Core Viewpoint - Yifan Pharmaceutical (002019.SZ) announced that its wholly-owned subsidiary, Suzhou Yifan Pharmaceutical Co., Ltd., received the acceptance notice for the domestic production drug registration application for Yihuang Decoction Granules from the National Medical Products Administration on January 6, 2026 [1] Group 1 - The company has received regulatory approval for a new product, indicating progress in its product pipeline [1] - The acceptance notice is a significant step towards the commercialization of Yihuang Decoction Granules [1]

Core Viewpoint - Yifan Pharmaceutical (002019.SZ) announced that its wholly-owned subsidiary, Suzhou Yifan Pharmaceutical Co., Ltd., received the acceptance notice for the domestic production drug registration application for Yihuang Decoction Granules from the National Medical Products Administration on January 6, 2026 [1] Group 1 - The company has received regulatory approval for a new product, indicating progress in its product pipeline [1] - The acceptance notice is a significant step towards the commercialization of Yihuang Decoction Granules [1] - This development may enhance the company's market position in the pharmaceutical industry [1]

Core Viewpoint - Yifan Pharmaceutical (002019) announced that its wholly-owned subsidiary, Suzhou Yifan Pharmaceutical Co., Ltd., received the acceptance notice for the domestic production drug registration application for Yihuang Decoction Granules from the National Medical Products Administration on January 6, 2026. This product is the first classic formula variety registered by the company, aimed at kidney strengthening and dampness clearing [1]. Company Summary - Yifan Pharmaceutical's subsidiary has successfully progressed in the drug registration process, indicating a positive step towards bringing Yihuang Decoction Granules to market [1]. - The product is positioned to address specific health needs, focusing on kidney health and the elimination of dampness, which may enhance the company's product portfolio [1].

Core Viewpoint - Yifan Pharmaceutical (002019.SZ) has received a registration acceptance notice from the National Medical Products Administration for its product Yihuang Decoction Granules, marking a significant step in its product development strategy [1] Group 1: Product Development - Yifan Pharmaceutical's wholly-owned subsidiary, Suzhou Yifan Pharmaceutical Co., Ltd., received the registration acceptance notice on January 6, 2026 [1] - Yihuang Decoction Granules is the first classic formula product registered by the company, based on a prescription from the "First Batch of Ancient Classic Formulas Catalog" published by the National Administration of Traditional Chinese Medicine in April 2018 [1] - The formula is derived from the Qing Dynasty work "Fu Qingzhu Nüke" by Fu Shan, and is indicated for treating kidney deficiency with damp-heat symptoms [1] Group 2: Indications and Usage - The primary function of Yihuang Decoction Granules is to solidify the kidney and stop abnormal discharge, as well as to clear heat and eliminate dampness [1] - It is specifically used for symptoms such as excessive, thick, yellow discharge resembling concentrated tea, with a foul odor, red tongue, and yellow greasy coating [1]

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]