Core Viewpoint - Junshi Biosciences announced the acceptance of a supplemental new drug application for toripalimab in combination with disitamab vedotin for treating HER2-expressing locally advanced or metastatic urothelial carcinoma, marking toripalimab's 13th marketing application in mainland China [1] Group 1: Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company focused on discovering, developing, and commercializing novel therapies, with a diversified R&D pipeline of over 50 drug candidates [11] - The company has five therapeutic focus areas: cancer, autoimmune, metabolic, neurological, and infectious diseases, and has received approvals for five products in China and international markets [11] - Toripalimab is China's first domestically produced and independently developed anti-PD-1 monoclonal antibody, approved in 40 countries and regions, including China, the US, and Europe [11][10] Group 2: Industry Context - Urothelial carcinoma (UC) is one of the ten most prevalent malignant tumors globally, with rising incidence and mortality rates in China; in 2022, there were 92,900 new cases and over 40,000 deaths [2] - The treatment landscape for advanced UC has been reshaped by the emergence of PD-(L)1 monoclonal antibodies and novel antibody-drug conjugates (ADCs), offering significant improvements in survival benefits and tolerability compared to conventional chemotherapy [3] - The RC48-C016 study demonstrated that toripalimab combined with disitamab vedotin significantly improved progression-free survival (PFS) and overall survival (OS) compared to traditional chemotherapy regimens [5][4]

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。 ...

Core Viewpoint - Junshi Biosciences (688180.SH) has received the Acceptance Notification from the National Medical Products Administration for the new indication application of Trastuzumab combined with Rongchang Biopharmaceutical's independently developed antibody-drug conjugate, Vidisizumab, for patients with locally advanced or metastatic urothelial carcinoma expressing HER2 [1] Group 1 - The application is primarily based on the RC48-C016 study, which is a multicenter, randomized, open-label, positive-controlled Phase III clinical trial [1] - The main study endpoints, Progression-Free Survival (PFS) and Overall Survival (OS), have both met the pre-defined superiority boundaries set in the study protocol [1]

Investment Rating - The report assigns a "Buy" rating to the company [12][14]. Core Insights - Junshi Biosciences is one of the earliest innovative biotech companies in China, with a strong focus on innovation and a robust pipeline that is expected to enter a harvest phase soon. The company is experiencing a sales acceleration in its existing business, with multiple innovative assets entering Phase III clinical trials, indicating a potential turning point in its fundamentals [4][9][12]. - The core product, Toripalimab, is projected to achieve sales of 1.501 billion yuan in 2024, representing a 66% year-on-year growth. The subcutaneous formulation of Toripalimab is currently in Phase III clinical trials, which, upon approval, is expected to further solidify its market position [9][12]. - The company has over 50 products in its pipeline, covering various therapeutic areas, including oncology, autoimmune diseases, chronic metabolic diseases, neurological disorders, and infectious diseases. The year 2025 is anticipated to be a breakthrough year for the company [9][35]. Summary by Sections Company Overview - Junshi Biosciences, established in December 2012, is an innovative pharmaceutical company focused on the discovery, development, and commercialization of innovative therapies. It was listed on the Hong Kong Stock Exchange in 2018 and on the Shanghai Stock Exchange's Sci-Tech Innovation Board in 2020 [9][22]. Sales and Financial Performance - The company reported a revenue of 1.948 billion yuan in 2024, a year-on-year increase of 29.67%. The net profit attributable to shareholders was -1.281 billion yuan, indicating a significant reduction in losses. The existing business is entering a phase of explosive growth, driven by the expansion of indications for Toripalimab and the launch of new products [33][35]. Pipeline and Clinical Development - Junshi Biosciences has a rich early-stage pipeline with comprehensive technology platforms. Key assets such as JS203, JS107, JS207, and JT002 are expected to advance to Phase III clinical trials soon. The company is also exploring various combination therapies to enhance the potential of its PD-1/VEGF dual antibody product, JS207 [10][11][51]. - The report highlights the potential of several innovative drug assets that require re-evaluation of their value, particularly JS107, JS207, and JS015, which are positioned favorably in the competitive landscape [10][12][40]. Future Outlook - The company is expected to see revenues of 2.681 billion yuan, 3.673 billion yuan, and 5.479 billion yuan from 2025 to 2027, with net profits projected to improve significantly by 2027 [12][33].

