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LQ036 IND application for COPD accepted by CDE
2023-06-28
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On June 27, 2023, Shanghai Novamab Biopharmaceuticals Co., Ltd. announced that the IND application for COPD indication of LQ036 (LQ036 Single-domain antibody inhalation powder), which is independently developed and has independent intellectual property rights, was accepted by the Center for Drug Evaluation (CDE) of the State Food and Drug Administration (acceptance number: CXSL2300435). This is the second indication for LQ036 after applying for asthma indications in 2021.



The global asthma/chronic obstructive pulmonary disease (COPD) drug market size exceeds 70 billion US dollars, and the Chinese market size for COPD exceeds 10 billion US dollars. The Global Initiative for Chronic Obstructive Lung Diseases(GOLD), Global Initiative for Asthma (GINA), and related guidelines in China unanimously recommend inhalation therapy as the first line basic treatment for patients with chronic obstructive pulmonary disease and asthma. LQ036 is delivered by oral inhalation, which  has the advantages of  convenient administration, fast onset, low systemic exposure, and higher concentration in the pathologic sites. All the advantages propose a huge potential market for LQ036.


Conduction of LQ036 phase I trial

 

(1) Phase I study in Australia has been completed, and LQ036 showed good safety and tolerance in healthy subjects. After oral inhalation, the bioavailability in the circulation is very low (1%). No treatment induced immunogenicity was observed in the subjects.


(2) Phase I SAD study in China has been completed, and the first dose group of MAD has been administered. At present, there is no report of Serious adverse events, and the overall safety is good. pSTAT6 level of whole blood was inhibited from 4mg dose, which demonstrated the excellent efficacy LQ036.


About COPD


Chronic obstructive pulmonary disease (COPD) is a life-threatening Respiratory disease, which can damage the lungs and lead to continuous decline in lung function. Symptoms include persistent coughing and dyspnea, which not only hamper daily activities, but also may cause anxiety, depression and Sleep disorder. The population of COPD patients is relatively large, expected to reach 259.5 million cases by 2024 and 299 million cases by 2030. COPD is one of the main causes of global death, disease, and healthcare costs, and is globally recognized as a disease with a heavy medical burden. There is still a significant demand gap for patient assessment and treatment, especially in the area of misdiagnosis.


There is currently no cure for COPD, and symptoms can only be relieved through medication. The drugs used to treat COPD can be divided into long-acting M-receptor agonists (LAMA), corticosteroids (ICS), and short-acting drugs β Receptor Agonists (SABA), Long acting β Four major types of receptor agonists (LABA). So far, no biological agents have been approved for the treatment of COPD. On March 23, 2023, Sanofi announced that its blockbuster IL-4R antibody Dupilumab had reached all major and key secondary endpoints in the phase III clinical BOREAS of COPD indications, which means Dupilumab will unlock the big indication of COPD, and will soon become the first targeted biological preparation for treating COPD. In 2022, Dupilumab's global sales were 8.3 billion euros, and once Dupilumab successfully unlocks the COPD indication, its peak sales are likely to increase to over 20 billion dollars.


About LQ036


LQ036 is an IL-4Rα neutralizing single domain antibody (sdAb). LQ036 was produced froma Pichia pastoris fermentation, which could significantly shorten the production cycle. LQ036 was delivered by oral inhalation, and now it was under phase I investigation in China.


About Novamab


Shanghai Novamab Biopharmaceuticals Co., Ltd. is an innovative biopharmaceutical enterprise committed to sdAb drug development and industrialization. Founded in October 2017, the company is located in Shanghai International Medical Park. It has Novamab has established the first and only sdAb development platform covering the full biopharmaceutical process in China. As of April 2023, we have nearly 90 employees, applied for nearly 70 patents with 25 authorized.


Novamab has independently created five core technology platforms: sdAb rapid screening platform, Pichia pastoris based CMC platform, biologcial drug inhalation platform, long-acting sdAb platform and bispecific sdAb platform. Each platform has unique leading technology, which makes it more competitive.The powerful paltform make it possible to rapidly bring the candidates to commercialization. The completion of the 500L GMP workshop for sdAb production using Pichia pastoris fills the industry gap in this field, which is extremely scarce and competitive.


Novamab has developed dozens of sdAb drugs, covering respiratory, anti-infection, ophthalmology and oncology. Currently, it has obtained three clinical approvals. LQ036 and LQ043 developed by Novamab have overturned the existing treatment methods for respiratory diseases, both of which are the world's first inhalable sdAb drug for their respective target. Phase I trials of LQ036 have been conducted in China and Australia, both demonstrating excellent safety and tolerability. The LQ036 IND files for COPD treatment will be submitted soon. In addition, phase I trial of LQ043 in China has completed the dosing of the third group of subjects. Most moderate to severe asthmatics would benefit from the LQ036 and LQ043 considering their mechanism of action.