君实生物(01877)拉升逾9%，截至发稿，涨8.36%，报38.36港元，成交额1.73亿港元。 据介绍，JS005是公司自主研发的特异性抗IL-17A单克隆抗体。截至本公告披露日，JS005此项多中心、 随机、双盲、平行、安慰剂对照的关键注册性Ⅲ期临床研究(研究编号：JS005-005-Ⅲ-PsO)已顺利完 成，并达到共同主要研究终点和关键次要终点。 研究结果显示，与安慰剂相比，JS005可显著改善参与者的银屑病皮损面积和严重程度，达到sPGA评分 为0或1的参与者比例显著优于安慰剂，并在中重度斑块状银屑病参与者中安全性良好，相关研究结果计 划在未来国际学术会议上予以公布。 消息面上，君实生物发布公告，近日，公司产品重组人源化抗IL-17A单克隆抗体(代号：JS005)在治疗 中重度斑块状银屑病的一项多中心、随机、双盲、平行、安慰剂对照的关键注册性Ⅲ期临床研究(研究 编号：JS005-005-III-PsO)中取得阳性结果，共同主要研究终点和关键次要终点均具有统计学显著性和临 床意义的改善。公司计划将于近期向监管部门递交该产品的上市许可申请。 ...

Group 1 - The core viewpoint of the news highlights the trading performance and financing activities of Junshi Biosciences, indicating a high level of financing and short-selling activity, which may suggest investor sentiment and market dynamics [1] - On September 8, Junshi Biosciences experienced a decline of 0.98% in stock price, with a trading volume of 867 million yuan. The net financing purchase on that day was 15.66 million yuan, with a total financing and securities lending balance of 1.307 billion yuan [1] - The financing balance of Junshi Biosciences reached 1.296 billion yuan, accounting for 3.56% of its market capitalization, which is above the 90th percentile level over the past year, indicating a high financing level [1] Group 2 - Junshi Biosciences, established on December 27, 2012, focuses on the research and commercialization of monoclonal antibody drugs and other therapeutic protein drugs, with 90.67% of its revenue coming from drug sales [2] - For the first half of 2025, Junshi Biosciences reported a revenue of 1.168 billion yuan, representing a year-on-year growth of 48.64%, while the net profit attributable to shareholders was -413 million yuan, showing a year-on-year increase of 36.01% [2] - As of June 30, 2025, the number of shareholders of Junshi Biosciences increased by 5.88% to 31,200, while the average circulating shares per person decreased by 5.56% to 24,543 shares [2] Group 3 - As of June 30, 2025, among the top ten circulating shareholders of Junshi Biosciences, the Huaxia SSE STAR 50 ETF held 29.7167 million shares, a decrease of 536,700 shares from the previous period, while the E Fund SSE STAR 50 ETF increased its holdings by 630,000 shares to 22.2132 million shares [3] - Hong Kong Central Clearing Limited ranked as the tenth largest circulating shareholder with 13.1291 million shares, a decrease of 186,650 shares compared to the previous period [3]

Group 1 - The core point of the article is the recent large transaction involving Junshi Biosciences (君实生物-U), which occurred on September 8, with a transaction volume of 1 million shares and a transaction amount of 47.2 million yuan [2] - The transaction price was 47.20 yuan, representing a discount of 0.69% compared to the closing price of the same day [2] - The buyer was from Founder Securities Co., Ltd., while the seller was from CITIC Securities Co., Ltd. [2] Group 2 - In the last three months, Junshi Biosciences has recorded a total of 2 large transactions, with a cumulative transaction amount of 94.86 million yuan [2] - On the same day, the closing price of Junshi Biosciences was 47.53 yuan, showing a decrease of 0.98%, with a daily turnover rate of 2.36% and a total transaction amount of 867 million yuan [2] - The net inflow of main funds for the day was 9.28 million yuan, and over the past five days, the stock has increased by 0.89% with a total net inflow of 8.70 million yuan [2] Group 3 - The latest margin financing balance for Junshi Biosciences is 1.28 billion yuan, which has decreased by 2.47 million yuan over the past five days, reflecting a decline of 0.19% [2]

Group 1 - On September 8, Junshi Biosciences executed a block trade of 1 million shares, with a transaction value of 47.2 million yuan, accounting for 5.16% of the total trading volume on that day [1][2] - The transaction price was 47.2 yuan per share, which represents a discount of 0.69% compared to the market closing price of 47.53 yuan [1]

