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Recently, Novamab announced that its independently developed anti-IL-4R nanoantibody (LQ036 aerosol) drug, which has independent intellectual property rights, has completed the first clinical study on asthma patients in Australia for the first time!
LQ036 is the world's first innovative nano-antibody drug targeting IL-4R to enter clinical trials, and also the first new drug of a class to enter clinical trials in Novamab "Inhalation macromolecular drug R&D platform".
Dr. Wan Yakun, CEO of Novamab, said:
"The Australian Phase I clinical study of LQ036 completed the first subject administration, marking the official entry of LQ036 into the clinical study phase. From the results of the first subject administration, LQ036 has good safety, which adds confidence to the promotion of our follow-up clinical trial. We hope that LQ036 can be listed as soon as possible and benefit patients at home and abroad as soon as possible."
About asthma
Up to now, asthma is still a recognized medical problem in the world. It is listed as one of the four major persistent diseases by the World Health Organization. It has also become the world's second largest fatal and disabling disease after cancer. There are many patients with asthma worldwide, and there is a huge clinical demand. Antibodies have become the mainstream drugs in the treatment of asthma. However, due to the large molecular weight of the antibody (about 150kD), the existing technology can not meet the requirements of macromolecule inhalation administration, and can only be treated by subcutaneous administration. So far, no inhaled macromolecular asthma drugs have been approved for marketing.
About LQ036
LQ036 is an anti-IL-4R sdAb drug developed by Novamab with independent intellectual property rights:
· LQ036 uses atomized inhalation to make the drug directly reach the lung focus area and take effect quickly, while avoiding the first-pass effect of the liver and reducing systemic exposure toxicity. It not only takes into account the advantages of inhalation administration, but also avoids the side effects of subcutaneous administration.
· LQ036 can be applied to the commercial portable atomizer, and the compliance of patients will also be greatly improved.
· With the excellent characteristics of nanoantibody, LQ036 can be produced and expressed by Pichia pastoris, with high yield, simple process and obvious drug cost advantage.
· The activity of LQ036 is 10~30 times that of Dupixent, and the process cost is about 1/9 of Dupixent. Dupixent (Dupilumab injection) is a targeted IL-4R developed by Regent and Sanofi α The global sales of human monoclonal antibodies reached 4.033 billion US dollars in 2020, up 70.4% year on year.
At present, LQ036's sequence, derivatives and uses have applied for patent protection in China and other countries/regions, and have obtained Chinese invention patent authorization (authorization announcement No. CN111825766B). In the future, it will also expand the global patent layout through PCT, laying the foundation for the product to enter the international market.