CSPC Pharmaceutical Group’s Independently Developed SYS6055 Injection Obtained An Implied Clinical Trial Approval From The National Medical Products Administration (NMPA)

On January 29th, CSPC Pharmaceutical Group's independently developed "SYS6055 Injection" obtained an implied clinical trial approval from the National Medical Products Administration (NMPA), acceptance number: CXSL2500947. This marks the first in vivo CAR-T therapy approved for clinical use in China, indicated for relapsed/refractory aggressive B-cell lymphoma. HYQURE extends its warmest congratulations on this achievement!

HYQURE provided this project with biosafety testing services aligned with international standards, including Cell Line Characterization and Replication-Competent Lentivirus (RCL) testing. Leveraging an internationally compliant quality and technical system, rapid delivery capabilities, and professional project management, we safeguard the launch and global expansion of innovative therapeutics.

CSPC Pharmaceutical Group Limited was established in 1997. Upholding the mission of "Producing Good Medicines for China, Benefiting People Worldwide," the group has maintained double-digit growth in key operational indicators over the years through innovation-driven development. It has now evolved into an international innovative enterprise with 28,000 employees. Its Hong Kong-listed subsidiary (01093.HK) is a constituent of the Hang Seng Index and ranks 19th globally in the pharmaceutical R&D pipeline scale ranking, representing Chinese pharmaceutical companies in serving patients worldwide.

According to incomplete statistics, HYQURE has successfully supported over 130 projects in obtaining clinical and marketing trial approvals through its internationally compliant biosafety testing services (including over 60 global submissions). The company has provided critical support for more than 60 BLA (Biologics License Application) and commercialization projects. The scope of submitted projects comprehensively covers diverse categories, including ADC drugs, mono-/bi-/multi-specific antibodies, recombinant proteins, CAR-T/CAR-NK therapies, iPSC/MSC cell therapies, gene editing, AAV-based gene therapies, among others.