炒股就看金麒麟分析师研报，权威，专业，及时，全面，助您挖掘潜力主题机会！ 近日，凌科药业（浙江）股份有限公司正式向港交所主板递交上市申请，由中信证券、建银国际担任联 席保荐人。招股书显示，凌科药业成立于2017年，专注于自身免疫及炎症疾病领域的小分子抑制剂研 发，其核心管线围绕JAK-STAT信号通路展开，最具代表性的产品是第二代JAK1抑制剂LNK01001和第 三代软性泛JAK抑制剂LNK01004。 公司创始团队出身于辉瑞、默克等跨国药企，自成立以来已完成多轮融资，累计金额超过10亿元人民 币，投后估值达34.22亿元，吸引了礼来亚洲基金、君联资本、盛世投资等知名机构加持。然而，资本 青睐的光环背后，凌科药业也面临着诸多挑战，包括持续亏损现金流承压、核心产品的研发进度落后于 同类竞品、JAK抑制剂赛道市场竞争日益激烈等。 累计亏损超11亿元 核心产品研发进度落后于竞品 从财务数据看，由于尚无商业化产品，公司营收主要源于政府补助等其他收入。2023年、2024年及2025 年前三季度，公司来自银行利息收入及政府补助的其他收入分别为2060万元、1700万元、5480万元。同 期净亏损分别高达2.6亿元、3 ...

Core Viewpoint - The company, Gaoguang Pharmaceutical, is seeking to go public on the Hong Kong Stock Exchange after eight years of operation, but faces significant financial challenges and market competition despite its strong founding team and investment backing [3][12]. Group 1: Company Overview - Gaoguang Pharmaceutical was founded by a scientist with a notable background in drug development, having led the creation of several successful small-molecule drugs [4]. - The company has attracted significant investment, raising a total of 662 million RMB through six rounds of financing since its inception [4][6]. - The core research focus is on high-barrier areas such as autoimmune and neurodegenerative diseases, with a pipeline that includes selective TYK2/JAK1 inhibitors [6][7]. Group 2: Financial Performance - The majority of the company's revenue has come from a licensing deal with Biohaven, which accounted for 99% of its 2023 revenue of 226 million RMB [7][10]. - The company has reported cumulative losses of approximately 340 million RMB from 2023 to mid-2025, with rising R&D expenses contributing to the financial strain [9][10]. - The revenue structure is heavily reliant on a single partnership, leading to concerns about sustainability and future income [12][14]. Group 3: Market Challenges - The JAK inhibitor market, where Gaoguang operates, is highly competitive and has faced safety concerns, leading to increased regulatory scrutiny [19][20]. - The company’s lead product, TLL-018, is under pressure due to its clinical trial results showing higher adverse reaction rates compared to existing treatments [22]. - The neurodegenerative disease sector, targeted by TLL-041, is known for its high failure rates in drug development, adding to the uncertainty surrounding the company's pipeline [23][25]. Group 4: Future Outlook - The company faces significant redemption pressure from investors if it does not complete its IPO by the end of 2027, with a substantial portion of its liabilities tied to financial instruments issued to investors [15][16]. - The performance of Biohaven, its sole partner, is critical to Gaoguang's future revenue, especially after Biohaven faced setbacks in its drug approvals [14][25]. - The company’s cash reserves are limited, and its current burn rate suggests that it may struggle to sustain operations without additional funding or successful commercialization of its products [17][18].

