Core Insights - Junshi Bioscience's stock increased by 0.72% on October 24, with a trading volume of 274 million yuan, indicating active market participation [1] - The company reported a financing net buy of -4.67 million yuan on the same day, suggesting a higher level of selling pressure compared to buying [1] - As of October 24, the total margin balance for Junshi Bioscience reached 1.39 billion yuan, indicating a high level of leverage in the market [1] Financing and Margin Data - On October 24, Junshi Bioscience had a financing buy amount of 27.26 million yuan, with a current financing balance of 1.378 billion yuan, accounting for 4.76% of its market capitalization [1] - The financing balance is above the 90th percentile of the past year, indicating a high level of borrowing [1] - In terms of securities lending, 941 shares were repaid while 700 shares were sold, with a selling amount of 26,400 yuan, and the remaining securities lending balance was 1.219 million yuan, also above the 90th percentile of the past year [1] Company Overview - Junshi Bioscience, established on December 27, 2012, focuses on the research and commercialization of monoclonal antibody drugs and other therapeutic protein drugs [2] - The company's main revenue sources include 90.67% from drug sales, 8.74% from technology licensing, and 0.59% from technical services [2] - As of June 30, 2025, the company reported a 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 [2] Shareholder Structure - As of June 30, 2025, Junshi Bioscience had 31,200 shareholders, an increase of 5.88% from the previous period [2] - The average number of circulating shares per shareholder decreased by 5.56% to 24,543 shares [2] - Major shareholders include Huaxia SSE STAR 50 ETF and E Fund SSE STAR 50 ETF, with notable changes in their holdings [3]

Core Insights - He Yuan Bio, a pioneer in "rice-based hematopoiesis" innovative drugs, is set to debut on the Sci-Tech Innovation Board, marking it as the first incremental enterprise in the Sci-Tech Growth Layer [1] - The Sci-Tech Growth Layer currently includes 13 innovative pharmaceutical companies with a total market capitalization of nearly 500 billion yuan, which have collectively facilitated the approval of 25 new drugs since their listing [1] - The establishment of the fifth set of listing standards on the Sci-Tech Board has enabled unprofitable companies to issue shares, significantly boosting the innovative drug sector and attracting substantial investment, with cumulative financing exceeding 1 trillion yuan since 2019 [1][2] Company Performance - The innovative pharmaceutical companies are transitioning from R&D investment phases to commercial revenue generation, with a projected total revenue of 31.9 billion yuan in 2024, reflecting a year-on-year growth rate of 54.39% [2] - These companies have achieved an average annual compound growth rate of 52.33% in revenue since 2019, significantly outpacing the sector's average growth [2] R&D Achievements - A total of 20 new drugs classified as "global new" have been launched, with 10 innovative drugs recognized as "breakthrough therapies" by the National Medical Products Administration [3] - Four original innovative drugs from Chinese companies, including BeiGene and Junshi Biosciences, have received FDA approval for the U.S. market, highlighting the international recognition of these firms [3] - The companies have engaged in potential overseas transactions totaling nearly 5 billion USD this year, indicating strong international market confidence in the innovative drug capabilities of the Sci-Tech Growth Layer [3]

Investment Rating - The report maintains a "Market Weight" rating for the pharmaceutical and biotechnology industry, indicating that the industry index is expected to perform within ±10% of the market index over the next six months [3][24]. Core Insights - The SW pharmaceutical and biotechnology industry underperformed the CSI 300 index, declining by 3.41% from October 10 to October 23, 2025, which is approximately 1.22 percentage points lower than the index [10][24]. - Most sub-sectors within the industry recorded negative returns during the same period, with offline pharmacies and traditional Chinese medicine showing positive growth of 4.19% and 1.55%, respectively, while medical R&D outsourcing and medical equipment sectors faced declines of 8.86% and 7.66% [13][24]. - Approximately 56% of stocks in the industry reported positive returns, with notable performers including ZhenDe Medical, which saw a weekly increase of 43.97% [14][16]. - The overall industry valuation has decreased, with the SW pharmaceutical and biotechnology index's PE (TTM) at approximately 53.10 times, and a relative PE to the CSI 300 of 3.90 times as of October 23, 2025 [17][24]. Summary by Sections 1. Market Review - The SW pharmaceutical and biotechnology industry underperformed the CSI 300 index, with a decline of 3.41% from October 10 to October 23, 2025 [10]. - Most sub-sectors recorded negative returns, with offline pharmacies and traditional Chinese medicine performing better than others [13]. - About 56% of stocks in the industry achieved positive returns during this period [14]. 2. Industry News - On October 21, the Ministry of Finance announced the allocation of funds for enhancing medical services and capacity building, aimed at supporting various healthcare initiatives [18][22]. 3. Company Announcements - Junshi Biosciences disclosed that its wholly-owned subsidiary passed an FDA inspection, indicating compliance with current Good Manufacturing Practices [23]. 4. Industry Outlook - The report suggests focusing on sectors with potential for exceeding expectations in the upcoming quarterly reports, including medical devices, pharmaceutical commerce, aesthetic medicine, scientific services, and innovative drugs [24][25].

