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[BUSINESS] · China, Taiwan · 3 sources

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Biopharmaceutical companies advance drug applications and clinical trials in China

Sino Biopharmaceutical subsidiary Sino Biopharmaceutical (01177) announced that two of its self-developed innovative drugs, TQH2722 injection and TQB2102 injection, have had their new drug marketing applications accepted by the Center for Drug Evaluation of China's National Medical Products Administration (NMPA).

TQH2722 is a fully human monoclonal antibody intended for treating moderate-to-severe atopic dermatitis in adults. TQB2102 is a HER2 bispecific antibody ADC designed for treating unresectable or metastatic HER2-low adult breast cancer. Phase III clinical studies for TQB2102 showed a significant reduction in the risk of disease progression or death compared to chemotherapy.

Separately, Aspire (6875-TW) announced that its inhaled drug candidate L606 has received NMPA approval to join the global Phase III pivotal trial (Re-Spire) for treating pulmonary hypertension associated with interstitial lung disease (PH-ILD) in China. The trial is being funded and executed by partner Liquidia, while Aspire remains responsible for manufacturing the clinical trial medication and retains commercialization rights for the Chinese market.

Entities

ASPIRE · China Biologics · Liquidia · NMPA · Sino Biopharmaceutical