On January 26, 2022, the China National Drug Administration Drug Evaluation Center (CDE) announced that LQ036, a core drug of Shanghai Luoqi Biomedical Technology Co., Ltd. for the treatment of moderate and severe asthma, is recombinant anti-IL-4R α The application for clinical trial (IND) of single-domain antibody aerosol (Pichia pastoris) was officially approved (Notice No.: 2022LP00124). It only took 2 months from the acceptance of IND to the approval, and there was no supplement.

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, is the fastest growing inhaled macromolecular therapy drug for severe asthma through the IL-4/IL-4R channel at home and abroad. 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 IND of LQ036 was approved, which 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.

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, there are no drug-related adverse reactions, and LQ036 shows excellent safety.

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 novamab"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, Luoqi Biological inhaled macromolecule drug research and development platform covers asthma, COPD, COVID-19, pulmonary fibrosis and other respiratory diseases; 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.

About novamab

Luoqi Biology is a high-tech enterprise dedicated to the research and development of innovative nano antibody drugs. The company was founded on October 16, 2017 and is located in Shanghai International Medical Park. It has a research and development and production base of more than 2600 square meters and a unique camel breeding base. Luoqi Biological has independently created five core technology platforms based on nanoantibodies, each of which has unique industry advantages. Based on the innovative technology platform, Rocky Biology has a diversified R&D pipeline composed of more than 50 nanoantibody drug projects, covering hot targets such as asthma, fibrosis, ophthalmology and cancer. Loqi Biological will soon build a 500L GMP Pichia pastoris production plant that meets the requirements of clinical phase II sample preparation. In the next two years, 3-5 products will successively enter the clinical research stage.