恒瑞医药公告，近日公司子公司山东盛迪医药有限公司的HRS-5346片被国家药品监督管理局药品审评 中心纳入突破性治疗品种名单。脂蛋白(a)[Lp(a)]水平升高是全球最普遍的单基因脂质疾病，是脂蛋白紊 乱的典型表现之一，HRS-5346是一种Lp（a）口服小分子抑制剂。经查询，目前国内外尚无同类产品获 批上市。截至目前，HRS-5346片相关项目累计研发投入约为7630万元（未经审计）。 ...

恒瑞医药(600276.SH)发布公告，近日,公司子公司苏州盛迪亚生物医药有限公司的注射用SHR-1826被国 家药品监督管理局药品审评中心纳入突破性治疗品种名单。拟定适应症(或功能主治)：单药治疗既往接 受过至少一线系统性治疗失败的c-Met过表达(2-3+，≥50%)驱动基因阴性局部晚期或转移性非鳞状非小 细胞肺癌。 ...

Group 1 - The core point of the article is that Heng Rui Medicine's injectable SHR-1826 has been included in the list of breakthrough therapeutic varieties by the National Medical Products Administration [1] Group 2 - The announcement was made by Heng Rui Medicine, specifically through its subsidiary Suzhou Sediya Biopharmaceutical Co., Ltd [1]

Core Viewpoint - The company’s subsidiary, Zhejiang Daor Biological Technology Co., Ltd., has developed a first-in-class long-acting tri-target agonist, DR10624, which has been included in the breakthrough therapy category for the treatment of severe hypertriglyceridemia (sHTG) [1][2]. Drug Information - Drug Name: DR10624 Injection - Registration Category: Class 1 Biologic Product - Acceptance Number: CXSB2300148 - Indication: Severe hypertriglyceridemia - Reason for Inclusion: The drug meets the criteria for breakthrough therapy as per the regulatory guidelines [1]. R&D and Registration Status - DR10624 is a globally innovative tri-specific agonist targeting FGF21R, GCGR, and GLP-1R, with clinical research approvals from China CDE and the US FDA expected in October 2023 and October 2025, respectively [2]. - The Phase II clinical study (DR10624-201) results are set to be presented at the AHA Scientific Sessions 2025, showcasing significant triglyceride (TG) reductions: 74.5% in the 12.5mg group, 66.2% in the 25mg group, and 68.9% in the 50mg titration group [2]. - 78.5% of participants in the treatment group experienced TG reductions exceeding 50%, and 89.5% had TG levels below 500 mg/dL [2]. - DR10624 also demonstrated efficacy in improving lipid profiles related to atherosclerosis and significantly reducing liver fat content, with a median percentage reduction of up to 67% [2]. Clinical Advantages - DR10624 exhibits strong lipid-lowering effects and good safety profiles, making it a promising treatment option for sHTG patients [3]. - The drug's ability to lower liver fat and regulate metabolic syndromes adds to its clinical value [3]. Market Context - The prevalence of sHTG is increasing, with approximately 10% of adults affected globally, and 1% suffering from severe cases [4]. - Traditional lipid-lowering medications have limited efficacy in reducing TG levels below 500 mg/dL, highlighting the need for innovative treatments like DR10624 [5]. - The public health threat posed by sHTG is gaining attention, necessitating better therapeutic options [5]. Future Considerations - Following its inclusion in the breakthrough therapy list, DR10624 must complete further clinical trials and receive regulatory approval before market launch [4]. - The drug development process is characterized by high investment, long timelines, and significant risks, with various factors influencing clinical trial outcomes and market competition [4].

