Anti-infective

In the field of liver disease treatment, on July 18, 2025, the National Medical Products Administration (NMPA) announced on its official website the approval of the marketing authorization for the therapeutic Class I biological product Recombinant Human Albumin Injection (Rice) (brand name: Aofumin), submitted by Wuhan Hevro Biotech Co., Ltd. (hereinafter referred to as Hevro Biotech). This drug is indicated for the treatment of hypoalbuminemia (≤30g/L) in patients with liver cirrhosis.

Boji Pharmaceutical provided Phase III clinical research services for this project, coordinating, supervising, and managing the entire clinical research process. In accordance with regulatory review requirements, Boji submitted the corresponding clinical trial summary report and a complete set of application materials (including but not limited to ethics review reports, case report forms/EDC, data management reports, statistical analysis reports, and summary reports). This demonstrates Boji Pharmaceutical's exceptional capabilities in delivering comprehensive, one-stop drug research services.

Regarding hepatitis B products, on October 29, 2024, Xi'an Gelan Xintong Pharmaceutical Co., Ltd.'s Class 1 innovative drug Prefovir Disoproxil Fumarate Tablets (brand name: Xinshu Mu) received marketing approval. This medication is indicated for the treatment of chronic hepatitis B in adults. The following day, a launch press conference for Prefovir Disoproxil Fumarate Tablets was held in Xi'an, marking Shaanxi Province's first-ever approval of a Class 1 innovative drug.

As the CRO for the clinical research of Prefovir Disoproxil Fumarate Tablets, Boji Pharmaceutical provided comprehensive support throughout the clinical trial process and participated in communications with the CDE. The project enrolled over 1,000 patients across more than 60 centers nationwide, completing all subject recruitment in under 10 months. This demonstrates Boji Pharmaceutical's exceptional R&D service capabilities and high-quality, efficient clinical operations in organizing multi-center, large-sample, and high-complexity clinical trials for innovative drugs.

In the field of antiviral and influenza products, on November 24, 2023, Fujian Guangsheng Zhonglin Biotechnology Co., Ltd.'s Class 1 innovative drug combination pack of atemivir tablets/ritonavir tablets (brand name: Taizhongding) received conditional approval for market launch from the National Medical Products Administration. This oral small-molecule drug is indicated for treating adult patients with mild to moderate COVID-19 infections.

Boji Pharmaceutical leveraged its extensive experience and professional team to provide scientific and rigorous management services for the clinical trial of the Atorvastatin/Ritonavir combination packaging project, ensuring the trial's smooth execution.

In the field of anti-infective products, on June 1, 2021, Kangtizolam Tablets—a Class 1 anti-infective new drug independently developed by Shanghai Mengke Pharmaceutical—was launched in mainland China under the priority review and approval pathway, marketed under the brand name “Youxitai.” As the world's third-approved oxazolidinone antibacterial agent, this drug reduces the risk of adverse reactions such as bone marrow suppression through molecular structural innovation. It is indicated for treating complicated skin and soft tissue infections caused by pathogens including Staphylococcus aureus (including methicillin-resistant strains) and Streptococcus pyogenes. Following its inclusion in the National Medical Insurance Reimbursement List in January 2022, it has become a critical therapeutic option for treating infections caused by multidrug-resistant Gram-positive bacteria.

Leveraging extensive experience and a specialized team, Boji Pharmaceutical provided scientific and rigorous management services for the clinical trials of the cantizolam tablets project, ensuring the trials' successful execution.

Following the market approval of human interferon gamma for injection produced by Shanghai Kaimiao Biopharmaceutical Co., Ltd., the company provided comprehensive post-marketing clinical research services for the product. Tailored to the clinical usage characteristics of this biologic, we designed a thorough post-marketing research plan focusing on safety monitoring, efficacy re-evaluation, and real-world studies.

Leveraging our expertise in post-marketing research for biological products, our team conducted high-quality data collection and analysis. This provided crucial evidence for the product's rational clinical application and safety evaluation, supporting the client in enhancing its product lifecycle management. This fully demonstrates our professional service capabilities and technical strengths in post-marketing research for biological drugs.

Familiar with the product characteristics and therapeutic features of liver disease at all stages, proficient in drug development strategies, protocol design, and project management essentials, providing one-stop services for quality and schedule management.

With extensive clinical resources in hepatology, we have established strong relationships with hundreds of hepatology and infectious disease specialists across the country and maintain close collaboration with them.