Korean botulinum toxin maker Medytox is likely to face a delay in winning Chinese license for Meditoxin (export name: Neuronox), industry watchers said.
Medytox recently clarified that the Chinese regulator’s suspension of review for Meditoxin was a “normal procedure for the next step.” However, industry officials noted that many other foreign pharmaceutical firms obtained the nod in China without going through any review suspension.
|Medytox’ botulinum toxin Meditoxin|
According to Yaozh.com, an online site for checking drug approval progress, China’s Center for Drug Evaluation (CDE) under the National Medical Products Administration ordered a suspension of review on Medytox’ Neuronox on May 24.
The CDE discloses drug assessment schedules only roughly.
According to a report by NH Investment & Securities on Yaozh.com’s data, many pharmaceuticals received Chinese greenlight without temporary discontinuation of review.
The Chinese regulator approved Novartis’ Lucentis on Nov. 30, 2018. On Aug. 9, 2018, the regulator began an additional assessment but completed the review on the same day without any review suspension. Amgen’s Repatha also did not have any mark of review suspension until the final approval on Aug. 8, 2018. It was the same case with Bayer’ Eylea, Janssen’s Simponi, and Eli Lilly’s Lartruvo.
Other drugs, including Allergan’s Botox, Sanofi’s Fasturtec Inj., Norvatis’ Xolair, and Ono Pharmaceutical’s Opdivo, won the license even after review suspension. It took a month for the regulator to resume the evaluation for Opdivo after the suspension of review. Fasturtec Inj. faced eight months of review suspension and had a total of one year and eight months to be finally cleared.
The Chinese regulator suspended review for Sanofi’s Pasteur DPT vaccine on Oct. 24, 2017, and completed the assessment in January 2018. However, the regulator did not approve of the drug in the end.
Medytox has claimed that it did not have any issue in getting Chinese nod as the review suspension was an ordinary procedural mark.
If Medytox’ explanation is true, all the other authorized drugs must have had the same mark, but they did not.
“There are many other successful cases such as Lucentis and Simponi, which won the Chinese approval without a suspension of review. It is a misunderstanding of the market that the suspension of license screening is accepted as a natural procedure,” said Ku Wan-sung, an analyst at NH Investment & Securities.
The estimated date of the final approval for Meditoxin has changed from July 29 (as of June 5) to Aug. 5 (as of June 11). As Yaozh.com is updated weekly, a continued display of “suspension of review” for Meditoxin could extend the period of winning the license.
The extension of review for Meditoxin gave an edge to rival drug Dysport by Ipsen, which was slower that Medytox to submit approval application.
Although Ipsen sought approval on Sept. 3, the estimated date of the final approval for Dysport is July 7, a month ahead of that for Meditoxin.
“While Meditoxin will suffer continued uncertainties over the timing of approval for Meditoxin, rival drug Dysport is expected to have a faster completion of the regulator’s assessment,” Ku said. “The competition in the botulinum toxin market in China will get more intense.
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