UPPSALA, SWEDEN – LIDDS AB (publ) A newly revised guideline from the Chinese National Medical Products Administration (NMPA) has extended the requirements to a full registration dossier for the conditional market approval (CMA). LIDDS licensee Jiangxi Puheng Pharma is therefore aiming to submit the application for CMA for the prostate cancer drug candidate Liproca® Depot in China during Q1, 2021.
The CMA is a faster regulatory pathway for the approval of a medicine that addresses patients’ unmet medical needs based on less comprehensive data than is normally required.
“LIDDS and Jiangxi Puheng Pharma have put intensive joint efforts in compiling the dossier to be able to hand in the application. The recent request of a full registration dossier requires additional documentation that is currently being compiled by LIDDS. Even though this is a shift in the timeline, this ongoing work would otherwise be required at a later stage to receive a product registration in China”, says Monica Wallter, CEO at LIDDS.
The prospect of Puheng Pharma registering Liproca® Depot in China, utilizing the CMA route, would shorten the time to market. Even without a direct approval of the CMA, the official introduction and communication with NMPA will promote the progress of the clinical program and subsequent market approval.
About prostate cancer and the market
Of the 1.3 million men diagnosed with prostate cancer globally each year, about 420,000 are assessed as intermediate risk and placed on ‘Active Surveillance’ where they are monitored regularly. There is no standard treatment for these cancer patients and many treating physicians see an unmet need. According to the market research firm GlobalData, the global market for prostate cancer drugs is expected to grow to USD 8.3 billion annually by 2023. Liproca® Depot’s target group is an untapped market, potentially USD 3 billion per year.
About Liproca® Depot and NanoZolid®
NanoZolid®- technology is a safe, flexible and functional method of delivering drugs. When injected, NanoZolid® forms a solid depot releasing the active drug over periods of up to six months or more. As it releases its drug load, the NanoZolid® depot dissolves and is absorbed harmlessly into the body.
Liproca® Depot combines NanoZolid® and 2-HOF (2-hydroxyflutamide), a well-established prostate cancer drug. Liproca® Depot’s target group is patients under Active Surveillance (AS) with intermediate risk of cancer progression. The final data from the LPC-004 study confirms Liproca® Depot’s potential as an anti-androgen treatment for prostate cancer patients that are currently under ‘Active Surveillance’. The study met both primary and secondary endpoints. PSA was decreased in 95 percent of the patients with maximum PSA response of 67 percent. MRI data showed no progression of prostate cancer in any patients and regression was even observed in some patients.
For additional information, please contact:
Monica Wallter, CEO LIDDS, +46 (0)737 07 09 22, monica.wallter@liddspharma.com
LIDDS AB (publ) is a Swedish-based pharmaceutical company with a unique drug delivery technology NanoZolid®. NanoZolid® is a clinically validated drug development technology and superior in its ability to provide a controlled and sustained release of active drug substances for up to six months or more. LIDDS has licensing agreements where NanoZolid is combined with antiandrogens and in-house development projects in clinical and preclinical phase for cytostatics and immunoactive agents. LIDDS (LIDDS) shares are listed on Nasdaq First North Growth Market. Redeye AB, certifiedadviser@redeye.se, +46 (0)8 121 576 90, is a certified adviser to LIDDS. For more information, please visit liddspharma.com