Core Viewpoint - The announcement highlights that East China Pharmaceutical's subsidiary, Zhejiang Daor Biotechnology, has developed a groundbreaking drug, DR10624, which has been included in the list of breakthrough therapies for severe hypertriglyceridemia (sHTG) by the National Medical Products Administration (NMPA) of China [1][4]. Drug Information - Drug Name: DR10624 Injection - Registration Category: Class 1 Biopharmaceutical - Acceptance Number: CXSB2300148 - Indication: Severe hypertriglyceridemia (sHTG) [1]. R&D and Registration Status - DR10624 is a globally innovative long-acting tri-specific agonist targeting FGF21R, GCGR, and GLP-1R, with clinical research approvals from both China CDE and the US FDA for sHTG [2]. - The Phase II clinical study (DR10624-201) results showed significant triglyceride (TG) reductions: 74.5% in the 12.5mg group, 66.2% in the 25mg group, and 68.9% in the 50mg titration group [2]. - 78.5% of participants experienced TG reductions exceeding 50%, and 89.5% had TG levels below 500 mg/dL [2]. - DR10624 also demonstrated significant improvements in lipid profiles and liver fat content, with a median percentage reduction of up to 67% in liver fat [2][3]. Clinical Advantages - DR10624's innovative tri-target mechanism provides strong lipid-lowering effects and good safety profiles, making it a promising treatment option for sHTG patients [3]. - The drug's efficacy in reducing liver fat and regulating metabolic syndrome is highlighted as a significant clinical advantage [3]. Market Context - sHTG, defined as TG levels exceeding 500 mg/dL, poses significant health risks, including cardiovascular diseases and pancreatitis, with a rising prevalence globally [4]. - Traditional lipid-lowering medications have limited efficacy in reducing TG levels below 500 mg/dL, indicating a clinical need for more effective treatments like DR10624 [4]. Future Steps - Following its inclusion in the breakthrough therapy list, DR10624 must complete further clinical trials and receive approval from the NMPA before market launch [5]. - The company is committed to advancing the drug's development in accordance with national regulations and will keep investors informed of progress [5].

Major Events - Defu Technology announced the termination of the acquisition of 100% equity in Luxembourg Copper Foil due to additional restrictions imposed by the Luxembourg Ministry of Economy, with a contract deposit of €17.4047 million to be fully refunded within 10 working days after termination [1] - China Nonferrous Mining expects a total copper production of approximately 484,000 tons in 2026, including 134,000 tons of cathode copper and 350,000 tons of crude/anode copper, with a decrease in crude/anode copper production due to planned maintenance [3] - Huadong Medicine's subsidiary, Zhejiang Daor Biotechnology, has its DR10624 injection included in the breakthrough therapy designation list for severe hypertriglyceridemia, with clinical research approvals from China CDE and the US FDA [4] Performance - Xiantan Co. reported chicken product sales revenue of CNY 530 million in December 2025, with a year-on-year increase of 9.41% and a sales volume of 55,100 tons [5] - Jinzizi Liquor expects to report a net loss for the fiscal year 2025, although the loss is anticipated to narrow compared to the previous year [6] - Dechang Co. forecasts a net profit of CNY 160 million to CNY 200 million for 2025, representing a year-on-year decrease of 51% to 61% [7] Stock Suspension and Resumption - Jiamei Packaging's stock will resume trading on January 12, 2026, after a price increase of 230.48% from December 17, 2025, to January 6, 2026, leading to a temporary suspension for investigation [8] - Yanjing Co. continues to suspend trading due to uncertainties related to asset acquisition plans, with an expected disclosure of the transaction plan by January 19, 2026 [9]

