香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容所產生或因依賴 該等內容而引致的任何損失承擔任何責任。 Jiangsu Hengrui Pharmaceuticals Co., Ltd. 江蘇恒瑞醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1276） 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2026-004 江苏恒瑞医药股份有限公司 关于获得药品注册批准的公告 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條刊發。 根據中華人民共和國的有關法例規定，江蘇恒瑞醫藥股份有限公司（「本公司」）在 上海證券交易所網站( www.sse.com.cn )刊發了以下公告。茲載列如下，僅供參閱。 承董事會命 江蘇恒瑞醫藥股份有限公司 董事長 孫飄揚先生 中國上海 2026年1月7日 於本公告日期，董事會成員包括(i)執行董事孫飄揚先生、戴洪斌先生、馮佶女 士、張連山先生、江寧軍先生及孫杰平先生；(ii)非執行董事郭叢照女士；及(iii) 獨立非執 ...

Fundraising - Amperon plans to raise no more than 544 million yuan for projects including pressure sensor capacity expansion, ceramic capacitive pressure sensor production line upgrades, force sensor production line construction, MEMS sensor chip R&D and industrialization, as well as to supplement working capital [1] Shareholding Changes - Longjin Technology's shareholder Zhejiang Jingjiantou intends to transfer 4.6 million shares, accounting for 5% [2] - Baomo Co., Ltd.'s actual controller is planning matters related to the change of company control [3] - Anfu Technology's directors and senior management plan to increase their holdings by 11.9 million to 13.4 million yuan [4] - Xiangyang Bearing's controlling shareholder Sanhuan Group is transferring 599% of its shares to Changjiang Industrial Group without compensation [5] - Meibang Fashion's controlling shareholder Huafu Investment intends to transfer 7.90% of the company's shares to Taizhou Xinmeng [6] External Investments and Daily Operations - Kechuan Technology's wholly-owned subsidiary has completed the construction of optical module capacity, and silicon optical chips have completed their first tape-out, but no revenue has been generated yet [7] - Guangqi Technology has signed batch production contracts for metamaterials products totaling 264 million yuan with four clients [8] - Heng Rui Medicine's innovative drug Ruilafup α injection has been approved for market launch, with no similar products approved domestically or internationally [9] - Chengdi Xiangjiang has decided not to proceed with the construction of the data center computing power infrastructure project, which is expected to reduce revenue by approximately 1.092 billion yuan [9] Performance Changes - Zhongke Lanyun expects a net profit of 1.4 billion to 1.43 billion yuan for 2025, an increase of 366.51% to 376.51% year-on-year, with significant growth attributed to fair value changes from investments in Moer Thread and Muxi Co., Ltd. [10] - Kangchen Pharmaceutical anticipates a net profit of 145 million to 175 million yuan for 2025, representing a year-on-year increase of 243% to 315%, with no impact from goodwill impairment provisions [10] - Beifang Navigation expects a net profit of 110 million to 140 million yuan for 2025, a year-on-year growth of 86.32% to 137.14%, driven by increased product deliveries and sales revenue [10] - Chuanjinno expects a net profit of 430 million to 480 million yuan for 2025, reflecting a year-on-year increase of 144.24% to 172.64% [11]

