Korean biotech firms SillaJen and Medytox said they have almost completed preparations to enter the Chinese pharmaceutical market, estimated to be around 20 trillion won ($17.8 billion).

Industry watchers are paying attention to whether the two drugmakers can benefit from securing the large market ahead of their rivals.

SillaJen is stepping up efforts to conduct a final stage clinical trial on oncolytic virus therapy Pexa-Vec in China, sources said.

SillaJen said it has put to notice that it would recruit Chinese patients for a phase-3 study on Pexa-Vec via China Drug Trial, a clinical trial information site run under the China Food and Drug Administration.

China Drug Trial provides information about the current status of patient recruiting and clinical process in China. Thus, the pharmaceutical industry can predict when SillaJen will begin the phase-3 study on Pexa-Vec.

SillaJen’s trials are expected to take place at 24 hospitals in China, under the helm of Shukui Qin, deputy director of People's Liberation Army 81 Hospital in Nanjing. The drugmaker aims to gather 600 patients for the trials and has recruited 290 to date.

The pharmaceutical industry estimates the number of liver cancer patients to be around 900,000 around the world and 500,000 in China alone. As more than half of the world’s liver cancer patients are in China, SillaJen hopes that it could quickly recruit patients and proceed with the trials.

SillaJen plans to not only compare Pexa-Vec with Nexavar but secure data on combination therapy. Nexavar is known to be the only remedy for Chinese liver cancer patients.

If the company succeeds in commercializing Pexa-Vec, it will be able to get access to 200,000 patients in China including those who have used Nexavar, SillaJen said.

The drugmaker aims to release Pexa-Vec in China in late 2020, after completing the trials and winning approval.

Medytox is another Korean pharmaceutical firm targeting the Chinese market.

At the earliest, the company may set a clear timeframe late this year to obtain approval for its botulinum toxin as early as this year-end.

Medytox completed the phase-3 trials on Meditoxin in June last year and sought regulatory nod in February. As it usually takes one year from requesting for approval to receiving sales permission in China, Medytox is likely to release its product in 2019.

In China, only two botulinum toxin products are available – Botox by Allergan, and BTX-A by Lanzhou, a Chinese firm.

China’s cosmetics market is predicted to reach 250 billion yuan ($36.6 billion) in 2020. Medytox’s goal is to sell 1 trillion won worth products in China.

The company will face competitions against existing drugs at the initial stage, but Meditoxin’s better quality than that of BTX-A and a high market share of partner firm Bloomage BioTechnology will help boost Meditox sales, according to Medytox.

Medytox hopes to benefit from the enforcement of China's regulation on illegally imported botulinum toxin products and the rising demand for licensed goods.

“Compared to other countries, it takes much more time and efforts to enter the Chinese market. However, it is still attractive because it can be the world’s largest market,” said an official at a pharmaceutical firm. “SillaJen has no rival product in China and Medytox is making the quickest move to target China among Korean drugmakers. So, they will be able to take up about 10 percent market share by entering China ahead of others.”

sjh@docdocdoc.co.kr

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