Core Insights - The report highlights the significant role of CFOs in listed companies, with the total salary scale for A-share CFOs reaching 4.27 billion yuan in 2024 [1] - The average annual salary for CFOs in the A-share biopharmaceutical sector is 1.0042 million yuan [1] Salary Distribution - The salary distribution among A-share biopharmaceutical CFOs shows that 13% earn below 500,000 yuan, 46% earn between 500,000 and 1 million yuan, 33% earn between 1 million and 2 million yuan, and 8% earn above 2 million yuan [1] - The top five highest-paid CFOs are from Kanghong Pharmaceutical, Junshi Biosciences-U, Shenzhou Cell, Tebao Bio, and Aopumai, with salaries of 3 million yuan, 2.0602 million yuan, 1.4297 million yuan, 1 million yuan, and 1 million yuan respectively [1] Age and Education Distribution - CFOs aged between 40 and 50 years constitute 54% of the market, while those over 50 years account for 38%, and those aged 40 and below represent 8% [1] - The educational background of CFOs shows that 8% have an associate degree, 50% hold a bachelor's degree, and 42% possess a master's degree [1] Salary Changes - Among CFOs with over two years of tenure, the largest salary decrease was observed for Xu Baohong from Junshi Biosciences-U, with a year-on-year decline of 24.66% [1] - The largest salary increase was recorded for Liu Liwen from Zhixiang Jintai-U, with a year-on-year increase of 35.91% [1]

Core Insights - The total salary scale of CFOs in A-share listed companies reached 4.27 billion yuan in 2024 [1] - The average annual salary of CFOs in the biopharmaceutical sector is 1.0042 million yuan [1] - The age distribution shows that CFOs aged 40-50 constitute 54% of the market, while those over 50 account for 38% [1] Salary Distribution - The salary distribution among CFOs is as follows: below 500,000 yuan (13%), 500,000-1,000,000 yuan (46%), 1,000,000-2,000,000 yuan (33%), and above 2,000,000 yuan (8%) [1] - The top five highest-paid CFOs are from Kanghong Pharmaceutical, Junshi Biosciences-U, Shenzhou Cell, Tebao Biologics, and Aopumai, with salaries of 3 million, 2.0602 million, 1.4297 million, 1 million, and 1 million yuan respectively [1] Salary Changes - The largest salary decrease was observed for Xu Baohong from Junshi Biosciences-U, with a year-on-year decline of 24.66% [1] - The largest salary increase was for Liu Liwen from Zhixiang Jintai-U, with a year-on-year increase of 35.91% [1]

Group 1 - The stock of Junshi Biosciences (01877) experienced a significant increase, rising over 11% recently, following a previous surge of over 33% on August 5 [1] - As of the latest report, the stock is up 8.14%, trading at HKD 29.5, with a trading volume of HKD 531 million [1] - Junshi Biosciences completed a placement of 41 million new shares on June 20, raising a net amount of approximately HKD 1.026 billion, with 70% allocated for innovative drug research and 30% for general corporate purposes [1] Group 2 - The company is focusing on the development of innovative drugs, including PD-1/VEGF bispecific antibodies, EGFR/HER3 ADC, and PD-1/IL-2 fusion proteins [1] - According to Fangzheng Securities, JJS207 has significant business development (BD) potential, as international pharmaceutical companies are interested in PD-1/VEGF products [1] - Open Source Securities noted that by May 2025, only Pfizer and Merck have entered this market segment among multinational corporations (MNCs), indicating potential for other early-stage PD-(L)1/VEGF bispecific antibodies to expand internationally as data matures [1]