适应症：拟用于原发性免疫球蛋白A肾病（IgA 肾病）的治疗 审批结论：根据《中华人民共和国行政许可法》第三十二条的规定，经审查， 决定予以受理。 二、 药品的其他相关情况 证券代码：688221 证券简称：前沿生物 公告编号：2026-001 前沿生物药业（南京）股份有限公司 关于 FB7013 境内生产药品注册临床试验申请获得受 理通知书的自愿性披露公告 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。 2025年12月22日，前沿生物药业（南京）股份有限公司（以下简称"公司"） 向国家药品监督管理局提交了公司自主研发的一款靶向补体系统凝集素途径关 键蛋白MASP-2靶点的siRNA药物（产品代码：FB7013）临床试验申请，2025年12 月31日，公司收到国家药品监督管理局核准签发的受理通知书，FB7013的临床试 验申请获得受理。现就相关信息公告如下： 一、 药品注册临床试验申请内容 产品名称：FB7013注射液 申请事项：境内生产药品注册临床试验 3、潜在市场前景 IgA 肾病是全球最常见的原发性肾小球肾病之一，其 ...

Core Viewpoint - Frontier Biotech (688221.SH) has submitted a clinical trial application for its self-developed siRNA drug targeting the MASP-2 protein, aimed at treating primary immunoglobulin A nephropathy (IgA nephropathy) [1] Group 1 - The clinical trial application for the drug, named FB7013 injection, was submitted to the National Medical Products Administration on December 22, 2025 [1] - On December 31, 2025, the company received a notice of acceptance from the National Medical Products Administration for the clinical trial application of FB7013 [1] - The drug is specifically intended for the treatment of primary immunoglobulin A nephropathy (IgA nephropathy) [1]

Core Viewpoint - Frontier Biotech (688221.SH) has submitted a clinical trial application for FB7013, a siRNA drug targeting the MASP-2 protein, aimed at treating primary immunoglobulin A nephropathy (IgA nephropathy), marking it as the first-in-class drug in this category [1] Group 1 - The clinical trial application was submitted to the National Medical Products Administration on December 22, 2025, and the acceptance notice was received on December 31, 2025 [1] - FB7013 demonstrates strong and sustained inhibition of the target protein in healthy crab-eating macaques and shows clear efficacy in a crab-eating macaque model of IgA nephropathy, with good safety profile [1] - This drug represents a significant advancement as it is the first globally to target the MASP-2 protein with siRNA technology [1]

Core Viewpoint - The company has submitted a clinical trial application for its self-developed siRNA drug FB7013 targeting the MASP-2 protein, which is intended for the treatment of primary immunoglobulin A nephropathy (IgA nephropathy) [1] Group 1 - The clinical trial application was submitted to the National Medical Products Administration on December 22, 2025, and the acceptance notice was received on December 31, 2025 [1] - FB7013 is the world's first siRNA drug targeting the MASP-2 protein to apply for clinical trials, indicating its potential as a first-in-class treatment [1]

Group 1 - The stock of Frontier Biotech (688221.SH) closed at 18.49 yuan, reflecting a decline of 3.09% and is currently in a state of underperformance [1] - Frontier Biotech was listed on the Shanghai Stock Exchange's STAR Market on October 28, 2020, with an initial share issuance of 89.96 million shares at a price of 20.50 yuan per share [1] - The highest stock price recorded since its listing was 35.53 yuan on the first trading day [1] Group 2 - The total amount raised from the initial public offering (IPO) was 1.84418 billion yuan, with a net amount of 1.71729 billion yuan after expenses [1] - The company planned to use the raised funds for various projects, including the development of an injectable HIV fusion inhibitor and a new transdermal analgesic patch [1] - The total issuance costs (excluding VAT) for the IPO amounted to 126.89 million yuan, with underwriting and sponsorship fees accounting for 116.13 million yuan [1] Group 3 - On September 22, 2022, Frontier Biotech announced a specific issuance of 14,818,653 shares at a price of 13.51 yuan per share, raising a total of approximately 200.20 million yuan [2] - After deducting issuance costs, the net amount raised from this issuance was approximately 195.67 million yuan [2] - The total fundraising from both the IPO and the subsequent issuance amounts to approximately 2.044 billion yuan [3] Group 4 - The actual controller of Frontier Biotech is Dong Xie, who holds American nationality and has permanent residency in China [4]

Investment Rating - The investment rating for the pharmaceutical industry is "Positive" (maintained) [4] Core Insights - The report highlights the promising data from CTLA-4 drugs, suggesting potential investment opportunities in related areas [3][5] - The pharmaceutical index experienced a slight decline of 0.14% from December 15 to December 19, 2025, but showed a relative outperformance of 0.14% against the CSI 300 index [5] - The report emphasizes the importance of innovative drugs as a key investment theme for 2026, with a focus on companies that are expected to show clear performance trends and potential reversals in operations [5][41] Summary by Sections 1. CTLA-4 Target - CTLA-4 is identified as a significant immune checkpoint that can inhibit T cell activation, presenting potential value in cancer immunotherapy [8][9] - The CTLA-4 monoclonal antibody Gotistobart shows promising clinical trial results for squamous non-small cell lung cancer (sqNSCLC) patients who are resistant to immunotherapy [14][15] - Gotistobart's innovative mechanism targets Treg cells in the tumor microenvironment, potentially leading to a new paradigm in tumor immunotherapy [20][24] 2. Industry Perspective - The report maintains that innovative drugs should be the main focus for the year, while also considering manufacturing exports and aging-related consumption as relatively undervalued assets [25][41] - The pharmaceutical index has shown a year-to-date increase of 14.49%, with a notable number of stocks experiencing significant gains [25][26] - The report suggests that the Chinese pharmaceutical industry has completed a transition from old to new growth drivers, with innovative drugs opening new growth avenues for companies [41][42] 3. Investment Recommendations - Recommended stocks include innovative drug companies such as Xinyi Tai, Zai Jian Pharmaceutical, and others, as well as companies in the medical device sector [5][45] - The report advises focusing on companies with strong performance trends and those expected to benefit from the aging population and outpatient consumption [42][44] - The report also highlights the potential of AI in the pharmaceutical sector, suggesting that related stocks may perform well in the coming years [42][44]

