SHANGHAI, China, Oct. 27, 2023 (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 the presentation of new clinical trial results at the European Society of Oncologists (“ESMO”) Immuno-Oncology Congress 2023, an international conference held in Madrid, Spain, from October 20th to 24th.

中国上海，2023年10月27日（GLOBE NEWSWIRE）-上海均石生物科技有限公司（“Junshi Biosciences”，HKEX:1877；SSE:688180），一家专注于发现的领先创新型生物制药公司，开发和商业化新疗法，宣布于10月20日至24日在西班牙马德里举行的国际会议欧洲肿瘤学会（“ESMO”）免疫肿瘤学大会2023上发布新的临床试验结果。

At the ESMO Congress 2023, Junshi Bioscience showcased a total of 11 clinical trials involving the groundbreaking immune-oncology drug, toripalimab (anti-PD-1 monoclonal antibody), in the forms of 1 late-breaking abstract, 2 proffered paper oral presentations, and 8 posters. These trials encompass ten diverse fields, including lung cancer, kidney cancer, head and neck cancer, breast cancer, colorectal cancer, cervical cancer, thymus cancer, and lymphoma..

在2023年ESMO大会上，Junshi Bioscience共展示了11项涉及开创性免疫肿瘤药物toripalimab（抗PD-1单克隆抗体）的临床试验，其中包括1篇最新摘要，2篇提供纸质口头报告，和8张海报。这些试验包括十个不同的领域，包括肺癌，肾癌，头颈癌，乳腺癌，结肠直肠癌，宫颈癌，胸腺癌和淋巴瘤。。

“This year’s ESMO Congress highlighted the most recent results from 11 clinical studies conducted with our core product, toripalimab,” said Dr. Jianjun ZOU, Global Research and Development President of Junshi Biosciences. “Among these studies, the results of EXTENTORCH study involving small cell lung cancer and the RENOTORCH study focusing on renal cell carcinoma were presented for the first time.

Junshi生物科学全球研究与发展总裁邹建军博士说：“今年的ESMO大会强调了我们核心产品toripalimab进行的11项临床研究的最新结果。“在这些研究中，首次提出了涉及小细胞肺癌的EXTENTORCH研究结果和关注肾细胞癌的RENOTORCH研究结果。

As ‘PD-1+X’ combination therapy achieves further clinical advancement across multiple indications, it will further bolster Junshi Biosciences’ extensive immuno-oncology pipeline, one that has been cultivated through many years of dedication.”.

由于“PD-1+X”联合治疗在多种适应症方面取得了进一步的临床进展，它将进一步支持Junshi Biosciences广泛的免疫肿瘤学管道，这是经过多年奉献培育而成的。

The RENOTORCH Study: Median PFS reaches 18.0 months! Record-setting results for 1st line immunotherapy in advanced kidney cancer

RENOTORCH研究：中位PFS达到18.0个月！晚期肾癌一线免疫治疗记录结果

Led by Professor Jun GUO of Beijing Cancer Hospital and Professor Yiran HUANG of Renji Hospital affiliated with Shanghai Jiao Tong University School of Medicine, RENOTORCH is China’s first phase III clinical study to focus on immunotherapy for advanced renal cell carcinoma. Study findings were unveiled for the first time during a proffered paper session at the ESMO Congress.

RENOTORCH由北京肿瘤医院郭军教授和上海交通大学医学院附属仁济医院黄一兰教授领导，是中国首个专注于晚期肾细胞癌免疫治疗的III期临床研究。研究结果首次在ESMO大会上的一篇论文中公布。

Professor Xinan SHENG of Beijing Cancer Hospital gave a comprehensive overview of the research results in the oral presentation. The full manuscript of the study has also been published in Annals of Oncology (Impact factor 51.8) on the day of presentation..

北京肿瘤医院的Xinan SHENG教授在口头报告中全面概述了研究结果。该研究的完整手稿也已在发表当天的《肿瘤学年鉴》（影响因子51.8）上发表。。

The RENOTORCH study (NCT04394975) is a randomized, open-label, multicenter phase III clinical study that enrolled 421 patients from 47 medical centers with intermediate to high-risk unresectable or metastatic renal cell carcinoma (RCC) who had received no prior systematic treatment. RENOTORCH is the first pivotal phase III study of immunotherapy for advanced RCC in China..

RENOTORCH研究（NCT04394975）是一项随机，开放标签，多中心的III期临床研究，纳入了来自47个医疗中心的421名患有中高危不可切除或转移性肾细胞癌（RCC）的患者，这些患者之前未接受过系统治疗。RENOTORCH是中国晚期RCC免疫治疗的第一个关键性III期研究。。

As of March 31, 2023 (median follow-up time of 14.6 months), the RENOTORCH interim analysis results demonstrated that when compared to sunitinib monotherapy, toripalimab combined with axitinib significantly improved the patients’ progression-free survival (PFS) and objective response rate (ORR) while maintaining a manageable safety profile..

