Toripalimab

March 26, 2025 -- 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, announced that the New Drug Application (the “NDA”) for toripalimab (Singapore trade name: LOQTORZI®) 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”) has been approved by the Singapore Health Sciences Authority (the HSA). Toripalimab has become the first and only approved immuno-oncology treatment for NPC in Singapore. NPC is a malignant tumor that occurs in the epithelium mucosae of the nasopharynx and is one of the most common types of head and neck cancers. According to GLOBOCAN 2022 statistics, the number of newly diagnosed NPC cases in 2022 exceeded 120,000 worldwide. Toripalimab is the only preferred regimen recommended for the comprehensive treatment of recurrent or metastatic NPC in the National Comprehensive Cancer Network (NCCN) Guidelines (Version 1.2025) for head and neck cancers. The approval is primarily based on the results from JUPITER-02 (NCT03581786), the first international multi-center, double-blind, randomized Phase 3 clinical study in NPC immunotherapy with the largest sample size. JUPITER-02 is also the world’s first Phase 3 clinical study with preset statistical verification (Type I error control) demonstrating a significant overall survival (“OS”) benefit for first-line immunotherapy combined with chemotherapy compared to chemotherapy alone in NPC. JUPITER-02’s results were presented in an oral report during a Plenary Session at the 2021 American Society of Clinical Oncology (ASCO) annual meeting (#LBA2). These results were subsequently featured on the cover of Nature Medicine and published in full in the Journal of the American Medical Association (JAMA). The results of the study 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 was presented at ASCO 2024, with a 5-year survival rate of 52%. Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, said, “Toripalimab’s approval in Singapore represents our formal entry into the Southeast Asian market. Southeast Asia is a region with a high incidence of NPC, and we are proud to introduce this groundbreaking therapy to address unmet medical needs and transform the local treatment landscape. As of now, toripalimab has received marketing authorization in over 35 countries and regions across four continents. We remain committed to our ‘In China, For Global’ strategy, advancing innovative medicines from China to improve healthcare for patients across the globe.” The NDA was submitted under Project Orbis. Project Orbis, initiated and advocated by the Oncology Center of Excellence (OCE) of the U.S. Food and Drug Administration (the “FDA”), provides a collaborative mechanism and framework among the FDA and regulatory authorities in other countries and regions, allowing different regulatory authorities to jointly review the applications for registration of oncology drugs. Toripalimab was the first domestic oncology drug to be included in Project Orbis. Previously, the Therapeutic Goods Administration of the Australian Government Department of Health and Aged Care (the “TGA”) approved two New Chemical Entity applications for toripalimab in NPC under Project Orbis. 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 to induce PD-1 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. More 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, Europe and Southeast Asia. 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 eleven 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); in combination with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) patients. The first 10 indications have been included in the National Reimbursement Drug List (NRDL) (2024 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma, perioperative treatment of NSCLC, treatment of RCC and treatment of TNBC. In October 2024, toripalimab for the treatment of recurrent or metastatic NPC was approved in Hong Kong SAR, China. Internationally, toripalimab has been approved for marketing in the United States, the European Union, India, the UK, Jordan, Australia, Singapore and other countries and regions. In addition, toripalimab BLAs are under reviews in many countries or regions around the global. 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 products have received approvals in China and international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 35 countries and regions including China, the US, and Europe. 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.). For more information, please visit: http://www.junshipharma.com. The content above comes from the network. if any infringement, please contact us to modify.

