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LIDDS licensee, Puheng Pharma, evaluates a novel expeditated regulatory path for Liproca Depot in China

LIDDS licensee, Puheng Pharma, evaluates a novel expeditated regulatory path for Liproca Depot in China
20 August, 2020 Anja Peters

UPPSALA, SWEDEN – LIDDS AB (publ) announces that its licensee Jiangxi Puheng Pharma is currently preparing documentation for an application targeting a newly issued regulatory guideline in China on conditional market approval (CMA) for the prostate cancer drug candidate Liproca® Depot. CMA is the approval of a medicine that addresses patients’ unmet medical needs based on less comprehensive data than is normally required.

The final data from the LPC-004 study confirmed 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.

-The new CMA guideline comes very timely and LIDDS is supporting Jiangxi Puheng Pharma’s in the preparation of the application. Provided that Liproca® Depot can meet the Chinese regulatory criteria for CMA, there is a chance that Puheng can take Liproca® Depot to the market with a less extensive clinical trial program which would shorten the time to market, said Monica Wallter, CEO of LIDDS.

-Puheng Pharma is excited about the new regulatory guidelines from NMPA and we are currently preparing the submission package with support from LIDDS. We plan to submit the application to NMPA this autumn. NMPA’s new guidelines and policies regarding CMA is judged to be beneficial to the market approval of Liproca® Depot in China. We believe that even if the Chinese authority wouldn’t directly approve a CMA, the official introduction and communication with the Chinese authority would promote subsequent progress of Phase III clinical studies and market approval, said Dai Dai, CEO of Puheng Pharma.

The prostate cancer market is substantial in China with around 500 000 patients diagnosed annually. Oncology is a key focus area for Jiangxi Puheng Pharma and the company expects that the sales of Liproca® Depot will reach yearly sales of 50 000 to 70 000 treatments in 3 to 5 years after launch.

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

This information is such that LIDDS AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact persons above on August 20, 2020 at 08:30 CET.

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. 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 www.liddspharma.com