DPBR112, the first targeted therapy drug for lung cancer to be researched in Taiwan, has an estimated market value of NT$5 billion (US$171.7 million) per year, and could be approved for market launch within five years, the Ministry of Science and Technology said on Tuesday.
Sixty percent of patients with non-small cell lung cancer, who comprise 85 percent of lung cancer patients nationwide, require treatment via targeted therapy, said researcher Hsu Tzu-an (徐祖安) of the National Health Research Institutes’ (NHRI) Institute of Biotechnology and Pharmaceutical Research.
First-generation targeted therapy medication, such as Iressa and Tarceva, have been deemed ineffective, as patients’ easily develop a tolerance to them, Hsu said, adding that second-generation drugs, such as Afatinib, produce side effects.
Lung carcinoma patients in Taiwan, Japan, South Korea and China have a 50 to 60 percent higher chance of developing epidermal growth factor receptor (EFGR) gene mutations, Hsu said.
Four percent of EGFR gene mutations are identified as EGFR exon 20-mutated lung cancer, while another 4 percent develop human epidermal growth factor receptor 2 (HER2) mutations, Hsu said.
Available targeted therapy options abroad are unable to treat both mutation types, Hsu said.
The research team tested the drug against multiple mutated proteins and found that DBPR112 performs well in suppressing effects of wild-type EGFR and its mutated variants, Hsu said, adding that the team also found that DBPR112 has a higher oral absorption rate.
In the tests on mice, the team observed that test subjects seemed to have higher dosage tolerance with lowered toxicity and side effects, Hsu said, adding that the drug’s suppression rates of specific EGFR or HER2-mutated lung carcinoma cells were excellent.
Once DBPR112 launches, patients around the globe would be able to benefit from better targeted therapy medication, Hsu said.
The NHRI began researching the drug after receiving a NT$300 million grant from the ministry, and the seven-year research project completed its preclinical trials last year and is now conducting first-phase human clinical trials, Deputy Minister of Science and Technology Su Fong-chin (蘇芳慶) said.
Patents for the drug have been applied for and approved in Taiwan, the US, China, Japan and South Korea, Su said.
Su called on the biotech industry to support the trials and assist the government’s push for domestically produced pharmaceuticals.
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