Mon, Apr 08, 2019 - Page 16 News List

Gongwin eyes Q3 debut and Chinese market

By Ted Chen  /  Staff reporter

After overcoming recent challenges, Gongwin Biopharm Holdings Co Ltd (共信生醫) expects to apply for a debut on the Taipei Exchange before the end of the third quarter and gain market approval for its new lung cancer drug in the Chinese market before the end of the year.

The company’s PTS302, a minimally invasive chemical ablation agent that is injected directly into malignant lung cancer tumors, is undergoing a safety review on raw materials and manufacturing processes by the Chinese Center for Drug Evaluation, reaching one of the final stages of the approval process, Gongwin general manager Morris Lin (林懋元) told the Taipei Times in an interview on March 25.

However, prior to securing its place on Chinese regulators’ long-review list, the company’s bid was severely affected by rapid policy changes, as stricter standards drove many Chinese manufacturers of active pharmaceutical ingredients out of business, constraining supply of p-toluenesulfonamide, the key reagent used to make PTS-302.

That was a major stumbling block, as without a steady supply of the reagent, the company would not have been able to provide doses for clinical trials or prove to regulators that it was ready to enter mass production while meeting drug safety standards, Lin said.

The company averted a crisis by securing agreements with suppliers from foreign markets, Lin said, adding that it was a difficult process to find manufacturers capable of making the pharmaceutical-grade reagents it requires.

However, the company would benefit from a having a more diversified list of qualified suppliers, he said.

Gongwin, which is listed on the preparatory Emerging Stock Board, plans to be listed on the Taipei Exchange before the end of this year on the expectation that PTS302 would be approved for the Chinese market in the third quarter.

Overall, China’s review procedure has become more efficient as Beijing adopts internationally accepted harmonized standards, Lin said, adding that this would make the outcome of new drug applications more predictable.

The company would also benefit from a change in drug approval criteria that recognize the benefits of PTS302’s ability to promote tumor necrosis through chemical ablation, he said.

Prior to the change, regulators favored tumor size reduction, which was what chemotherapy drug infusions were designed to do, Lin said.

China remains the primary market for PTS302 due to high rates of lung diseases linked to air pollution and a large population of smokers.

“A solid revenue stream from an approved drug would make our initial public offering much more appealing to investors,” Lin said, adding that following upheavals in the past few years, Taiwan’s biotechnology investment environment has begun to recover from a dip in confidence.

Gongwin would stay in its home market, Lin said.

The company in May last year raised NT$297 million (US$9.64 million) via a capital increase, meeting the Taipei Exchange’s listing requirement for biotechnology companies, under which an applicant’s net value must not dip below two-thirds of its market capitalization.

Gongwin vice president Pierre Hsiao (蕭斯欣) said that due to the way PTS302 is administered, sales would need to be facilitated by a network of medical institutions and physicians who are familiar with the injection process.

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