On November 26, 2021, Shanghai Luoqi Bio-pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Luoqi Biotechnology") announced that its application for LQ036 (recombinant anti-IL-4Ra single-domain antibody aerosol) IND, which is independently developed and has independent intellectual property rights, was accepted by the National Drug Administration Drug Evaluation Center (CDE) (acceptance number: CXSL2101446). In addition, LQ036 drug is undergoing clinical phase I study in Australia. From the results of the current subjects, LQ036 has good safety.

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.

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 nanoantibody drug developed by Rocky Biology 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.

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 1-2 years, three products will enter the clinical research phase in succession.