The first domestic allergic asthma therapeutic antibody new drug submitted to NDA!

Recently, Maibo Pharmaceuticals announced that its core product CMAB007 (omalizumab) has been accepted by the National Medical Products Administration for its marketing registration application (NDA), which is mainly used for the treatment of allergic asthma.
This is the first domestic allergy to submit an NDA in China.
A new therapeutic antibody drug for asthma
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Omalizumab is a recombinant humanized anti-immunoglobulin (lgE) monoclonal antibody, which is used to treat inadequately after medium/high-dose inhaled corticosteroids plus long-acting β-adrenergic receptor agonists.
New monoclonal antibody drug for alleviating asthma patients
.

Omalizumab combines with free lgE to form an anti-lgE complex, which can inhibit high-affinity lgE receptors, thereby preventing allergic reactions
.

 The safety and efficacy of omalizumab have been confirmed by 4 clinical trials.
The test results show that omalizumab can improve the condition of asthma patients and reduce the incidence of acute asthma with lower doses of inhaled corticosteroids
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In the future, the indications of omalizumab may extend to chronic idiopathic urticaria, seasonal allergic rhinitis and food allergies
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 Omalizumab is expected to be approved by the National Food and Drug Administration in the fourth quarter of 2022.
After its listing, it is expected to become a more effective and affordable bio-specific therapeutic drug for more than 20 million patients with allergic diseases in China
.

 This product is Maibo Pharmaceutical's second drug to submit a marketing application.
If omalizumab is approved by the National Food and Drug Administration, it is expected to become the first monoclonal antibody asthma therapy developed by a Chinese company and marketed in China
.

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