Novamab has announced that the CDE of the NMPA has approved its IND application for LQ036, the world’s first inhaled nanobody for moderate to severe asthma. LQ036 is a recombinant anti-IL-4Rα single-domain antibody nebulizing solution produced in Pichia pastoris. Medicilon leveraged its dedicated Inhalation Formulation R&D Platform to deliver high quality services for the inhalation formulation of LQ036, providing critical support for IND approval.
Lower dosing frequency and higher potency: LQ036 poised to transform asthma care
Inhalation remains the optimal route for asthma therapy. Among large-molecule inhaled therapies targeting the IL-4/IL-4R pathway, AstraZeneca’s PRS-060, an inhaled IL-4R scaffold protein, has been the most advanced globally, currently in Phase II in the United States. Compared with PRS-060, LQ036 offers a lower dosing frequency and superior potency. A Phase I study of LQ036 is also underway in Australia, where it has demonstrated excellent safety to date.
The IND clearance for LQ036 is expected to provide Chinese and global patients with moderate to severe asthma a completely new treatment option.
Breaking new ground in nanobody inhalation formulation development
The technical requirements for inhalation formulations are extremely high, and transforming nanobody particles into an inhalable product presents an even greater challenge. Throughout preclinical development, Medicilon leveraged its dedicated Inhalation Formulation R&D Platform to deliver integrated services, enabling high quality and time efficient IND submission. Equipped with COPLEY NGI impactors, BRS2100 breathing simulators, and Sympatec laser diffraction analyzers, the platform designed a tailored characterization package aligned with ICH, NMPA, FDAand TGA guidelines, securing simultaneous regulatory acceptance globally.
Medicilon congratulates Novamab on achieving this milestone and wishes LQ036 a swift path to market so that patients worldwide may benefit from its improved efficacy. Medicilon looks forward to continuing to empower more inhaled therapeutics.