Core Viewpoint - The company has submitted a clinical trial application for its self-developed siRNA drug FB7013, targeting the MASP-2 protein, for the treatment of primary IgA nephropathy, marking it as the first-in-class drug in this category [1][2]. Drug Registration Clinical Trial Application - Product Name: FB7013 Injection - Application Matter: Domestic production drug registration clinical trial - Indication: Intended for the treatment of primary IgA nephropathy - Approval Conclusion: The application has been accepted according to the Administrative Licensing Law of the People's Republic of China [1]. Drug Mechanism - FB7013 is the first siRNA drug globally to target the MASP-2 protein, with potential for first-in-class status. It aims to inhibit MASP-2 activity to block the abnormal activation of the lectin pathway, thereby reducing complement-mediated kidney tissue damage. Future applications may extend to diseases related to complement activation, such as membranous nephropathy and diabetic nephropathy [2]. Preclinical Research Data - In healthy crab-eating macaques, FB7013 demonstrated strong and lasting inhibition of the target protein, achieving over 95% knockdown of serum MASP-2 protein after a single subcutaneous injection, with over 90% knockdown maintained for 105 days. This suggests potential for administration every 3-6 months in clinical settings, enhancing patient compliance. In IgA nephropathy models, FB7013 showed significant efficacy and good safety profile, with dose-dependent reductions in urinary protein levels and increases in glomerular filtration rate. High-dose treatment for 8 weeks resulted in a 36% reduction in mesangial cell numbers and a 43% reduction in IgA deposition. No significant off-target risks were identified [3]. Potential Market Outlook - IgA nephropathy is one of the most common primary glomerular diseases globally, characterized by abnormal deposition of IgA immune complexes in the glomeruli, leading to chronic kidney failure. According to Frost & Sullivan, the number of IgA nephropathy patients increased from 8.8 million in 2015 to 9.3 million in 2020, and is expected to reach 10.2 million by 2030. The global market for IgA nephropathy treatment drugs is projected to grow from $567 million in 2020 to $1.196 billion by 2025, with a compound annual growth rate of 16.1%, indicating significant market potential [5].

Group 1 - The chemical pharmaceutical sector increased by 3.63% on January 5, with Frontier Biotech leading the gains [1] - The Shanghai Composite Index closed at 4023.42, up 1.38%, while the Shenzhen Component Index closed at 13828.63, up 2.24% [1] - Notable stock performances included Frontier Biotech with a closing price of 21.20, up 17.45%, and Beilu Pharmaceutical at 66.8, up 13.22% [1] Group 2 - The chemical pharmaceutical sector saw a net inflow of 716 million yuan from institutional investors, while retail investors contributed a net inflow of 131 million yuan [2] - Major stocks with significant net inflows included Heng Rui Pharmaceutical with 17.4 million yuan and ST Renfu with 9.15 million yuan [3] - Conversely, stocks like ST Jinfeng and Kangzhiyue experienced net outflows of 6.90 million yuan and 11.61 million yuan respectively [2][3]

Market Overview - The Shanghai Composite Index closed at 4018.63 points, above the five-day moving average, with an increase of 1.25% [1] - The total trading volume of A-shares reached 24,812.35 billion yuan [1] Stocks Performance - A total of 1,955 A-shares have surpassed the five-day moving average, with notable stocks showing significant deviation rates [1] - The stocks with the highest deviation rates include: - BeiYikang (18.85% deviation rate, 29.98% increase, latest price 44.96 yuan) [1] - WeiSi Medical (15.01% deviation rate, 20.00% increase, latest price 58.08 yuan) [1] - ChengYiTong (14.78% deviation rate, 19.98% increase, latest price 23.06 yuan) [1] Additional Notable Stocks - Other stocks with significant performance include: - GuanHao Biological (14.72% deviation rate, 20.00% increase, latest price 16.62 yuan) [1] - DiNaiKe (14.64% deviation rate, 20.00% increase, latest price 17.76 yuan) [1] - MeiHao Medical (14.46% deviation rate, 20.00% increase, latest price 28.86 yuan) [1] Trading Metrics - The trading turnover rates for the top performing stocks vary, with BeiYikang at 12.85% and WeiSi Medical at 7.20% [1] - The five-day moving average prices for these stocks range from 14.49 yuan to 282.35 yuan [1][2]

Core Viewpoint - Frontier Biotech's siRNA drug FB7013 has received clinical trial approval from the National Medical Products Administration, marking a significant milestone in the treatment of IgA nephropathy [1][2] Company Summary - FB7013 is the world's first siRNA drug targeting the key protein MASP-2 in the complement lectin pathway, developed independently by Frontier Biotech [1] - The drug aims to treat primary immunoglobulin A nephropathy (IgA nephropathy) by specifically inhibiting MASP-2, thereby reducing complement-mediated kidney tissue damage [1] - Clinical pre-research indicates that a single subcutaneous injection in healthy monkeys resulted in over 95% reduction of serum MASP-2 protein, with effects lasting over 105 days [1] - The drug shows significant dose-dependent efficacy in IgA nephropathy models, with improvements in urinary protein levels and kidney function [1] - The clinical trial approval is a crucial step for Frontier Biotech in establishing itself as a competitive player in the global siRNA innovation market [2] Industry Summary - The global IgA nephropathy patient population is projected to reach 10.2 million by 2030, with the treatment market expected to grow from $567 million in 2020 to $1.196 billion by 2025, reflecting a compound annual growth rate of 16.1% [2] - Current treatments primarily involve corticosteroids and immunosuppressants, which have limited efficacy and significant side effects [2] - If successful, FB7013 could provide a new treatment option for IgA nephropathy and potentially expand to other diseases related to complement pathway abnormalities, such as membranous nephropathy and diabetic nephropathy [2]