Group 1 - Yili Co., Ltd. announced that Chairman Pan Gang plans to reduce his holdings by up to 62 million shares, accounting for 0.98% of the company's total share capital, to repay stock pledge financing loans [1] - New Hongze's Vice Chairman Meng Xue voluntarily waived his salary, including a basic annual salary of 1.07 million yuan, to focus on the company's strategic decisions and long-term development [2] - Guangqi Technology's subsidiary signed contracts totaling 264 million yuan for the mass production of metamaterials with four clients, with expected delivery by December 31, 2026 [3] Group 2 - Zhuhai Ming Technology's subsidiary received an allocation of 66,900 H-shares from Zhipu, amounting to 7.77 million Hong Kong dollars [4] - Chengdi Xiangjiang announced that the revenue from the construction of two data center buildings will decrease by approximately 1.09 billion yuan due to changes in business conditions [5] - Siquan New Materials' shareholder Wu Pan plans to reduce his holdings by up to 1.79% of the company's shares due to personal funding needs [6] Group 3 - Zhenxin Technology's subsidiary was banned from participating in procurement activities in the Western Theater for three years due to collusion in bidding [8] - Xinlitai's innovative drug SAL0145 injection clinical trial application has been accepted by the National Medical Products Administration, targeting MASH treatment [9] - Hengrui Medicine's innovative drug Ruira Fup α injection has been approved for market launch, with no similar products approved domestically or internationally [10] Group 4 - Baoneng New Energy's actual controller was fined 12 million yuan and had illegal gains of 25.54 million yuan confiscated due to violations of information disclosure [11] - Beidou Star Communication announced that several directors and executives plan to reduce their holdings by a total of 0.012% of the company's shares due to personal funding needs [12] - Pulit announced that its LCP film technology has a high barrier to entry and is the only domestic company to achieve breakthroughs in this technology, with ongoing clinical trials for brain-machine interface applications [13]

Investment Rating - The report indicates that the overall credit risk of the pharmaceutical manufacturing industry is controllable, with stable operating performance expected in 2026 [5][6][11]. Core Insights - The pharmaceutical manufacturing industry has shown a slight increase in the number of enterprises, with a deepening degree of differentiation within the industry. Revenue and total profit have remained stable year-on-year due to a stabilizing policy environment [6][11]. - The "14th Five-Year Plan" supports the development of innovative drugs, with the scale of license-out exceeding the total for 2024 in the first three quarters of 2025, indicating a positive outlook for innovative drug development [6][11]. - The industry has maintained net inflows in bond market financing, with overall debt pressure being manageable despite a significant amount of bonds maturing within one year [6][11]. Industry Fundamentals Industry Policy - The pharmaceutical industry is highly sensitive to policy changes, with a "three medical linkage" policy framework encouraging innovation, improving medical services, and optimizing medical insurance payments. The "14th Five-Year Plan" emphasizes the strategic importance of the biomanufacturing industry [7][8]. - Recent policies have focused on cost control in medical insurance, reforming payment methods, and promoting the development of generic drugs and innovative medicines [7][8]. Industry Operating Conditions - As of the end of 2024, the number of pharmaceutical manufacturing enterprises in China reached 9,793, with a slight increase in the number of loss-making enterprises, indicating a growing differentiation within the industry [12][11]. - The basic medical insurance fund's income and expenditure structure has improved, with significant cost control effects observed [11][12]. Financial Performance Growth Metrics - In 2024, the pharmaceutical manufacturing industry reported total revenue of 25,298.5 billion yuan and total profit of 3,420.7 billion yuan, with minor fluctuations expected in 2025 [22][23]. - For the first three quarters of 2025, total revenue was 18,211.4 billion yuan, a decrease of 2.00% year-on-year, while total profit was 2,534.8 billion yuan, down 0.70% [22][23]. Profitability - The gross profit margin for the pharmaceutical manufacturing industry has shown a declining trend, with the sales expense ratio remaining stable and the management expense ratio slightly decreasing [24][25]. - The net cash flow from operating activities has been declining, indicating potential liquidity risks [24][25]. Leverage and Solvency - The leverage level in the pharmaceutical manufacturing industry remains low, with a slight fluctuation observed in recent years. The debt-to-asset ratio has been stable, and the overall solvency indicators are at a high level [30][31]. - As of September 2025, the liquidity ratios have slightly improved, indicating a manageable debt repayment risk [31][32]. Bond Market Performance Issuance Overview - In 2025, the pharmaceutical manufacturing industry experienced a net inflow in bond market financing, with a total of 104 bonds issued amounting to 713.80 billion yuan [39][41]. - The industry has seen a concentration of bond issuers at the AA+ level, with a significant number of private enterprises involved [39][41].

