8月8日，沪深两融数据显示，君实生物获融资买入额0.95亿元，居两市第190位，当日融资偿还额1.02亿 元，净卖出664.07万元。 最近三个交易日，6日-8日，君实生物分别获融资买入1.73亿元、1.01亿元、0.95亿元。 融券方面，当日融券卖出0.73万股，净卖出0.67万股。 本文源自：金融界 作者：智投君 ...

Core Viewpoint - Shanghai Junshi Biosciences has received acceptance for a new indication application for Toripalimab in treating HER2-expressing urothelial carcinoma, highlighting the company's ongoing innovation in cancer treatment [1][2]. Group 1: Drug Information - Toripalimab (brand name: Tuoyi) is a PD-1 monoclonal antibody that has been approved for multiple indications in China, including advanced urothelial carcinoma [4]. - The new indication application is based on the RC48-C016 study, a Phase III clinical trial comparing Toripalimab combined with the antibody-drug conjugate Vadimezumab against traditional chemotherapy in patients with HER2-expressing locally advanced or metastatic urothelial carcinoma [2][3]. - The study's primary endpoints, progression-free survival (PFS) and overall survival (OS), met the pre-defined efficacy boundaries, indicating significant benefits over traditional chemotherapy [3]. Group 2: Market Context - Urothelial carcinoma is one of the top ten most common malignant tumors globally, with increasing incidence and mortality rates in China, posing a significant unmet clinical need [2]. - The introduction of new therapies, including PD-(L)1 inhibitors and novel antibody-drug conjugates, is reshaping the treatment landscape for advanced urothelial carcinoma, offering more diverse and precise treatment options compared to traditional chemotherapy [2]. Group 3: Regulatory and Approval Status - The application for the new indication has been officially accepted by the National Medical Products Administration, with the registration numbers CXSS2500079 and CXSS2500080 [1]. - Toripalimab has been involved in over 40 clinical studies across more than 15 indications globally, demonstrating its extensive research and development efforts [4].

Core Viewpoint - Shanghai Junshi Biosciences has received acceptance for a new indication application for Toripalimab in treating HER2-expressing locally advanced or metastatic urothelial carcinoma, marking a significant step in expanding treatment options for this cancer type [1][2][3] Group 1: Drug Information - The drug Toripalimab (brand name: Tuoyi) is a PD-1 monoclonal antibody and is the first domestically approved PD-1 targeted monoclonal antibody in China [4] - The application for the new indication is based on the RC48-C016 study, a Phase III clinical trial comparing the efficacy and safety of Toripalimab combined with Vadimezumab against Gemcitabine combined with Cisplatin/Carboplatin in patients with HER2-expressing locally advanced or metastatic urothelial carcinoma [3] - The study demonstrated that Toripalimab combined with Vadimezumab significantly prolonged progression-free survival (PFS) and overall survival (OS) compared to traditional chemotherapy [3] Group 2: Market Context - Urothelial carcinoma is one of the top ten most common malignant tumors globally, with a rising incidence and mortality rate in China, highlighting a significant unmet clinical need [2] - The emergence of PD-(L)1 monoclonal antibodies and novel antibody-drug conjugates over the past five years is reshaping the treatment landscape for advanced urothelial carcinoma, offering improved survival benefits and tolerability compared to traditional chemotherapy [2]

Core Viewpoint - Junshi Biosciences (01877) has received a notice of acceptance from the National Medical Products Administration for the new indication application of Toripalimab (brand name: Tuoyi®, product code: JS001) in combination with the antibody-drug conjugate Vidisirtan for patients with locally advanced or metastatic urothelial carcinoma expressing HER2 [1] Group 1: Clinical Research and Results - The new indication application is based on the RC48-C016 study, a Phase III clinical trial comparing the efficacy and safety of Toripalimab combined with Vidisirtan versus Gemcitabine combined with Cisplatin/Carboplatin in patients with locally advanced or metastatic urothelial carcinoma expressing HER2 [1] - The primary endpoints of the RC48-C016 study, progression-free survival (PFS) and overall survival (OS), met the predefined superiority boundaries, indicating that the combination therapy significantly extends PFS and OS compared to the standard treatment [2] Group 2: Product and Market Position - Toripalimab is the first domestically approved PD-1 monoclonal antibody in China and has been involved in over 40 clinical studies covering more than 15 indications globally [3] - As of the announcement date, Toripalimab has received approval for 12 indications in mainland China and has been included in the national medical insurance directory for 10 indications, making it the only PD-1 monoclonal antibody listed for treating melanoma, non-small cell lung cancer perioperatively, renal cancer, and triple-negative breast cancer [3] - The product has also gained approval in various international markets, including the US, EU, India, UK, Jordan, Australia, and Singapore [3]

