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Chinese Regulators Accept Henlius' Serplulimab New Drug Application

NEW YORK – Shanghai Henlius Biotech said last week that China's National Medical Products Administration (NMPA) has accepted its new drug application seeking approval for the anti-PD-1 monoclonal antibody serplulimab as a treatment for unresectable or metastatic solid tumors with high microsatellite instability (MSI) that do not respond to standard treatments.

The NMPA will evaluate data from a Phase II trial, in which serplulimab demonstrated a "favorable safety and efficacy" profile in patients with MSI-high solid tumors, according to a statement from Shukui Qin of the Cancer Center of Nanjing Jinling Hospital, who co-led the study.

In addition to the MSI-high solid tumor indication, Henlius is studying serplulimab in a range of tumor types as a monotherapy, and in combination with chemotherapy and VEGF- and EGFR-targeting monoclonal antibodies. "Focusing on combination immunotherapy and international clinical trials, we have built up a differentiation development strategy for the product," Henlius CEO Wenjie Zhang said in a statement. "Steady progress has been made in all clinical studies … We will push forward the clinical process in more indications as soon as possible and look forward to benefiting more patients around the world."