Its new pancreatic cancer drug is likely to gain regulatory approval and begin commercialization in 2021, SynCore Biotechnology Co (杏國) said at the BioTaiwan Exhibition in Taipei yesterday.
The late-stage pancreatic cancer drug, SB05, has passed phase I and II clinical trials in the US, and has received approval to conduct a phase III trial, the Taipei-based company said.
SB05 has also gained orphan drug designation from US and EU regulators, which is expected to speed up the review process, it said.
“SB05 has shown favorable results in its phase II trial, demonstrating improved overall survival [OS] and progression-free survival [PFS] readings compared with patients given gemcitabine, the standard treatment for pancreatic cancer,” SynCore general manager Su Muh-hwan (蘇慕寰) said.
While SB05 would be introduced to the market as a pancreatic cancer treatment, it has completed phase II studies against triple-negative breast cancer and neoadjuvant HER2(-) breast cancer, as well as liver metastasis, Su said.
Despite the tremendous market potential for breast cancer treatments, there are already a lot of companies in the field, and the disease has many variations, he said.
Only about 15 percent of breast cancer patients worldwide have triple-negative breast cancer, but in Asia the figure is about 10 percent due to genetic factors, he said.
Other potential applications include lung, prostate and neoadjuvant pancreatic cancer, he said.
SB05’s effectiveness in clinical trials is due to the firm’s proprietary EndoTAG technology platform, he said.
EndoTAG is a delivery mechanism that can “envelope”’ a variety of drugs, he said, adding that the company is open to working with other drug developers.
However, production facilities at the company’s parent, Sinphar Group (杏輝藥業集團), cannot mass produce EndoTAG drugs as they have not been certified by European and US regulators, Su said.
“We currently rely on a German contract manufacturer to make small batches of SB05 for clinical trials, but our Taiwanese facility should be ready in time for the drug’s commercialization,” Su said.
In the pipeline are SB01, a head and neck cancer treatment; SB02, a gastric cancer treatment; and SB04, an eye-drop for age-related macular degeneration, he said.
Su said that biotech companies manufacturing lower-priced generic drugs and health supplements, such as Sinphar Group, have the most to gain from the government’s “new southbound policy,” but the high cost of oncology drugs and other medicines might be out of reach of most the region’s population.
SynCore is the development arm of Sinphar Group. It oversees clinical trials and seeks regulatory approval for drugs producted by the parent’s preclinical research department.
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