Chinese Regulator Accepts NDA for Sino Biopharm's Breast Cancer Drug

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Sino Biopharmaceutical (HKG:1177) said China's Center for Drug Evaluation (CDE) has officially accepted the New Drug Application (NDA) for its breast cancer treatment, TQB2102 injection, according to a Wednesday bourse filing.

The randomized study of 543 patients met its primary endpoint at interim analysis, showing a statistically significant improvement in progression-free survival compared to standard chemotherapy, the filing said.

TQB2102 is undergoing multiple clinical trials across distinct solid tumor indications, three of which have been granted Breakthrough Therapy Designations by health regulators in China, the filing noted.

The injection has secured two regional licensing partnerships, generating roughly $30 million in upfront and milestone payments for

the company.

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