截至2023年3月31日（中位随访时间为14.6个月），RENOTORCH中期分析结果显示，与舒尼替尼单药治疗相比，toripalimab联合axitinib显着改善患者的无进展生存期（PFS）和客观缓解率（ORR），同时保持可管理的安全性。。

According to assessments by the independent review committee (IRC), the median PFS was 18.0 months in the toripalimab-axitinib group, nearly double that of the sunitinib group, which had a median PFS of 9.8 months. Toripalimab plus axitinib reduced the risk of disease progression or death by 35% (HR=0.65; 95% CI: 0.49-0.86; P=0.0028) compared to sunitinib.

根据独立审查委员会（IRC）的评估，toripalimab-axitinib组的中位PFS为18.0个月，几乎是舒尼替尼组的两倍，舒尼替尼组的中位PFS为9.8个月。与舒尼替尼相比，Toripalimab加axitinib可将疾病进展或死亡风险降低35%（HR=0.65；95%CI:0.49-0.86；P=0.0028）。

The 1-year and 2-year PFS rates of these two groups were 62.7% vs. 45.4% and 44.6% vs. 30.2%, respectively. Notably, unlike previous studies of a similar nature that included patients across all risk levels, this study only enrolled patients at intermediate to high risk and yet still achieved the longest median PFS ever reported in 1st line RCC..

这两组的1年和2年PFS率分别为62.7%和45.4%，44.6%和30.2%。值得注意的是，与之前包括所有风险水平患者的类似性质的研究不同，本研究仅纳入中高危患者，但仍达到一线RCC报道的最长中位PFS。。

When compared to patients in the sunitinib group, toripalimab-axitinib provided a superior ORR (IRC-assessed ORR of 56.7% vs. 30.8%, P<0.001) and a prolonged duration of response (DoR) (median DoR not yet reached vs. 16.7 months; HR=0.614; 95% CI: 0.340-1.137).

与舒尼替尼组患者相比，toripalimab axitinib提供了更好的ORR（IRC评估的ORR为56.7%对30.8%，P<0.001）和延长的反应持续时间（DoR）（中位DoR尚未达到vs.16.7个月）；HR=0.614；95%CI:0.340-1.137）。

At the interim analysis, an OS trend favoring the toripalimab plus axitinib combination over sunitinib monotherapy (median OS not yet reached vs. 26.8 months) has also been demonstrated, with a 39% lower risk of death (HR=0.61; 95% CI: 0.40-0.92). The 1-year and 2-year OS rates of the toripalimab-axitinib group and sunitinib group were 90.5% vs.

在中期分析中，也证实了支持toripalimab加axitinib联合治疗优于舒尼替尼单药治疗的OS趋势（中位OS尚未达到vs.26.8个月），死亡风险降低了39%（HR=0.61；95%CI:0.40-0.92）。toripalimab axitinib组和舒尼替尼组的1年和2年OS率分别为90.5%和90.5%。

81.9% and 71.8% vs. 63.2%, respectively..

分别为81.9%和71.8%对63.2%。。

The combination had a manageable safety profile and no new safety signals were identified.

该组合具有可管理的安全性，未发现新的安全信号。

In July 2023, based on RENOTORCH’s promising results, the National Medical Products Administration (NMPA) formally accepted the supplemental new drug application for toripalimab plus axitinib as the first-line treatment for patients with unresectable or metastatic RCC.

2023年7月，基于RENOTORCH的有希望的结果，国家医疗产品管理局（NMPA）正式接受toripalimab加axitinib的补充新药申请，作为不可切除或转移性RCC患者的一线治疗。

The EXTENTORCH Study: World’s 1st PD-1 inhibitor to achieve both positive PFS and OS results in phase III SCLC study

EXTENTORCH研究：世界上第一个在III期SCLC研究中获得阳性PFS和OS结果的PD-1抑制剂

EXTENTORCH, a phase III study of toripalimab combined with chemotherapy as first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), made its debut as a late-breaking abstract at the ESMO Congress 2023. The study was led by principal investigator Professor Ying CHENG of Jilin Cancer Hospital, and presented by Professor Ying LIU from Jilin Cancer Hospital at the ESMO Congress..

EXTENTORCH是toripalimab联合化疗作为广泛期小细胞肺癌（ES-SCLC）一线治疗的III期研究，在2023年ESMO大会上首次亮相，成为最新的摘要。该研究由吉林省肿瘤医院首席研究员应成教授领导，由吉林省肿瘤医院刘颖教授在ESMO大会上发表。。

The EXTENTORCH study (NCT04012606) is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study designed to compare the efficacy and safety of toripalimab vs. placebo in combination with etoposide plus platinum for the first-line treatment of ES-SCLC. EXTENTORCH enrolled a total of 442 ES-SCLC patients who had received no prior systematic treatment from 51 medical centers in China.