Group 1 - The report highlights the recent performance of various industries, with notable gains in sectors such as non-ferrous metals, electronics, and power equipment, while retail and real estate sectors faced declines [1][1][1] - The central economic work conference emphasized the importance of technological breakthroughs and supply-demand optimization, indicating a shift towards quality improvement in economic growth [11][12][19] - The commercial aerospace sector is experiencing significant growth, with the establishment of a dedicated regulatory body and a notable increase in the commercial aerospace index, which has risen by 46.52% since April 7 [47][48] Group 2 - The report indicates a seasonal recovery in social financing, with November seeing an increase of 24,885 billion yuan, driven primarily by government bond issuance [4][7] - The credit environment is showing signs of marginal improvement, particularly in corporate loans, which increased by 6,100 billion yuan in November, reflecting a recovery in demand [5][6] - The report notes that the retail sector is undergoing a transformation, with a focus on quality, as highlighted by the Ministry of Commerce's emphasis on retail quality upgrades [1][1][1] Group 3 - The report discusses the rising interest in inquiry transfers, which have seen a significant increase in both project numbers and transfer scale, indicating a growing trend in the market [51][52] - The technology sector is expected to remain a key focus, with upcoming events such as the Volcano Engine FORCE conference anticipated to showcase advancements in AI and cloud services [56]

证券代码：688221 证券简称：前沿生物 公告编号：2025-047 前沿生物药业（南京）股份有限公司 关于向 2025 年限制性股票激励计划激励对象 授予预留限制性股票的公告 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： 《前沿生物药业（南京）股份有限公司 2025 年限制性股票激励计划(草案)》 （以下简称"本次激励计划"或"《激励计划》"）规定的前沿生物药业（南京） 股份有限公司（以下简称"公司"）2025 年限制性股票授予条件已经成就，根据 公司 2025 年第二次临时股东大会授权，公司于 2025 年 12 月 11 日召开的第四届 董事会第九次会议，审议通过了《关于向 2025 年限制性股票激励计划激励对象 授予预留限制性股票的议案》，确定 2025 年 12 月 11 日为授予日，以 8.56 元/股 的授予价格向 4 名激励对象预留授予 75.00 万股限制性股票。现将有关事项说明 如下： 一、限制性股票授予情况 （一）本次限制性股票授予已履行的决策程序和信息披露情况 1、2025 年 ...

董事会薪酬与考核委员会关于 2025 年限制性股票激励计划 预留授予激励对象名单的核查意见（截至预留授予日） 前沿生物药业（南京）股份有限公司（以下简称"公司"或"前沿生物"）董 事会薪酬与考核委员会依据《中华人民共和国公司法》（以下简称"《公司法》"）、 《中华人民共和国证券法》（以下简称"《证券法》"）、《上市公司股权激励管理办法》 （以下简称"《管理办法》"）、《上海证券交易所科创板股票上市规则》（以下简称"《上 市规则》"）、《科创板上市公司自律监管指南第 4 号——股权激励信息披露》等相关 法律、法规及规范性文件和《前沿生物药业（南京）股份有限公司章程》（以下简 称"《公司章程》"）的有关规定，对公司 2025 年限制性股票激励计划（以下简称"本 次激励计划"）预留授予激励对象名单（截至预留授予日）进行了核查，发表核查 意见如下： 1、公司本次激励计划所确定的预留授予激励对象均不存在《管理办法》规定 的不得成为激励对象的下列情形： （1）最近 12 个月内被证券交易所认定为不适当人选； （2）最近 12 个月内被中国证监会及其派出机构认定为不适当人选； 前沿生物药业（南京）股份有限公司 （6）中国证 ...

（截至预留授予日） 一、 2025 年限制性股票激励计划（以下简称"本激励计划"）的预留分配情况 | 姓名 | 职务 | 获授的第二类限 制性股票数量 （万股） | 占本激励计划拟授 出全部权益数量的 比例 | 占预留授予日股 本总额的比例 | | --- | --- | --- | --- | --- | | 董事会认为需要激励的其他人员（共 | 4 | 人） | | | | 按研发类指标考核的人员（2 | 人） | 15.00 | 3.00% | 0.04% | | 按综合类指标考核的人员（2 | 人） | 60.00 | 12.00% | 0.16% | | 合计 | | 75.00 | 15.00% | 0.20% | 前沿生物药业（南京）股份有限公司 1、公司全部在有效期内的股权激励计划所涉及的标的股票总数累计未超过公司股本总额的 20.00%。上述任何一名激励对象通过全部在有效期内的股权激励计划获授的公司股票数量累计未 超过公司股本总额的 1.00%。 2025 年限制性股票激励计划预留授予激励对象名单 注： 3、合计数与各明细数直接相加之和在尾数上如有差异，是由于四舍五入所造成。 前沿生物药业（ ...