Osemitamab (TST001) on Track to Become a Global Therapy that Elevates the Current Standard of Care for HER2-Negative G/GEJ Adenocarcinoma

SUZHOU, China, July 31, 2023 -- 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 it has received approval from China Center for Drug Evaluation (CDE) to initiate Phase II clinical trial of TST002(Blosozumab). This study aims to evaluate the safety, tolerability, and pharmacokinetics of TST002(Blosozumab) after single and multiple intravenous administrations in patients with reduced bone mineral density.

SUZHOU, China, July 7, 2023 -- 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, announce that it has received approvals from China CDE (Center for Drug Evaluation) and South Korea MFDS (Ministry of Food and Drug Safety) to initiate TranStar 301 global Phase III pivotal trial of Osemitamab (TST001) in combination with Nivolumab and chemotherapy for the first-line treatment of patients with HER2 negative, CLDN18.2 expressing locally advanced or metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma. In addition, we are in the process of EU and FDA regulatory interaction.

SUZHOU, China, June 30, 2023 -- 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, has presented progression free survival (PFS) data by CLDN18.2 expression level from phase I/II study of Osemitamab (TST001) plus Capecitabine and Oxaliplatin (CAPOX) as the first-line treatment of advanced gastric/gastroesophageal junction (G/GEJ) cancer at ESMO World Congress on Gastrointestinal Cancer 2023. These data will support the upcoming global Phase III pivotal trial to be initiated in the second half of 2023.

SUZHOU, China, June 6, 2023 -- 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, has presented updated data of Cohort C from a phase I/IIa, multi-center study of Osemitamab (TST001) in combination with Capecitabine and Oxaliplatin (CAPOX) as a first-line treatment of advanced G/GEJ cancer at 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. The data showed that Osemitamab (TST001) has durable anti-tumor activity in all the study population including both high and low to median CLDN18.2-expressing gastric cancer. These data will support the upcoming global Phase III pivotal trial to be initiated in the second half of 2023.

SUZHOU, China, May. 17, 2023, 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 encouraging phase I clinical data of TST002 (Blosozumab) in Chinese patients with reduced bone mineral density (BMD). TST002 (Blosozumab) was well tolerated and significantly increased BMD at day 85 following single intravenous injection at various doses.