EXTENTORCH研究（NCT04012606）是一项随机，双盲，安慰剂对照，多中心III期临床研究，旨在比较toripalimab与安慰剂联合依托泊苷加铂用于一线治疗的疗效和安全性。ES-SCLC。EXTENTORCH共招募了442名来自中国51个医疗中心的未接受过系统治疗的ES-SCLC患者。

In May 2023, EXTENTORCH successfully reached its primary endpoints, and toripalimab became the world’s first PD-1 inhibitor to achieve two primary endpoints, OS and PFS, in a phase III study of first-line treatment for ES-SCLC..

2023年5月，在ES-SCLC一线治疗的III期研究中，EXTENTORCH成功达到其主要终点，toripalimab成为世界上第一个实现两个主要终点OS和PFS的PD-1抑制剂。。

The findings from the EXTENTORCH study revealed that compared to chemotherapy alone, toripalimab plus chemotherapy for the first-line treatment of patients with ES-SCLC, coupled with toripalimab monotherapy as maintenance therapy, significantly prolonged PFS and OS while maintaining a manageable safety profile.

来自EXTENTORCH研究的结果显示，与单独化疗相比，toripalimab加化疗用于ES-SCLC患者的一线治疗，加上toripalimab单药治疗作为维持治疗，显着延长了PFS和OS，同时保持了可控的安全性。

With these promising results, toripalimab combined with chemotherapy is poised to become a standard first-line therapy for ES-SCLC..

有了这些有希望的结果，toripalimab联合化疗有望成为ES-SCLC的标准一线治疗方法。。

The final PFS analysis (median follow-up time of 11.8 months) demonstrated that compared to chemotherapy alone, toripalimab combined with chemotherapy significantly improved patients’ PFS (researcher-assessed median PFS of 5.8 vs. 5.6 months) while reducing the risk of disease progression or death by 33% (HR=0.667; 95% CI: 0.539-0.824; P=0.0002)..

最终的PFS分析（中位随访时间为11.8个月）表明，与单独化疗相比，toripalimab联合化疗显着改善了患者的PFS（研究人员评估的中位PFS为5.8对5.6个月），同时降低了疾病进展的风险或死亡33%（HR=0.667；95%CI:0.539-0.824；P=0.0002）。。

Biomarker analyses revealed that both PFS and OS improved in the toripalimab-chemotherapy group, regardless of the patients’ tumor mutational burden (TMB) status. Additionally, mutations in focal adhesion/integrin pathway were associated with poorer PFS and OS prognoses in patients receiving toripalimab plus chemotherapy..

生物标志物分析显示，无论患者的肿瘤突变负荷（TMB）状态如何，toripalimab化疗组的PFS和OS均有所改善。此外，在接受toripalimab加化疗的患者中，粘着斑/整联蛋白途径的突变与较差的PFS和OS预后相关。。

In terms of safety, toripalimab combined with chemotherapy has a manageable safety profile and no new safety signals were identified.

在安全性方面，toripalimab联合化疗具有可控的安全性，未发现新的安全性信号。

In July 2023, based on the EXTENTORCH trial results, the NMPA accepted the supplemental new drug application for toripalimab plus etoposide and platinum as the first-line treatment of ES-SCLC.

2023年7月，根据EXTENTORCH试验结果，NMPA接受了toripalimab加依托泊苷和铂的补充新药申请，作为ES-SCLC的一线治疗。

About Junshi Biosciences

关于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.

Junshi Biosciences（HKEX:1877；SSE:688180）成立于2012年12月，是一家创新驱动的生物制药公司，致力于创新疗法的发现，开发和商业化。该公司已建立多元化的研发渠道，包括50多种候选药物，其中五个治疗重点领域涵盖癌症，自身免疫，代谢，神经和传染病。

Four of the company’s innovations have already reached the Chinese or international markets, one of which is China’s first self-developed anti-PD-1 monoclonal antibody, toripalimab. 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..

该公司的四项创新已经进入中国或国际市场，其中之一是中国第一个自行开发的抗PD-1单克隆抗体toripalimab。此外，目前有30多种药物正在临床开发中。在COVID-19大流行期间，Junshi Biosciences通过参与开发etesevimab，MINDEWEI®和其他用于预防和治疗COVID-19的新疗法，积极承担中国制药公司的社会责任。。

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).

Junshi Biosciences的使命是“为患者提供世界一流，值得信赖，价格合理和创新的药物”，其使命是“在中国，全球”。目前，该公司在美国（旧金山和马里兰州）拥有约3000名员工。和中国（上海，苏州，北京，广州等）。

For more information, please visit: http://junshipharma.com..

欲了解更多信息，请访问：http://junshipharma.com..

Junshi Biosciences Contact Information

Junshi Biosciences联系信息

IR Team:

IR团队：

Junshi Biosciences

Junshi生物科学

info@junshipharma.com

info@junshipharma.com

+ 86 021-6105 8800

+ 86 021-6105 8800

PR Team:

公关团队：

Junshi Biosciences

Junshi生物科学

Zhi Li

李志

zhi_li@junshipharma.com

zhi_li@junshipharma.com

+ 86 021-6105 8800

+ 86 021-6105 8800