Core Viewpoint - Lingke Pharmaceutical (Zhejiang) Co., Ltd. has submitted its IPO application to the Hong Kong Stock Exchange, focusing on innovative small molecule inhibitors for autoimmune and inflammatory diseases, particularly in the JAK-STAT signaling pathway [1][2]. Company Overview - Lingke Pharmaceutical has completed multiple rounds of financing, raising over 1 billion RMB, with notable investments from institutions like Eli Lilly Asia Fund and Junlian Capital [1]. - The company has a strong focus on R&D, with its lead product LNK01001 currently in Phase III clinical trials for atopic dermatitis, rheumatoid arthritis, and ankylosing spondylitis [5][12]. Financial Performance - The company reported revenues of 20.573 million RMB in 2023, with projected revenues of 16.978 million RMB in 2024 and 54.780 million RMB in the first three quarters of 2025 [4]. - Lingke Pharmaceutical has incurred significant net losses, totaling 2.6 billion RMB in 2023, 3.12 billion RMB in 2024, and 1.45 billion RMB in the first three quarters of 2025, with cumulative losses reaching 7.17 billion RMB [2][4]. - As of September 30, 2025, the company had cash and cash equivalents of 147 million RMB, indicating a liquidity pressure with an estimated operational runway of about 15 months [3]. R&D Pipeline - The company is advancing several differentiated small molecule drugs targeting autoimmune and inflammatory diseases, with LNK01001 being the most advanced [5]. - LNK01004, a third-generation pan-JAK inhibitor, has shown promising results in Phase II trials and is expected to enter Phase III trials in mid-2027 [5]. - The IsoNova protein degradation platform has been established to enhance R&D efficiency, producing several preclinical candidates [5]. Market Landscape - The JAK inhibitor market is experiencing significant growth, with global market size projected to expand from $5.5 billion in 2019 to $25.6 billion by 2028 [7][8]. - The Chinese market for JAK inhibitors is also expected to grow from 400 million RMB in 2019 to 17.1 billion RMB by 2028, indicating strong clinical demand [7][8]. - Lingke Pharmaceutical's LNK01001 faces competition from established products in the market, which may impact its commercial success [12].

苏州泽璟生物制药股份有限公司 关于自愿披露盐酸吉卡昔替尼片纳入2025年 国家医保药品目录的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性依法承担法律责任。 重要内容提示： 2025年12月7日，国家医疗保障局、人力资源和社会保障部公布了《国家基本医疗保险、生育保险和工 伤保险药品目录（2025年）》（以下简称"国家医保药品目录"），苏州泽璟生物制药股份有限公司（以 下简称"公司"）自主研发的盐酸吉卡昔替尼片通过国家医保谈判，被纳入国家医保药品目录。2025年国 家医保药品目录将于2026年1月1日起执行。 本次盐酸吉卡昔替尼片被纳入国家医保药品目录将有利于产品的销售，对公司的长期经营发展具有积极 影响，预计短期内不会对经营业绩产生重大影响。敬请广大投资者谨慎决策，注意防范投资风险。 现将相关情况公告如下： 证券代码：688266 证券简称：泽璟制药 公告编号：2025-056 盐酸吉卡昔替尼（商品名：泽普平）是一种新型的JAK抑制剂，属于1类新药，公司拥有该产品的自主 知识产权。吉卡昔替尼作为JAK抑制剂，其用于治疗骨髓纤维化的分子 ...

Company Overview - Lingke Pharmaceutical (Zhejiang) Co., Ltd. has submitted an application for listing on the Hong Kong Stock Exchange, with CITIC Securities and Jianyin International as joint sponsors [1] - The company is a leading developer of innovative differentiated small molecule inhibitors targeting autoimmune and inflammatory diseases, focusing on the JAK-STAT signaling pathway [3] Product Pipeline - Key products include LNK01001, a highly selective second-generation JAK1 inhibitor, and LNK01004, a potential first-in-class third-generation soft pan-JAK inhibitor, both targeting autoimmune and inflammatory diseases [3] - LNK01006 is a cutting-edge, highly selective allosteric TYK2 inhibitor designed to penetrate the central nervous system, targeting related diseases [3] - The company has developed the proprietary IsoNova protein degradation platform, which enhances target selectivity and reduces off-target effects, expanding the range of degradable targets [3][4] Market Potential - The global JAK inhibitor market is projected to grow from $5.5 billion in 2019 to $13.9 billion in 2024, with expectations to reach $25.6 billion by 2028 and $40.8 billion by 2033 [6][16] - In China, the JAK inhibitor market is expected to expand from RMB 400 million in 2019 to RMB 3.8 billion in 2024, with forecasts of RMB 17.1 billion by 2028 and RMB 46.5 billion by 2033 [6][16] Clinical Development - As of the last feasible date, the company has 53 issued patents and 106 pending patent applications, with 34 issued patents and 45 pending applications related to its core and key products [7] - LNK01001 is currently undergoing multiple Phase III clinical trials, with new drug application stages expected in 2026 and 2027 for various indications [7] - LNK01004 has completed Phase II trials in China and plans to initiate Phase III trials in mid-2027 [7] Financial Performance - The company reported other income of RMB 20.57 million in 2023, RMB 16.98 million in 2024, and RMB 54.78 million for the nine months ending September 30, 2025 [9] - Annual losses were approximately RMB 260 million in 2023, RMB 312 million in 2024, and RMB 145 million for the nine months ending September 30, 2025 [10] - Research and development expenses were RMB 186 million in 2023, RMB 223 million in 2024, and RMB 121 million for the nine months ending September 30, 2025 [11] Industry Overview - The global market for autoimmune and inflammatory disease drugs grew from $133 billion in 2019 to $160.8 billion in 2024, with a compound annual growth rate (CAGR) of 3.9% [13] - The Chinese market for autoimmune and inflammatory disease drugs is expected to grow from RMB 42.7 billion in 2019 to RMB 66.5 billion in 2024, with a CAGR of 9.3% [13][14]

