TaiGen Biotechnology Co (太景生技) is confident its can meet increasingly stringent requirements for new drug approvals in China, after it became the first Taiwanese firm to receive regulatory approval for its non-fluorinated quinolone antibacterial drug, Taigexyn, in Taiwan and China last month.
The Chinese Food and Drug Administration (CFDA) gave Taigexyn a class 1.1 designation, due to its indications for community-borne pneumonia and infections caused by diabetic foot ulcers.
CROSS-STRAIT PRECEDENT
“A precedent for new drug approvals in cross-strait collaborations in the biotechnology field has been set by Taigexyn,” TaiGen chairman and chief operating officer Hsu Ming-chu (許明珠) said at a BioTaiwan Exhibition forum yesterday.
Three more products are on track to be approved by the CFDA, thanks to what it has learned, Hsu said.
Hsu said that the company has seen a change in the CFDA throughout its decade-long efforts for CFDA approval, and that the process began to speed up 2012, six years after it established a level of trust and communication with the regulator.
During that time, the company began benefiting from bilateral agreements between food and drug regulators in Taiwan and China to cut down on redundant clinical trial requirements, with authorities now recognizing clinical study data conducted in both nations, Hsu said, adding that Taiwanese and Chinese share a very similar genetic makeup.
However, China had elevated its data assessment requirements significantly during the same period, she said.
SHIFT FROM GENERIC
Facing immense healthcare and medical expenses in China, the CFDA has shifted its focus from generic drugs to new drugs development, leading to more stringent regulatory requirements, Hsu said.
China’s change was driven by its goal to better control national healthcare costs by expanding domestic development and reducing reliance on imported products, Hsu said.
In 2014, the CFDA announced stricter data requirements for more than 2,000 New Drug Applications that were awaiting assessment and companies were advised to ensure that their data was valid.
UNABLE TO ADJUST
Consequently, all but about 200 companies, including TaiGen, retracted their applications, she said, adding that many companies were unable to adjust to the new standards.
In addition, TaiGen faced a 24-member review committee for Taigexyn, which Hsu said was significantly more strenuous than compared with US regulators.
In terms of competition in antibiotics of Taigexyn class, Beyer’s Avelox recorded sales of 1.6 billion yuan (US$239.75 million), while Lai Li Xin, which is sold by Zhejiang Medicine Co (浙江醫藥), TaiGen’s partner in China, posted sales of 1.03 billion yuan.
China’s total market for antibiotics is estimated at 79.7 billion yuan, Hsu said.
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