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丽珠集团:公司微球技术平台研发始终围绕公司战略核心
Zheng Quan Ri Bao Wang· 2025-10-27 08:09
Core Viewpoint - Lijun Group (000513) focuses on the development of microsphere technology, particularly in the areas of GnRH-α and mental health products, with significant advancements in long-acting formulations and international market expansion [1] Group 1: Product Development - The core product, Leuprolide microsphere (one-month release), is the first GnRH-α long-acting formulation approved by the FDA based on individual drug guidelines [1] - The injectable Triptorelin microsphere has received approval for prostate cancer and is expected to be approved for endometriosis in 2024, with ongoing Phase III clinical trials for central precocious puberty [1] - A three-month release Leuprolide microsphere application has been submitted, with expected approval in 2026 [1] - The company is also developing a microsphere formulation of Ganirelix, which currently has no market presence globally [1] Group 2: Mental Health Product Line - The company has launched an injectable Aripiprazole microsphere, which offers the longest dosing interval (once a month) for schizophrenia treatment globally [1] - Additional products like Brexpiprazole microsphere are in development to strengthen the long-acting product line for mental health [1] Group 3: Market Expansion in Vietnam - The acquisition of Imexpharm in Vietnam is under approval, with the company showing over 20% growth in revenue, profit, and EBITDA in the third quarter [1] - Imexpharm has the largest EU-GMP product line in Vietnam, and both companies are planning product and process transfers to leverage Imexpharm's established market channels and EU-GMP certification for expanding innovative drug products overseas [1]
技术突破带动治疗革新 丽珠集团全球首个注射用阿立哌唑微球获批上市
Zheng Quan Shi Bao Wang· 2025-05-09 10:16
Core Viewpoint - Lijun Group's self-developed injectable aripiprazole microspheres (brand name: Alivai) have been approved for marketing in China, marking a significant breakthrough in long-acting formulations for the treatment of schizophrenia [1][3] Company Summary - The approval of Alivai represents a potential blockbuster product for Lijun Group, following the success of its previous microsphere product, which generated over 10 billion yuan in revenue over nearly a decade [1][5] - The company has established a national-level microsphere technology platform and has launched several complex formulations, enhancing its competitive edge in the long-acting treatment of mental disorders [5] - Lijun Group plans to accelerate the clinical application and accessibility of Alivai, focusing on building a standardized diagnosis and treatment system, deepening doctor-patient education, and upgrading grassroots services [6] Industry Summary - The global market for antipsychotic drugs is expected to grow from 7.27 billion yuan in 2020 to 15.9 billion yuan by 2030, with a CAGR of 8.14% [1] - The long-acting market for antipsychotic medications in China is currently limited, with only a few billion yuan in annual sales, indicating significant growth potential [1][2] - The approval of Alivai is expected to elevate the ceiling of the long-acting market for psychiatric medications, addressing the high treatment interruption and relapse rates among schizophrenia patients in China [2][3]