医药生物行业周报 药辅行业迈入成熟期，关注医药辅料优 势企业 2026 年 03 月 02 日 【行情回顾】 【本周观点】 【风险提示】 医药行业政策风险；研发进展不及预期风险；业绩不及预期风险 挖掘价值 投资成长 强于大市（维持） 东方财富证券研究所 证券分析师：何玮 证书编号：S1160517110001 证券分析师：崔晓倩 证书编号：S1160525080001 相对指数表现 -10% -2% 6% 14% 22% 30% 2025/3 2025/9 2026/3 医药生物 沪深300 相关研究 《"小而美"药辅行业迎来产业升级》 2026.02.24 《ADC 商业化进程提速，本土创新药企多 路径布局产能》 2026.02.09 《《药品管理法实施条例》全面修订，推动 医药产业创新与监管升级》 2026.02.03 《医药零售高质量发展政策发布，行业有 望加速整合利好龙头》 2026.01.27 《J.P. Morgan 健康大会召开，中国创新药 企扬帆出海》 2026.01.20 行 业 研 究 / 医 药 生 物 / 证 券 研 究 报 告 本周(2026/02/23-2026/02/27，下同） ...

此次该药物获批的适应症中轴型脊柱关节炎(axSpA)是一种慢性炎症性疾病。nr-axSpA则属于中轴型脊 柱关节炎的早期阶段。 由于nr-axSpA患者初治多使用非甾体抗炎药(NSAIDs)及物理治疗。然而NSAIDs往往只能起到缓解症状 的作用，难以改变疾病病程，对预防结构损伤的作用不明确，延迟诊断会给患者和社会带来显著的临床 负担和经济负担。因此，早诊早治对改善nr-axSpA患者临床结局并减轻患者负担具有重要意义。 经济观察网2月3日，诺华公司宣布，司库奇尤单抗新适应症获得国家药品监督管理局批准，适用于治疗 对非甾体类抗炎药(NSAID)应答不佳的活动性放射学阴性中轴型脊柱关节炎成人患者。此次新适应症获 批，是该药物继在成人和儿童中重度斑块状银屑病、强直性脊柱炎、银屑病关节炎和化脓性汗腺炎后， 在中国获批的第六个适应症。 PREVENT研究是司库奇尤单抗在nr-axSpA患者中开展的全球III期研究。该研究显示，相较于安慰剂 组，司库奇尤单抗治疗第16周nr-axSpA患者ASAS40应答率高，且改善持续至第52周，安全性良好。研 究次要终点显示出统计学上的显著改善。 ...

研究表明，白介素(IL)-17A是参与axSpA、银屑病、银屑病关节炎病理机制的关键细胞因子。司库奇尤 单抗作为一款IL-17A抑制剂，可特异性中和多种来源的IL-17A，抑制其促炎作用，缓解nr-axSpA的症 状，持续改善病情，为患者带来长期获益。 诺华表示，中轴型脊柱关节炎患者以中青年群体为主，他们正处于工作与生活的黄金期，疾病的进展会 严重影响患者的生活质量，甚至导致其丧失劳动能力。司库奇尤单抗新适应症的获批能够为更多nr- axSpA患者提供有效的治疗选择，有望延缓疾病进展，助力实现规范、全程化管理。 目前，司库奇尤单抗在axSpA、银屑病及银屑病关节炎领域在全球已积累超过10年的临床使用经验，并 拥有5年长期临床研究及真实世界证据的支持，被多项国际与国内指南列入axSpA一线治疗的生物制 剂。 2月3日，诺华制药(NVS.US)宣布，其创新生物制剂可善挺(司库奇尤单抗)新适应症获得国家药品监督管 理局(NMPA)批准，适用于治疗对非甾体类抗炎药(NSAID)应答不佳的活动性放射学阴性中轴型脊柱关 节炎成人患者(其客观征象表现为C反应蛋白(CRP)升高和/或磁共振成像(MRI)证据)。此次nr-ax ...

Core Viewpoint - The company, Lizhu Group, has announced that its core product, Lakanqita monoclonal antibody, has outperformed Secukinumab in the primary endpoint of a Phase III head-to-head clinical trial for moderate to severe psoriasis, with a PASI 100 response rate at week 12 [1] Group 1 - The product is the first IL-17A/F dual-target inhibitor in China, offering advantages such as less frequent dosing, convenient administration, and excellent safety profile [1] - The company has submitted for market approval and has been included in the CDE's priority review, with the earliest expected approval by the end of 2026 [1] - Cost competitive barriers have been established through the localization of raw materials and process optimization, laying a foundation for future market access and commercialization [1]

Drug Information - The drug "Lai Kang Qi Ta" monoclonal antibody injection has received acceptance for domestic production registration from the National Medical Products Administration (NMPA) [1] - It is classified as a Class 1 therapeutic biological product and is intended for adult patients with moderate to severe plaque psoriasis suitable for systemic therapy or phototherapy [1] - The drug is a self-developed innovative IL-17A/F dual-target inhibitor, which is the first of its kind in China and the second globally [1][2] Clinical Development - A clinical trial for the drug is set to achieve primary and secondary efficacy endpoints by July 2025, demonstrating superior efficacy compared to the control group [1] - The trial results indicate faster onset, better short-term efficacy, long-lasting effects, and less frequent dosing compared to the control drug [1] - The cumulative R&D investment for the drug is approximately RMB 204.03 million [2] Market Situation - As of the announcement date, there are no approved products in China for psoriasis indications targeting the IL-17A/F dual-target [3] - There are three imported and two domestic products approved for IL-17A and IL-17RA single-target indications [3] - The estimated domestic terminal sales for IL-17A and IL-17RA single-target drugs in 2024 is RMB 2.833 billion [3]

