院东一直以来非常重视研发,每年将收入的20%投入研发,这在 A 股市场中名列 前茅。尽管仿制药政策波动较大,导致公司业绩出现过山车现象,但这并不影响 其研发能力。近年来,公司逐步从高端仿制药转向更具竞争力的精麻领域,并取 得了一定成果。2024年,公司的纳布啡和布托啡诺两款二类精麻产品获批,2025 年奥沙西洋也顺利获批并与恩华合作销售。目前,公司已储备超过五个管制精麻 更多资料加入知识星球:水木调研纪要 关注公众号:水木纪要 苑东生物 20260104 摘要 Q&A 请介绍一下院东在研发方面的整体表现及其未来展望。 争 匆 - 公司战略转型初见成效,从高端仿制药向精麻领域拓展,2024年两款二 . 类精麻产品获批,预计 2026年精麻领域收入将从 2025年的 6,000 万增长 至2亿以上,但需关注市场竞争和政策变化。 公司在非管制拮抗剂产品(如纳洛酮、纳美芬)的布局因集采影响未见显 ● 著增量,一类新药研发效率低于竞争对手(如恒瑞、海思科),肿瘤一类 新药进展缓慢,十年仅一个 TFADC 进入一期临床。 · 上海超阳平台为公司带来蛋白降解技术,提升一类新药研发能力。核心产 品 IKZF13 分子胶针对多 ...

Company Overview - Lingke Pharmaceutical has submitted its IPO application to the Hong Kong Stock Exchange, with CITIC Securities and Jianyin International as joint sponsors [1] - Founded in November 2017 in Hangzhou by former executives from Pfizer, Merck, and Johnson & Johnson, the company focuses on the development of small molecule targeted innovative drugs for diseases such as cancer, immunity, and inflammation [1][2] - The company’s core products are in the clinical key stage, but financial data indicates significant pressure [1] Product Pipeline - The core competitiveness of Lingke Pharmaceutical lies in two main areas: JAK-STAT signaling pathway drugs and protein degradation technology [2] - The lead product, LNK01001, is a highly selective second-generation JAK1 inhibitor, currently undergoing three Phase III clinical trials for atopic dermatitis, rheumatoid arthritis, and ankylosing spondylitis, with new drug applications planned for 2026 and 2027 [2][3] - Another key product, LNK01004, is a potential first-in-class third-generation pan-JAK inhibitor, which has shown promising results in Phase II trials for atopic dermatitis [2][3] Research and Development - Lingke Pharmaceutical plans to initiate Phase II clinical trials for chronic hand eczema and vitiligo in China in 2026, and advance Phase III trials for atopic dermatitis in 2027 [3] - The company’s IsoNova protein degradation platform significantly enhances target selectivity and reduces off-target risks, shortening the R&D cycle from 18-24 months to just a few months for some candidates [3] - The R&D team consists of 57 members, with a strong focus on new drug exploration and clinical development, holding 53 issued patents and 106 pending patent applications [3] Financial Performance - Lingke Pharmaceutical has reported net losses of 260 million yuan and 312 million yuan for 2023 and 2024, respectively, with a loss of 145 million yuan in the first three quarters of 2025 [4] - The company’s cash flow from operating activities was negative, with net cash flows of -228 million yuan and -241 million yuan for 2023 and 2024, improving to -85.67 million yuan in 2025 [4][5] - The company primarily relies on equity financing for operations and has established a commercial partnership with Xiansheng Pharmaceutical for the commercialization of LNK01001 [5] Market Landscape - The global JAK inhibitor market is highly competitive, projected to grow from 13.9 billion USD in 2024 to 40.8 billion USD by 2033, with the Chinese market expected to increase from 3.8 billion yuan in 2024 to 46.5 billion yuan by 2033 [6] - Major multinational pharmaceutical companies like Pfizer and AbbVie have established a competitive advantage, while several domestic companies are also in Phase III clinical trials for their JAK inhibitors [6]

Core Viewpoint - Haichuang Pharmaceutical (688302) is focusing on the sales strategy of its drug, Dihenzalutamide, which is expected to fill a clinical gap in treating specific mCRPC patients and has significant market potential in China [1][2]. Group 1: Sales Strategy and Market Position - The sales strategy for Dihenzalutamide revolves around a "medical-market-access-sales" four-wheel drive model, emphasizing the establishment of new standards and accumulation of real-world data [1]. - The drug has a differentiated competitive advantage compared to competitors, significantly improving the primary endpoint by extending rPFS by 5.5 months and reducing the risk of imaging progression or death by 42% [1][2]. - The prostate cancer market in China is projected to reach 50 billion by 2030, indicating substantial market potential for Dihenzalutamide [1]. Group 2: Clinical Research and Development - Dihenzalutamide has been included in the CSCO guidelines in 2023 and is expected to be included again after product approval in 2025 [2]. - The company has been exploring protein degradation technology since 2016 and has developed a mature PROTC and molecular glue technology platform [2]. - HP518 is the first oral R PROTC drug in clinical trials in China, with the first subject enrolled in a Phase II trial expected to complete by December 2024 [2]. Group 3: Financial and Operational Outlook - The company plans to maintain annual R&D expenditures at around 200 million over the next 2-3 years, with cash reserves of 880 million as of March 2025 [2]. - The company is considering refinancing needs based on product commercialization and progress of ongoing projects [2]. - An experienced business development team has been established overseas to advance various business development activities [2].