SHANGHAI, July 17, 2024 (GLOBE NEWSWIRE) -- 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 National Medical Products Administration (NMPA) has accepted for review the supplemental new drug application (sNDA) for toripalimab (trade name: TUOYI, product code: JS001) combined with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC).
Liver cancer is a common malignant tumor of the digestive system worldwide, and the predominant pathological type is HCC (accounting for about 90% of global cases). According to the 2022 GLOBOCAN Report, there were 866,000 new cases and 759,000 deaths from liver cancer globally that year. China is particularly affected by liver cancer, with new liver cancer cases reaching 368,000 (accounting for 42.4% of global cases) in 2022, ranking fourth in new cases among domestic malignant tumors, and the number of deaths reaching 317,000 (accounting for 41.7% of global cases), ranking second among domestic malignant tumors. Due to its insidious onset, about 70%-80% of liver cancer patients in China are already at the intermediate or advanced stage upon first diagnosis, with a median OS of approximately only 10 months and a 5-year survival rate of approximately 12%. In recent years, the continuous emergence of combination therapies based on immunotherapy drugs has transformed the treatment landscape of advanced liver cancer, and achieving a radical cure after downstaging is gradually becoming a possibility.
The sNDA is based on the HEPATORCH study (NCT04723004), a multicenter, randomized, open-label, active-controlled phase III clinical study aiming to evaluate the efficacy and safety of toripalimab in combination with bevacizumab for the first-line treatment of unresectable or metastatic HCC compared to the standard treatment with sorafenib. Conducted across 57 centers nationwide in China, HEPATORCH was led by Principal Investigator Professor Jia FAN, President of Zhongshan Hospital affiliated to Fudan University and academician of the Chinese Academy of Sciences.
In June 2024, the primary endpoints of progression-free survival (PFS, based on independent radiological review) and overall survival (OS) of the HEPATORCH study met the pre-defined efficacy boundary. The results of the study showed that toripalimab in combination with bevacizumab for the first-line treatment of patients with advanced HCC could significantly prolong the PFS and OS of the patients compared with sorafenib, while improving the secondary endpoints such as objective response rate and time to progression. The safety profile of toripalimab was consistent with the known risks, and no new safety signals were identified. Further details will be presented at a future international academic conference.
Principal investigator Professor Jia FAN, Academician of Chinese Academy of Sciences and President of Zhongshan Hospital, said, "Due to the hidden onset of HCC, most domestic patients have already missed the opportunity for radical surgery at the time of initial diagnosis. The HEPATORCH study results show that first-line treatment of advanced HCC with toripalimab combined with bevacizumab offers significant survival benefits. The study also reaffirms the efficacy of combining immunosuppressants with anti-angiogenesis targeting drugs for advanced HCC. We eagerly await the approval of this therapy that combines toripalimab with bevacizumab, which will provide new treatment options for advanced HCC patients in China!"
"I'm delighted to see the successful submission of the sNDA for toripalimab's 11th indication," General Manager and CEO of Junshi Biosciences, Dr. Jianjun ZOU, said. "Since receiving marketing approval in 2018 as the first domestically developed anti-PD-1 monoclonal antibody, toripalimab has targeted the unmet needs of cancer patients in China and even internationally. As of now, it has been approved for 10 indications in 7 cancer types, many of which are exclusive indications. This sNDA is toripalimab's first indication in liver cancer, and once again, toripalimab is demonstrating its 'broad-spectrum' when battling cancer. Going forward, we will actively communicate with regulatory authorities to speed up the approval of this indication, so that more advanced liver cancer patients can benefit from our innovative therapy."
About Toripalimab
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.
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, 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 eight 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 April 2024, the Drug Office at the Department of Health in the Government of the Hong Kong Special Administration Region (DO) accepted the NDA 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.
In the United States, the US FDA has approved the Biologics License 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 in October 2023. The FDA has granted toripalimab 2 Breakthrough Therapy designations for the treatment of NPC, 1 Fast Track designation for the treatment of mucosal melanoma, and 5 Orphan Drug designations for the treatment of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and small cell lung cancer (SCLC).
In Europe, marketing authorization applications (MAA) were accepted by the European Medicines Agency (EMA) and the MHRA for 1) toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic NPC and 2) toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic ESCC, in December 2022 and February 2023.
In Australia, the new chemical entity (NCE) application was accepted by the Australia Therapeutic Goods Administration (TGA) in November 2023. The TGA has also granted toripalimab an Orphan Drug designation for the treatment of NPC.
