Deuremidevir Hydrobromide

上海 2024年11月28日 /美通社/ -- 北京时间11月28日，君实生物（1877.HK，688180.SH）宣布，公司自主研发的抗PD-1单抗产品特瑞普利单抗（商品名：拓益 ® ） 新增 4项 适应症成功被纳入《国家基本医疗保险、工伤保险和生育保险药品目录（2024年）》（国家医保目录）。新版国家医保目录将于2025年1月1日起正式实施。至此，拓益 ® 在国内获批的10个适应症已全部纳入国家医保目录，是目录中 唯一 用于黑色素瘤、非小细胞肺癌围手术期、肾癌和三阴性乳腺癌治疗的抗PD-1单抗。 以下为拓益 ® 纳入本次新版国家医保目录的适应症： 原有适应症： 既往接受全身系统治疗失败的不可切除或转移性黑色素瘤的治疗； 含铂化疗失败包括新辅助或辅助化疗12个月内进展的局部晚期或转移性尿路上皮癌的治疗； 既往接受过二线及以上系统治疗失败的复发/转移性鼻咽癌患者的治疗； 局部复发或转移性鼻咽癌患者的一线治疗； 不可切除局部晚期/复发或转移性食管鳞癌的一线治疗； 表皮生长因子受体（EGFR）基因突变阴性和间变性淋巴瘤激酶（ALK）阴性、不可手术切除的局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）的一线治疗。 新增适应症： 联合化疗围手术期治疗，继之本品单药作为辅助治疗，用于可切除ⅢA-ⅢB期非小细胞肺癌（NSCLC）的成人患者； 联合阿昔替尼用于中高危的不可切除或转移性肾细胞癌患者的一线治疗； 联合依托泊苷和铂类用于广泛期小细胞肺癌（ES-SCLC） 的 一线治疗； 联合注射用紫杉醇（白蛋白结合型）用于经充分验证的检测评估PD-L1阳性（CPS≥1）的复发或转移性三阴性乳腺癌（TNBC）的一线治疗。 作为公司的核心产品之一，特瑞普利单抗在开发过程中，即采用差异化的优效策略，其具有独特的结合位点，高亲和力，强劲诱导PD-1受体内吞。2018年，特瑞普利单抗（拓益 ® ）正式在国内获批上市，成为我国首个批准上市的国产PD-1单抗。2023年10月，特瑞普利单抗的上市申请获得美国食品药品监督管理局（FDA）批准，成为美国首个且目前唯一获批用于鼻咽癌治疗的药物，也是FDA批准上市的首个中国自主研发和生产的创新生物药。 目前，特瑞普利单抗已在包括中国、美国、欧盟、英国、印度等在内超过35个国家及地区正式获批上市，累计在全球开展了覆盖超过15个适应症的40多项临床研究，全球商业化网络布局超过50个国家或地区，是首个获得中、美、欧三大权威指南（NCCN/ESMO/CSCO）推荐的国产抗PD-1单抗。 君实生物首席商务官王行远先生 表示："近年来，国家医保局支持医药创新，建立了以新药为主体的医保准入和谈判续约机制。获益于此，拓益 ® 累计10项适应症纳入国家医保，为其2024年成功达成'十全实美'画上了圆满的句号。让我们倍感振奋的是，今年拓益 ® 新纳入的4项适应症均实现了目录中免疫治疗药物'零的突破'，是目录中首次纳入肺癌围手术期、小细胞肺癌、肾癌以及三阴性乳腺癌免疫疗法。我们非常期待在新版医保落地后，这款已在中、美、欧等地获批上市的首个国产免疫创新药，能够将国际品质和亲民价格带给更广泛的中国患者。未来，我们也将继续助力国家医改，推进解决看病难、看病贵问题，积极践行公司使命：'打造世界一流、值得信赖的创新药普惠患者'！" 1. 本材料旨在传递前沿信息，无意向您做任何产品的推广，不作为临床用药指导。 2. 若您想了解具体疾病诊疗信息，请遵从医疗卫生专业人士的意见与指导。 关于特瑞普利单抗注射液（拓益 ® ） 特瑞普利单抗注射液（拓益 ® ）作为我国批准上市的首个国产以PD-1为靶点的单抗药物，获得国家科技重大专项项目支持，并荣膺国家专利领域最高奖项"中国专利金奖"。 特瑞普利单抗至今已在全球（包括中国、美国、东南亚及欧洲等地）开展了覆盖超过15个适应症的40多项由公司发起的临床研究。正在进行或已完成的关键注册临床研究在多个瘤种范围内评估特瑞普利单抗的安全性及疗效，包括肺癌、鼻咽癌、食管癌、胃癌、膀胱癌、乳腺癌、肝癌、肾癌及皮肤癌等。 截至目前，特瑞普利单抗已在中国内地获批10项适应症：用于既往接受全身系统治疗失败的不可切除或转移性黑色素瘤的治疗（2018年12月）；用于既往接受过二线及以上系统治疗失败的复发/转移性鼻咽癌患者的治疗（2021年2月）；用于含铂化疗失败包括新辅助或辅助化疗12个月内进展的局部晚期或转移性尿路上皮癌的治疗（2021年4月）；联合顺铂和吉西他滨用于局部复发或转移性鼻咽癌患者的一线治疗（2021年11月）；联合紫杉醇和顺铂用于不可切除局部晚期/复发或远处转移性食管鳞癌患者的一线治疗（2022年5月）；联合培美曲塞和铂类用于表皮生长因子受体（EGFR）基因突变阴性和间变性淋巴瘤激酶（ALK）阴性、不可手术切除的局部晚期或转移性非鳞状非小细胞肺癌的一线治疗（2022年9月）；联合化疗围手术期治疗，继之本品单药作为辅助治疗，用于可切除IIIA-IIIB期非小细胞肺癌的成人患者（2023年12月）；联合阿昔替尼用于中高危的不可切除或转移性肾细胞癌患者的一线治疗（2024年4月）；联合依托泊苷和铂类用于广泛期小细胞肺癌一线治疗（2024年6月）；联合注射用紫杉醇（白蛋白结合型）用于经充分验证的检测评估PD-L1阳性（CPS≥1）的复发或转移性三阴性乳腺癌的一线治疗（2024年6月）。2020年12月，特瑞普利单抗首次通过国家医保谈判，目前已有10项获批适应症纳入《国家医保目录（2024年）》，是目录中唯一用于黑色素瘤、非小细胞肺癌围手术期、肾癌、三阴性乳腺癌治疗的抗PD-1单抗药物。2024年10月，特瑞普利单抗用于复发/转移性鼻咽癌治疗的适应症在中国香港获批。 在国际化布局方面，特瑞普利单抗目前已在美国、欧盟、印度、英国、约旦等国家和地区获得批准上市。此外，澳大利亚药品管理局（TGA）和新加坡卫生科学局（HSA）分别受理了特瑞普利单抗联合顺铂/吉西他滨作为转移性或复发性局部晚期鼻咽癌成人患者的一线治疗，以及作为单药治疗既往含铂治疗过程中或治疗后疾病进展的复发性、不可切除或转移性鼻咽癌的成人患者的上市许可申请。 关于君实生物 君实生物（688180.SH，1877.HK）成立于2012年12月，是一家以创新为驱动，致力于创新疗法的发现、开发和商业化的生物制药公司。依托全球一体化源头创新研发能力，公司已构建起涵盖超过50款创新药物的多层次产品管线，覆盖恶性肿瘤、自身免疫、慢性代谢类、神经系统、感染性疾病五大治疗领域，已有5款产品在国内或海外上市，包括我国首个自主研发、在中美欧等地超过35个国家和地区获批上市的PD-1抑制剂特瑞普利单抗（拓益 ® ），临床开发阶段的药物超过30款。疫情期间，君实生物还参与开发了埃特司韦单抗、民得维 ® 等多款预防和治疗新冠的创新药物，积极承担本土创新药企的责任。 君实生物以"用世界一流、值得信赖的创新药普惠患者"为使命，立足中国，布局全球。目前，公司在全球拥有约2500名员工，分布在美国旧金山和马里兰，中国上海、苏州、北京、广州等。 官方网站： www.junshipharma.com 官方微信：君实生物 媒体联系人 ：Zhi LI, zhi_li@junshipharma.com

