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 - 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].

Core Viewpoint - He Mei Pharmaceutical is urgently seeking an IPO after 23 years of product development, with its first drug Mufemilast recently approved, amidst a highly competitive market for psoriasis treatments [1][4]. Company Overview - Founded in 2002, He Mei Pharmaceutical has raised over 1.2 billion yuan and incurred losses exceeding 1.1 billion yuan, achieving a valuation of 3.9 billion yuan without any products on the market [1][3]. - The company has been in a continuous state of high cash burn, with significant R&D expenditures primarily focused on Mufemilast, which has taken over 16 years to develop [2][3]. Product Development - Mufemilast's development timeline began in 2009, with clinical trials starting in 2012, and it received approval for treating moderate to severe plaque psoriasis in September 2025 [2]. - The R&D costs for Mufemilast accounted for 60% of the total R&D expenses from 2023 to mid-2025, reflecting the heavy investment required for its development [2]. Market Competition - The psoriasis drug market in China is highly competitive, with 18 approved targeted therapies, including 5 small molecules and 13 biologics, leading to a fierce price war [4][5]. - Major competitors include established products from international pharmaceutical giants, which have already captured significant market shares [4][5]. Pricing Strategy - He Mei Pharmaceutical plans to set Mufemilast's initial annual treatment cost between 52,700 and 119,900 yuan, positioning it above some small molecule competitors but below the price of leading biologics [7]. - The relatively high pricing strategy may hinder Mufemilast's competitiveness, especially among price-sensitive patients requiring long-term treatment [7][8]. Commercialization Challenges - The commercialization of Mufemilast is expected to be slow due to the nature of psoriasis as a chronic disease, which requires extensive academic promotion and trust-building among healthcare professionals [8]. - Even if Mufemilast successfully launches, it may not generate significant revenue quickly enough to offset the company's ongoing losses [8].

Core Viewpoint - He Mei Pharmaceutical is urgently seeking an IPO after 23 years of product development, with its first drug Mufemilast recently approved, amidst a highly competitive market for psoriasis treatments [1][6]. Company Overview - Founded in 2002, He Mei Pharmaceutical has raised over 1.2 billion RMB and incurred losses exceeding 1.1 billion RMB, achieving a valuation of 3.9 billion RMB despite having no products on the market [1][5]. - The company has been heavily reliant on external financing, completing six rounds of funding from 2021 to the end of 2024, with a post-investment valuation reaching 3.9 billion RMB after the E round [5]. Product Development - The development of Mufemilast has taken 16 years, starting from preclinical research in 2009 to receiving approval for treating moderate to severe plaque psoriasis in September 2025 [3]. - Research and development expenses for Mufemilast accounted for 60% of the total R&D costs, with losses reported at 156.4 million RMB for 2023 and projected losses of 123.4 million RMB for 2024 [3][4]. Market Competition - The psoriasis drug market in China is projected to grow from 18.2 billion RMB in 2024 to 48.3 billion RMB by 2028, with 18 approved targeted therapies already available, including 13 biologics [6][7]. - He Mei Pharmaceutical faces intense competition from established players like Novartis and Eli Lilly, which have already captured significant market shares with their products [6][7]. Pricing Strategy - He Mei Pharmaceutical plans to price Mufemilast between 52,700 RMB and 119,900 RMB annually, positioning it above some small molecule competitors but below the price of established biologics [8]. - The higher pricing strategy may hinder Mufemilast's competitiveness in a market where patients are sensitive to treatment costs, especially for chronic conditions requiring long-term medication [8][9]. Commercialization Challenges - The commercialization of Mufemilast is expected to be slow due to the need for long-term academic promotion and building trust among healthcare professionals [9]. - Even with successful market entry, Mufemilast is unlikely to generate significant revenue quickly, making it difficult for He Mei Pharmaceutical to reverse its overall loss situation [9].

