On November 30, 2022, Shanghai Luoqi Bio-pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Luoqi Biotech") announced that its independently developed LQ036 (recombinant anti-IL-4Ra single-domain antibody aerosol), which has independent intellectual property rights, has completed the first phase I clinical study on asthma patients in China! LQ036 is the world's first innovative nano-antibody drug targeting IL-4R to enter clinical trials, and also the first new drug to enter clinical trials in Loqi Biological "Inhalation macromolecular drug R&D platform".

In addition, LQ036 is carrying out Phase I clinical trials in Australia, mainly to investigate the safety, tolerance and pharmacokinetics of LQ036 in healthy people and asthma patients. At present, LQ036 has completed the climbing test of all healthy subjects, showing good safety and tolerance.

The administration of asthma includes intravenous, subcutaneous, oral and inhalation, among which inhalation is the best. At present, AstraZeneca's IL-4R inhaled skeleton protein product PRS-060, which is currently in phase II clinical treatment in the United States, has the fastest progress at home and abroad in the treatment of severe asthma with inhaled macromolecular drugs targeting the IL-4/IL-4R pathway. Its Australian clinical phase I data is excellent. Compared with Dupilumab, it has obvious advantages such as rapid onset, low dosage and obvious advantages.

Compared with PRS-060, LQ036 of Loqi Biological has lower frequency of administration and higher activity. As the world's first inhaled nanoantibody drug for the treatment of severe asthma, the clinical application of LQ036 is a milestone in the research and development pipeline of Loqi biological new drugs, and is expected to provide a new treatment plan for patients with severe asthma in China and even the world.

About asthma

Up to now, asthma is still a recognized medical problem in the world. It is listed by the World Health Organization as one of the four major persistent diseases, and is the world's second largest fatal and disabling disease after cancer. About 350 million people worldwide suffer from asthma, of which 10% - 15% are severe patients, 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 Loqi Biological "Inhalation macromolecular drug R&D platform"

Luoqi Biological has independently created five core technology platforms based on nano-antibody: nano-antibody rapid screening platform, Pichia pastoris CMC process development platform, inhaled macromolecular drug research and development platform, nano-antibody long-acting platform and nano-antibody dual-antibody platform, all of which have very unique industry advantages.

Among them, the research and development platform for inhaled macromolecular drugs of Luoqi Biological covers asthma, COPD, COVID-19, pulmonary fibrosis and other respiratory diseases, including IL-4R, TSLP, COVID-19 S protein and other popular targets; The drug directly reaches the focus, with high utilization rate and low toxicity and side effects; Good portability with small atomizer, stable quality before and after atomization. At present, the second drug LQ043H of the inhaled macromolecular drug R&D platform, China Clinical Phase I IND, has also been officially accepted (acceptance number CXSL2200548).

About LQ036

· LQ036It is an anti-IL-4R nanoantibody drug developed by Loki Biological 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 In 2021, the global sales of human monoclonal antibodies reached 5.249 billion euros, up 52.7% 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.