亿帆医药股份有限公司 关于全资子公司收到药品注册受理通知书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚 假记载、误导性陈述或重大遗漏。 亿帆医药股份有限公司（以下简称"公司"）全资子公司宿州亿帆药业有限 公司于 2026 年 1 月 6 日收到国家药品监督管理局（以下简称"药监局"）签发 的易黄汤颗粒境内生产药品注册上市许可申请《受理通知书》。现将相关情况公 告如下： 一、申请注册药品的基本情况 受理号：CXZS2600002 药品名称：易黄汤颗粒 申请事项：境内生产药品注册上市许可 规格：每袋相当于饮片47.90g 证券代码：002019 证券简称：亿帆医药 公告编号：2026-005 易黄汤颗粒是公司申报注册的第一个经典名方品种，品种处方为国家中医药 管理局 2018 年 4 月发布的《古代经典名方目录（第一批）》中的第 85 首处方， 出自清代傅山《傅青主女科》，其功能主治为：固肾止带，清热祛湿。用于肾虚 湿热带下证。症见带下黏稠量多，色黄如浓茶汁，其气腥秽，舌红，苔黄腻。 截至本报告披露日，国内尚无与易黄汤颗粒出自同一处方产品上市，除本公 司外，仅有 1 家企业处于申请上市 ...

Core Viewpoint - Yifan Pharmaceutical's wholly-owned subsidiary, Suzhou Yifan Pharmaceutical Co., Ltd., has received the acceptance notice for the registration and marketing application of Yihuang Decoction Granules from the National Medical Products Administration, marking a significant step in the company's product development [1] Group 1 - The Yihuang Decoction Granules is the first classic prescription product registered by the company, aimed at treating kidney deficiency with damp-heat symptoms [1] - The product is indicated for functions such as kidney strengthening and dampness elimination, specifically for conditions related to kidney deficiency and damp-heat [1] - As of the date of this report, there are no other products on the domestic market that are derived from the same prescription as Yihuang Decoction Granules [1]

Core Viewpoint - The company has been focusing on the research and development of large molecule biopharmaceuticals and small molecule chemical drugs since 2015, aiming to enter the innovative drug market through self-research and collaborative research efforts [1] Group 1: R&D and Innovation - The company has increased its investment in R&D and talent acquisition to gradually penetrate the innovative drug sector [1] - The innovative drug Yili Shou has successfully launched in China, the United States, and Europe, with its commercial value in China becoming increasingly evident [1] - The company has accumulated valuable experience over more than a decade in R&D innovation, particularly in overseas clinical trials, registration, and commercialization [1] Group 2: Future Strategy - The company emphasizes the importance of not only enhancing and validating its R&D capabilities but also ensuring that innovative products quickly enter the market to realize commercial value [1] - Future efforts will continue to focus on R&D innovation, with a more cautious and targeted approach in areas such as oncology, dermatology, and orthopedics [1] - While concentrating on the Chinese market, the company will leverage its initial achievements in internationalization to also address overseas markets, particularly in Southeast Asia [1]

Summary of the Conference Call for Yifan Pharmaceutical Company Overview - **Company**: Yifan Pharmaceutical - **Focus**: Development of innovative drugs, particularly in oncology, with a current emphasis on ACT001 for small cell lung cancer brain metastases Key Points Industry and Product Development - **Collaboration**: Yifan Pharmaceutical has partnered with Tianjin Shangde to accelerate the market entry of ACT001, an innovative drug targeting small cell lung cancer brain metastases [2][4] - **Clinical Trials**: The Phase III clinical trial for ACT001 is ongoing, with 44 centers initiated and 52 patients enrolled. Enrollment is expected to complete by July-August 2026, with statistical reporting by Q3 2027 and NDA submission by the end of 2027 [2][8][11] - **Financial Impact**: The total cost for the Phase III clinical trial is estimated at approximately 120 million RMB, which will be amortized as an intangible asset and will not significantly impact the profit statement for 2026 [3][25] Market Potential - **Patient Reach**: Yifan anticipates that ACT001 could reach approximately 15,000 patients in its first year post-launch in China, with a potential to cover 30,000 to 35,000 patients within five years, generating sales of up to 1 billion RMB [2][17] - **Southeast Asia Market**: The drug also has significant commercialization potential in Southeast Asia, with a population of 685 million and an estimated 180,000 lung cancer cases in 2024 [16][18] Clinical Efficacy - **Trial Results**: ACT001 has shown promising results in clinical trials, with a 68.6% objective response rate (ORR) in combination with radiotherapy, significantly higher than the placebo group. The median survival time was extended by 53% when combined with PD-1/PD-L1 immunotherapy [6][11] Strategic Direction - **Research and Development**: Yifan is committed to integrating R&D pathways for small molecule innovation, leveraging both in-house capabilities and collaborative efforts to expedite clinical translation [12][19] - **Future Plans**: The company aims to continue developing innovative small molecule drugs that meet clinical needs and provide essential treatment options for patients [14][15] Challenges and Solutions - **Market Entry Challenges**: The Southeast Asian market presents challenges due to diverse healthcare systems. Yifan has established a regional operations center in Singapore to streamline market entry and registration processes [22] - **Risk Management**: Yifan has implemented multiple risk control measures in its agreements to ensure transparency and safety in project funding [29] Additional Insights - **Long-term Vision**: Since 2015, Yifan has prioritized innovation and internationalization in its strategic planning, aiming to enhance global market access for new products [19][20] - **Collaboration Benefits**: The partnership with Tianjin Shangde is expected to maximize the commercial value of ACT001 through shared expertise and resources [4][7] This summary encapsulates the critical aspects of Yifan Pharmaceutical's conference call, highlighting the company's strategic initiatives, market potential, and ongoing clinical developments.

