厉, 智, Author at 开云体育首存 - kaiyun体育全站入口 //www.yitiaoweiba.com/en/author/zhi_li/ 创新疗法的发现、开发和商业化的生物制药公司。 Thu, 27 Mar 2025 08:51:30 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.2 //www.yitiaoweiba.com/wp-content/uploads/2022/07/cropped-favicon-32x32.png 厉, 智, Author at 开云体育首存 - kaiyun体育全站入口 //www.yitiaoweiba.com/en/author/zhi_li/ 32 32 Junshi Biosciences Announces Toripalimab’s Approval in Singapore //www.yitiaoweiba.com/en/%e5%90%9b%e5%ae%9e%e7%94%9f%e7%89%a9%e5%ae%a3%e5%b8%83%e7%89%b9%e7%91%9e%e6%99%ae%e5%88%a9%e5%8d%95%e6%8a%97%e5%9c%a8%e6%96%b0%e5%8a%a0%e5%9d%a1%e8%8e%b7%e6%89%b9-2-2/ Wed, 26 Mar 2025 11:00:00 +0000 //www.yitiaoweiba.com/%e5%90%9b%e5%ae%9e%e7%94%9f%e7%89%a9%e5%ae%a3%e5%b8%83%e7%89%b9%e7%91%9e%e6%99%ae%e5%88%a9%e5%8d%95%e6%8a%97%e5%9c%a8%e6%96%b0%e5%8a%a0%e5%9d%a1%e8%8e%b7%e6%89%b9-2/ SHANGHAI, China, 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.

]]> 开云体育首存宣布特瑞普利单抗在新加坡获批 //www.yitiaoweiba.com/en/%e5%90%9b%e5%ae%9e%e7%94%9f%e7%89%a9%e5%ae%a3%e5%b8%83%e7%89%b9%e7%91%9e%e6%99%ae%e5%88%a9%e5%8d%95%e6%8a%97%e5%9c%a8%e6%96%b0%e5%8a%a0%e5%9d%a1%e8%8e%b7%e6%89%b9-2/ Wed, 26 Mar 2025 11:00:00 +0000 //www.yitiaoweiba.com/%e5%90%9b%e5%ae%9e%e7%94%9f%e7%89%a9%e5%ae%a3%e5%b8%83%e7%89%b9%e7%91%9e%e6%99%ae%e5%88%a9%e5%8d%95%e6%8a%97%e5%9c%a8%e6%96%b0%e5%8a%a0%e5%9d%a1%e8%8e%b7%e6%89%b9-2-2/ 北京时间2025年3月26日，开云体育首存（1877.HK，688180.SH）宣布，由公司自主研发的抗PD-1单抗药物特瑞普利单抗（新加坡商品名：LOQTORZI®）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（HSA）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。

鼻咽癌是一种发生于鼻咽部黏膜上皮的恶性肿瘤，是常见的头颈部恶性肿瘤之一。据了解，2022年鼻咽癌在全球范围内确诊的新发病例数超过12万1。特瑞普利单抗是《美国国家综合癌症网络（NCCN）头颈部肿瘤临床实践指南2025.V1》中推荐用于复发/转移性鼻咽癌全线治疗的唯一首选药物2。

本次鼻咽癌适应症的获批主要基于JUPITER-02（一项针对一线治疗鼻咽癌的随机、双盲、安慰剂对照、国际多中心Ⅲ期临床研究，NCT03581786）的研究结果。JUPITER-02研究是鼻咽癌免疫治疗领域首个国际多中心、样本量最大的双盲、随机对照III期临床研究，也是全球首个鼻咽癌一线免疫联合化疗对比单纯化疗将总生存期（OS）预设有统计学检验（一类错误控制）并确证具有生存获益的Ⅲ期临床研究。该研究结果曾以口头报告形式亮相2021年美国临床肿瘤学会（ASCO）年会全体大会（#LBA2），随后荣登《自然-医学》（Nature Medicine）杂志封面，并获得《美国医学会杂志》（Journal of the American Medical Association，JAMA）全文发表。

