The China National Medical Products Administration (NMPA) has accepted and granted priority review to Overland ADCT BioPharma’s biologics license application (BLA) for ZYNLONTA (loncastuximab tesirine-lpyl).
Overland ADCT BioPharma is a joint venture between Overland Pharmaceuticals and ADC Therapeutics.
This therapy is seeking an indication to treat adults with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) following two or more lines of systemic therapy in the country.
The BLA was filed based on the positive data from the Phase II OL-ADCT-402-001 bridging trial of ZYNLONTA.
The study assessed the safety and efficacy of ZYNLONTA as monotherapy in patients with r/r DLBCL.
Overland Pharmaceuticals co-founder and CEO Ed Zhang said: “Our partnership with ADC Therapeutics began in December 2020, and it took us only two and a half years to complete the clinical study and submit the first BLA.
“We would like to extend our sincere gratitude to participating patients, clinical investigators, the health authority and our partner ADC Therapeutics for their strong support in making this achievement possible.
“We look forward to our continued collaboration with all stakeholders to maximise the potential benefits of ZYNLONTA for patients in China.”
Overland ADCT BioPharma gained rights to develop and market ZYNLONTA in Singapore and Greater China.
ZYNLONTA BLA’s have already been submitted for the same indication in Taiwan, Hong Kong, and Singapore.
Based on overall response rate and continued approval for this indication, ZYNLONTA has received accelerated approval from the FDA and conditional approval from the European Medicines Agency.