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Comparing lanbotulinumtoxinA (Hengli®) with onabotulinumtoxinA (Botox®) and incobotulinumtoxinA (Xeomin®) in the mouse hemidiaphragm assay

Journal of Neural Transmission volume 126, pages 1625–1629 (2019)Cite this article

Abstract

LanbotulinumtoxinA (LAN) is manufactured and registered in China since 1994. Despite its widespread use in China and its increasing use in other Asian countries and in South America, it is not yet well known elsewhere. We wanted to compare its potency labelling using the mouse diaphragm assay (MDA), an isolated muscle model for botulinum toxin (BT) potency measurements, which is superior to clinical tests and which was recently refined as an alternative batch release assay for BT manufacturing. We also wanted to estimate LAN manufacturing quality by testing its inter-batch potency consistency. Potencies of 20, 60 and 100 MU of LAN, onabotulinumtoxinA (ONA) and incobotulinumtoxinA (INCO) were measured by the inversely related paresis time (PT) in the MDA. The PT (M ± SD) of all doses of LAN, ONA and INCO was 90.4 ± 27.0 min, 114.9 ± 46.5 min and 94.3 ± 29.9 min, respectively. Statistical analysis demonstrated indistinguishable potency labelling of LAN and INCO, but revealed a slightly lower potency of ONA compared to LAN and INCO. PT of LAN batch 1 and LAN batch 2 was 86.9 ± 21.2 min and 94.0 ± 32.8 min, respectively (no statistically significant difference), suggesting an adequate LAN manufacturing consistency. The MDA is an appropriate instrument for potency testing of BT drugs, including new ones currently under development. Our results allow comparing therapeutic effects, adverse effects and economics of LAN, ONA and INCO. They also suggest adequate manufacturing consistency of LAN.

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Funding

LP was funded by: National Natural Science Foundation of China (81500970), National Key R&D Program of China (2018YFC1314700) and Shanghai Hospital Development Center (16CR3009A). LJ was funded by: National Key R&D Program of China (2018YFC1314700), National Natural Science Foundation of China (81500970) and Shanghai Hospital Development Center (16CR3009A).

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Affiliations

  1. Movement Disorders Section, Department of Neurology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany

    Lizhen Pan & Dirk Dressler

  2. Department of Neurology, Hannover Medical School, Hannover, Germany

    Bruno Kopp

  3. Department of Neurology, Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai, China

    Lizhen Pan & Lingjing Jin

  4. Toxogen, Hannover, Germany

    Hans Bigalke

Authors
  1. Lizhen Pan
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  2. Hans Bigalke
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  3. Bruno Kopp
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  4. Lingjing Jin
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  5. Dirk Dressler
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Corresponding author

Correspondence to Dirk Dressler.

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Conflict of interest

DD received honoraria for consultations from Allergan, Ipsen, IAB-Interdisciplinary Working Group for Movement Disorders, Merz and Syntaxin. He is a shareholder of Allergan. He holds patents in botulinum toxin research and provides professional consulting services to pharmaceutical companies and professional investment institutions on all aspects of botulinum toxin drugs. HB is the founder and co-owner of Toxogen. LP, BK and LJ have nothing to disclose.

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Pan, L., Bigalke, H., Kopp, B. et al. Comparing lanbotulinumtoxinA (Hengli®) with onabotulinumtoxinA (Botox®) and incobotulinumtoxinA (Xeomin®) in the mouse hemidiaphragm assay. J Neural Transm 126, 1625–1629 (2019). https://doi.org/10.1007/s00702-019-02100-1

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  • DOI: https://doi.org/10.1007/s00702-019-02100-1

Keywords

  • LanbotulinumtoxinA
  • OnabotulinumtoxinA
  • IncobotulinumtoxinA
  • Hemidiaphragm assay
  • Potency labelling
  • Conversion factors
  • Drug comparability
  • Manufacturing consistency