Core Viewpoint - Zejing Pharmaceutical (688266.SH) announced that its self-developed first-class new drug, Jikaxitinib Hydrochloride Tablets, has achieved the primary efficacy endpoint in the Phase III clinical trial for active ankylosing spondylitis, demonstrating statistical significance (p<0.0001) [1] Company Summary - The company plans to accelerate the drug's market launch process following the successful trial results [1] - Currently, there are only three JAK inhibitors approved by the National Medical Products Administration (NMPA) in China for the treatment of active ankylosing spondylitis: Tofacitinib, Upadacitinib, and Ivarmacitinib [1]

Investment Rating - The report indicates a positive outlook for the atopic dermatitis (AD) market, highlighting significant unmet medical needs and potential for new therapies, particularly in small molecules and biologics [4][10][12]. Core Insights - Atopic dermatitis is a chronic, recurrent inflammatory skin disease characterized by severe itching, affecting approximately 600-700 million patients globally, with around 67 million in China, indicating a substantial unmet demand for effective treatments [1][18][20]. - Recent advancements in small molecules and biologics have marked a new phase in AD treatment, with several new products entering the market, although the number remains limited [1][10][32]. - JAK inhibitors have shown excellent efficacy but come with safety concerns, while TYK2 inhibitors are emerging as a promising new option due to their selective action and potentially better safety profile [2][11][12]. - Biologics targeting IL-4Rα and IL-13 have demonstrated significant efficacy in improving skin lesions, with IL-31 showing strong itch relief capabilities [3][12][13]. - The development of dual/multi-target antibodies is seen as a new strategy to enhance treatment efficacy by combining the advantages of different targets [4][13][21]. Summary by Sections Investment Highlights - The AD market has immense potential, with a pressing need for effective therapies [4][10]. - The patient population is large, with over 600 million affected globally, necessitating urgent treatment options [1][18]. Disease Characteristics - AD is characterized by chronic inflammation and severe itching, significantly impacting patients' daily lives [1][14]. - The disease burden is heavy, with a complex pathogenesis involving multiple factors, primarily driven by Th2-type inflammation [21][24]. Current Treatment Landscape - Traditional therapies have safety concerns, leading to a shift towards biologics and small molecules [32][35]. - JAK inhibitors are the most approved class of drugs for AD, but they carry black box warnings due to safety issues [11][12]. - Emerging therapies, particularly TYK2 inhibitors, show promise for better safety and efficacy [2][11]. Biologics and Emerging Therapies - Currently approved biologics include IL-4Rα, IL-13, TSLP, and IL-31, with ongoing research into additional targets [3][12][13]. - Dual/multi-target antibodies are being explored to improve treatment outcomes and extend dosing intervals [4][13][21]. Market Potential - The report emphasizes the significant market potential for AD treatments, with projected growth driven by increasing patient numbers and the introduction of innovative therapies [4][10][20].

Core Viewpoint - The rising public awareness of autoimmune diseases, particularly ankylosing spondylitis, has led to increased interest in the pharmaceutical company Ganzhou Hemei Pharmaceutical Co., Ltd. as it seeks to go public with its core drug Mufemilast targeting psoriasis and ankylosing spondylitis [1][6]. Company Overview - Ganzhou Hemei Pharmaceutical is preparing for an IPO under the Hong Kong Stock Exchange's 18A biotechnology rules, focusing on high investment and potential returns typical of biopharmaceutical companies [2]. - The company has not yet generated revenue and relies heavily on government subsidies and continuous financing to sustain operations [2][11]. Product Pipeline - The company has seven clinical-stage small molecule candidates aimed at addressing unmet medical needs in autoimmune diseases and oncology [2]. - Mufemilast is a dual-action PDE4 inhibitor that has entered the NDA priority review process, targeting multiple indications including psoriasis and ankylosing spondylitis [2][3]. Market Potential - The market for psoriasis drugs in China has seen rapid growth, with a compound annual growth rate (CAGR) of 30.4% from 2019 to 2023, reaching a market size of 13.9 billion yuan in 2023, projected to soar to 89.4 billion yuan by 2032 [3]. - The autoimmune disease drug market in China has expanded from $2.5 billion in 2019 to $4 billion in 2023, with expectations to reach $26.3 billion by 2032, reflecting a CAGR of 23.3% [6]. Competitive Landscape - The competitive environment for Mufemilast is intense, with existing competitors having undergone significant price reductions due to national procurement policies, with price drops exceeding 93% for some products [5]. - There are currently five approved small molecule targeted therapies for psoriasis in China, with 37 more in clinical development, indicating a crowded market for Mufemilast [5][8]. Financial Status - The company reported significant losses of 156 million yuan in 2023 and 123 million yuan in 2024, with minimal other income [11]. - The company has undergone multiple rounds of financing since 2021, raising over 500 million yuan to support its operations, with a post-investment valuation of 3.9 billion yuan [11]. Leadership - The founder and chairman, Zhang Hesheng, has over 20 years of experience in biopharmaceuticals and holds a significant voting power in the company [12].