Core Viewpoint - Junshi Biosciences aims to establish itself as a global innovative pharmaceutical company with a complete industry chain capability from drug discovery to commercialization, focusing on quality and innovation [2][3]. Company Overview - Junshi Biosciences, founded on December 27, 2012, and listed on July 15, 2020, specializes in the research and commercialization of monoclonal antibody drugs and other therapeutic protein drugs [7]. - The company is headquartered in Shanghai, China, and operates in the biopharmaceutical sector, specifically in the development of innovative drugs [7]. Product Development - The company has developed a significant product portfolio, including the first domestically approved PD-1 monoclonal antibody, Toripalimab, which has received approval for 11 indications in mainland China and is also approved in multiple countries including the US and EU [2]. - Junshi is also advancing its pipeline with Tifcemalimab, the first anti-BTLA monoclonal antibody entering clinical development, currently undergoing two Phase III trials [2]. Vaccine Development - Junshi's subsidiary, JunTuo Biotech, is collaborating with research institutions to develop vaccines, including those for monkeypox and Zika, which are currently in preclinical development [3]. - A partnership has been established with Peking University and other institutions to jointly develop a recombinant protein vaccine for monkeypox [3]. Financial Performance - For the first half of 2025, Junshi reported revenue of 1.168 billion yuan, a year-on-year increase of 48.64%, while the net profit attributable to shareholders was -413 million yuan, reflecting a 36.01% increase in losses [8]. - As of June 30, 2025, the number of shareholders increased to 31,200, with an average of 24,543 shares held per shareholder, a decrease of 5.56% [8]. Market Activity - On September 8, 2023, Junshi's stock price decreased by 0.98%, with a trading volume of 867 million yuan and a market capitalization of 48.799 billion yuan [1]. - The stock has shown no clear trend in major fund inflows, with a net outflow of 7.31 million yuan on the same day [4][5].

Core Insights - Company Junshi Biosciences announced positive results from a Phase III clinical trial of its recombinant humanized anti-IL-17A monoclonal antibody (code: JS005) for the treatment of moderate to severe plaque psoriasis, achieving both primary and key secondary endpoints with statistical significance and clinical relevance [1][2] - The company plans to submit a marketing authorization application to regulatory authorities in the near future for JS005 [1] Group 1 - JS005 is a specific anti-IL-17A monoclonal antibody developed by the company, targeting IL-17A, a cytokine associated with autoimmune diseases such as psoriasis, rheumatoid arthritis, and ankylosing spondylitis [1] - The mechanism of JS005 involves high-affinity binding to IL-17A, selectively blocking its interaction with receptors IL-17RA/IL-17RC, thereby inhibiting downstream signaling pathways and the release of inflammatory factors [1] Group 2 - As of the announcement date, the Phase III clinical trial for JS005 in moderate to severe plaque psoriasis has met its primary and key secondary endpoints, while the Phase II clinical trial for active ankylosing spondylitis has completed primary endpoint visits and entered an extended treatment phase [2]

Core Insights - The company is actively expanding sales channels for its commercialized products beyond Toripalimab, focusing on enhancing revenue generation [1][2] - The management has outlined a clear strategy for business development, emphasizing collaboration and resource integration [2] Group 1: Product Commercialization - Mindewei® (Dexamethasone Hydrochloride Tablets) received conditional approval from the National Medical Products Administration in January 2023 and has achieved full-channel coverage by mid-2025, partnering with major e-commerce platforms and pharmacies [1] - Junmaikang® (Adalimumab) has eight approved indications and is included in the national medical insurance directory, with promotion managed by Maiwei Biotech [1] - Junshida® (Ongokrezi Monoclonal Antibody) was approved in October 2024 with three approved indications, and its commercialization is being advanced by partner Bochuang Pharmaceuticals [1] Group 2: Business Development Strategy - The company's business development team is actively pursuing connections between its pipeline and domestic and international resources, engaging in in-depth research and communication on multiple potential collaboration directions [2] - The company maintains an open and proactive attitude towards various types of business cooperation and aims to accelerate pipeline research and development [2] - Regular reviews of the pipeline will be conducted to identify candidates with business development potential and share innovative results promptly [2]

