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，並明確表示概不就因本公告全部或任何部分內容而產生或因依賴 該等內容而引致的任何損失承擔任何責任。 BeOne Medicines Ltd. 百濟神州有限公司 （根據瑞士法律註冊成立的公司） （股份代號：06160） 海外監管公告 本公告乃百濟神州有限公司（BeOne Medicines Ltd., 「本公司」）根據香港聯合交易 所有限公司證券上市規則第13.10B條作出。 茲載列本公司於上海證券交易所網站刊發的《百濟神州有限公司2025年第三季度 報告》，僅供參閱。 承董事會命 百濟神州有限公司 主席 歐雷強先生 香港，2025年11月12日 於本公告日期，本公司董事會包括主席兼執行董事歐雷強先生、非執行董事 王曉東博士，以及獨立非執行董事Olivier Brandicourt博士、Margaret Han Dugan 博士、Michael Goller先生、Anthony C. Hooper先生、Ranjeev Krishana先生、 Alessandro Riva博士、Corazon (Corse ...

Core Viewpoint - The article emphasizes the challenges and opportunities in the biopharmaceutical research and development sector, highlighting the importance of innovative disease models in drug development [5][7]. Group 1: Company Overview - Jingcheng Zhiyan, founded by Xu Jie, has established over 500 disease models in just over a year, serving more than 100 companies in the biopharmaceutical industry [5][6]. - The company operates as a "model factory" in Shanghai Zhangjiang and Hainan, focusing on developing differentiated animal disease models to meet diverse client needs [9][10]. Group 2: Industry Challenges - The biopharmaceutical R&D process is lengthy and costly, with an average of 10-15 years and expenditures reaching billions, while the success rate is below 10% [7]. - Traditional disease models are inadequate for evaluating innovative drugs, necessitating continuous iteration and development of new models [7][9]. Group 3: Quality and Safety - Jingcheng Zhiyan has implemented its own Standard Operating Procedures (SOP) and achieved ISO9001 quality management certification shortly after its establishment, emphasizing the importance of quality in pharmaceutical R&D [11][12]. - The company also obtained ISO27001 information security management certification, ensuring robust data protection for client projects [14][12]. Group 4: Recognition and Growth - Within a year, Jingcheng Zhiyan received multiple recognitions, including being designated as a "Technology-based Small and Medium-sized Enterprise," reflecting its innovation and research capabilities [16]. - The company successfully passed the stringent requirements for the "High-growth Youth Sci-tech Project" funding from Zhangjiang Science City, further validating its development potential [17]. Group 5: Entrepreneurial Development - Xu Jie, as a participant in the Pudong Science and Technology Innovation - Haiwang Summit (Phase II) CEO Training Camp, has benefited from cross-industry exchanges and systematic training, enhancing his management and strategic planning skills [19][21]. - The training camp aims to empower early-stage tech entrepreneurs, helping them transition from founders to effective business leaders [22].

Core Viewpoint - Jindike experienced a significant stock price increase, closing at 24.97 yuan per share, up 19.99%, marking its second consecutive trading limit up, with related flu concept stocks also rising [1] Company Overview - Jindike's main business includes research and production in biotechnology, particularly in the development of vaccines and related biological products [1] - The company is actively advancing its research projects to meet market demands, as evidenced by its ongoing Phase III clinical trials for the quadrivalent influenza virus split vaccine for children [1] Financial Performance - In the third quarter, Jindike reported a total R&D expenditure of 17.93 million yuan, which accounted for 25.21% of its operating revenue [1] - The increase in R&D expenses is primarily attributed to the Phase III clinical trials for the quadrivalent influenza virus split vaccine for children, indicating a year-on-year rise in R&D investment [1]

Core Viewpoint - Baili Tianheng has announced the launch of its H-share global public offering, marking a significant step in its internationalization strategy and aiming to enhance its position as a leading multinational pharmaceutical company in the oncology sector [1][2]. Group 1: H-share Offering Details - The company plans to issue 8,634,300 shares, with 863,500 shares allocated for public offering in Hong Kong and 7,770,800 shares for international offering [1]. - The price range for the H-share issuance is set between 347.50 HKD and 389.00 HKD, with the public offering starting on November 7, 2025, and expected to conclude by November 12, 2025 [1]. - Major investment banks, including Goldman Sachs, J.P. Morgan, and CITIC Securities, are acting as joint sponsors for the offering [1]. Group 2: Strategic Partnerships and Market Position - The offering has attracted cornerstone investors, including strategic partner Bristol-Myers Squibb (BMS) and several top-tier investment institutions, indicating strong market confidence [2]. - Baili Tianheng aims to leverage its innovative research capabilities in the field of oncology, focusing on unmet clinical needs and aspiring to achieve global commercialization by 2029 [2]. Group 3: Research and Development Capabilities - The company has established R&D centers in the U.S. and China, focusing on early product development and subsequent clinical research [3]. - Baili Tianheng has developed a leading innovative drug R&D platform and is currently conducting nearly 90 clinical trials globally, including 15 Phase III trials in China and 10 in the U.S. [3]. Group 4: Key Drug Developments - The drug Iza-bren, a first-in-class EGFR×HER3 bispecific ADC, is in Phase III clinical trials and has shown promising interim results, with plans for commercialization in China expected next year [6][7]. - Another significant drug, T-Bren, targeting HER2, is undergoing 14 clinical trials, demonstrating strong anti-tumor efficacy across various cancer types [8]. Group 5: Strategic Collaborations - In December 2023, Baili Tianheng entered a strategic collaboration with BMS, involving an upfront payment of 800 million USD and a potential total deal value of up to 8.4 billion USD, setting a record in the ADC field [9].

