长效微晶注射剂平台
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四川科伦药业股份有限公司 关于公司棕榈酸帕利哌酮注射液获得药品注册批准的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-11-15 23:15
Core Viewpoint - Sichuan Kelun Pharmaceutical Co., Ltd. has received drug registration approval from the National Medical Products Administration for its injectable drug Paliperidone Palmitate, which is expected to enhance the company's competitiveness in the central nervous system field [1][2][3]. Group 1: Drug Information - The drug name is Paliperidone Palmitate, available in injection form with specifications of 75mg, 100mg, and 150mg per 0.75ml, 1.0ml, and 1.5ml respectively [1]. - It is classified as a Class 4 chemical drug and has been approved for domestic production [1]. - The drug was developed by Janssen Pharmaceuticals and was first approved in the U.S. in 2009, with China approving its import in 2011 [2]. Group 2: Advantages and Market Potential - Paliperidone Palmitate is the first long-acting atypical antipsychotic approved for monthly administration, offering advantages such as improved patient compliance, reduced risk of disease relapse, and enhanced safety [2]. - The drug is widely recommended in various authoritative guidelines and is included in the national essential drug list and Class B medical insurance [2]. - The global sales forecast for 2024 is approximately $3.5 billion [2]. Group 3: Company Technology and Pipeline - The long-acting microcrystal injection platform of the company has independent intellectual property rights and addresses stability issues in microcrystal formulations [3]. - Paliperidone Palmitate is the first product approved from this microcrystal platform, with multiple other products under development [3]. - The approval of this drug is expected to enhance the company's pipeline competitiveness in the central nervous system disease sector [3].