Group 1 - Jia Mei Packaging's stock will resume trading on January 12, 2026, after completing a review due to a 230.48% price increase from December 17, 2025, to January 6, 2026 [1] - Yan Jiang Co. continues to suspend trading as it plans to acquire assets, with a disclosure expected by January 19, 2026 [2] - Defu Technology terminated its acquisition of 100% of Luxembourg Copper Foil due to restrictions from the Luxembourg Ministry of Economy, with a refund of €17.4047 million expected [3] Group 2 - Defu Technology plans to acquire at least 51% of Huiru Technology through cash and capital increase, with Huiru focusing on high-performance electrolytic copper foil [4] - Shangluo Electronics' application for issuing convertible bonds has been accepted by the Shenzhen Stock Exchange [5] - Xianle Health intends to issue H-shares and list on the Hong Kong Stock Exchange to enhance its global strategy and capital strength [6] Group 3 - Hangyu Technology plans to sell up to 752,800 repurchased shares to supplement working capital, with a potential cancellation of unsold shares [7] - Fangsheng Pharmaceutical's production facility failed a GMP compliance check, but it will not significantly impact operations [8][9] - East China Pharmaceutical's subsidiary's product has been included in the list of breakthrough therapeutic varieties for severe hypertriglyceridemia [10] Group 4 - Dechang Co. expects a net profit decrease of 51% to 61% for 2025, primarily due to competitive pressures and foreign exchange losses [12] - Hebang Bio anticipates a net loss for 2025 due to asset impairment provisions [13] - Qu Mei Home expects a net loss for 2025, with significant negative figures reported for the first nine months [14] Group 5 - Jinzongzi Wine forecasts a net loss for 2025, although the loss is expected to narrow compared to the previous year [15] - Sichuan Electronics expects a net loss of between 265 million to 340 million yuan for 2025, attributed to market competition and delayed orders [16] - Wansheng Co. anticipates a net loss for 2025 [17] - Weiyuan Co. also expects a net loss for 2025 [19] - Kosen Technology predicts a net loss for 2025 due to low capacity utilization and strategic adjustments [20] - Zhongheng Group expects a net loss for 2025 [21] Group 6 - Xiantan Co. reported a 9.41% year-on-year increase in chicken product sales revenue to 530 million yuan in December 2025 [22] Group 7 - Huate Gas shareholders plan to reduce their holdings by up to 2% through block trades [24] - Meidike shareholders plan to reduce their holdings by up to 1% through market transactions [25]

格隆汇1月11日丨华东医药(000963.SZ)公布，近日，根据国家药品监督管理局药品审评中心(CDE)发布 的公示信息，公司控股子公司浙江道尔生物科技有限公司(以下简称"道尔生物")自主研发的同类首创 (FIC)的靶向成纤维细胞生长因子 21 受体(Fibroblast growthfactor 21 receptor，FGF21R)，胰高血糖素受 体(Glucagon receptor，GCGR)，和胰高血糖素样肽-1 受体(Glucagon-like peptide-1 receptor，GLP-1R)的 长效三靶点激动剂 DR10624 被纳入突破性治疗品种，拟定适应症为重度高甘油三酯血症(severe hypertriglyceridemia，sHTG)。 ...

Core Viewpoint - The announcement by the company regarding its core product, Furmonertinib (brand name "Aifusha"), being included in the list of proposed breakthrough therapies by the National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR PACC mutations [1] Group 1 - Furmonertinib is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) and is a first-class new drug independently developed by the company, classified as a small molecule targeted therapy [1] - Clinical research results indicate that Furmonertinib shows broad efficacy against various EGFR mutations, with its first-line treatment indication and the 20 exon insertion mutation first and second-line treatment indications included in the NMPA's breakthrough therapy list [1] - The 20 exon insertion mutation first-line treatment indication has also received breakthrough therapy designation (BTD) from the U.S. Food and Drug Administration (FDA) [1] Group 2 - Currently, both first-line and second-line treatment indications for Furmonertinib have been included in the National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog (2025) [1]

Core Viewpoint - Shanghai Ailis Pharmaceutical Technology Co., Ltd. announced that its core product, Furmonertinib (also known as "Aifusha"), has been included in the proposed list of breakthrough therapy products by the National Medical Products Administration (NMPA) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) PACC mutations [2][3] Group 1: Drug Information - Furmonertinib is a first-class new drug developed by the company, classified as a small molecule targeted therapy, specifically an EGFR tyrosine kinase inhibitor (TKI) [3] - The EGFR PACC mutation includes approximately 70 subtypes, accounting for about 12.5% of all EGFR-mutated NSCLC patients, indicating an unmet clinical need for this patient population [2] - The drug has shown significant efficacy and safety in clinical studies, with an objective response rate (ORR) of 81.8% and a disease control rate (DCR) of 100% in patients treated with 240mg of Furmonertinib [3] Group 2: Regulatory Status - The proposed breakthrough therapy designation is currently in the public announcement period from December 25, 2025, to January 4, 2026, during which there is a risk of objections being raised [2][4] - The drug has previously been included in the NMPA's breakthrough therapy product list for its first-line and second-line treatment indications, and it has also received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for the 20 exon insertion mutation [3]