Core Insights - The management of Junshi Biosciences discussed the commercialization progress of its products beyond Toripalimab during the 2025 semi-annual performance briefing [1] - The company is actively expanding sales channels for its commercialized products and is open to various types of business collaborations [2] Group 1: Product Commercialization - Mindewei® (Dexamethasone Hydrochloride Tablets) received conditional approval from the National Medical Products Administration in January 2023 and has achieved full-channel coverage by mid-2025, launching on major e-commerce platforms like Meituan, JD.com, and Ali Health [1] - Junmai Kang® (Adalimumab) has eight approved indications and is included in the national medical insurance catalog, with promotion responsibilities assigned to Maiwei Biopharmaceuticals [1] - Junshida® (Ongorilumab) was approved in October 2024 with three approved indications, and its commercialization efforts in mainland China are being advanced by partner Bochuang Pharmaceuticals [1] Group 2: Business Development Strategy - The business development team is actively working on aligning the company's pipeline with domestic and international resources, conducting in-depth research and communication on multiple potential collaboration directions [2] - The company maintains an open and proactive attitude towards various types of business cooperation and aims to accelerate pipeline research and development [2] - Regular reviews of the pipeline will be conducted to identify candidates with business development potential and share innovative results in a timely manner [2]

Core Points - The stock price of Junshi Biosciences dropped by 2.00% on September 8, reaching 47.04 CNY per share, with a total market capitalization of 48.295 billion CNY [1] - Year-to-date, the stock has increased by 72.12%, with a slight decline of 0.15% over the last five trading days, and increases of 10.58% and 31.58% over the last 20 and 60 days, respectively [1] - As of June 30, 2025, Junshi Biosciences reported a revenue of 1.168 billion CNY, representing a year-on-year growth of 48.64%, while the net profit attributable to shareholders was -413 million CNY, an increase of 36.01% year-on-year [2] Company Overview - Junshi Biosciences, established on December 27, 2012, and listed on July 15, 2020, is located in Shanghai and focuses on the research and industrialization of monoclonal antibody drugs and other therapeutic protein drugs [1] - The company operates in the pharmaceutical and biotechnology sector, specifically in the biopharmaceuticals category, and is involved in the development and technology transfer of monoclonal antibody drugs [1] Shareholder Information - As of June 30, 2025, the number of shareholders increased by 5.88% to 31,200, while the average number of circulating shares per person decreased by 5.56% to 24,543 shares [2] - The top ten circulating shareholders include notable ETFs, with the Huaxia SSE Sci-Tech Innovation Board 50 ETF holding 29.7167 million shares, a decrease of 536,700 shares from the previous period [2]

Core Viewpoint - Shanghai Junshi Biosciences Co., Ltd. has achieved positive results in a pivotal Phase III clinical trial for its product JS005, a humanized anti-IL-17A monoclonal antibody, for the treatment of moderate to severe plaque psoriasis, with plans to submit a marketing authorization application soon [1][3]. Group 1: Product Information - JS005 is a specific anti-IL-17A monoclonal antibody developed by the company, targeting IL-17A, a cytokine associated with autoimmune diseases such as psoriasis, rheumatoid arthritis, and ankylosing spondylitis [1][2]. - The drug works by binding with high affinity to IL-17A and selectively blocking its interaction with receptors IL-17RA/IL-17RC, thereby inhibiting downstream signaling pathways and the release of inflammatory factors [1][2]. Group 2: Clinical Trial Details - The Phase III clinical trial (JS005-005-III-PsO) was a multicenter, randomized, double-blind, parallel, placebo-controlled study conducted across 60 research centers in China, led by Professor Zhang Jianzhong from Peking University People's Hospital [3]. - The primary objective was to achieve at least a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) and a static Physician Global Assessment (sPGA) score of 0 or 1 at week 12, with results showing significant improvement compared to placebo [3]. Group 3: Disease Context - Psoriasis is a common chronic, relapsing, inflammatory systemic disease with a global prevalence of 2.0%-3.0%, while in China, it is approximately 0.47%, affecting around 125 million people worldwide [2]. - The disease is associated with increased risks of metabolic syndrome, atherosclerotic cardiovascular diseases, and mental health issues such as depression and anxiety, highlighting the urgent need for effective treatments [2].