In Singapore, the NDA application was accepted by the Singapore Health Sciences Authority (HSA) in January 2024. The HSA has also granted priority review designation for the NDA.
About Junshi Biosciences
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. Four 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 China and the US. 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 3,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit:
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上海,2024年7月17日(GLOBE NEWSWIRE)——致力于新疗法发现、开发和商业化的领先创新驱动型生物制药公司上海君实生物科学股份有限公司(君实生物科技,香港交易所:1877;上交所:688180)宣布,国家药品监督管理局(NMPA)已接受麻醉药补充新药申请(snDa)的审查奥利单抗(商品名:TUOYI,产品代码:JS001)与贝伐珠单抗联合用于不可切除或转移性肝细胞癌的一线治疗(HCC)。
肝癌是全球消化系统的常见恶性肿瘤,主要病理类型是肝癌(约占全球病例的90%)。根据2022年GLOBOCAN报告,当年全球有86.6万例肝癌新发病例和75.9万例死亡。中国尤其受到肝癌的影响,2022年肝癌新发病例达到36.8万例(占全球病例的42.4%),在国内恶性肿瘤中新发病例中排名第四,死亡人数达到31.7万例(占全球病例的41.7%),在国内恶性肿瘤中排名第二。由于其发病隐性,中国约70%-80%的肝癌患者在首次诊断时已经处于中期或晚期,中位操作系统只有大约10个月,5年生存率约为12%。近年来,基于免疫疗法药物的联合疗法的不断出现改变了晚期肝癌的治疗格局,在降期后实现根本性治愈已逐渐成为可能。
该snDA基于HEPATORCH研究(NCT04723004),这是一项多中心、随机、开放标签、主动对照的III期临床研究,旨在评估与索拉非尼标准治疗相比,托瑞帕利单抗与贝伐珠单抗联合用于不可切除或转移性肝癌一线治疗的疗效和安全性。HEPATORCH在中国全国57个中心开展,由首席研究员、复旦大学附属中山医院院长、中国科学院院士范佳教授领导。
2024年6月,HEPATORCH研究的无进展生存期(PFS,基于独立放射学审查)和总存活率(OS)的主要终点达到了预定义的疗效界限。研究结果表明,与索拉非尼相比,托利单抗与贝伐珠单抗联合用于晚期肝癌患者的一线治疗,可以显著延长患者的PFS和操作系统,同时改善客观反应率和进展时间等次要终点。托利单抗的安全特征与已知风险一致,没有发现新的安全信号。更多细节将在未来的国际学术会议上公布。
首席研究员、中国科学院院士、中山医院院长范佳教授说:“由于肝癌的隐性发作,大多数国内患者在初步诊断时已经错过了根治性手术的机会。HEPATORCH的研究结果表明,使用托利单抗联合贝伐珠单抗对晚期肝癌进行一线治疗可带来显著的生存益处。该研究还重申了将免疫抑制剂与抗血管生成靶向药物联合治疗晚期肝癌的疗效。我们热切地等待这种结合托瑞帕利单抗和贝伐珠单抗的疗法获得批准,它将为中国的晚期肝癌患者提供新的治疗选择!”
君实生物科技总经理兼首席执行官邹建军博士说:“我很高兴看到托利单抗第11个适应症的snDA成功提交。”“自2018年作为首款国内开发的抗PD-1单克隆抗体获得上市批准以来,托利单抗一直针对中国乃至国际癌症患者未满足的需求。截至目前,它已获准用于7种癌症类型的10种适应症,其中许多是独家适应症。该snDA是托利单抗在肝癌中的第一个适应症,托利单抗再次证明了其在对抗癌症时的 “广谱”。展望未来,我们将积极与监管机构沟通,以加快该适应症的批准,以便更晚期的肝癌患者可以从我们的创新疗法中受益。”
关于托利帕利单抗
托瑞帕利单抗是一种抗PD-1单克隆抗体,因其能够阻断PD-1与其配体 PD-L1 和 PD-L2 的相互作用以及增强受体内化(内吞功能)而开发。阻断 PD-1 与 PD-L1 和 PD-L2 的相互作用可增强免疫系统攻击和杀死肿瘤细胞的能力。
