Cemiplimab-RWLC

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） 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2月2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) 獨立非執行董事董家鴻先生、曾慶生先生、孫金雲先生及周紀恩先生。 江苏恒瑞医药股份有限公司 关于重新提交注射用卡瑞利珠单抗的生物制品 许可申请获FDA 受理的提示性公告 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”）收到美国食品药品 监督管理局（以下简称“FDA”）的《确认函》，公司重新提交的注射用卡瑞利 珠单抗联合甲磺酸阿帕替尼片用于不可切除或转移性肝细胞癌患者的一线治疗 的生物制品许可申请（Biologics License Application，以下简称“BLA”）获 得FDA 受理。根据《处方药用户付费法案（PDUFA）》，FDA 对注射用卡瑞利珠单 抗的目标审评日期为2026 年7 月23 日。现将相关情况公告如下： 一 一、药品的基本情况 药品名称：注射用卡瑞利珠单抗 剂型：注射剂 申请人：江苏恒瑞医药股份有限公司 拟定适应症（或功能主治）：本品联合甲磺酸阿帕替尼片用于不可切除或转 移性肝细胞癌患者的一线治疗。 二 二、药品的临床试验情况 2018 年12 月，注射用卡瑞利珠单抗联合甲磺酸阿帕替尼片一线治疗肝细胞 癌的国际多中心Ⅲ期临床试验（研究编号：SHR-1210-Ⅲ-310）获准在美国开展。 2021 年4 月，注射用卡瑞利珠单抗用于治疗肝细胞癌适应症获得FDA 授予的孤 儿药资格认定。2022 年二季度，SHR-1210-Ⅲ-310 研究由独立数据监察委员会 （IDMC）判定主要研究终点结果达到方案预设的优效标准，研究结果表明卡瑞利 珠单抗联合阿帕替尼对比索拉非尼作为一线治疗可以显著延长晚期肝细胞癌患 者的无进展生存期（PFS）以及总生存期（OS）。 SHR-1210-Ⅲ-310 是一项评估卡瑞利珠单抗联合阿帕替尼对比索拉非尼治 疗既往未接受过系统治疗的不可切除或转移性肝细胞癌患者有效性和安全性的 随机对照、开放性、国际多中心Ⅲ期临床研究，由南京金陵医院肿瘤中心秦叔逵 教授担任全球主要研究者，全球13 个国家和地区的95 家中心共同参与。研究主 要终点是由独立评审委员会（BIRC）基于RECISTv1.1 标准评估的无进展生存期 （PFS）和总生存期（OS），次要终点包括疾病进展时间（TTP）、客观缓解率（ORR）、 疾病控制率（DCR）、客观缓解持续时间、安全性等。本研究共入组543 名受试 者，按1:1 随机入组，分别接受卡瑞利珠单抗（200mg，每2 周注射1 次）联合 阿帕替尼（250mg，每日口服1 次）或索拉非尼（400mg，每日口服2 次）治疗。 研究结果显示，卡瑞利珠单抗联合阿帕替尼一线治疗晚期肝细胞癌具有显著的生 存获益和可耐受的安全性，中位无进展生存期（PFS）为5.6 个月，中位总生存 期（OS）达到22.1 个月（2025 年9 月，发表在Lancet Oncology（《柳叶刀·肿 瘤》的最终生存分析文章结果显示，OS 延长至23.8 个月），为目前晚期肝细胞 癌一线治疗最长OS 获益组合，这是首个也是目前唯一一个免疫治疗联合小分子 酪氨酸激酶抑制剂治疗晚期肝细胞癌获得成功的Ⅲ期试验。 三 三、药品的其他情况 注射用卡瑞利珠单抗是人源化抗PD-1 单克隆抗体，可与人PD-1 受体结合并 阻断PD-1/PD-L1 通路，恢复机体的抗肿瘤免疫力，从而形成癌症免疫治疗基础。 国外有多款PD-1 单克隆抗体获批上市，包括帕博利珠单抗（默沙东，商品名可 瑞达）、纳武利尤单抗（百时美施贵宝，商品名欧狄沃）、cemiplimab（再生元 制药，商品名Libtayo）和dostarlimab（葛兰素史克，商品名Jemperli）等。 国内也有多款同类产品获批上市。经查询EvaluatePharma 数据库，2024 年抗PD- 1 抗体全球销售额合计约为415.46 亿美元。截至目前，注射用卡瑞利珠单抗相 关项目累计研发投入约为319,740 万元（未经审计）。 四、风险提示 由于FDA 现场核查的时间及结果存在不确定性，本次BLA 能否获得批准存在 不确定性。药品从研制、临床试验报批到投产的周期长、环节多，药品研发及至 上市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。公司将积极推进上述项目，并严格按照有关规定及时对项目后续进展情 况履行信息披露义务。 特此公告。 江苏恒瑞医药股份有限公司董事会

In its fourth-quarter presentation, Regeneron said that the slide in sales for its Eylea franchise will continue in the first quarter of this year while the company awaits a key FDA decision on its pre-filled syringe option for the treatment. Earlier this month at the J.P. Morgan Healthcare Conference, Regeneron got its Eylea sales news out of the way. As has been the case for several quarters, as sales of Eylea HD have increased, those of Eylea’s original formula have declined by a larger margin.The result over time has been a significant decline in U.S. sales of the overall Eylea franchise, from $1.50 billion in the fourth quarter of 2024 to $1.08 billion in the fourth quarter of last year.Friday, when Regeneron presented its Q4 and 2025 financial results in full, the company said that it expects the trend to continue in the first quarter of this year, with high single-digit growth for Eylea HD being more than offset by a double-digit decline for Eylea’s original version. Two seasonal timing factors are at play that will affect the performance of the eye disease drug in the first quarter, Regeneron’s commercial chief Marion McCourt said during a conference call.