Group 1: ACT001 Development and Clinical Trials - ACT001 has undergone 8 years of clinical trials globally, focusing on small cell lung cancer brain metastases and other indications [3][16] - The drug has shown a significant increase in intracranial effective rate, approximately 2.7 times higher compared to placebo in combination with whole brain radiotherapy [5][6] - In clinical trials, the median survival time for small cell lung cancer patients treated with ACT001 has shown a trend of extension by about 53% (9.5 months vs. 6.2 months) [6][9] Group 2: Market Potential and Demand - In 2022, there were approximately 1.0606 million new lung cancer cases in China, accounting for 22.0% of all malignant tumors [9] - Small cell lung cancer represents about 15% of total lung cancer cases, with a high incidence of brain metastases [9][10] - The annual new patients with small cell lung cancer brain metastases exceed 90,000, indicating a substantial unmet clinical need [10] Group 3: Commercialization Strategy - The company aims to leverage its established capabilities in drug development and commercialization to expedite the market entry of ACT001 [8][9] - The commercialization strategy will focus on Southeast Asia, with a population of nearly 700 million, where the disease prevalence is similar to that in China [10][11] - The company plans to utilize academic collaborations and rapid market access strategies to enhance the product's market presence [10][11] Group 4: Financial Implications and Risk Management - The initial payment of 100 million yuan is allocated for the smooth progress of the Phase III clinical trial in China [15] - Future milestone payments are contingent upon regulatory approvals, with a potential payment of 100 million yuan if the drug is approved for overseas listing by June 30, 2027 [15][16] - The agreement includes risk control measures to protect the company's interests in case of regulatory delays or unmet clinical expectations [16]

Core Viewpoint - The company announced that its wholly-owned subsidiary, Hefei Yifan Biopharmaceutical Co., Ltd., received the drug registration certificate for Vitamin K1 injection from the National Medical Products Administration on January 5, 2026, indicating a significant milestone in its product development [1] Group 1 - The Vitamin K1 injection is intended for the prevention and treatment of vitamin K deficiency bleeding in infants [1] - The company has invested approximately 20.66 million yuan in the research and development of the Vitamin K1 injection as of the date of the report [1]

证券代码：002019 证券简称：亿帆医药 公告编号：2026-004 亿帆医药股份有限公司 3、申请事项：药品注册（境内生产） 4、注册分类：化学药品3类 5、规格：0.2ml:2mg 6、药品受理号：CYHS2401631 7、证书编号：2025S04086 关于获得药品注册证书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚 假记载、误导性陈述或重大遗漏。 亿帆医药股份有限公司（以下简称"公司"）全资子公司合肥亿帆生物制药 有限公司于2026年1月5日收到国家药品监督管理局核准签发的维生素K1注射液 《药品注册证书》。现将相关情况公告如下： 一、药品注册证书主要信息 1、药品名称：维生素K1注射液 2、剂型：注射剂 8、药品批准文号：国药准字H20256509 9、药品批准文号有效期：至2030年12月29日 10、上市许可持有人：合肥亿帆生物制药有限公司 11、生产企业：合肥亿帆生物制药有限公司 12、审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查， 本品符合药品注册的有关要求，批准注册，发给药品注册证书。 二、产品简介 维生素 K1注射液适用于预防和治疗婴儿维生 ...

