The first batch of new drugs targeting specific targets produced in Changshu High-tech Zone has been dispatched.

On February 26th, the global launch ceremony of Huahui Anjian Huayounuo® (Libevetta monoclonal antibody injection) was held at the Changshu factory of ZhiXiang Biotechnology. This is the third commercial product that ZhiXiang Biotechnology has helped its clients successfully obtain market approval. It marks the increasingly mature large-scale commercial production capacity of enterprises in Changshu High-tech Zone and further validates the value of the entire industrial chain platform. 
Liberveta monoclonal antibody injection is independently developed by Huahui Anjian. It is the world's first monoclonal antibody drug targeting the pre-S1 region of the surface large envelope protein of hepatitis B and delta hepatitis viruses. It is mainly used for the treatment of chronic delta hepatitis infections, providing a new treatment option for patients with severe viral hepatitis and filling the treatment gap in this field in China. 
As an important partner of Huahui Anjian, ZhiXiang Biology provided the project with full-process support ranging from process development to commercial production. Facing challenges such as the complexity of drug preparation processes and the strict compliance standards for both Chinese and American regulations, ZhiXiang Biology, leveraging its advanced process development capabilities, large-scale production capacity, and strict risk management system, successfully overcame the challenges of scaling up from laboratory processes to industrial production, ensuring the stability and reliability of product quality throughout the process, and providing solid support for the rapid approval and launch of the drug. 
As one of the few domestic pharmaceutical contract research and development enterprises that possess core technologies, large-scale production capabilities and a commercialized closed-loop service system, Zhi Xiang Biotechnology provides one-stop outsourcing services for large-molecule biopharmaceuticals to global biotechnology and pharmaceutical companies, covering the entire chain of processes such as process development, quality inspection, clinical and commercial production, and registration application. The company has established three production bases, with 10 raw material production lines and 7 formulation production lines. The production capacity upon completion is 113,400 liters, firmly ranking among the top enterprises in the domestic pharmaceutical contract research and development industry. Currently, the company has served over 180 biopharmaceutical companies worldwide and 400 projects. Among them, 3 drugs have been successfully approved for market launch, and 23 projects have entered the late-stage clinical phase. It is the CDMO enterprise with the largest number of late-stage projects in China. 
In the future, ZhiXiang Biotechnology will focus on the cutting-edge fields such as antibodies, fusion proteins, and bispecific antibodies, increase investment in ADC and small nucleic acid drugs, and optimize the entire process delivery capability through expansion and efficiency enhancement. This will not only precisely meet the market demand, but also help local innovative pharmaceutical enterprises accelerate the approval and listing process, injecting strong momentum into the high-quality development of the regional biopharmaceutical industry.