Transcenta Announces NMPA Acceptance of IND Application of its Anti-Sclerostin Monoclonal Antibody TST002

Transcenta Holding Limited, a clinical stage global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, announces that NMPA has accepted IND application of its anti-sclerostin monoclonal antibody TST002.

TST002 (Blosozumab) is a humanized anti-sclerostin monoclonal antibody candidate for severe osteoporosis. It has a dual effect possessing both anabolic and anti-resorptive effects, which stimulates bone formation and inhibits bone absorption, resulting in fast increase in bone density and bone strength. Blocking sclerostin activity in human with anti-sclerostin antibody or with naturally occurring sclerostin genetic deletion has been shown to be an effective approach in increasing bone mineral density (BMD) and reducing bone fracture.

Eli Lilly has completed phase Ⅱ clinical studies of Blosozumab in the United States and Japan, and obtained excellent clinical efficacy results in patients with severe osteoporosis. Transcenta in-licensed Blosozumab from Eli Lilly for development and commercialization in Greater China in 2019, completed tech transfer, established manufacturing process in Transcneta's own manufacturing facility and completed GMP production for clinical use.

"Currently, there are more and more patients with severe osteoporosis in China due to growing aging population. There are no approved anti-sclerostin targeting monoclonal antibody drugs for the treatment of severe osteoporosis in China. In clinical studies, anti-sclerostin antibody has been shown to be able to increase BMD and bone strength faster than RANKL Ligand inhibitor in severe osteoporotic patients." said Dr. Michael Shi, Transcenta's EVP, Head of Global R&D and CMO, "We believe that TST002 could be a highly effective and differentiated therapy for patients with severe osteoporosis at a high risk of fracture."

About Transcenta Holding Limited.

Transcenta is a clinical stage global biotherapeutics company that fully integrates antibody-based biotherapeutics discovery, development and manufacturing. Transcenta has established global footprint, with Headquarter and Discovery 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, US. Transcenta is developing nine therapeutic antibody molecules for oncology and selected non-oncology indications including bone and kidney disorders. Upon the latest financing, the company has raised over $342 million from globally prominent investors.