Core Viewpoint - The clinical trial application for FB7013, a novel siRNA drug targeting the MASP-2 protein for IgA nephropathy treatment, has been accepted by the National Medical Products Administration of China, marking a significant advancement in innovative drug development for this condition [1] Group 1: Drug Mechanism and Innovation - FB7013 is the first-in-class siRNA drug targeting the MASP-2 protein, aiming to block the abnormal activation of the lectin pathway and reduce complement-mediated kidney damage, providing a new targeted treatment option for IgA nephropathy [1] - The drug has potential for expansion into other complement-related diseases such as membranous nephropathy and diabetic nephropathy, potentially benefiting a wider patient population [1] Group 2: Preclinical Data and Efficacy - Preclinical studies demonstrate FB7013's strong, long-lasting, and safe effects, with over 95% reduction in serum MASP-2 protein levels after a single injection, maintaining over 90% reduction for 105 days [2] - In IgA nephropathy models, FB7013 shows significant dose-dependent efficacy, with reductions in urinary protein levels and increases in glomerular filtration rate, indicating substantial improvement in kidney pathology [2] - Safety assessments indicate no significant off-target risks and no adverse effects on cardiovascular, respiratory, or central nervous systems in preclinical studies [2] Group 3: International Recognition and Market Potential - FB7013 has gained international academic recognition, with the company presenting its preclinical efficacy data at the 2025 ASN Kidney Week conference in Houston, Texas, showcasing the strength of Chinese innovative drugs [3] - The global IgA nephropathy patient population is projected to grow from 9.3 million in 2020 to 10.2 million by 2030, with the treatment market expected to increase from $567 million in 2020 to $1.196 billion by 2025, reflecting a compound annual growth rate of 16.1% [4] - The acceptance of FB7013's clinical trial application represents a significant breakthrough for the company in the small nucleic acid innovative drug sector, reinforcing its commitment to advancing innovative drug development [4]

Group 1: Innovation in Pharmaceuticals - In 2025, China approved a record 76 innovative drugs, significantly surpassing the 48 approved in 2024, marking a historical high [1] - The total amount of foreign licensing transactions for innovative drugs in China exceeded $130 billion in 2025, with over 150 transactions, also a historical high [1] - Among the 76 approved innovative drugs, 47 are chemical drugs, 23 are biological products, and 6 are traditional Chinese medicines, with a high proportion of domestic innovations [1] Group 2: Drug Approval and Clinical Trials - China Medical's subsidiary Tianfang Pharmaceutical received approval for clarithromycin tablets, which passed the consistency evaluation for generic drugs [2] - Microchip Biotech announced that its CS08399 tablets for treating tumors with MTAP deficiency have had their clinical trial application accepted [3] - Frontier Biotech's FB7013 injection, targeting MASP-2 for IgA nephropathy, received acceptance for its clinical trial application, marking it as a first-in-class drug [4] Group 3: Capital Market Activities - Yifang Biotechnology submitted a listing application to the Hong Kong Stock Exchange, with CITIC Securities as the exclusive sponsor [5] - Wanyi Medical also submitted a listing application to the Hong Kong Stock Exchange, with Guotai Junan International as the exclusive sponsor [6] Group 4: Corporate Investments and Acquisitions - Yunnan Baiyao plans to invest up to 45% of its net assets in financial products in 2026 [7] - Haili Biological's subsidiary intends to acquire 51% stakes in seven dental chain companies for 61.2 million yuan, expecting to increase revenue by approximately 100 million yuan [9] Group 5: Corporate Restructuring and Legal Matters - *ST Chang Pharmaceutical announced that its restructuring investors intend to terminate the restructuring investment agreement [10] - Zai Lab entered a global strategic cooperation and licensing agreement with AbbVie for the development and commercialization of ZG006, with potential milestone payments totaling up to $10.75 billion [11] - Tianyu Biotech's actual controller received a notice from the China Securities Regulatory Commission regarding an investigation into alleged illegal stock reduction [13]

Group 1: Company Announcements - Zhongwei Company plans to acquire 64.69% equity of Hangzhou Zhonggui through a combination of share issuance and cash payment, aiming to enhance its capabilities in CMP equipment and solutions [1] - Lixun Precision intends to repurchase shares worth between 1 billion to 2 billion RMB for employee stock ownership plans or equity incentives, with a maximum repurchase price of 86.96 RMB per share [2] - ZaiJing Pharmaceutical has reached a global strategic cooperation and licensing agreement with AbbVie for the development and commercialization of ZG006, receiving an upfront payment of 100 million USD [3] - Tianci Materials expects a net profit increase of 127% to 231% for 2025, driven by significant growth in lithium-ion battery material sales [4] - Meike Home plans to acquire 100% equity of Shenzhen Wande Technology through share issuance and cash payment, with stock resuming trading on January 5, 2026 [6][7] - ST KeliDa is planning a change in control, with stock suspension starting January 5, 2026, due to the transfer of 100% equity of its controlling shareholder [8] - Xinzhou Bang intends to invest approximately 260 million USD in a lithium-ion battery materials project in Saudi Arabia, enhancing its global capacity and supply chain [9] Group 2: Financial Performance - Kid's King anticipates a net profit increase of 51.72% to 82.06% for 2025 [9] - Guangku Technology expects a net profit growth of 152% to 172% for 2025 [9] Group 3: Mergers and Acquisitions - Xidi Micro plans to acquire 100% equity of Chengxin Micro for 310 million RMB [9] - Haili Biological's subsidiary intends to acquire 51% equity of seven dental chain companies for 61.2 million RMB [9]

前沿生物12月31日公告，12月22日，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。 ...

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]