LIDDS licensee Jiangxi Puheng Pharma has after reviewing the preliminary results in LPC-004 decided to move ahead and has initiated discussions with Chinese medical authority, CFDA.
The phase III study protocol will be developed in close collaboration with LIDDS.
An exclusive agreement
LIDDS signed in 2018 an exclusive license agreement for Liproca Depot for Mainland China with Jiangxi Puheng Pharma, a company focusing on oncology and immuno-oncology. Liproca Depot, is an injectable cancer drug candidate for local treatment of prostate cancer. LIDDS is with Liproca Depot targeting patients under Active Surveillance with intermediate risk of progression, a patient group that are not getting surgery or radiation.
Jiangxi Puheng Pharma is a Chinese pharmaceutical company specializing in global collaborations and in-licensing. LIDDS received a signing fee exceeding USD 1 million in 2018 which will be followed by milestone payments and royalty on sales as long as NanoZolid patents are valid, currently until 2037.
The phase III clinical trial
The phase III clinical trial will be conducted in urology clinics in China and will be fully financed by the Jiangxi Puheng Pharma. LIDDS and Jiangxi Puheng will work closely together to optimize time to market for launching Liproca Depot in China.
“We are very pleased to receive the positive Phase IIb results and we have already started preparations for conducting the Liproca® Depot clinical trial in China. We hope to extend the partnership with LIDDS and get other products based on the NanoZolid technology into our pipeline,” says Mr. Dai Dai, CEO of Jiangxi Puheng.
“Liproca Depot will benefit prostate cancer patients both in terms of efficacy and maintained quality of life. Prostate cancer is a fast-growing cancer disease in China, why research and development in this field is of great importance. We are pleased that Jiangxi Puheng already has decided to progress with the phase III trial in China,” says Monica Wallter, CEO, LIDDS.