Core Viewpoint - Lijun Pharmaceutical and Xinkanghe Biotech have submitted an application for the market approval of Lakanqita Monoclonal Antibody (LZM012/XKH004) for the treatment of plaque psoriasis [2] Group 1: Product Development - Lakanqita Monoclonal Antibody is an IL-17A/IL-17F monoclonal antibody that targets both homodimer IL-17A-A and IL-17F-F, as well as heterodimer IL-17A-F [4] - Lijun Pharmaceutical's subsidiary, Lijun Monoclonal Antibody, has exclusive rights for the global development, registration, production, sales, and sublicensing of this product [4] Group 2: Clinical Trial Results - In July, Lijun Pharmaceutical announced that Lakanqita Monoclonal Antibody (320mg, once every 4 weeks) met the primary endpoint in a Phase III clinical trial compared to Secukinumab (300mg, once every 4 weeks) for moderate to severe plaque psoriasis patients with or without psoriatic arthritis [4] - At week 12 of treatment, the proportion of patients achieving PASI 100 in the Lakanqita group was 49.5%, compared to 40.2% in the Secukinumab group, meeting both non-inferiority and superiority standards [4] - The overall safety profile of Lakanqita Monoclonal Antibody was good, with the incidence of common adverse events comparable to that of the control group [4]

Core Viewpoint - Lijun Pharmaceutical and Xinkanghe Biotech have submitted an application for the market approval of Lakanqita monoclonal antibody (LZM012/XKH004) for the treatment of plaque psoriasis [1] Group 1: Product Development - Lakanqita monoclonal antibody is an IL-17A/IL-17F monoclonal antibody that targets both homodimer IL-17A-A and IL-17F-F, as well as heterodimer IL-17A-F [2] - Lijun Pharmaceutical's subsidiary, Lijun Monoclonal Antibody, has obtained exclusive rights for the global development, registration, production, sales, and sublicensing of this product [2] Group 2: Clinical Trials - In July, Lijun Pharmaceutical announced that Lakanqita monoclonal antibody (320mg, once every 4 weeks) met the primary endpoint in a Phase III clinical trial compared to Secukinumab (300mg, once every 4 weeks) for moderate to severe plaque psoriasis patients with or without psoriatic arthritis [3] - At week 12 of treatment, the proportion of patients achieving PASI 100 in the Lakanqita group was 49.5%, compared to 40.2% in the Secukinumab group, meeting both non-inferiority and superiority standards [3] - The overall safety profile of Lakanqita monoclonal antibody was good, with the incidence of common adverse events comparable to that of the control group [3]

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 - The company Zhixiang Jintai (688443.SH) is gaining attention as it progresses towards commercializing its core product, the Sairiqi monoclonal antibody injection, despite its initial poor stock performance and ongoing losses. Investors are keen to understand when the company will achieve profitability as it moves into a phase of revenue realization [1][4]. Financial Performance - In the third quarter, Zhixiang Jintai reported a revenue of 162.16 million yuan, a year-on-year increase of 1199.88%, while the net profit attributable to shareholders was a loss of 53.28 million yuan, significantly narrowing from a loss of 187 million yuan in the same period last year [3][4]. - For the first three quarters, the company achieved a total revenue of 208 million yuan, reflecting a year-on-year increase of 1562.05%, with the net loss narrowing from 550 million yuan to 370 million yuan, a reduction of 32.73% [4]. Product Development and Market Position - Zhixiang Jintai focuses on the development of monoclonal and bispecific antibodies for autoimmune, infectious diseases, and oncology. Currently, only one product has been approved for sale, and the company has incurred a cumulative net loss of 2.869 billion yuan from 2020 to 2024 [5][7]. - The Sairiqi monoclonal antibody injection has been approved for two indications and is expected to contribute significantly to revenue, having generated 45.38 million yuan in sales in the first half of the year [7][8]. - The company is facing competition from multiple IL-17A targeted drugs, including Novartis's Secukinumab, which has established a strong market presence with sales reaching 2.08 billion yuan in 2022 and increasing to 2.75 billion yuan in 2023 [8][9]. Research and Development - Zhixiang Jintai has over ten products in its research pipeline, with three currently under review for approval. The company has invested heavily in R&D, with expenditures of 4.54 billion yuan, 6.20 billion yuan, and 6.10 billion yuan over the last three years, totaling 16.85 billion yuan [10][11]. - Recent collaborations have provided short-term financial relief, including a partnership with Cullinan Therapeutics that brought in a $20 million upfront payment and potential milestone payments totaling $692 million [12][13]. Future Outlook - The company aims to enhance its product pipeline and market presence through innovative drug discovery technologies and expanding its therapeutic targets. However, long-term sustainability will depend on the success of its proprietary products in generating consistent revenue [13].