TaiGen Biotechnology Co (太景生技) plans to seek regulatory approval for its new drug Taigexyn to be used in the treatment of diabetic ulcers as the company’s novel antibiotic starts sales in China.
The company expects sales of the new antibiotic in one of the world’s fastest-growing markets to bring in royalty income and provide an additional revenue stream, it said in a statement on Sunday.
Taigexyn — a non-fluorinated, broad-spectrum quinolone for the treatment of drug-resistant bacterial infections — has been approved for the treatment of community-acquired pneumonia by health regulators in Taiwan and China.
Commercialization of the new drug is limited, as the drug has only received approval for the treatment of a single indication via oral administration, the company said.
“Although Taigexyn is primarily marketed as a treatment for community-acquired pneumonia in China, drug prescriptions are determined by physicians and medical institutions,” a TaiGen investor relations official told the Taipei Times by telephone.
The official added that the company’s development efforts remain unhampered by regulatory limitations.
Regulatory policies are changing rapidly in China, and favorable turns might accelerate approval for additional indications, the official said.
The race to develop new treatments to fight superbugs — such as methicillin-resistant Staphylococcus aureus and penicillin-resistant Streptococcus pneumonia — has been growing in importance across the world, in particular in developing nations, and regulators have given fast-track approval for antibiotics.
Taigexyn is the first new Class 1.1 drug developed by a Taiwanese company to receive market approval in China, while its approval in the US is being helped by incentives and fast-track designations under the country’s antibiotics reforms.
Sales of quinolones in China last year totaled an estimated 6.4 billion yuan (US$944.9 million), the company said, citing data from IMS Health Inc, a US-based healthcare industry information and services provider.
Market observers have said that Taigexyn could see annual sales in China peak at about 1 billion yuan.
Zhejiang Medicine Co (浙江醫藥), which partnered with TaiGen to market and manufacture Taigexyn, is expected to receive 7 percent to 11 percent of sales proceeds, TaiGen said.
TaiGen is also evaluating sales in developing markets such as India, where drug-resistant bacterial infections are more prevalent, the official said.
The company has also licensed Taigexyn to Russia’s R-Pharm and Mexico’s Productos Cientificos SA to tap into 30 Latin American, Central Asian and Eastern European markets.
TaiGen shares yesterday rose 3.63 percent to close at NT$30 in Taipei trading, bucking a 0.16 percent decline on the Taipei Exchange, the local bourse for firms with small and medium-sized capitalizations, exchange data showed.
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