“The first quarter is typically impacted by patient reauthorizations and—as we disclosed earlier this month—wholesaler inventory levels were elevated by approximately $30 million at the end of the fourth quarter for Eylea HD as well as Eylea,” McCourt said. “We expect first-quarter net sales will be negatively impacted as the inventory is absorbed.”For 2025 overall, combined U.S. sales of the Eylea treatments reached $4.4 billion, which was a 27% decline from 2024. The figure is also down from Eylea’s peak figure of $6.3 billion in 2022.Much of the four-year slide can be attributed, of course, to Roche’s competing treatment Vabysmo, which was approved in 2022 and raked in worldwide sales of 4.1 billion Swiss francs ($5.3 billion) last year. But there are other headwinds at play as well that are affecting the entire category of anti-vascular endothelial growth factor (VEGF) drugs.In its presentation on Thursday, Roche identified a “contraction of the U.S. branded market” for anti-VEGF drugs, as doctors are prescribing less expensive alternatives such as Avastin and Eylea biosimilars.These factors even knocked Vabysmo off its juggernaut trajectory, as its sales in the second half of 2025 were less than those in the first half by 32 million Swiss francs ($42 million). It was the first time since its launch that Vabysmo had a sequential decline.Regeneron acknowledged the category’s recent market decline, citing a 7% sequential sales slide from the third to the fourth quarter of 2025 for the class. Despite that, there still are positive signs for Eylea HD, which benefited from a 10% increase in sequential physician demand, according to Regeneron.This trend highlighted “Eylea HD’s strong clinical profile and commercial momentum,” McCourt said.There are other reasons to believe that Eylea HD can spearhead a turnaround, Regeneron said. In November, the company got two long-awaited FDA expansions for a monthly dosing option and retinal vein occlusion. “Eylea HD now has the broadest label and greatest dosing flexibility of any anti-VEGF medicine,” McCourt said. “Physicians were eagerly awaiting both label enhancements and we are seeing positive early launch signals in our efforts to get this medicine to even more patients.”Another boost is expected with an anticipated approval for Eylea HD to be available to physicians in a pre-filled syringe. The company is projecting that an FDA nod will come in the second quarter.Additionally, Regeneron said on Friday that the FDA has approved a new manufacturer, which will be able to perform fill-finish for vials of Eylea HD. FDA approvals for the previous label expansions for Eylea HD were held up by problems at the company’s primary third-party manufacturer, Novo Nordisk (Catalent). As for Regeneron’s overall performance, the company reported total sales of $3.9 billion for the quarter, which were up by 3% year over year and topped the analyst consensus. For the year, Regeneron's revenues were up 1% to $14.3 billion.Doing the heavy lifting, as usual, was Sanofi-partnered Dupixent, which achieved sales of $4.9 billion in the quarter, which were up 34%, with Regeneron’s collaboration revenue coming to $1.6 billion.Cancer drug Libtayo also continued to surge, with revenues reaching $425 million for the quarter and $1.45 billion for the year, which was a 19% gain from 2024.