Core Business and Business Model - Lingke Pharmaceutical focuses on innovative drugs for autoimmune and inflammatory diseases, with a core pipeline centered on the JAK-STAT signaling pathway, featuring three clinical-stage candidates [1] - The company has partnered with a single external collaborator, Siheng Pharmaceutical, for the commercialization of LNK01001, which poses a risk due to reliance on a single sales channel [1][5] Financial Data Alerts - Lingke Pharmaceutical has reported a continuous increase in net losses for three consecutive years, with a projected net loss of 312.3 million yuan in 2024, a 20.3% increase from 2023 [2] - The current ratio has dropped significantly from 35.3% in 2023 to 15.0% in 2024, indicating deteriorating short-term liquidity [2] Cash Flow and Funding Pressure - The company’s cash flow has worsened, with negative operating cash flows of -227.6 million yuan in 2023 and -240.9 million yuan in 2024, leaving cash reserves sufficient for only about 15 months of operations [3] Supply Chain and Customer Risks - The concentration of suppliers has increased, with the top five suppliers accounting for 68.5% of procurement in 2025, which may weaken bargaining power and affect clinical progress if core suppliers face capacity constraints [4] Equity Structure and Capital Risks - Management controls 34.97% of voting rights, with institutional investors holding 57.5%, which may dilute the interests of ordinary shareholders [6] - The company faces high redemption risk due to stringent terms that could require repayment of 1.197 billion yuan if certain milestones are not met by specified deadlines [7] Core Team and Governance Risks - Management compensation is significantly below industry averages, which may impact team stability [8] - Frequent transactions with related parties raise concerns about the clarity of financial boundaries and potential internal control issues [8] R&D Risks - Prepaid research expenses have decreased by 85.7%, indicating a reduction in R&D investment that could slow clinical progress [9] - The core product LNK01001 faces competition from established products, necessitating proof of superior efficacy in its Phase III trials to ensure commercial viability [10]

Company Overview - Lingke Pharmaceutical (Zhejiang) Co., Ltd. has submitted its application for listing on the Hong Kong Stock Exchange, with CITIC Securities and Jianyin International as joint sponsors [1] - The company is a leading developer of innovative small molecule inhibitors for autoimmune and inflammatory diseases, focusing on the JAK-STAT signaling pathway [3] Product Pipeline - The core products include LNK01001, a highly selective second-generation JAK1 inhibitor; LNK01004, a potential first-in-class third-generation soft pan-JAK inhibitor; and LNK01006, a cutting-edge TYK2 inhibitor targeting central nervous system diseases [3][4] - The company has developed an innovative proprietary IsoNova protein degradation platform, enhancing target selectivity and reducing off-target effects, with potential applications beyond autoimmune diseases to oncology and neurodegenerative diseases [4] Market Potential - The global JAK inhibitor market is projected to grow from $5.5 billion in 2019 to $13.9 billion by 2024, with expectations to reach $25.6 billion by 2028 and $40.8 billion by 2033 [6][16] - In China, the JAK inhibitor market is expected to expand from RMB 400 million in 2019 to RMB 3.8 billion by 2024, with forecasts of RMB 17.1 billion by 2028 and RMB 46.5 billion by 2033 [6][16] Clinical Development - As of the last feasible date, the company has advanced its core candidates LNK01001 and LNK01004 into clinical stages, with LNK01001 undergoing multiple Phase III trials and LNK01004 having completed Phase II trials in China [7][8] - The company aims to maximize patient efficacy and safety through the development of innovative candidates, with several preclinical candidates also in the pipeline [8] Financial Performance - The company reported other income of RMB 20.57 million, RMB 16.98 million, and RMB 54.78 million for the years 2023, 2024, and the nine months ending September 30, 2025, respectively [9] - The annual losses for the same periods were approximately RMB 260 million, RMB 312 million, and RMB 145 million [10] - Research and development expenditures were approximately RMB 186 million, RMB 223 million, and RMB 121 million for the years 2023, 2024, and the nine months ending September 30, 2025, respectively [11] Industry Overview - The global market for autoimmune and inflammatory disease drugs has grown from $133 billion in 2019 to $160.8 billion in 2024, with a projected CAGR of 3.9% [12] - The Chinese market for autoimmune and inflammatory disease drugs is expected to grow from RMB 42.7 billion in 2019 to RMB 66.5 billion by 2024, with a CAGR of 9.3% [13][14]

