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IASO Bio and Innovent’s CT103A/ IBI326 Receive the US FDA’s Orphan Drug Designation for Multiple Myeloma

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IASO Bio and Innovent’s CT103A/ IBI326 Receive the US FDA’s Orphan Drug Designation for Multiple Myeloma

IASO Bio and Innovent’s CT103A/ IBI326 Receive the US FDA’s Orphan Drug Designation for Multiple Myeloma

Shots:

  • The US FDA’s OOPD has granted orphan drug designation (ODD) to fully human anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy, CT103A/IBI326, for relapsed and/or refractory multiple myeloma (R/R MM)
  • The ODD will accelerate drug development and registration action of CT103A in the US. CT103A will be eligible for development incentives, including FDA support for clinical studies, a waiver or reduction of registration application fee, and a 7yrs. US market exclusivity granted upon product approval
  • The companies are planning to launch CT103A both in China and the US. In Feb’2021, NMPA has granted BTD to CT103A for RRMM

 Ref: PR Newswire | Image: Newsbreak

Click here to­ read the full press release 

Tuba

Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

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