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Transcenta Successfully Passed the Audit of EU Qualified Person for the Manufacturing of TST001

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Transcenta Holding Limited (“Transcenta”) (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that HJB (Hangzhou) Co., Ltd. (the “HJB”), a wholly-owned subsidiary of the Company, has successfully passed the audit of European Union qualified person on April 13, and an QP Declaration has been issued on April 21, 2022.

TST001 is one of the most advanced antibody therapeutics targeting Claudin18.2 being developed globally. The audit is part of the preparation for a global phase III clinical trial application of TST001, which will include EU region, and subsequently for the commercialization of TST001 globally. An experienced QP auditor conducted a comprehensive, systematic and in-depth inspection of quality assurance system, production and material management, equipment and facility management, QC laboratory, packaging and labelling in accordance with the regulations of EudraLex Volume 4 (EU GMP) and ICH guidance. Due to COVID-19, the EU QP audit was conducted by remote video.

There were no critical or major deficiencies in this audit and the QP highly recognized the robustness and maturity of Transcenta’s Quality Management System to ensure compliance of GMP requirements, the quality of procedures and records and comprehensive risk assessment and mitigation.

“Passing QP audit successfully is an important step for EU submission. It demonstrates Transcenta’s full capability in manufacturing and delivering products that meet requirements of relevant regulations of EU GMP (Good Manufacturing Practice), and is qualified to provide clinical supply materials for trials conducted in EU market. This is noticeably important for TST001 which is advancing its global clinical strategy rapidly.” said Dr. Frank Ye, Transcenta’s EVP and Chief Operating Officer.

About TST001

TST001 is a high affinity humanized anti-Claudin18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) activities and potent anti-tumor activities in tumor xenograft models. TST001 is the second Claudin18.2 targeting antibody therapeutic candidate being developed globally. TST001 is generated using Transcenta’s Immune Tolerance Breaking Technology (IMTB) platform. TST001 kills Claudin18.2 expressing tumor cells by mechanisms of antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Leveraging advanced bioprocessing technology, the fucose content of TST001 was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of TST001. Clinical trials for TST001 are ongoing in China and US (NCT04396821, NCT04495296/CTR20201281). TST001 was granted Orphan Drug Designation in the US by FDA for the treatment of patients with gastric cancer or gastroesophageal junction (GC/GEJ).


Transcenta (HKEX: 06628) is a clinical stage biopharmaceutical company with fully integrated capabilities in antibody-based biotherapeutics discovery, research, development and manufacturing.

Transcenta has established global footprint, with Headquarters and Discovery, Clinical and Translational Research Center in Suzhou, Process and Product Development Center and Manufacturing Facility in Hangzhou, and Clinical Development Centers in Beijing, Shanghai and Guangzhou in China and in Princeton, US, and External Partnering Center in Boston and Los Angeles, US. Transcenta has also initiated the construction of the Group Headquarters and the second high-end biopharmaceutical facility with ICB as its core technology in Suzhou Industrial Park. Transcenta is developing ten therapeutic antibody molecules for oncology and selected non-oncology indications including bone and kidney disorders.

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