Nov. 16, 2024 -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, and its wholly-owned subsidiary, TopAlliance Biosciences Inc. (TopAlliance Biosciences), announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved toripalimab (UK trade name: LOQTORZI®) for the treatment of two indications: Toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma (NPC); Toripalimab in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). In UK, toripalimab is the first and only drug for the treatment of NPC and the only first-line treatment for advanced or metastatic ESCC, regardless of PD-L1 status. NPC is a malignant tumor that occurs in the nasopharyngeal mucosal epithelium and is one of the most common types of head and neck cancers globally. According to GLOBOCAN 2022 statistics, the number of newly diagnosed NPC cases in 2022 exceeded 120,000 worldwide. Due to the location of the primary tumor, surgery is rarely an option. The latest European Society of Medical Oncology (ESMO) Guidelines recommend immunotherapy combined with chemotherapy as the first-line treatment for recurrent or metastatic NPC. The approval of the NPC indication is primarily based on the results from the JUPITER-02 study (a randomized, double-blind, placebo-controlled, multinational multi-center Phase 3 clinical study, NCT03581786). JUPITER-02 is the first international multi-center, double-blind, randomized Phase 3 clinical study in NPC immunotherapy with the largest sample size, and the world’s first Phase 3 clinical study with preset statistical verification (Type I error control) for overall survival (“OS”) in first-line immunotherapy combined with chemotherapy for NPC compared to chemotherapy alone that demonstrated a survival benefit. The study results were presented in an oral report during the Plenary Session of the 2021 annual meeting of the American Society of Clinical Oncology (ASCO) (#LBA2) and were subsequently featured on the cover of Nature Medicine. The results were also published in full in the Journal of the American Medical Association (JAMA). Results showed that, compared to chemotherapy alone, toripalimab in combination with chemotherapy reduced the risk of disease progression by 48% and the risk of death by 37%. The median progression-free survival (“PFS”) in the toripalimab plus chemotherapy group was prolonged by 13.2 months compared to chemotherapy alone, from 8.2 months to 21.4 months. In addition, patients treated with this combined therapy achieved a higher objective response rate (ORR) and longer duration of response (DoR), with a complete response (CR) rate of 26.7%, and no new safety signal was identified. Long-term survival follow-up data, presented at ASCO 2024, reported a 5-year survival rate of 52.0%. EC is one of the most common malignant tumors in the alimentary tract. According to GLOBOCAN 2022 statistics, esophageal cancer is the 11th most commonly diagnosed cancer and the seventh leading cause of cancer death worldwide, with over 511,000 new cases and over 445,000 deaths in 2022. ESCC and esophageal adenocarcinoma are the two main histological subtypes of esophageal cancer. The approval of the ESCC indication is primarily based on the results from the JUPITER-06 study (a randomized, double-blind, placebo-controlled, multi-center Phase 3 clinical study, NCT03829969). The study aimed to evaluate the efficacy and safety of toripalimab in combination with paclitaxel/cisplatin (TP) for the first-line treatment of advanced ESCC compared with placebo in combination with chemotherapy. The results were first presented in an oral session during the ESMO Congress 2021 and later published in Cancer Cell and Journal of Clinical Oncology, two leading international oncology journals. Study findings showed that toripalimab in combination with chemotherapy resulted in superior PFS and OS in patients with advanced or metastatic ESCC, the median OS was prolonged by 6 months to 17 months and the risk of disease progression or death in patients was significantly reduced by 42%. Futhermore, there was a significant improvement in survival benefits regardless of PD-L1 status. Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, said, “The approval of toripalimab by MHRA marks another significant milestone for toripalimab in Europe, not only making toripalimab the first and only drug in UK for the treatment of NPC, but also the only first-line treatment for ESCC, regardless of PD-L1 status. We are extremely proud to introduce innovative Chinese biopharmaceuticals to Europe that can address longstanding unmet medical needs of the patients there. Moving forward, we will remain committed to our globalization strategy, ‘In China, For Global.’ We will continue working towards the commercialization of toripalimab, and offer high-quality, innovative, domestically developed medicines to benefit more patients around the world.” Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells. ore than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Southeast Asia, and Europe. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin. In the Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are ten approved indications for toripalimab in the Chinese mainland: unresectable or metastatic melanoma after failure of standard systemic therapy; recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy; locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy; in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC; in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC); in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC); in combination with chemotherapy as perioperative treatment and subsequently with monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB NSCLC; in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma (RCC); in combination with etoposide plus platinum for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC); in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC). The first six indications have been included in the National Reimbursement Drug List (NRDL) (2023 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma. In October 2024, toripalimab for the treatment of recurrent or metastatic NPC was approved in Hong Kong SAR, China. In terms of international layout, toripalimab has been approved for marketing in the United States, the European Union, India, the UK, Jordan and other countries and regions. In addition, the Australia Therapeutic Goods Administration (TGA) and the Singapore Health Sciences Authority (HSA) accepted the new chemical entity application and the new drug application for toripalimab in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and for toripalimab, as a single agent, for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy, respectively. Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Five of the company’s innovations have already reached the Chinese or international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody, approved in over 35 countries and regions including China, the US, and Europe. Additionally, more than 30 drugs are currently in clinical development. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19. With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). 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