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Core Viewpoint - Shanghai Heng Rui Medicine Co., Ltd. has received acceptance for the clinical trial application of Leuprolide Acetate Microspheres, a Class 3 chemical drug, which has already surpassed annual sales of 5 billion yuan in the domestic market [1][4]. Group 1: Market Overview - Leuprolide Acetate is a synthetic peptide analog of gonadotropin-releasing hormone (GnRH), primarily used for treating diseases related to elevated sex hormone levels, such as endometriosis, uterine fibroids, precocious puberty, prostate cancer, and breast cancer [3]. - The domestic market for Leuprolide Acetate has shown stable sales exceeding 5 billion yuan over the past three years, with sales figures of 5.206 billion yuan in 2022, 5.391 billion yuan in 2023, and projected 5.623 billion yuan in 2024, indicating a steady growth trend [4][6]. Group 2: Competitive Landscape - The original manufacturer, Takeda, and AbbVie developed the injectable Leuprolide Acetate microspheres, which were approved by the FDA in 1989 and have achieved significant success. In China, it was approved in 2000 and is included in the national medical insurance category B [6]. - Currently, there are two domestic companies, Lijun Group and Beijing Bont Pharmaceutical, that hold production licenses for Leuprolide Acetate long-acting microspheres, with Lijun Group being the first to obtain approval for the generic version [8][10]. - The sales share of Lijun Pharmaceutical's Leuprolide Acetate microspheres is the highest at 39.85%, followed by the original manufacturer Takeda [10]. Group 3: Future Market Potential - The market for injectable Leuprolide Acetate microspheres is expected to reach 6.8 billion yuan by 2025 and exceed 8.7 billion yuan by 2030, indicating a promising outlook for the product [6]. - The domestic market for microsphere formulations has grown significantly, with sales increasing from 2.5 billion yuan in 2015 to 7.9 billion yuan in 2023, and the market share rising from 34.6% to 49.7% [13][15]. - As the technology for microsphere formulations matures and pharmaceutical companies continue to innovate, Leuprolide Acetate microspheres are expected to play a crucial role in building competitive advantages and capturing market share [17].