研究结果显示，与单纯化疗相比，特瑞普利单抗联合化疗使患者的疾病进展风险降低48%，死亡风险降低37%。特瑞普利单抗联合化疗组的中位无进展生存期（PFS）对比单纯化疗延长了13.2个月，从8.2个月提升至21.4个月。此外，接受该联合疗法治疗的患者可获得更高的客观缓解率（ORR）和更长的持续缓解时间（DoR），完全缓解（CR）率达到26.7%，且未发现新的安全性信号。长期生存随访数据在2024年ASCO年会展示，特瑞普利单抗治疗组5年生存率达到52%。

开云体育首存总经理兼首席执行官邹建军博士表示：“特瑞普利单抗在新加坡获批标志着我们正式登陆东南亚市场。东南亚是鼻咽癌的高发地区之一，我们很高兴能够将鼻咽癌领域具有划时代意义的创新疗法带给东南亚患者，以改变当地的治疗格局。目前，特瑞普利单抗已成功在全球四个大洲的超过35个国家和地区获批上市。我们将继续深化‘立足中国，布局全球’的国际化战略，推动中国创新药造福世界患者。”

此次上市许可申请的递交是通过奥比斯项目（Project Orbis）。该项目由美国食品药品监督管理局（FDA）肿瘤学卓越中心（OCE）发起和倡导，为FDA和其它国家及地区的监管机构搭建合作机制和框架，允许不同监管机构共同审评肿瘤药品的注册申请。特瑞普利单抗治疗是首个被纳入奥比斯项目的国产肿瘤药，此前开云体育首存通过奥比斯项目向澳大利亚药品管理局（TGA）递交的特瑞普利单抗鼻咽癌适应症的2项上市许可申请已获得TGA批准。

【参考文献】
1. https://gco.iarc.who.int/media/globocan/factsheets/cancers/4-nasopharynx-fact-sheet.pdf.
2. 2025NCCN 临床实践指南：头颈部肿瘤（2025.V1）

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。

]]> Junshi Biosciences Announces Four New Indications of Toripalimab Included in the NRDL //www.yitiaoweiba.com/en/junshi-biosciences-announces-four-new-indications-of-toripalimab-included-in-the-nrdl/ Thu, 28 Nov 2024 09:30:00 +0000 //www.yitiaoweiba.com/?p=3172 SHANGHAI, China, November 28, 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, announced that four new indications of the company’s product toripalimab injection (trade name: TUOYI®, product code: JS001) were successfully included in Category of the National Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (Year 2024) (the “NRDL”). The new edition of the NRDL will be officially come into effect on 1 January 2025.

Up till now, ten approved indications of TUOYI® in Chinese mainland were all included in the NRDL and it is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma, perioperative treatment of non-small cell lung cancer (“NSCLC”), treatment of renal carcinoma and treatment of triple-negative breast cancer (“TNBC”).

Indications:

  1. Treatment for unresectable or metastatic melanoma after failure of standard systemic therapy;
  2. Treatment for locally advanced or metastatic urothelial carcinoma that failed platinum containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum containing chemotherapy;
  3. Treatment for patients with recurrent/metastatic nasopharyngeal carcinoma (“NPC”) after failure of at least two lines of prior systemic therapy;
  4. First-line treatment for patients with locally recurrent or metastatic NPC;
  5. First-line treatment for patients with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma;
  6. First-line treatment for patients with EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous NSCLC;
  7. The product in combination with chemotherapy as perioperative treatment and subsequently, monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB NSCLC;
  8. The product in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma;
  9. The product in combination with etoposidein plus platinum for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC);
  10. The product in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic TNBC with a well-validated test to evaluate PD-L1 positive (CPS ≥ 1).

Items 7 to 10 are new indications included in the NRDL.

In addition, the successful inclusion of the 4 new indications of TUOYI® in the NRDL is the first time that the NRDL included immunotherapy for perioperative NSCLC, renal carcinoma, small cell lung cancer and TNBC.

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