公司要闻： 国邦医药（605507）：公司发布公告，公司拟对董事、高管在内的270名员工实施员工持股计划，拟筹 集资金总额不超过1.85 亿元，涉及的股票总数不超过股本总额的10%，存续期为24 个月，锁定期为12 个月。 泰恩康（301263）：公司发布公告，子公司山东华铂凯盛于近日收到国家药品监督管理局签发的巴瑞替 尼片《药品注册证书》，经审查，本品符合药品注册的有关要求，批准注册。 一品红（300723）：公司发布公告，子公司广州一品红于近日收到国家药品监督管理局核准签发的艾司 奥美拉唑镁肠溶干混悬剂《药品注册证书》，，经审查，本品符合药品注册的有关要求，批准注册。 恩华药业（002262）：公司发布公告，近日收到国家药品监督管理局签发的盐酸羟考酮缓释片《药品注 册证书》，经审查，本品符合药品注册的有关要求，批准注册。 市场表现： 2025 年11 月28 日，医药板块涨跌幅+0.14%，跑输沪深300 指数0.11pct，涨跌幅居申万31 个子行业第27 名。各医药子行业中，医疗设备(+1.53%)、医院（+0.95%)、其他生物制品(+0.70%)表现居前，线下药 店（-0.55%）、疫苗(-0.4 ...

Core Transaction Details - The license target is the subsidiary Fosun Pharma, which has obtained exclusive rights for the development, production, registration, and commercialization of the AC-201 molecule and its drugs in mainland China and Hong Kong and Macau [1] - The licensor is Aikeno Biopharmaceuticals (Suzhou) Co., Ltd. [1] - The licensing field is for the diagnosis, prevention, and treatment of human diseases [1] Product Information - AC-201 is an oral small molecule JAK inhibitor primarily used for autoimmune diseases [1] - Clinical progress includes the completion of Phase II clinical trials for the first indication (moderate to severe plaque psoriasis), with positive data indicating good safety and tolerability [1] - The market size for JAK inhibitors is projected to reach approximately $16.8 billion in global sales by 2024 [1] Payment Arrangement - The total payment amount is up to 156 million yuan (including an upfront payment of 60 million yuan and milestone payments of up to 96 million yuan) [1] - Sales commissions will be paid based on a predetermined percentage of annual net sales [1] - Milestone payments will be made based on the achievement of annual net sales targets [1]

Core Viewpoint - Vitiligo is a complex autoimmune disease with no clear treatment options, affecting approximately 30 million people in China, with a significant portion of patients experiencing anxiety and depression due to the condition [3][4]. Treatment Landscape - Current treatment methods for vitiligo in China are limited, primarily involving topical corticosteroids and calcineurin inhibitors, which only suppress immune responses and do not promote repigmentation or prevent relapse [4]. - The FDA has approved the JAK inhibitor ruxolitinib cream for the treatment of non-segmental vitiligo in patients aged 12 and older, but it is not yet available in China and cannot be used for children under 12 [5]. Market Potential - The market for innovative vitiligo treatments in China is projected to reach 120 billion to 259 billion yuan under conservative to optimistic scenarios, indicating a significant opportunity for new products [6]. - The current pipeline for vitiligo treatments is not overly crowded, suggesting that successful new therapies that balance safety and efficacy could quickly gain market share due to unmet clinical needs [6]. Research and Development - Several domestic pharmaceutical companies are actively developing new treatments for vitiligo, including new JAK inhibitors and innovative approaches like the CKBA ointment being developed by TianKang, which targets T-cell fatty acid metabolism [5][6]. - TianKang has reported promising results from the Phase II clinical trials of CKBA ointment and is advancing to Phase III trials while seeking breakthrough therapy designation from the National Medical Products Administration [5].