SHANGHAI JUNSHI BIOSCIENCES CO., LTD.* 上海君實生物醫藥科技股份有限公司 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 於本公告日期，本公司董事會包括執行董事熊俊先生、李寧博士、鄒建軍博士、 李聰先生、張卓兵先生、姚盛博士、王剛博士及李鑫博士；非執行董事湯毅先 生；以及獨立非執行董事張淳先生、馮曉源博士、楊悅博士、酈仲賢先生及魯琨 女士。 （於中華人民共和國註冊成立的股份有限公司） * 僅供識別之用 （股份代號：1877） 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條規則作出。 茲載列上海君實生物醫藥科技股份有限公司在上海證券交易所網站刊發之《上海 君實生物醫藥科技股份有限公司自願披露關於特瑞普利單抗一線治療HER2表達 的尿路上皮癌的新適應症上市申請獲得受理的公告》，僅供參閱。 承董事會命 上海君實生物醫藥科技股份有限公司 熊俊先生 主席 中國，上海，2025年8月8日 二、药 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 SHANGHAI JUNSHI BIOSCIENCES CO., LTD.* 上海君實生物醫藥科技股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1877） 自願性公告－ 特瑞普利單抗一線治療HER2表達的尿路上皮癌的 新適應症上市申請獲得受理 尿路上皮癌是全球十大常見惡性腫瘤之一，在我國的發病率和死亡率呈逐年上 升趨勢。根據國家癌症中心最新數據，2022年我國尿路上皮癌新發病例數9.29萬 例，死亡超4萬例，嚴重威脅着患者生命健康，存在巨大尚未被滿足的臨床需求。 1 2021年，特瑞普利單抗獲批用於晚期尿路上皮癌的二線及以上治療，是我國首個 獲批的晚期尿路上皮癌非選擇性人群適應症的免疫治療藥物。過去5年間，PD- (L)1單抗與新型抗體偶聯藥物的出現，正在不斷重塑晚期尿路上皮癌的治療格 局。與傳統化療相比，新型療法在生存獲益和耐受性方面均展現出顯著優勢，使 患者的治療選擇更加多元 ...

Core Viewpoint - Junshi Biosciences (688180.SH) has received the acceptance notice from the National Medical Products Administration for the new indication application of Toripalimab (brand name: Tuoyi, product code: JS001) in combination with the antibody-drug conjugate Vidutolimab for patients with locally advanced or metastatic urothelial carcinoma expressing HER2 [1] Group 1 - The new indication application is based on the RC48-C016 study (NCT05302284), which is a multicenter, randomized, open-label, positive-controlled Phase III clinical trial [1] - The study aims to compare the efficacy and safety of Toripalimab combined with Vidutolimab versus Gemcitabine combined with Cisplatin/Carboplatin in patients with locally advanced or metastatic urothelial carcinoma expressing HER2 who have not previously received systemic antitumor therapy [1] - The study is led by Professor Guo Jun from Peking University Cancer Hospital and Professor Zhou Aiping from the Chinese Academy of Medical Sciences Cancer Hospital, conducted across 74 clinical centers nationwide [1]

申请事项：境内生产药品注册上市许可 受理号：CXSS2500079、CXSS2500080 申请人：上海君实生物医药科技股份有限公司 证券代码：688180 证券简称：君实生物 公告编号：临 2025-038 上海君实生物医药科技股份有限公司 自愿披露关于特瑞普利单抗一线治疗HER2表达的尿 路上皮癌的新适应症上市申请获得受理的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 近日，上海君实生物医药科技股份有限公司（以下简称"公司"）收到国家 药品监督管理局核准签发的《受理通知书》，特瑞普利单抗（商品名：拓益®， 产品代号：JS001）联合荣昌生物制药（烟台）股份有限公司自主研发的抗体偶 联药物维迪西妥单抗用于 HER2 表达的（HER2 表达定义为 HER2 免疫组织化学 检查结果为 1+、2+或 3+）局部晚期或转移性尿路上皮癌患者的新适应症上市申 请获得受理。由于药品的研发周期长、审批环节多，容易受到一些不确定性因素 的影响，本次新适应症上市申请能否获得批准存在不确定性，敬请广大投资者谨 慎决策，注意防范投资风险 ...

君实生物(688180.SH)发布公告，近日，公司收到国家药品监督管理局核准签发的《受理通知书》，特 瑞普利单抗(商品名：拓益，产品代号：JS001)联合荣昌生物制药(烟台)股份有限公司自主研发的抗体偶 联药物维迪西妥单抗用于HER2表达的(HER2表达定义为HER2免疫组织化学检查结果为1+、2+或3+)局 部晚期或转移性尿路上皮癌患者的新适应症上市申请获得受理。 本次新适应症的上市申请主要基于RC48-C016研究(NCT05302284)，该研究是一项多中心、随机、开 放、阳性药对照的Ⅲ期临床研究，旨在比较特瑞普利单抗联合维迪西妥单抗对比吉西他滨联合顺铂/卡 铂在既往未接受系统抗肿瘤治疗的HER2(人表体生长因子受体-2)表达的局部晚期或转移性尿路上皮癌患 者中的有效性和安全性。该研究由北京大学肿瘤医院郭军教授和中国医学科学院肿瘤医院周爱萍教授担 任主要研究者，在全国74家临床中心开展。 ...

本次新适应症的上市申请主要基于RC48-C016研究(NCT05302284)，该研究是一项多中心、随机、开 放、阳性药对照的Ⅲ期临床研究，旨在比较特瑞普利单抗联合维迪西妥单抗对比吉西他滨联合顺铂/卡 铂在既往未接受系统抗肿瘤治疗的HER2(人表体生长因子受体-2)表达的局部晚期或转移性尿路上皮癌患 者中的有效性和安全性。该研究由北京大学肿瘤医院郭军教授和中国医学科学院肿瘤医院周爱萍教授担 任主要研究者，在全国74家临床中心开展。 智通财经APP讯，君实生物(688180.SH)发布公告，近日，公司收到国家药品监督管理局核准签发的 《受理通知书》，特瑞普利单抗(商品名：拓益®，产品代号：JS001)联合荣昌生物制药(烟台)股份有限 公司自主研发的抗体偶联药物维迪西妥单抗用于HER2表达的(HER2表达定义为HER2免疫组织化学检查 结果为1+、2+或3+)局部晚期或转移性尿路上皮癌患者的新适应症上市申请获得受理。 ...