本周，第十一批集采传来新消息。3月27日，一份名为《进一步优化药品集采政策的方案（征求意见稿）》的文件在业内流传，其中提到集采药品将聚焦竞争充分的“老药”，竞争不充分或市场规模小的品种不纳入，高风险品种审慎纳入。又一集采品种停采。3 月 26 日，西藏自治区医疗保障局发布公告，近期药监部门对天津未名生物医药有限公司生产的 α2b 喷雾剂进行抽检，检验结果为“生物学活性不符合规定”。按照相关要求，建议西藏自治区医疗机构暂停采购天津未名生物生产的人干扰素 α2b 喷雾剂，中选企业封存召回，恢复时间另行通知。海外方面，3 月 27 日，美国卫生与公众服务部 (HHS) 宣布，将裁减约10000个全职工作岗位，其中涉及FDA约3500名全职员工。美国卫生部称这将不会影响医疗器械和药品的审批。更多详细资讯，健识局整理如下：重磅政策一览1、医保追溯平台已对接超350家药品耗材企业3月25日，据国家医保局消息，目前已搭建医保药品耗材追溯信息采集应用平台，鼓励药耗生产流通企业上传追溯信息，并提供了详细的操作指南。截止3月20日，已有超350家药品耗材生产、流通企业对接医保药品耗材追溯信息采集应用平台，上传及下载本企业产品的追溯信息，同时有近8000家药耗生产、流通企业咨询追溯信息上传查询相关情况，并积极筹备对接上传工作。2、又一集采品种停采3 月 26 日，西藏自治区医疗保障局发布公告，近期药监部门对天津未名生物医药有限公司生产的 α2b 喷雾剂进行抽检，检验结果为“生物学活性不符合规定”。按照《关于暂停采购天津未名生物医药有限公司人干扰素 α2b 喷雾剂的公告》、《干扰素省际联盟集中带量采购文件（文件编号：JX-YP2023-01）》相关要求，建议西藏自治区医疗机构暂停采购天津未名生物医药有限公司生产的人干扰素 α2b 喷雾剂，中选企业封存召回，恢复时间另行通知。3、10款药物被重点监控3月24日，上海阳光医药采购网发布《关于公布2025年1月药品挂网公开议价采购监管品种名单的通知》，公布2025年1月挂网公开议价超“黄线”、未通过公允性评估、重点监控药品幅度靠前且有一定采购金额的品种。此次利肺片、注射用二羟丙茶碱、注射用糜蛋白酶、活血通脉胶囊、富马酸福莫特罗吸入溶液、枣仁安神液、注射用氨苄西林钠、替米沙坦氢氯噻嗪胶囊等10个品种被纳入重点监控品种名单。其中，注射用二羟丙茶碱首次被纳入重点监控品种名单。4、第十一批国采规则或生变3月27日，一份名为《进一步优化药品集采政策的方案（征求意见稿）》的文件在业内流传。其中提到：集采药品聚焦竞争充分的“老药”，竞争不充分或市场规模小的品种不纳入，高风险品种审慎纳入；持有人或受托生产企业应当具有累计2年以上同类型制剂药品实际生产经验；防范过度内卷，对过评企业超20家，发布“超强竞争”提醒等。在业内人士看来，这份征求意见稿是“唯低价”集采政策转变的重要拐点，无底线低价时代过去，重质量时代来临。5、2025年版《中国药典》发布3月25日，国家药监局、国家卫健委发布了关于颁布2025年版《中华人民共和国药典》的公告，自2025年10月1日起施行。新版《中国药典》自2025年10月1日起施行，收载品种总计6385种，新增159种，修订1101种，不再收载32种。医药卫生事件1、卫材出售雷贝拉唑钠中国权益3月28日，日本卫材制药宣布，已将质子泵抑制剂雷贝拉唑钠肠溶片在中国的权利转让给康桥资本集团控制的北京顶峰生物医药有限公司。顶峰生物医药已开始销售活动，卫材将在过渡期间管理生产制造和营销授权的转让。根据协议条款，卫材将获得7.25亿元合同预付款，以及获得销售里程碑付款的权利。2、恒瑞医药19.7亿美元出海3月25日，恒瑞医药发布公告，将公司的脂蛋白（a）[Lp（a）]口服小分子项目HRS-5346大中华地区以外的权益有偿许可给默沙东。协议包括2亿美元首付款，最高17.7亿美元的里程碑付款，以及根据HRS-5346在大中华地区以外的销售情况支付的销售提成。