that grants Joincare Group (搜索) exclusive rights to develop and commercialize the novel antibiotic BRII-693 in Greater China. The partnership addresses the growing threat of antimicrobial resistance in the region while allowing Brii Bio to focus on global development opportunities.
Novel Antibiotic Targets Critical Resistance Challenge
BRII-693 represents a significant advancement in the fight against multidrug-resistant bacterial infections (搜索). The novel synthetic lipopeptide is specifically designed for treating critically ill patients with multidrug- and extensively drug-resistant (MDR/XDR) gram-negative bacterial infections (搜索), particularly those caused by carbapenem-resistant Acinetobacter baumannii (搜索) (CRAB), Pseudomonas aeruginosa (搜索) (CRPA) and Enterobacterales (搜索) (CRE).
The drug was discovered through iterative structural modifications of the polymyxin (搜索) scaffold, with the specific goal of enhancing antibacterial potency while reducing the toxicity commonly associated with older polymyxin agents, including renal and neuro-toxicities. This design approach addresses a critical limitation of existing treatments in this therapeutic area.
Promising Clinical Development Progress
BRII-693 has demonstrated encouraging clinical results in early-stage development. In Phase 1 studies, the drug showed a favorable safety, tolerability, and pharmacokinetic profile in both healthy non-Chinese and Chinese participants. The positive safety profile represents a significant improvement over existing polymyxin (搜索)-based therapies.
Brii Bio has received IND approval from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for a Phase 1 PK bridging study in China. This approval supports the pathway toward a future Phase 3 registrational trial in patients with hospital-acquired bacterial pneumonia (搜索) and ventilator-associated bacterial pneumonia (搜索).
Strategic Partnership Structure
Under the terms of the licensing agreement, Joincare Group (搜索) will assume full responsibility for the development, regulatory approval and commercialization of BRII-693 in Greater China. In return, Brii Bio has received an upfront payment and will receive additional development and commercial milestone payments upon certain future milestone events, plus tiered royalties on net product sales.
Dr. Zhi Hong, Chairman and Chief Executive Officer of Brii Bio, emphasized the strategic importance of the partnership: "The growing threat of antimicrobial resistance in Greater China underscores the urgency for novel hospital antibiotics. With Joincare Group (搜索)'s proven capabilities in manufacturing and commercializing hospital antibiotics, we found the ideal partner to accelerate the development and commercialization of BRII-693. This partnership enables us to deliver a critical care medicine to Chinese patients facing life threatening infections."
Partner Capabilities and Market Position
Joincare Group (搜索) brings significant expertise to the partnership, with a long-standing track record in innovative drug research and development. Established in 1992, the company is an integrated pharmaceutical group that owns two major listed companies, Joincare and Livzon Pharmaceutical (搜索), as well as more than 20 major holding subsidiaries.
Mr. Nanqi Lin, Chief Executive Officer of Joincare Group (搜索), expressed confidence in the collaboration: "Early data showing encouraging results in terms of therapeutic potential, pharmacodynamics, and pharmacokinetics, suggesting BRII-693's high potential to become a best-in-class therapy to address the critical unmet clinical needs. We are confident in the clinical prospects of BRII-693. This collaboration further strengthened Joincare Group's strategic positioning in the anti-infection disease area."
Global Development Strategy
While Joincare Group (搜索) will lead development in Greater China, Brii Bio retains exclusive global rights to develop and commercialize BRII-693 outside the region. This structure allows the company to continue addressing global antimicrobial resistance threats while leveraging local expertise for the Chinese market.
The partnership represents a strategic focus for Brii Bio, which continues to advance a broad pipeline of therapeutic candidates with a focus on infectious diseases, including lead programs against hepatitis B virus infection. The company maintains operations in key biotech hubs including Raleigh-Durham, the San Francisco Bay Area, Beijing and Shanghai.