Top 50 Biotech Innovators: Guobiao Pharma, Xinyue Bio, Akeso Inc., and Kunshi Bio Announce Key Milestones

March 2025,The 50 Leading Enterprises in Biotechnology Innovation of the 7th Edition – Guangzhou Guobiao Inspection and Testing Co., Ltd. Successfully Passes the Renewal Assessment by the China National Accreditation Service for Conformity Assessment (hereinafter referred to as “CNAS”)., once again obtained the CNAS laboratory accreditation certificate, with the registration number CNAS L12081.

HONG KONG GUOBIAO INSPECTION AND TESTING CO., LIMITED is a national high-tech enterprise. Its core members include university experts, members of the National Pharmacopoeia Commission, technical leaders of authoritative official pharmaceutical inspection institutions, core application experts from major global instrument companies, and R&D experts from well-known pharmaceutical enterprises. The company has an excellent technical management team with extensive experience in project initiation and R&D declaration, and it can undertake overall contract research for generic drugs and innovative drugs. The company serves as the Inspection and Testing Branch of the State Key Laboratory of Innovative Drugs and Energy-Efficient Pharmaceutical Equipment, and is the first third-party inspection agency in South China with comprehensive drug testing capabilities. It adopts dual quality management systems based on cGMP and ISO17025, and its test reports carry the same authority as those issued by official pharmaceutical inspection institutions.

Recently,Top 50 Biotech Innovation Enterprises of the First Session - Akeso (9926.HK) announced that the Phase I clinical study in Australia for its self-developed differentiated HER3-targeted ADC new drug AK138D1 for treating advanced malignant tumors has completed the enrollment of its first subject.AK138D1 is the first ADC drug developed by Akeso to enter the clinical stage.

Akeso's self-developed differentiated PD-1 monoclonal antibody drug Penpulimab (trade name: Anliko®), in combination with chemotherapy for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC), has officially received approval from the China National Medical Products Administration (NMPA) for marketing.。

Akeso (9926.HK) is a leading company that integrates the research, development, production, and commercialization of globally pioneering or best-in-class innovative biologics. Since its establishment in 2012, the company has always been patient-centered and clinically value-oriented, creating a unique end-to-end Akeso comprehensive new drug R&D platform. It has built an innovative R&D system centered on Tetrabody bispecific antibody technology, Antibody-Drug Conjugate (ADC) technology, mRNA technology, and cell therapy technology. With a GMP production system meeting international standards and an advanced commercial operation model, Akeso has become a competitive biopharmaceutical innovation company on a global scale.