Core Viewpoint - Ganfeng Pharmaceutical Co., Ltd. (referred to as "Ganfeng Pharma") has submitted a main board listing application to the Hong Kong Stock Exchange, seeking new funding avenues for its ongoing losses in research and development [1][4]. Financial Performance - Ganfeng Pharma reported losses of 156 million RMB and 123 million RMB for the years 2023 and 2024, respectively [3][4]. - The company has a net current asset value of only 4.5 million RMB by the end of 2024, with current liabilities reaching 25.5 million RMB by March 2025 [1][4]. - Cash flow remains negative, with net cash used in operating activities amounting to 141 million RMB and 91.3 million RMB for 2023 and 2024, respectively [4][5]. - The company has raised approximately 951 million RMB through multiple financing rounds, with a valuation of 3.9 billion RMB following the E-round financing in September 2024 [4][5]. Product Pipeline and Market Competition - Ganfeng Pharma's product pipeline includes seven small molecule candidates, with four in Phase II, III clinical trials, or NDA stages, targeting 12 indications [1][2]. - The core product Mufemilast is a novel small molecule PDE4B inhibitor, with an NDA submitted for psoriasis and expected approval in the second half of 2025 [1][2]. - The Chinese psoriasis drug market is projected to grow from 13.9 billion RMB in 2023 to 89.4 billion RMB by 2032, with increasing competition from existing therapies [2]. Research and Development Strategy - The company has invested heavily in R&D, with expenditures of 123 million RMB and 97 million RMB for 2023 and 2024, respectively, but has yet to generate revenue [4][5]. - Ganfeng Pharma plans to establish a commercialization team of about 80 members within a year of Mufemilast's launch [4]. Management and Governance - The company's ownership structure is highly concentrated, with the founders controlling approximately 46.51% of the voting rights [6]. - The CEO, Dr. Zhang Hesheng, has over 20 years of experience in biomedical research and management, with significant compensation tied to equity [6]. Challenges and Risks - The company faces significant cash flow pressures, with only 150 million RMB in cash and cash equivalents by the end of 2024, alongside 25.5 million RMB in current liabilities [4][5]. - There are concerns regarding the company's ability to successfully develop and commercialize its pipeline products, particularly given the lack of a marketed product [7].

Investment Rating - Investment Rating: Positive [2] Core Insights - The pharmaceutical and biotechnology industry index increased by 3.36%, ranking 6th among 31 primary industries, outperforming the CSI 300 index, which decreased by 0.21% [5][17] - The valuation of the pharmaceutical and biotechnology industry as of June 6, 2025, is 28.24x (TTM, excluding negative values), up from 27.60x in the previous period, indicating an upward trend but still below the average [5][23] - Notable sub-industry performance includes chemical preparations and other biological products, with increases of 5.77% and 4.68% respectively, while offline pharmacies saw a decline of 1.15% [5][17] Industry Review - The report highlights three major investment opportunities: 1) Companies with dual-antibody/multi-antibody technology platforms that have differentiated target design capabilities and clinical advancement efficiency are likely to attract international giants [9] 2) Areas with unmet clinical needs, such as advanced liver cancer and non-small cell lung cancer, are promising for dual-antibody therapy development [9] 3) Potential license-out candidates, as domestic innovative pharmaceutical companies continue to engage in global collaborations [9] Important Industry News - CDE launched the "Star Plan" to encourage the development of pediatric anti-cancer drugs, addressing significant unmet clinical needs in this area [7][32] - Alcon's dry eye medication "Tryptyr" received FDA approval, marking it as the first of its kind globally [39] - Hansoh Pharmaceutical's third-generation EGFR-TKI "Amivantamab" was approved in the UK for first-line treatment of NSCLC, becoming the first domestically developed EGFR-TKI approved overseas [42] - BMS and BioNTech entered a collaboration for the dual-antibody candidate BNT327, with an upfront payment of $1.5 billion and potential milestone payments of $7.6 billion [51] Company Dynamics - Stone Pharmaceutical is negotiating three potential deals totaling $5 billion, involving several products including EGFR ADCs [49] - BMS's "Rotecip" was approved for treating lower-risk myelodysplastic syndromes, marking a significant innovation in this therapeutic area [45] - AbbVie’s JAK inhibitor "Upadacitinib" was approved for treating giant cell arteritis, becoming the first approved treatment for this condition in China [48]