CDE approves IND application for LQ036 in the treatment of COPD 

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SHANGHAI, Sept 15th, 2023-- Novamab announces the Center for Drug Evaluation ("CDE") has approved its Investigational New Drug ("IND") application supporting its pivotal clinical trial of LQ036 for the treatment of chronic obstructive pulmonary disease ("COPD") in mainland China. This is the second indication applied for LQ036, with the first indication of asthma applied in 2021.

The global market for asthma/chronic obstructive pulmonary disease (COPD) drug is over 70 billion US dollars,  with market in China accounting for 1/7. Inhalation therapy as the first-line basic treatment was recommended for COPD and asthma patients according to Global Initiative for Chronic Obstructive Lung Disease (GOLD), Global Initiative for Asthma (GINA), and the guidelines in China. LQ036 is administrated by convenient oral inhalation, which has several advantages, such as fast onset of action, low systemic side effects, and lower dosage needed to work. Given LQ036 applies to nebulizer, DPI and SMI, there would be a huge market for LQ036 once it is approved. Compared to other drugs used in clinical practice to treat COPD, LQ036 has significant clinical differentiation and is expected to bring significant clinical benefits to patients with moderate to severe COPD.

Clinical progress for LQ036 in asthma treatment

(1) Phase I trial in Australia: l Phase I trial in Australia has been completed. And the results demonstrated that LQ036 were safe and well tolerated in healthy subjects. No serious and severe adverse events were reported. No LQ036 treatment induced immunogenicity were found and no immunogenicity caused TEAEs were reported.

(2) Phase I trial in China: SAD part has been completed, and the 4mg and 10mg dose groups of MAD have been administered. Currently, there are no reports of severe adverse events, and the overall safety is good. The PD marker analysis after LQ036 administration predicted excellent therapeutic potential.

About COPD

Chronic obstructive pulmonary disease (COPD) is a serious life-threatening respiratory disease that can damage the lung tissue structure and lead to a continuous decline in lung function. The symptoms of COPD include persistent coughing and breathing difficulties, which seriously affect the patient's health. COPD not only hinders the progress of daily activities, but may also cause anxiety, depression, and sleep disorders. The population of COPD patients is relatively large, and the global number of COPD patients is expected to reach 259.5 million by 2024 and 299 million by 2030 (data derived from Frost Sullivan analysis). COPD is one of the main causes of death and increased healthcare costs globally, and is widely recognized as a disease with a heavy medical burden. There are still a large number of unmet needs for the evaluation and treatment of COPD patients.

For COPD patients, medication can currently be used to alleviate symptoms. At present, the basic therapeutic drugs for COPD mainly include long-acting M-receptor agonists (LAMA), corticosteroids (ICS), short-acting drugs β Receptor Agonists (SABA), and long acting β (LABA). So far, no biologics have been approved for the treatment of COPD. On March 23, 2023, Sanofi announced its heavyweight product, the IL-4R antibody Dupilumab (Dupilumab), achieved positive results in the key phase III BOREAS for treating type 2 COPD. This means that Dupilumab will soon become the first approved biologic for treating COPD. In 2022, Dupilumab's global sales were 8.3 billion euros, with expected peak sales to reach 13 billion euros. Once Dupilumab's indication for treating COPD is successfully approved, its peak sales would likely to increase to over $20 billion.

About LQ036

LQ036 showed excellent activity in preclinical studies, with a 5-fold  and 10-fold increase in activity compared to Dupilumab and AZD1402/PRS060  respectively.

LQ036 is produced by Pichia pastoris, which could significantly shortens the production cycle compared to conventional monoclonal antibodies. And the high yieldcan reduce production costs by about 90%, greatly enhancing the competitiveness of the product. It has a huge competitive advantage in product commercialization promotion and drug penetration rate improvement.

About Novamab

S Novamab is an innovative Biotech dedicated to the research and industrialization of Nanobody drugs. The company was found in October 2017 and is located in the Shanghai International Medical Park. It has established a comprehensive  R&D, CMC, and pilot production platform, and is currently the only company in China with the ability to develop Nanobody drug throughout the entire process. As of August 2023, we have nearly 90 employees, applied for nearly 80 patents, and obtained 25 authorizations.

Novamab has independently created five core technology platforms based on Nanobody: rapid Nanobody screening platform, Pichia pastoris CMC process development platform, inhaled biologics  R&D platform, long-acting Nanobody platform, and bi/tri-specific Nanobody platform. Each platform has unique technological leadership and obvious industry competitive advantages, which can quickly promote the discovery and industrialization of Nanobody drugs.

In addition, Novamab has built a 500 L Pichia pastoris Nanobody GMP pilot production workshop, filling the industry gap in this field in China, which is highly scarce and competitive. Novamab has developed dozens of Nanobody drugs across multiple therapeutic areas, including respiratory diseases, infectious diseases, ophthalmology and oncology.. Currently, it has obtained three clinical approvals. In the future, Novamab will further accelerate  its clinical development, hoping to bring more treatment options to patients as soon as possible.