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长春高新:子公司金赛药业,以长效技术与多元管线引领儿童医疗生态重构
2025年10月23日,在厦门举办的"创新引领,成长无界"儿科多领域研发与儿童健康管理研讨会上,长春高新(000661)(000661.SZ)子公司金赛药业创始人、 首席科学家兼总经理金磊博士发表了题为《聚焦儿科,持续创新》的主题演讲,引发儿科医疗界的广泛关注。演讲不仅展示了金赛药业在儿童健康领域的最 新研发成果,系统阐释了公司从"生长激素单核驱动"向"儿童健康平台型企业"的战略转型路径,也成为金赛持续研发与锐意创新的有力见证。 金赛药业创始人、首席科学家兼总经理金磊博士 十年铸就高质量长效生长激素:从"剂型创新"到"标准制定" 2014年,金赛药业上市了全球首款长效生长激素,将治疗从每日注射推进至每周一次的新阶段。上市十年来,金赛持续投入,全面提升全产业链能力,着力 突破工艺复杂性、质量均一性和规模化稳定性三大质控难关。例如,公司建成国际规模领先的中试和生产基地,确保PEG达到全球最高纯度;持续改进工 艺,首创集成化检测体系,构建杂质全谱识别能力,并创新引入分子排阻层析作为吸附层析的补充。仅此一步,就使每批生长激素收率损失20%,2015至 2025年间直接成本投入达3亿元人民币。 纯度和工艺的不断精进,为 ...
圣兆药物20250520
2025-05-20 15:24
Summary of Shengzhao Pharmaceutical Conference Call Company Overview - Shengzhao Pharmaceutical has 26 pipelines under development, focusing on indications such as malignant tumors and schizophrenia, with a business model primarily based on contract manufacturing and self-production, leveraging the MAH system in collaboration with Jilin Aodong, Haizheng Pharmaceutical, and Aoya Biological [2][3][8] - The company has a strong core technical team of over 90 R&D personnel, with a high proportion of PhD holders (75%), including several former CDE new drug review experts, making it one of the strongest teams in the domestic innovative formulation field [2][5] Market and Product Insights - The development of complex injectables is challenging, involving multiple stages such as process, active pharmaceutical ingredients, and quality control, but the market size is substantial, with products like Bupivacaine V0 exceeding 5 billion RMB in domestic sales [2][6] - Shengzhao has approved and filed for 8 complex injectable products, with 2 already approved and 6 under review, expected to be approved around 2026 [2][12] - The company has achieved breakthroughs in foreign industrialization technology barriers, implementing linear scaling continuous production processes and holds the largest single-batch production capacity globally, with 99 authorized invention patents [2][12] Competitive Landscape - Complex injectables are considered the pinnacle of the pharmaceutical industry due to high R&D difficulty and significant market potential, with products like liposomal formulations maintaining high sales even after patent expiration due to their complex formulation barriers [6][9] - Shengzhao's strategy includes focusing on long-acting and targeted formulations, which enhance therapeutic efficacy while reducing side effects, particularly in oncology and postoperative pain management [3][11] Financial and Production Strategy - The company is actively pursuing international market expansion, with a total investment of approximately 200 million RMB in the Linping project for Bupivacaine liposome production, with an annual capacity of 30 million units [3][27] - The pricing strategy for products like Doxorubicin liposome is competitive, with a bid price of 109.96 RMB in the tenth batch of centralized procurement, ensuring profitability before participating in bids [15][20] Future Outlook - Shengzhao aims to become a leading enterprise in the innovative formulation sector and is committed to global expansion, contributing to the rise of the Chinese pharmaceutical industry [14] - The company plans to further increase production capacity to meet domestic and international market demands and is pursuing GMP certification compliant with European and American standards [21][27] R&D and Financial Projections - R&D expenses are expected to decrease to around 70-80 million RMB in 2025, following a peak in 2024 due to multiple clinical trials [28] - The company has faced challenges in its IPO process, but with significant R&D achievements and product approvals, it anticipates improved cash flow and financial performance in the coming years [26][29] Key Products and Market Potential - Bupivacaine liposome is positioned as a unique long-acting analgesic with significant market potential, especially given the high volume of surgeries in China and the U.S. [21] - Paliperidone long-acting injection has shown rapid growth in sales, with domestic sales reaching approximately 600 million RMB in 2024, and significant potential in international markets [22][24] Conclusion - Shengzhao Pharmaceutical is well-positioned in the complex injectable market with a robust pipeline, strong technical capabilities, and a clear strategy for growth and international expansion, making it a noteworthy player in the pharmaceutical industry [30][34]