Investment Rating - The report maintains a rating of "Accumulate" for the company [8]. Core Views - The company is advancing its PD-1/VEGF combination therapy, JS207, which shows significant potential for market leadership and business development opportunities. The drug has demonstrated excellent anti-tumor effects in preclinical studies and is currently undergoing multiple Phase II clinical trials globally [4]. - The core product, Toripalimab, has seen substantial growth in sales, with domestic revenue reaching 954 million yuan in the first half of 2025, a year-on-year increase of approximately 42%. The product has been approved in over 40 countries and regions, including the U.S. and EU, and is the first drug approved by the FDA for nasopharyngeal carcinoma treatment [5]. - The company has a robust pipeline with multiple promising products in development, including JS207 and JS212, which target drug resistance issues. The combination of PD-1/VEGF and ADC therapies presents significant synergistic potential [6]. - A stock incentive plan has been announced, reflecting the company's strong confidence in future performance, with options granted for 25.97 million shares, approximately 2.53% of total shares [6]. Summary by Sections Company Overview - The company, established in December 2012, focuses on discovering, developing, and commercializing innovative therapies. It has a strong drug discovery capability and advanced biotechnological research and development [16]. Management and Pipeline - The management team has extensive experience in the innovative drug sector, with many members having multinational corporation backgrounds. The company has expanded its pipeline to cover three major overseas markets, including PD-1 plus, small nucleic acids, and ADC plus [17][24]. Financial Performance - In the first half of 2025, the company achieved revenue of 1.17 billion yuan, with a compound annual growth rate (CAGR) of 5.13% from 2020 to 2024. The net loss was 410 million yuan, showing significant improvement compared to previous years [28][31]. Commercial Products - Toripalimab is the first domestically approved PD-1 monoclonal antibody, with 12 approved indications in China and ongoing clinical studies for over 15 indications globally. The sales revenue is projected to grow significantly due to expanding indications and international market access [33][37]. Clinical Pipeline - The company has several key products in clinical development, including JS207 and JS212, with promising early data. The ongoing clinical trials are progressing well, with significant patient enrollment [6][7]. International Expansion - The company has established a strong international presence, with Toripalimab approved in multiple countries and regions. The production facility has received GMP certifications, supporting its global commercialization efforts [46][47].

近日，君实生物发布公告称，公司全资子公司苏州众合生物医药科技有限公司于2025年6月16日至2025 年6月24日期间接受了美国食品药品监督管理局（FDA）的CGMP（现行药品生产质量管理规范）飞行 检查（指在日常期间不事先通知的检查）。 近日，苏州众合收到FDA签发的现场检查报告，该报告表明苏州众合已通过本次CGMP现场检查。 ...

Core Insights - Junshi Bioscience experienced a decline of 1.15% in stock price on October 22, with a trading volume of 324 million yuan [1] - The company reported a net financing outflow of 10.19 million yuan on the same day, with a total financing and securities balance of 1.399 billion yuan [1] Financing Summary - On October 22, Junshi Bioscience had a financing buy-in amount of 28.94 million yuan, while the financing balance stood at 1.388 billion yuan, accounting for 4.70% of the circulating market value [1] - The financing balance is above the 90th percentile level over the past year, indicating a high level of financing activity [1] Securities Lending Summary - On October 22, the company repaid 1,033 shares in securities lending and sold 200 shares, with a selling amount of 7,708 yuan based on the closing price [1] - The remaining securities lending volume was 292,600 shares, with a balance of 11.275 million yuan, also exceeding the 90th percentile level over the past year [1] Company Overview - Junshi Bioscience, established on December 27, 2012, focuses on the research and commercialization of monoclonal antibody drugs and other therapeutic protein drugs [2] - The company's main revenue sources include 90.67% from drug sales, 8.74% from technology licensing, and 0.59% from technical services [2] Financial Performance - For the first half of 2025, Junshi Bioscience reported a revenue of 1.168 billion yuan, representing a year-on-year growth of 48.64% [2] - The net profit attributable to shareholders was -413 million yuan, showing a year-on-year improvement of 36.01% [2] Shareholder Structure - As of June 30, 2025, the number of shareholders increased by 5.88% to 31,200, with an average of 24,543 circulating shares per person, a decrease of 5.56% [2] - Major shareholders include Huaxia SSE STAR 50 ETF and E Fund SSE STAR 50 ETF, with changes in their holdings noted [3]

Group 1 - The company’s subsidiary, Suzhou Zhonghe Biopharmaceutical Technology Co., Ltd., successfully passed an unannounced FDA CGMP inspection from June 16 to June 24, 2025, indicating ongoing international recognition of its high-quality manufacturing system [1][2] - The inspection report confirms that Suzhou Zhonghe has met the necessary standards for the production of its product, Toripalimab injection, which is crucial for its overseas commercialization efforts [1][2] - The Suzhou Wujiang production base has a fermentation capacity of 4,500 liters and has obtained GMP certifications from multiple countries and regions, including the US, EU, and Australia, enhancing its ability to supply the overseas market [1] Group 2 - The successful FDA inspection is a significant step for the company’s strategy to expand in the US market, providing a solid foundation for future growth and positively impacting its operations [2]

