The pharmaceutical industry is closely watching whether a Korean botulinum toxin (BTX) product will win approval in the Chinese BTX market, five times larger than the Korean one, this year.
Industry sources said Wednesday Medytox, Hugel, Daewoong Pharmaceutical, Pharma Research Bio, and Huons are preparing to enter the Chinese market.
Among them, Medytox and Hugel are hoping to obtain a Chinese license within this year, as the two have completed receiving the Chinese government’s drug review and are waiting for the final decision.
Medytox moved first to knock on the door of the Chinese market with Meditoxin (export name: Neuronox). The company finished the phase-3 trial in China in June 2017 and became the first Korean BTX maker to submit a new drug application (NDA) to the National Medical Products Administration (NMPA) in February 2018.
Hugel followed suit for its product Botulax. The company sought sales approval in China in April 2019 and the Chinese regulator has completed the review last month, Hugel said. The company recently submitted additional complementary data.
Earlier, industry watchers had expected Medytox would be the first Korean BTX manufacturer to sell botox products in China.
However, the company’s alleged violation of the law in manufacturing Meditoxin clouded the outlook recently.
The prosecution said Medytox allegedly used unauthorized ingredients to produce Meditoxin and faked titer test results to get nods for exporting the product.
Analysts pushed the expected timing of the company’s winning of Meditoxin license in China several times from early last year to early this year.
Medytox said it expected to obtain the nod in China within this year, adding that it was “very difficult to predict the approval timing in China, unlike in the U.S. or Europe where a drug review usually follows a planned schedule.”
As the review for Meditoxin prolonged, Hugel’s Botulax has caught up on the approval procedure. Some even predict that Hugel will get the license faster than Medytox.
“I heard Medytox needs to receive GMP (Good Manufacturing Practices) inspection on the Meditoxin manufacturing plant in Korea from the Chinese licensing authorities who can conduct a GMP inspection if deemed necessary,” an industry official said. “But the new coronavirus pandemic made it almost impossible for them to enter Korea. So, it is likely that the inspection will be delayed.”
Hugel has not received any notice for GMP inspection. If the Chinese regulator completes the review for Botulax with complementary data only, Hugel can beat Medytox in getting the first Chinese approval for a Korean BTX.
“It is difficult to predict a situation in China easily. But if we don’t have to submit additional data, we hope that we could win the license in the middle of this year,” a Hugel official said.
Other companies – Daewoong, Pharma Research Bio with LG Chem, and Huons – are expected to enter the Chinese market much later than Medytox or Hugel.
Daewoong began phase-3 trials on its botox product Nabota in December 2019.
Huons just got approval from the NMPA to test Liztox (export name: Hutox) in a phase-3 study in China.
Industry watchers said it would take four or five years for the three companies to sell their BTX products in China, given the time that took for Medytox or Hugel.
Pharma Research Bio licensed out the development rights of Rientox in China to LG Chem. LG Chem will be in charge of conducting clinical trials, seeking approval, and selling the product in China. The Chinese study will come after Pharma Research Bio completes a local phase-3 study on Rientox.
The market of authorized BTX products in China is estimated to be about 500 billion won ($408.9 million) but the black market for BTX is worth 1.8 trillion won, sources said.
The legally clean BTX market is still small because China has given the license to only two BTX products so far – BTX-A by the Lanzhou Institute of Biological Product of China and Botox by Allergan, a U.S. company.
Industry officials predict that if Korean BTX products win the Chinese nod, the legal BTX market in China will grow.