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Transcenta Announces First Patient Dosed in China Study of Anti-sclerostin Monoclonal Antibody TST002 for the Treatment of Osteoporosis

28 Apr, 2022

SUZHOU, China, April 28, 2022, 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 the successful dosing of first patient in China Phase I Study of TST002 for the treatment of osteoporosis.

This Phase I clinical trial is a randomized and double-blind, placebo-controlled, single-ascending-dose, multi-center study designed to evaluate the safety, tolerability, and pharmacokinetics profile of TST002 as a treatment in patients with osteoporosis.

TST002 (Blosozumab) is a humanized anti-sclerostin monoclonal antibody as a drug candidate for osteoporosis and other bone loss diseases. 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 mineral density and bone strength. Blocking sclerostin activity in human treated with anti-sclerostin antibody or with naturally occurring genetic deletion has been shown to be an effective approach in increasing bone mineral density (BMD) and reducing bone fracture. Currently there is no approved anti-sclerostin antibody therapy in China yet although Romosozumab from Amgen has been approved in the United States, Europe and Japan.

Transcenta in-licensed Blosozumab (TST002) from Eli Lilly and Company ("Eli Lilly") for development and commercialization in Greater China in 2019. Eli Lilly has completed phase II clinical studies of Blosozumab in the United States and Japan and obtained promising safety profile and efficacy data. Transcenta successfully completed technology transfer, established manufacturing process in its Hangzhou HJB facility, and completed GMP production for clinical use as well as the additional preclinical studies as required by the CDE for TST002 IND application in China. IND for TST002 China study was cleared from the NMPA on Sept. 22nd, 2021 for testing TST002 directly in patients with osteopenia.

"TST002 can potentially become the second anti-sclerostin monoclonal antibody in the world." said Dr. Michael Shi, EVP, Head of Global R&D and CMO of Transcenta. "We look forward to conducting in-depth study to further evaluate the safety and tolerability of TST002 and bring more efficient and diversified treatment options for Chinese patients with osteoporosis."

Currently there are over 100 million of people with various degree of osteoporosis in China and over 4 million of them are suffering from osteoporotic fractures. These numbers are increasing due to the influence of lifestyle, diet and aging population, which result in significant health, economic and social burdens associated with osteoporosis related fractures. There are significant unmet needs in this disease area especially in patients with severe osteoporosis despite the availability of a number of agents anti-resorptives such as bisphosphonate and anti-RANKL inhibitor and anabolic agent targeting PTH.

About Transcenta Holding Limited

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.

For more information, please visit www.transcenta.com and https://www.linkedin.com/company/transcenta.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Transcenta, are intended to identify certain of such forward-looking statements. Transcenta does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Transcenta with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Transcenta's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Transcenta's competitive environment and political, economic, legal and social conditions.

Transcenta, the Directors and the employees of Transcenta assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.

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