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Bio Thera's QLETLI (biosimilar- adalimumab) Receives NMPA's Approval for Auto-Immune Diseases in China

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Bio Thera's QLETLI (biosimilar- adalimumab) Receives NMPA's Approval for Auto-Immune Diseases in China

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  • The approval of QLETLI is based on P-III study resulted in meeting its 1EPs- demonstrating bio-similarity to the reference product- Humira (adalimumab) including clinical/nonclinical- PK/PD data
  • The approval of QLETLI marks the first approval in a regulated market from Bio Thera’s biosimilar portfolio and is the second biosimilar to be approved by NMPA
  • QLETLI (BAT1406) is an anti-TNF- α mAb- available as a prefilled syringe for SC injection- indicated for all indications including rheumatoid arthritis- ankylosing spondylitis- and plaque psoriasis of the reference product- Humira in China

Click here to­ read full press release/ article | Ref: Bio Thera  | Image: Bio Thera


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