Recently, Shanghai Novamab Biopharmaceuticals Co., Ltd. (Novamab), LQ036 - recombinant anti-IL-4Rα single-domain antibody nebulizer (Pichia pastoris), a core drug for the treatment of moderate to severe asthma, was successfully approved for IND by National Medical Products Administrations (NMPA).
In the development process of the world's first inhaled nanobody drug for the treatment of moderate and severe asthma, Shanghai Medicilon Inc. (Medicilon) relies on the Medicilon Inhalation Drug Research and Development Platform to assist LQ036 to complete the quality research services of inhaled preparations with high quality and efficiency, and provided strong support for the project to be approved for clinical use.
Inhalation is the best route of administration for asthma treatment. Targeting the IL-4/IL-4R pathway, AstraZeneca's IL-4R inhaled scaffold protein product PRS-060 is the fastest-growing inhaled macromolecule therapeutic drug for severe asthma, which is in Phase II clinical trials in the United States currently. Compared with PRS-060, Novamab's LQ036 has lower dosing frequency and higher activity. In addition, LQ036 is undergoing Phase I clinical trials in Australia, showing an excellent safety profile.
The IND approval of LQ036 is expected to provide a new treatment option for moderate-to-severe asthma patients in China and around the world.
Medicilon is familiar with the development process and has extensive R&D experience of various inhalation formulations, especially in the field of DPI, nebulizer and nasal spray. The R&D are fully integrated with the requirements of domestic and foreign policies, regulations and guidelines.
Medicilon's preparation laboratory and workshop area is about 4,000 square meters, with 100 professional R&D teams, of which more than 40% are masters/doctors, and more than 95% are undergraduates. The team has rich experience in successful research and development of innovative drugs, consistency evaluation, and improved new drugs, and experience in China-US dual filing and project management. The Medicilon pharmaceutical preparation R&D team has successfully cooperated with well-known large and medium-sized pharmaceutical companies worldwide, and has accumulated 18 years of experience in the research and application of innovative drugs and generic drugs. We provide one-stop and systematic preparation R&D services covering innovative drugs and generic drugs to meet the needs of customers at different stages of R&D.
As a new and difficult formulation, inhaled formulations face many challenges in the development process. The development of nanobody particles into inhaled formulations faces many difficulties in the research process. When conducting the experiments, Medicilon has established a professional R&D team to formulate a special research plan for the inhalation characteristics of inhaled preparations for LQ036 with reference to the guiding principles of inhaled preparations and the application requirements of various countries, and assisted Novamab’s LQ036 to successfully complete the preparation of Chinese NMPA and Australian TGA IND application materials, and successfully obtained approval finally.
LQ036 has ushered in a new dawn of innovative treatment options under the full collaboration of Novamab and Medicilon. At the same time, the R&D strength of the Medicilon inhalation formulation R&D platform has been further expanded. The Medicilon inhalation formulation R&D platform is familiar with the development process of various inhalation formulations with rich experience, especially in the field of Dry Powder Inhaler (DPI), aerosol inhalation and nasal spray. Medicilon also equipped with the inhalation R&D related equipment, such as COPLEY's Next Generation Impactor (NGI), COPLEY's BRS2100 breathing simulator and Germany's Sympatec laser particle size analyzer. The equipment not only could undertake the overall development and application of traditional small molecule chemical drug inhalation preparations, but also has the ability to study the inhalation characteristics of protein inhalation preparations such as nanobodies and peptides.
Medicilon congratulates Novamab’s LQ036 on the successful clinical approval and the new drug R&D pipeline for its milestone achievement. Medicilon wishes the LQ036 could be approved and marketed as soon as possible to benefit the moderate and severe asthma patients around the world with better efficacy. Medicilon also look forward to helping more inhaled preparations to be successfully developed in the future.
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Shanghai Novamab Biopharmaceuticals Co., Ltd. (Novamab) is a high-tech enterprise dedicated to the research and development of nanobody innovative drugs. The company was established on October 16, 2017 and is located in Shanghai International Medical Zone. Novamab has a research and development production base of more than 2,600 square meters and a unique camel-breeding base. Novamab has created five core technology platforms based on nanobodies, and each platform has very unique industry advantages. Based on an innovative technology platform, Novamab has a diversified R&D pipeline composed of more than 50 nanobody drug projects, covering popular targets such as asthma, fibrosis, ophthalmology and tumors. Novamab is about to build a 500L GMP Pichia production plant that meets the preparation of clinical phase II samples. In the next two years, there will be 3-5 products entering the clinical research stage.
Since the founding of our company in 2004, Medicilon (Stock Code: 688202.SH) has grown into one of the professional drug discovery contract research organizations (CRO) in China. Over the years, Medicilon keeps improving their services in biotechnology and pharmaceutical research. Their services now span across medicinal chemistry, process chemistry, in vitro and in vivo DMPK, preclinical development and bioanalytical support. Medicilon grows together with the clients and delivers the new drug research and development services to more than 900 clients globally. Medicilon is proud to contribute to human health in the globe.
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