Gongwin Biopharm Holdings Co Ltd (共信生醫) yesterday said that its new lung cancer drug, PTS302, is expected to gain marketing approval in China before the end of the first half of the year.
As revenue contribution from China begins to take hold next year, the company is expected to wipe out accumulated losses by 2020 and is aiming to pay out its first cash dividends in 2021, company general manager Morrice Lin (林懋元) told a news conference in Taipei.
About 340,000 people have lung cancer in China, of which 81,000 develop obstructive pulmonary conditions and fall into the target market for PTS302, which is going through final technical analysis by regulators, the company said.
The approval process in China has been progressing ahead of expectations as the drug was included on local health regulators’ “green channel,” a fast-track pathway for new drugs that have not been marketed elsewhere, Lin said.
Gongwin Biopharm was the only company to stand by its new drug application to health authorities in Tianjin, while 21 other firms retracted their filings to verify their clinical trial data, Lin said.
The company is also confident that its closer relationships with major hospitals in China would help ensure the adoption of the drug among oncologists in the country.
Healthcare reform in China has made drug prices more transparent across suppliers, distributors and hospitals, although the reform has added difficulty to the drug approval process, Lin said.
“We welcome improvements in regulators’ predictability and its clearly defined rules,” he said.
The company said it is expected to begin enrolling patients for a phase II clinical trial of PTS100, its new liver cancer treatment next month.
The number of liver cancer patients in Taiwan has been rising by about 11,000 people annually, and the disease claims about 8,000 lives per year, the company said.
Based on p-Toluenesulfonic acid, the company’s proprietary small molecule cancer drug, the line of PTS treatments is mini-invasive targeted chemo-ablation therapy that can be injected directly into tumors to induce the breakdown of cancerous cells.
While other ablation treatment destroys the tumor, clinical studies have shown that PTS is capable of also destroying “roots” put out by existing tumors that lead to tumor regrowth between treatments, Lin said.
The effectiveness of PTS has also benefited from advancements in medical imaging technology, as physicians are now able to perform ablations on tumor sites with significantly improved accuracy, he added.
The company is aiming to hold an initial public offering on the Taipei Exchange, advancing from its current listing on the TPEX’s Emerging Stock Board, Lin said.
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