CCMDB said on Wednesday its unit Duopharma (M) Sdn Bhd (DMSB) and PanGen had successfully completed a three-year joint phase III clinical trial for the EPO (code-named as PDA10) in South Korea and Malaysia.
PDA10 is expected to be launched in the Malaysia market upon receiving the marketing authorisation from National Pharmaceutical Regulatory Agency (NPRA), it said.
“Biosimilars is a very attractive market within the pharmaceutical industry, forecasted to expand at a compound annual growth rate of 12% in Asia to an estimated RM8bil in the South East Asian region by 2020.
“To date, only several biosimilars products have been successfully developed and marketed and global pharmaceutical players have been dominating this market,” CCMDB said.
Recall that in 2012, DMSB and PanGen had inked a joint clinical trial and licence and distribution agreement to carry out a joint clinical trial for EPO in South Korea and Malaysia.
EPO is the protein present in the human body that adjusts the red blood cell (RBC) generation in accordance with the oxygen requirement of the human body.
Recombinant version of EPO is used as the therapeutic agent of all anemia patients, acute anemia in kidney dialysis patients, anemia due to anti-cancer chemotherapy and patients requiring blood transfusion.
CCMDB said through Duopharma’s investment into the RM18mil joint clinical trials, the latter obtained exclusive licence to package, fill & finish, and distribute the EPO product in Malaysia, Singapore and Brunei.The joint clinical trial started in February 2014 and was conducted in South Korea and Malaysia at multi-centers with a total of 298 subjects of which 228 subjects or 76.5% were from Malaysia and 70 subjects or 23.5% were from South Korea.
“The clinical trial was completed in January 2017 and 'code break' was conducted in early February 2017.
“The 'code break' showed excellent result in terms of equivalence to pharmacokinetics, pharmacodynamics and toxicity to the reference product. The result of the clinical trial demonstrated that PDA10 has similar efficacy with the reference product and is biosimilar to the reference product,” it said.
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