HRS-5346是一种在研的Lp（a）口服小分子抑制剂，目前正在中国进行Ⅱ期临床试验。上述协议的签署有助于拓宽HRS-5346的海外市场，为全球患者提供优质的治疗选择，也将进一步提升恒瑞医药创新品牌和海外业绩。3、丽珠生物获10亿元增资3月26日，丽珠医药发布公告，拟使用自有资金人民币10亿元向丽珠生物增资，以认购丽珠生物8.43%股权，以满足丽珠生物研发项目及日常经营活动的资金需求。增资完成后，公司在丽珠生物的直接权益将由60.23%增加至66.54%。丽珠生物2023年净亏损10.26亿元，2024年亏损收窄至4.92亿元。增资后，其他股东股权被稀释，健康元持股比例从26.84%降至22.58%。4、上海莱士拟以42亿元收购南岳生物3月26日，上海莱士宣布，拟支付现金42亿元收购南岳生物100%股权。若南岳生物2025年采血浆量冲上305吨，上海莱士将额外向南岳生物实控人刘令安支付5000万元。南岳生物是湖南省唯一拥有GMP证照的血液制品生产企业，其生产基地的设计产能达500吨，目前旗下在运营的单采血浆站共9家，2024年采浆量达278吨。5、30余名医务人员主动上交讲课费3 月 27 日，重庆市北碚区纪委监委通报了一起以“讲课费”名义收受医药企业礼金的典型案件。发现部分药品供应商为维系与临床医生、科室主任的关系，同时为了推广公司药品，长期以“讲课”的名义组织相关人员参与会议活动，变相进行利益输送。据报道，2024年以来，北碚区全区对5家医疗机构违规收受红包礼金、诱导消费、不合理诊疗等方面突出问题开展监督检查。在区纪委监委的监督推动下，全区30余名医务人员主动上交“讲课费”。6、FDA裁员3500人3月27日，美国卫生与公众服务部（HHS）宣布，将再裁减约10000个全职工作岗位，其中涉及FDA约3500名全职员工。HHS强调，裁员计划不会影响FDA对药品、医疗器械或食品的审查进程。一周药械盘点1、君实生物宣布特瑞普利单抗在新加坡获批3月26日，君实生物宣布，特瑞普利单抗联合顺铂和吉西他滨用于复发、不能手术或放疗的，或转移性鼻咽癌成人患者的一线治疗的上市许可申请获得新加坡卫生科学局批准。特瑞普利单抗成为新加坡首个且唯一获批用于鼻咽癌的肿瘤免疫治疗药物。2、阿斯利康哮喘靶向药国内商业化上市3月24日，阿斯利康宣布，重度嗜酸粒细胞性哮喘（SEA）创新靶向生物制剂本瑞利珠单抗注射液在中国正式商业上市，用于成人和12岁及以上青少年重度嗜酸粒细胞性哮喘的维持治疗。3、礼来阿尔茨海默病药物欧洲上市申请被拒3月28日，欧洲药品管理局的人用药品委员会（CHMP）建议，拒绝批准礼来的阿尔茨海默病药物多奈单抗注射液上市。被拒的主要原因是，欧盟认为其在减缓患者认知能力下降方面效果有限，且患者使用后出现严重脑部肿胀的风险较高。4、赛诺菲新型siRNA疗法获FDA批准上市3月28日，赛诺菲宣布，FDA已批准Qfitlia作为首个抗凝血酶（AT）降低疗法，用于预防或减少成人及12岁以上儿童血友病A或B患者（无论是否存在VIII或IX因子抑制剂）的出血发作频率。Qfitlia是一款siRNA疗法，通过降低抗凝血酶，从而促进凝血酶生成，以实现止血平衡。该药通过皮下注射给药（50mg预充式注射笔），每年仅需注射6次。5、卡博替尼获批治疗神经内分泌肿瘤3月26日，Exelixis宣布FDA已批准卡博替尼用于治疗既往接受过治疗、不可切除的、局部晚期或转移性的、分化良好的胰腺神经内分泌肿瘤（pNET）和胰腺外NET（epNET）儿童（≥12岁）和成人患者。这是第一个获得FDA批准，用于系统治疗无论原发肿瘤部位、分级、生长抑素  受体表达和功能状态的经治神经内分泌肿瘤（NET）的药物。撰稿 | 方涛之编辑 | 江芸 贾亭运营 | 雾纪插图 | 视觉中国声明：健识局原创内容，未经许可请勿转载儿科爆满，身高焦虑让药企年入百亿上岸了，但200亿拿什么实现？信达生物请回答！营收净利双双爆雷，投资也亏了5亿，泰格医药路在何方？