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关于我们
Proji Company was founded in August 2004. It is a high-tech research and development enterprise established by returned overseas students, undertaking the task of industrializing and transforming various scientific research projects. -
Scientific research technology
Scientific research technology
科研技术
Proji Company is a constituent unit of the "National Engineering Research Center for Protein Technology" of Tsinghua University. It is the first national engineering laboratory established by the National Development and Reform Commission at Tsinghua University. Former President of the Chinese Academy of Sciences, Zhou Guangzhao, and the "Father of DNA", Nobel laureate James D. Watson served as honorary directors of the laboratory, with Professor Luo Yongzhang serving as the director. -
Products
公司产品
For nearly two decades, Proji Company has been primarily engaged in the development and production of recombinant protein drugs, antibody drugs, and in-vitro diagnostic reagents. It has established a unique R&D and large-scale preparation technology platform for recombinant protein drugs that has reached international standards. -
Project
项目公司
The company has long received strong support from various levels of government, including the National Development and Reform Commission, the Ministry of Science and Technology, and the municipal governments of Beijing, Yantai, Shenzhen, and Changzhou. -
新闻资讯
The company's marketing network spans 18 provinces and cities across the country (including 6 provinces and cities covered by medical insurance), benefiting more than 4 million patients, and gradually growing into a new benchmark in the biopharmaceutical industry. -
职业发展
From small-scale research institutions to advanced biopharmaceutical bases, the company's marketing network spans 18 provinces and cities across China.
Protgen’s Phase III Clinical Trial of Recombinant Human Serum Albumin Injection Meets Dual Endpoints
Published Time:
2025-08-08 00:00
The phase III clinical trial of recombinant Human Serum Albumin (rHSA) i.v. infusion with indications of liver cirrhosis and ascites successfully met the primary endpoint and the key secondary endpoint set by the National Medical Products Administration of China. The new drug application (NDA) has been initiated.
Protgen's rHSA phase III clinical trial adopts a multicenter, randomized, double-blind, positive-controlled, parallel-group design. The primary endpoint measured the change of serum albumin concentrations after treatment. The efficacy equivalence verifications of rHSA and plasma-derived human serum albumin (pHSA) on this endpoint in patients with liver cirrhosis and ascites were conducted. The improvement rate of ascites after rHSA or pHSA administration is the key secondary endpoint for comparing non-inferiority of rHSA over pHSA, and to evaluate the clinical benefits of supplementing rHSA for the subjects.
The results of the phase III clinical trial show that Protgen’s rHSA significantly improved the albumin level of patients with liver cirrhosis and ascites, demonstrating equivalence to pHSA; and the improvement effect on ascites was superior to that of pHSA. The safety data shows that rHSA is safe and well tolerated, with all negative immunogenicity results in the rHSA group, which demonstrates an extremely low immunogenicity.
Protgen will accelerate both the NDA process and industrialization layout, striving to supply the premier product globally, with safer and more accessible life protection for patients worldwide.
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Postcode: 100085
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