Zheng Quan Zhi Xing·2025-05-09 10:38Core Viewpoint - Health元药业's subsidiary, Lijuzhu Microball Technology Co., Ltd., has received approval for the injectable Aripiprazole microspheres, which is expected to enhance medication adherence and reduce relapse rates in adult schizophrenia patients [1][2]. Group 1: Drug Registration Details - The drug is named Aripiprazole Microspheres for Injection, with a dosage of 350mg [1]. - The registration certificate was issued by the National Medical Products Administration, confirming compliance with drug registration requirements [1]. - The drug is classified as a chemical drug of category 2.2 and is produced by Zhuhai Lijuzhu Microball Technology Co., Ltd. [1]. Group 2: Drug Development and Market Context - The injectable Aripiprazole microspheres were submitted for market approval in September 2023, with the acceptance number CXHS2300080 [2]. - This long-acting formulation is designed for monthly administration, which can improve patient compliance and reduce both economic and social burdens [2]. - As of the announcement date, Lijuzhu Microball is the only company with production approval for Aripiprazole microspheres, with no other similar products available globally [2]. Group 3: Market Potential - The estimated terminal sales value of antipsychotic drugs in China for 2024 is approximately RMB 6.048 billion, with long-acting formulations accounting for around RMB 1.418 billion [2].