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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]
丽珠集团(000513) - 2025年10月24日投资者关系活动记录表
2025-10-27 00:58
Financial Performance - The company achieved a total revenue of 91.16 billion yuan in the first three quarters of 2025, representing a year-on-year growth of 0.38% [2] - The net profit attributable to the parent company, after deducting non-recurring items, was 4.98 billion yuan, reflecting a year-on-year increase of 17.12% [2] - The formulation segment saw growth in major categories such as digestive, mental health, and traditional Chinese medicine, contributing to overall revenue stability [2] R&D Progress - The company has made significant advancements in key projects, including the submission of the P-CAB tablet for market approval and the completion of Phase II clinical trials for the injection form [3][8] - The IL-17A/F project for psoriasis and ankylosing spondylitis has completed Phase III clinical trials, with data expected to be submitted for market approval by the end of the year [4] - The NS-041 tablet for epilepsy and depression has entered Phase II clinical trials, with promising results in preclinical models [3] Market Strategy - The company plans to leverage its established sales channels in the digestive field to ensure rapid market penetration for new products like JP-1366, which is projected to achieve a sales figure of approximately 12.5 billion yuan in 2024, marking an 81% year-on-year growth [8] - The company is focusing on international expansion, particularly in Vietnam, where it aims to utilize the existing EU-GMP certified product lines of Imexpharm to enhance its market presence [6] Future Outlook - The company anticipates a stable revenue trend for the year, with profit growth expected to outpace revenue growth [11] - A clear roadmap for the launch of innovative drugs has been established, with multiple products set to enter the market over the next few years, including the IL-17A/F project and various formulations in the digestive and mental health sectors [9][10] - The company has committed to a high dividend payout, having repurchased shares worth 17.2 billion yuan and distributed nearly 60 billion yuan in dividends from 2020 to 2024 [13]