Core Viewpoint - Yifan Pharmaceutical has signed exclusive agreements to develop, produce, and commercialize the innovative drug ACT001 for small cell lung cancer brain metastasis in specific regions, marking a significant step in its internationalization strategy [1][2] Group 1: Agreement Details - Yifan Pharmaceutical's subsidiary Hefei Yifan Biopharmaceutical has obtained exclusive rights for ACT001 in mainland China, South Korea, and several Southeast Asian countries [1] - The agreement includes an upfront payment of 100 million RMB and a commitment to invest 100 million RMB as a cornerstone investor if the partner achieves an overseas IPO by June 30, 2027 [1] - Yifan will also pay a milestone fee of 50 million RMB if certain clinical trial endpoints are met, along with a tiered sales revenue share based on net sales [1] Group 2: Product Information - ACT001 is a next-generation immune modulator developed by Shangde Yaoyuan, designed to enhance treatment outcomes for brain metastases in conjunction with chemotherapy and immunotherapy [2] - The drug received "breakthrough therapy" designation from the National Medical Products Administration in January 2025 and has enrolled 52 patients in its Phase III clinical trial by the end of 2025 [2] - There are currently no approved products specifically for small cell lung cancer brain metastasis, making ACT001 one of the fastest progressing candidates in this field [2] Group 3: Strategic Implications - This collaboration is a key move in Yifan Pharmaceutical's innovation and internationalization strategy, allowing for rapid expansion of its oncology pipeline with controlled risk [2] - The partnership aligns well with Yifan's existing sales network in Southeast Asia, facilitating faster international market entry for the product [2] - Yifan will independently handle the commercial production of ACT001 in the designated regions, ensuring supply chain autonomy and potentially enhancing its production standards to meet international benchmarks [2]

Group 1: Regulatory Developments - The National Healthcare Security Administration (NHSA) is seeking public opinions on the draft guidelines for the real-world comprehensive value assessment of medical services, aiming to establish a unified evaluation system across the country [1] - CanSino Biologics has received approval for clinical trials of its 24-valent pneumococcal polysaccharide conjugate vaccine, which targets major circulating serotypes and is intended for individuals aged 2 months and older [2] - Merck has announced that its breakthrough therapy, Sotatercept, has been approved in China for treating adult patients with pulmonary arterial hypertension (PAH), based on data from the STELLAR Phase III clinical trial [3] - ST. Renfu has received approval for clinical trials of HW221043 tablets, intended for the treatment of advanced solid tumors, with no similar drugs currently approved in the market [4] - Heng Rui Medicine has received approval for clinical trials of HRS-4357 injection and HRS-5041 tablets, aimed at treating PSMA-positive prostate cancer [5] Group 2: Market Activities - Shenzhou Cell has received approval from the China Securities Regulatory Commission for its application to issue stocks to specific investors [6] - Tianchen Medical has signed a strategic cooperation agreement with Inspur Digital Technology to promote innovation in medical intelligent manufacturing and robotics [7] - Zhonghong Medical's subsidiary has participated in a bidding project for centralized procurement of medical consumables, with some products expected to be selected, enhancing market presence [8] - Yifan Pharmaceutical's subsidiary has signed an exclusive agreement with Shangde Yaoyuan for the ACT001 drug, involving a total payment of 1 billion yuan [9] - Yijiahe is exploring the application of "brain-computer interface + embodied intelligent robots" technology in smart healthcare scenarios, having signed a strategic cooperation agreement with Mairande [10]

Group 1 - Victory Energy announced that its stock price increased by 213.97% from December 12 to December 29, 2025, leading to a review of trading fluctuations, with stock resuming trading on January 6, 2026 [2] - Tianqi Materials plans to conduct maintenance on its 150,000-ton liquid lithium hexafluorophosphate production line for 20 to 30 days, ensuring no significant impact on operations [3] - Yingfang Micro is planning to acquire controlling stakes in several companies, leading to a significant asset restructuring, with stock suspension starting January 6, 2026 [4] Group 2 - Weigao Blood Purification intends to acquire 100% of Weigao Purui for 8.511 billion yuan, which will enhance its product offerings in medical packaging [6] - Zhongtian Rocket reported losses in its carbon/carbon thermal field materials business due to intensified competition in the photovoltaic industry, significantly impacting its consolidated financial statements [7] - Fulin Precision plans to invest 6 billion yuan in a project to produce 500,000 tons of high-end lithium iron phosphate for energy storage, alongside additional projects for precursor materials [8] Group 3 - Deyun Co. announced that its actual controller was arrested for illegal public deposit collection, but this will not significantly affect the company's governance or operations [9] - Jushen Co. signed a 1.34 billion USD bauxite transfer agreement, which is expected to positively impact future financial performance [10] - Sanxia New Materials intends to acquire a 40% stake in a subsidiary for 0 yuan, which is classified as a related party transaction [11] Group 4 - Kelun Pharmaceutical plans to repurchase shares worth 50 million to 100 million yuan for employee stock ownership plans, with a maximum price of 35 yuan per share [13] - Juxing Technology expects a net profit increase of 5.00% to 20.00% for 2025, projecting a profit of 2.419 billion to 2.764 billion yuan [15] - China National Materials Technology anticipates a net profit increase of 73.79% to 118.64% for 2025, driven by improved product structure and sales growth [16] Group 5 - Chifeng Gold forecasts a net profit increase of 70% to 81% for 2025, with gold product sales prices rising approximately 49% [17] - Dingtai High-Tech expects a net profit of 410 million to 460 million yuan for 2025, reflecting an 81% to 103% increase due to rising demand in high-end PCB markets [18] - Zhonggang Luoyang announced plans for shareholders to reduce their stakes by up to 1% of total shares [20]