批准的适应症：本品联合氟尿嘧啶类和铂类药物用于经充分验证的检测评估PD-L1阳性(CPS≥1)的局部 晚期不可切除、复发或转移性胃及胃食管结合部腺癌的一线治疗。 智通财经APP讯，恒瑞医药(600276.SH)发布公告，公司子公司苏州盛迪亚生物医药有限公司收到国家 药品监督管理局的通知，批准公司自主研发的1类创新药瑞拉芙普α注射液上市。 ...

北京商报讯（记者 王寅浩 宋雨盈）1月7日，恒瑞医药发布公告称，公司子公司苏州盛迪亚生物医药有 限公司收到国家药品监督管理局的通知，批准公司自主研发的1类创新药瑞拉芙普α注射液上市。批准 的适应症为瑞拉芙普α注射液联合氟尿嘧啶类和铂类药物用于经充分验证的检测评估PD-L1阳性 （CPS≥1）的局部晚期不可切除、复发或转移性胃及胃食管结合部腺癌的一线治疗。 ...

恒瑞医药1月7日晚间公告，公司子公司苏州盛迪亚生物医药有限公司收到国家药监局的通知，批准公司 自主研发的1类创新药瑞拉芙普α注射液上市。批准的适应症：本品联合氟尿嘧啶类和铂类药物用于经 充分验证的检测评估PD-L1阳性（CPS≥1）的局部晚期不可切除、复发或转移性胃及胃食管结合部腺癌 的一线治疗。经查询，国内外尚无同类产品获批上市。截至目前，瑞拉芙普α注射液相关项目累计研发 投入约71,130万元。 ...

格隆汇1月7日丨恒瑞医药(600276.SH)公布，子公司苏州盛迪亚生物医药有限公司收到国家药品监督管 理局的通知，批准公司自主研发的1类创新药瑞拉芙普α注射液上市。瑞拉芙普α注射液是公司自主研发 并具有知识产权的抗PD-L1/TGF-βRII双功能融合蛋白，本品能够通过特异性阻断PD-1/PD-L1的相互作 用，同时中和肿瘤微环境中的TGF-β，发挥抗肿瘤作用。经查询，国内外尚无同类产品获批上市。截至 目前，瑞拉芙普α注射液相关项目累计研发投入约71,130万元。 ...

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2026-004 药品名称：瑞拉芙普α注射液 剂型：注射剂 规格：300mg（6ml）/瓶 注册分类：治疗用生物制品 1 类 受理号：CXSS2400101 江苏恒瑞医药股份有限公司 关于获得药品注册批准的公告 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、准确性和完整性承担法律责任。 近日，江苏恒瑞医药股份有限公司（以下简称"公司"）子公司苏州盛迪亚 生物医药有限公司收到国家药品监督管理局（以下简称"国家药监局"）的通知， 批准公司自主研发的 1 类创新药瑞拉芙普α注射液上市。现将相关情况公告如下： 一、药品的基本情况 处方药/非处方药：处方药 批准的适应症：本品联合氟尿嘧啶类和铂类药物用于经充分验证的检测评估 PD-L1 阳性（CPS≥1）的局部晚期不可切除、复发或转移性胃及胃食管结合部腺 癌的一线治疗。 三、风险提示 公司高度重视药品研发，并严格控制药品研发、制造及销售环节的质量及安 全。药品获得批件后生产和销售容易受到一些不确定性因素的影响。敬请广大投 资者谨慎决策，注意防范投资风险。 特 ...

人民财讯1月7日电，恒瑞医药(600276)1月7日公告，近日，公司子公司苏州盛迪亚生物医药有限公司收 到国家药监局的通知，批准公司自主研发的1类创新药瑞拉芙普α注射液上市。该药品联合氟尿嘧啶类 和铂类药物用于经充分验证的检测评估PD-L1阳性（CPS≥1）的局部晚期不可切除、复发或转移性胃及 胃食管结合部腺癌的一线治疗。经查询，国内外尚无同类产品获批上市。 转自：证券时报 ...