智通财经获悉，君实生物(01877)、荣昌生物(09995)午后齐涨。截至发稿，君实生物涨4.53%，报30.48 港元；荣昌生物(09995)涨1.55%，报65.7港元。 据悉，这是特瑞普利单抗在中国内地递交的第十三项适应症上市申请。该申请主要基于RC48-C016研 究，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，主要研究终点无进展生存期 (PFS)和总生存期(OS)均达到方案预设的优效边界。 本文源自：智通财经网 消息面上，近日，君实生物宣布，国家药品监督管理局已于近日受理公司自主研发的抗PD-1单抗药物 特瑞普利单抗合荣昌生物(09995)自主研发的抗体偶联(ADC)药物维迪西妥单抗用于HER2表达的局部晚 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。 ...

Group 1 - Tsinghua Unigroup's control will change as Hunan Sailuxian will acquire approximately 58.61 million shares from its controlling shareholder, Tsinghua Technology Service Co., Ltd, leading to a shift in control of Tsinghua Unigroup [1] - The new controlling shareholder will need to stabilize the company's operations amidst industry consolidation, and investors should pay attention to future asset integration and the new shareholder's resource injection capabilities, with potential short-term stock price volatility [1] Group 2 - Shuoshi Bio reported a revenue of 176 million yuan, a year-on-year decrease of 1.05%, and a net profit attributable to shareholders of 3.99 million yuan, down 86.35% year-on-year, primarily due to the deepening of centralized procurement in the in vitro diagnostic industry and an increase in the VAT rate to 13% [2] - The decline in net profit is attributed to pressure on product prices from industry procurement, a significant drop in gross margin, and a 13.11% reduction in R&D investment, which may weaken long-term competitiveness [2] Group 3 - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotech, received FDA approval to conduct Phase I clinical trials for HLX43, a targeted PD-L1 antibody-drug conjugate for thymic cancer, marking a significant step in the internationalization of innovative drugs [3] - The drug's dual advantages of immune modulation and precise targeting position it competitively in the global market, with the potential to fill a treatment gap for thymic cancer if subsequent data is positive [3] Group 4 - Junshi Biosciences announced that the National Medical Products Administration has accepted the application for the 13th indication of its PD-1 monoclonal antibody, Toripalimab, for use in combination with HER2 ADC for patients with locally advanced or metastatic urothelial carcinoma expressing HER2 [4] - This combination is expected to further strengthen Junshi's differentiated positioning in the PD-1 market and enhance collaboration with Rongchang Bio on ADC development [4]

Investment Rating - The report maintains an investment rating of "Outperform" with a target price set for leading stocks [3][4]. Core Insights - The innovative drug sector is experiencing fluctuations, but several catalysts are anticipated, including academic conferences, business development achievements, and negotiations for medical insurance [2]. - The National Medical Insurance Administration has updated the data on innovative drugs included in the medical insurance directory, showing rapid hospital admissions for several newly included domestic innovative drugs [2][22]. Summary by Sections Weekly New Drug Market Review - From August 4 to August 10, 2025, the top five companies in the new drug sector by stock price increase were: Beihai Kangcheng (+73.1%), Jiahe Biotech (+39.0%), Gilead Sciences (+30.3%), Heyu Biotech (+21.1%), and Hengrui Medicine (+15.3%). The top five companies with the largest declines were: Hutchison China MediTech (-13.8%), Frontier Biotech (-13.4%), Yifang Biotech (-11.7%), Haichuang Pharma (-9.9%), and Maiwei Biotech (-9.2%) [1][16]. Recommended Stocks to Watch - The report suggests focusing on potential overseas licensing opportunities for significant products, including differentiated GLP-1 assets from companies like Zhongsheng Pharma, Kangyuan Pharma, and Gilead Sciences. Additionally, upgraded PD-1 products from Kangfang Biotech and others are highlighted [2][22]. Key Analysis of the New Drug Industry - The report notes that several innovative drugs newly included in the medical insurance directory are rapidly entering hospitals, with notable growth in hospital admissions for drugs such as Zaiqiang Pharma's recombinant thrombin and Hengrui Medicine's Tazemetostat [2][22][23]. New Drug Approval and Acceptance Status - This week, three new drug applications were approved, including Adalimumab injection from Wuhan Biological Products Research Institute, Dulaglutide injection from Shandong Boan Biotech, and Evinacumab injection from Xi'an Janssen [28][29]. Additionally, four new drug applications were accepted, including Trastuzumab injection from Amgen and others [28][30]. Clinical Application Approval and Acceptance Status - A total of 55 new drug clinical applications were approved this week, while 31 new drug clinical applications were accepted [10][31].

Core Viewpoint - Junshi Biosciences, a leading domestic BioPharma company, is experiencing accelerated sales growth in its existing business and is on the verge of significant advancements in its innovative drug pipeline [1][3] Group 1: Sales Performance - Junshi Biosciences' core product, Toripalimab, is projected to achieve sales of 1.501 billion yuan in 2024, representing a 66% year-on-year growth, indicating a return to sales momentum [1] - The subcutaneous formulation of Toripalimab is currently in Phase III clinical trials, which, upon approval, is expected to further solidify the product's market position [1] Group 2: Innovative Drug Pipeline - Multiple innovative assets are approaching critical stages, with several candidates expected to enter Phase III clinical trials soon, including JS203 (CD20/CD3), JS107 (CLDN18.2 ADC), JS207 (PD-1/VEGF), JT002 (siRNA), and JS015 (DKK1) [2] - The JS107 asset is leading in the domestic development of CLDN18.2 ADC, showing excellent efficacy and safety, and may become one of the first approved treatments for first-line gastric cancer [2] - JS207, a PD-1/VEGF dual antibody, is positioned competitively in the market and has initiated multiple Phase II clinical studies in combination therapies, potentially allowing it to outperform competitors [2] - JS015, a globally leading DKK1 monoclonal antibody, has demonstrated impressive data in early trials, achieving a 100% overall response rate (ORR) in evaluable patients for first-line colorectal cancer treatment [2] Group 3: Early Pipeline and Technology Platforms - The company has a rich early-stage pipeline and a comprehensive technology platform, including dual antibodies, dual antibody-drug conjugates (ADCs), and small nucleic acids [2] - The company is also developing a PD-1/IL-2 dual antibody (JS213) with promising early data in Australian solid tumors, which could become a significant product in the next generation of immuno-oncology [2] - JT002, a licensed nasal spray immunomodulatory small nucleic acid drug targeting seasonal allergic rhinitis, has completed patient enrollment in Phase II clinical trials [2] - JS212 (EGFR/HER3 dual antibody ADC) has received clinical approval, further enhancing the company's asset portfolio [2] Group 4: Financial Projections - Revenue projections for Junshi Biosciences are estimated at 2.681 billion yuan, 3.673 billion yuan, and 5.479 billion yuan for the years 2025 to 2027, respectively [3] - The company is expected to report net losses of 940 million yuan, 350 million yuan, and a profit of 420 million yuan for the same period, with corresponding earnings per share (EPS) of -0.92 yuan, -0.34 yuan, and 0.41 yuan [3] - The company is rated as a "buy" based on its growth potential and upcoming product launches [3]

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 ...