君实生物科学已在全球范围内开展了四十多项由公司赞助的托瑞帕利单抗临床研究,涵盖了超过十五种适应症,包括在中国、美国、东南亚和欧洲。正在进行或已完成的评估托利单抗安全性和有效性的关键临床试验涵盖多种肿瘤类型,包括肺癌、鼻咽癌、食道癌、胃癌、膀胱癌、乳腺癌、肝癌、肾癌和皮肤癌。
在中国大陆,托利单抗是国内首个获准上市的抗PD-1单克隆抗体(在中国获批为拓益)。目前,托利单抗在中国大陆有八种获批的适应症:
- 标准全身治疗失败后无法切除或转移的黑色素瘤;
- 在先前的至少两条全身治疗失败后,复发性或转移性鼻咽癌(NPC);
- 含铂化疗失败或在新辅助或辅助含铂化疗后 12 个月内进展的局部晚期或转移性尿路上皮癌;
- 与顺铂和吉西他滨联合用作局部复发性或转移性鼻咽癌患者的一线治疗;
- 与紫杉醇和顺铂联合用于不可切除的局部晚期/复发性或远处转移性食管鳞状细胞癌(ESCC)患者的一线治疗;
- 与培美曲塞和铂联合用作表皮生长因子突变阴性和ALK突变阴性、不可切除、局部晚期或转移性非鳞状非小细胞肺癌(NSCLC)的一线治疗;
- 与化疗联合作为围手术期治疗,随后与单一疗法联合作为辅助疗法,用于治疗可切除的IIIA-IIB期非小细胞肺癌的成年患者;
- 与阿西替尼联合用于中到高风险不可切除或转移性肾细胞癌(RCC)患者的一线治疗;
- 与依托泊苷加铂联合用于广泛期小细胞肺癌(ES-SCLC)的一线治疗;
- 与注射用紫杉醇(白蛋白结合型)联合用于复发性或转移性三阴性乳腺癌(TNBC)的一线治疗。
前六种适应症已被纳入国家报销药品清单(NRDL)(2023年版)。托利单抗是NRDL中唯一一种用于治疗黑色素瘤的抗PD-1单克隆抗体。2024年4月,香港特别行政区政府卫生署药物办公室接受了托利单抗与顺铂和吉西他滨联合用于一线治疗局部晚期鼻咽癌的成年人的保密协议,以及托利单抗作为单一药物的保密协议,用于治疗复发、不可切除或转移性鼻咽癌的成年人含铂化疗期间或之后出现疾病进展的PC。
在美国,美国食品药品管理局批准了托利单抗联合顺铂和吉西他滨的生物制剂许可申请,用于一线治疗转移性或复发性局部晚期鼻咽癌的成年人,以及托瑞帕利单抗作为单一药物,用于治疗在含铂化疗期间或之后出现疾病进展的复发、不可切除或转移性鼻咽癌的成年人于 2023 年 10 月。美国食品药品管理局已授予治疗鼻咽癌的托利单抗2突破性疗法称号,1项用于治疗粘膜黑色素瘤的快速通道称号,以及5种用于治疗食管癌、NPC、粘膜黑色素瘤、软组织肉瘤和小细胞肺癌(SCLC)的孤儿药称号。
在欧洲,欧洲药品管理局(EMA)和MHRA接受了以下申请的上市许可申请(MAA):1)托利单抗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;2)托利单抗联合紫杉醇和顺铂用于一线治疗局部晚期/复发性不可切除患者的上市许可申请(MAA)转移性 ESCC,于 2022 年 12 月和 2023 年 2 月。
在澳大利亚,新的化学实体(NCE)申请于2023年11月被澳大利亚治疗用品管理局(TGA)接受。TGA还授予托利单抗治疗鼻咽癌的孤儿药称号。
在新加坡,保密协议的申请于2024年1月被新加坡健康科学管理局(HSA)接受。HSA还批准了NDA的优先审查指定。
关于君实生物科技
君实生物科技(香港交易所:1877;上交所:688180)成立于2012年12月,是一家以创新为导向的生物制药公司,致力于创新疗法的发现、开发和商业化。该公司已经建立了多元化的研发渠道,包括50多种候选药物,五个治疗重点领域涵盖癌症、自身免疫、代谢、神经系统和传染病。该公司的四项创新已经进入中国或国际市场,其中之一是托利单抗,这是中国首个国产和自主开发的抗PD-1单克隆抗体,已在中国和美国获得批准。此外,目前有30多种药物正在临床开发中。在 COVID-19 疫情期间,君实生物科学积极承担了一家中国制药公司的社会责任,参与开发依替西维单抗、明德威和其他用于预防和治疗 COVID-19 的新疗法。
君实生物以 “为患者提供世界一流、值得信赖、价格合理的创新药物” 为使命,“在中国,面向全球”。目前,该公司在美国(旧金山和马里兰州)和中国(上海、苏州、北京、广州等)拥有约3,000名员工。欲了解更多信息,请访问:
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