On October 11, Qidu Biopharma officially received the ISO9001 Quality Management System and ISO13485 Medical Devices Quality Management System certification certificates. The company established and implemented its ISO9001 and ISO13485 Quality Management Systems in November 2024, submitting the certification application to the CQM Group this August, covering products such as culture media and Class I Medical Devices (Phosphate Buffered Saline, RPMI-1640). In mid-September, experts from CQM Group conducted a comprehensive evaluation and on-site audit. The company ultimately passed the audit with zero deficiencies.

Many of the products that passed the certification were independently developed:

Phosphate Buffered Saline (PBS) is used for washing, diluting, or as a solvent in various biological scenarios, including cell culture, centrifugation, Western blot, and ELISA.

RPMI-1640 Medium, a basal cell culture medium, is suitable for cultivating various cells such as HeLa, Jurkat, MCF-7, PC12, PBMC, astrocytes, and multiple cancer cell lines.

Peimeiyou®- Serum-Free Medium for Human Umbilical Cord Mesenchymal Stem Cells is a xeno-free product intended for the primary isolation, expansion, and subculture of human umbilical cord tissue-derived mesenchymal stem cells. It maintains their multilineage differentiation potential without requiring serum or serum replacements.

The company will leverage this achievement to persistently implement its "Quality-Founded Enterprise" strategy, deepen its expertise in high-end culture media, and focus on breakthroughs in cutting-edge products and core technologies. Committed to continuously enhancing product processes and quality research standards, Qidu Biopharma aims to introduce more and superior biopharmaceutical products, contributing significantly to advancing high-quality development within the biopharmaceutical industry.