Transcenta Received IND Clearance from NMPA of its Anti-sclerostin Monoclonal Antibody TST002

Transcenta Holding Limited, a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that it received IND clearance on Sept. 22 from NMPA for initiating Phase I clinical trial of TST002, a humanized sclerostin monoclonal antibody for postmenopausal osteoporosis.

Currently there are over 100 million of people with various degree of osteoporosis and 4 million people in China with severe osteoporosis which could be target population for TST002 if approved.

TST002 (Blosozumab) is a humanized anti-sclerostin monoclonal antibody as a drug 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 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.

Eli Lilly and Company (“Eli Lilly”) has completed phase II clinical studies of Blosozumab in the United States and Japan. Transcenta in-licensed Blosozumab (TST002) from Eli Lilly for development and commercialization in Greater China in 2019, completed technology transfer, established manufacturing process in Transcenta’s own manufacturing facility, and completed GMP production for clinical use and all the additional preclinical studies as required by the CDE for IND application in China.

“Osteoporosis poses a significant burden to China’s health system due to the increasingly growing aging population,” said Dr. Michael Shi, EVP, Head of Global R&D and CMO of Transcenta. “Considering anti-sclerostin monoclonal antibody is the only innovative bone-building therapy with dual effects of stimulating bone formation and inhibiting bone resorption, it has been a well validated therapeutic for the treatment of severe osteoporosis in the world. We will expedite the development of TST002 to meet the needs of patients with severe osteoporosis.”