药品研发与获批
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马应龙药业集团股份有限公司关于子公司获得药品注册证书的公告
Shang Hai Zheng Quan Bao· 2025-08-25 21:08
Group 1 - The company announced that its subsidiary, Jiangxi Mayinglong Meikang Pharmaceutical Co., Ltd., received the drug registration certificate for Olopatadine Hydrochloride Eye Drops from the National Medical Products Administration [1][2] - The drug is indicated for the treatment of allergic conjunctivitis-related eye itching and was first approved in the United States in 2004, with the original import approval in China granted in 2020 [2] - The domestic market sales of Olopatadine Hydrochloride Eye Drops reached 255 million yuan in 2023, and the company's cumulative R&D investment for this drug is 4.9224 million yuan [2] Group 2 - The approval of the drug registration certificate will help enrich the company's ophthalmic product line [3] - The production and sales of the drug are subject to uncertainties due to industry policies and market competition [3]
人福医药:屈螺酮炔雌醇片获批
news flash· 2025-07-31 09:37
Core Viewpoint - The approval of the drug "Drosperinone and Ethinyl Estradiol Tablets" by the National Medical Products Administration marks a significant milestone for the company, enabling it to sell the product in the domestic market and enhancing its product line [1] Group 1 - The company's subsidiary, Wuhan Jiulong Renfu Pharmaceutical Co., Ltd., received the drug registration certificate for Drosperinone and Ethinyl Estradiol Tablets [1] - The drug is intended for female contraception and the company submitted its application for marketing authorization in March 2024, which has been accepted [1] - The total R&D investment for this product amounts to approximately RMB 8.5 million [1] Group 2 - The projected national sales revenue for Drosperinone and Ethinyl Estradiol Tablets in 2024 is approximately RMB 320 million [1] - The approval signifies the company's qualification to market the drug domestically, which is expected to have a positive impact on its business [1]
福元医药:盐酸阿莫罗芬搽剂获药品注册证书
news flash· 2025-07-04 07:45
Core Viewpoint - Fuyuan Pharmaceutical (601089) has received the drug registration certificate for Amorolfine Hydrochloride Solution from the National Medical Products Administration, indicating a significant advancement in its product portfolio aimed at treating fungal infections of nails [1] Company Summary - Fuyuan Pharmaceutical's wholly-owned subsidiary, Fuyuan Pharmaceutical Co., Ltd., has been granted the drug registration certificate for Amorolfine Hydrochloride Solution, which is intended for the treatment of nail infections caused by sensitive fungi [1] - The company received the acceptance notice for the application on January 2, 2024, and has recently obtained approval [1] - As of the announcement date, Fuyuan Pharmaceutical has invested a total of RMB 3.9783 million in the research and development of this drug [1] Industry Summary - According to data from Minet, the sales revenue of Amorolfine Hydrochloride Solution in China's three major terminal markets is estimated to be approximately RMB 456 million in 2024 [1]
羚锐制药: 羚锐制药关于获得药品注册证书的公告
Zheng Quan Zhi Xing· 2025-07-01 16:31
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]
国药现代:培哚普利吲达帕胺片获药品注册证书
news flash· 2025-06-30 09:52
Core Viewpoint - The approval of Perindopril Indapamide tablets by the National Medical Products Administration enhances the product portfolio of the company in the cardiovascular field and strengthens its market competitiveness [1] Group 1 - The company's wholly-owned subsidiary, China National Pharmaceutical Group Industrial Co., Ltd., received the drug registration certificate for Perindopril Indapamide tablets [1] - The drug is a compound tablet consisting of Perindopril tert-butylamine and Indapamide, intended for the treatment of primary hypertension in adults [1] - The projected sales revenue for Perindopril Indapamide tablets in public medical institutions and urban pharmacies across the country in 2024 is estimated to be 269 million yuan [1] Group 2 - The cumulative research and development investment for this project by the company amounts to approximately 18.568 million yuan [1] - The approval of this drug will enrich the company's formulation product line in the cardiovascular sector [1] - The new product is expected to enhance the company's competitiveness in the market [1]
莎普爱思:获得聚乙烯醇滴眼液药品注册证书
news flash· 2025-04-09 08:00
Core Viewpoint - The company Shapais (603168) has received approval from the National Medical Products Administration for its polyethylene glycol eye drops, which can be used to prevent or treat symptoms such as dry eyes, foreign body sensation, and eye fatigue [1] Summary by Relevant Categories Product Approval - The polyethylene glycol eye drops are classified as an ophthalmic preparation with a specification of 1.4% (0.4 ml: 5.6 mg) [1] - The approval signifies a significant milestone for the company in expanding its product offerings in the ophthalmic market [1] Research and Development Investment - The cumulative R&D investment for this product has reached approximately 8.11 million RMB [1] - This investment reflects the company's commitment to developing innovative solutions for eye care [1]