Core Viewpoint - The article summarizes significant announcements from various listed companies in the Shanghai and Shenzhen stock markets, highlighting potential investment opportunities and risks based on recent developments and financial performance. Group 1: Company Announcements - Tianpu Co., Ltd. warns that its stock price has significantly deviated from its fundamentals, with a cumulative increase of 246.02% from August 22 to October 22, indicating a potential for rapid decline [4] - Shenzhen Sanda A plans to sell stakes in several subsidiaries to focus on its core business, including 80% of Zhongdian Continental Environmental Technology [5][6] - Zhongchong Co., Ltd. received an administrative regulatory measure from the Shandong Securities Regulatory Bureau for failing to announce a significant change in shareholding [7] - Construction Machinery has reported a net loss of 447 million yuan for the first half of 2025, marking three consecutive years of losses [8] - Junshi Biosciences announced that its subsidiary passed a recent FDA inspection, indicating compliance with CGMP standards [9] Group 2: Financial Performance - Duofuduo reported a net profit increase of 407.74% year-on-year for the first three quarters of 2025, with a revenue of 6.73 billion yuan [17] - Weihuaxincai achieved a net profit growth of 250.04% year-on-year in Q3, with revenues of 660 million yuan [18] - Guangdong Jianke reported a net profit increase of 190.62% year-on-year for the first three quarters, despite a revenue decline [19] - Xianggang Technology reported a net profit increase of 186.19% year-on-year for the first three quarters, with revenues of 742 million yuan [20] - Defu Technology reported a net profit increase of 132.63% year-on-year for the first three quarters, driven by increased copper foil sales [21] Group 3: Major Transactions and Investments - Tangrenshen plans to establish two investment funds with a total investment of 11.04 million yuan to focus on the agricultural sector [13] - Farsen intends to sell a 10% stake in Bekaert Steel Cord, constituting a major asset restructuring [14] - Shikong Technology plans to acquire 100% of Jiahe Jingwei, entering the storage sector [15] - Jiangsu New Energy's controlling shareholder is investing in offshore wind power projects and will manage the project companies [11][12] Group 4: Shareholder Actions - Qianyuan Pharmaceutical's shareholder plans to reduce its stake by up to 3% [42] - Zhengfan Technology's board members plan to collectively reduce their holdings by up to 1.88% [43]

Group 1: Company Performance - China Unicom reported a 1.0% increase in revenue to 292.985 billion yuan for the first three quarters of 2025, with a net profit of 8.772 billion yuan, up 5.2% year-on-year [1] - Tonghuashun's third-quarter revenue reached 1.481 billion yuan, a 56.72% increase, with a net profit of 704 million yuan, up 144.5% year-on-year [2] - Duofu Du achieved a net profit of 78.054 million yuan for the first three quarters, a significant increase of 407.74% compared to the previous year [11] - Wehua New Materials reported a third-quarter net profit of 25.384 million yuan, a 250.04% increase year-on-year [12] - Xianggang Technology's net profit for the first three quarters grew by 186.19% to 95.471 million yuan [13] Group 2: Stock and Market Activity - Tianpu Co. warned of potential rapid declines in stock price due to a 246.02% increase since August 22, indicating a significant deviation from the company's fundamentals [3] - Deep Sanda A announced plans to sell stakes in several subsidiaries to focus on core business operations [4] - Jiangsu New Energy's controlling shareholder plans to invest in offshore wind power projects and will manage the projects through the company [10] Group 3: Regulatory and Compliance Issues - Zhongchong Co. received an administrative regulatory decision from the Shandong Securities Regulatory Bureau for failing to announce a significant change in shareholding [5] - Two consecutive years of losses were reported by Lianban Construction Machinery, prompting a risk warning for investors [6] Group 4: Corporate Developments - Junshi Biosciences' subsidiary passed a CGMP inspection by the FDA, marking its second successful inspection [8] - Xinguang Optoelectronics announced the lifting of restrictions on its chairman, allowing him to resume normal duties [9] - Defu Technology plans to invest an additional 1 billion yuan in special copper foil production facilities [30]

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。 FDA現場檢查的相關信息 企業名稱：蘇州眾合生物醫藥科技有限公司 檢查地點：蘇州市吳江經濟技術開發區龍橋路999號（蘇州吳江生產基地） 涉及產品：特瑞普利單抗注射液 FDA FEI：3014164694 1 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－ 全資附屬公司通過FDA現場檢查 本公告由上海君實生物醫藥科技股份有限公司（「本公司」）自願作出。請亦參見本 公司於2025年10月22日刊發的海外監管公告。 本公司董事（「董事」）會（「董事會」）欣然宣佈，本公司全資附屬公司蘇州眾合生 物醫藥科技有限公司（「蘇州眾合」）於2025年6月16日至2025年6月24日期間接受 了美國食品藥品監督管理局（「FDA」）的CGMP（現行藥品生產質量管理規範）飛行 檢查（ ...