羚锐制药: 羚锐制药关于获得药品注册证书的公告

Group 1 - The company, Henan Lingrui Pharmaceutical Co., Ltd., announced that its subsidiary, Yingu Pharmaceutical Co., Ltd., received a drug registration certificate from the National Medical Products Administration for a new indication of the innovative drug, Phenylquaternary Ammonium Bromide Nasal Spray, to improve symptoms of runny nose, nasal congestion, nasal itching, and sneezing caused by colds [1] - The drug is classified as a prescription medication and is categorized as a Class 2.4 chemical drug, with specifications of 5ml:5mg and 10ml:10mg [1] - The nasal spray was initially approved for marketing in March 2020 for allergic rhinitis symptoms and is the only approved anticholinergic nasal medication for this condition in China [2] Group 2 - The market size for competing drug types, including nasal corticosteroids and antihistamines, is approximately 5.4 billion RMB [2] - The newly approved indication for the nasal spray is significant as it is the first M receptor antagonist nasal spray for post-cold nasal symptoms in China, offering advantages such as convenience and high safety [2] - The total research and development investment for expanding the indication of the nasal spray has reached approximately 35.97 million RMB [2]