Group 1 - The company signed a technology transfer contract with Nanjing Gulou Hospital for the transfer of technical secrets related to NK cell-specific antigens and tumor-specific antigen cell connectors, with a total contract amount of 78.5 million yuan (including tax) [6][10] - The payment structure includes an upfront fee of 1.5 million yuan, progress rewards totaling 2.5 million yuan, and sales sharing up to 74.5 million yuan based on future sales [10][11] - The transaction is not classified as a related party transaction and does not constitute a major asset restructuring as per relevant regulations [6][7] Group 2 - The technology involved aims to enhance the targeting ability of NK cells against tumors without the need for transfection, which is a significant advancement in biomedicine [9] - The contract allows the company to develop, produce, and sell products based on the transferred technology globally and indefinitely [13] - The company anticipates that this transaction will help expand its pipeline in the biopharmaceutical sector, aligning with its long-term strategic goals [17] Group 3 - The company held a board meeting on October 24, 2025, where it approved the signing of the technology transfer contract [6][20] - The company plans to revise its articles of association and related meeting rules, including the cancellation of the supervisory board, which will be replaced by the audit committee of the board [20][21] - The proposed changes to the articles of association and meeting rules will be submitted for approval at the upcoming third extraordinary general meeting of shareholders [20]

Core Viewpoint - Baiaosaitu-B (02315) has seen a significant stock price increase, with a rise of over 12% during trading, currently up 9.5% at HKD 25.12, with a trading volume of HKD 11.11 million. The company has received approval from the China Securities Regulatory Commission (CSRC) for its IPO application on the STAR Market, aiming to raise approximately RMB 1.185 billion for various projects and working capital [1]. Group 1 - The company plans to use RMB 454 million for the construction of an early drug research and development service platform [1]. - RMB 316 million is allocated for the research and evaluation of antibody drugs [1]. - RMB 165 million is designated for preclinical and clinical research projects [1]. - RMB 250 million will be used to supplement working capital [1]. Group 2 - Baiaosaitu has recently announced collaborations with Germany's Tubulis and global technology leader Merck [1]. - The partnership with Tubulis involves the introduction of Baiaosaitu's self-developed fully human antibodies to advance the development and commercialization of ADC products, with the company set to receive an upfront payment and potential milestone payments based on development, regulatory, and commercialization achievements, along with a single-digit percentage of net sales [1]. - The collaboration with Merck focuses on developing antibody-conjugated lipid delivery solutions for nucleic acid drugs, such as antibody-conjugated lipid nanoparticles (LNP) [1].

Core Viewpoint - The company reported a significant increase in revenue and net profit for the first three quarters of 2025, driven by growth in licensing income and CDMO business, alongside ongoing investments in innovative research and development [5]. Financial Performance - The company achieved operating revenue of 1.116 billion RMB, representing a year-on-year growth of 18.80% [5]. - The net profit attributable to shareholders reached 399 million RMB, marking a substantial increase of 71.15% compared to the same period last year [5]. - Research and development expenses totaled 368 million RMB, with a year-on-year increase of 3.87%, and the R&D expense ratio remained at a healthy level [5]. Research and Development Progress - The company has several ongoing clinical trials and projects, including: 1. NDA application for anti-IL-17A monoclonal antibody for moderate to severe plaque psoriasis has been accepted [7]. 2. Clinical trials for anti-IL-5 monoclonal antibody for severe eosinophilic asthma are ongoing [8]. 3. Clinical trials for anti-IL-4Rα monoclonal antibody for various indications are progressing, with several phases completed [10]. 4. NDA application for anti-IL-1β monoclonal antibody for acute gouty arthritis has been accepted [11]. 5. Clinical trials for anti-BDCA2 monoclonal antibody for SLE are in progress [12]. 6. Clinical trials for anti-TLIA monoclonal antibody for ulcerative colitis are ongoing [13]. Corporate Governance - The board of directors and senior management have guaranteed the authenticity, accuracy, and completeness of the quarterly report, assuming legal responsibility for its content [2].

Core Viewpoint - Ansh Biotechnology Co., Ltd. has transitioned its IPO status to "inquired" on the Sci-Tech Innovation Board, indicating progress in its public offering process [1] Group 1: Company Overview - Ansh Biotechnology is an innovative biopharmaceutical company that has entered the commercialization phase, focusing on diseases with significant unmet clinical needs, particularly in oncology [1] - The company aims to provide high-quality innovative anti-tumor drugs through efficient independent research and development, enhancing the quality of life for patients [1] Group 2: IPO Details - The IPO application for Ansh Biotechnology was accepted on September 26 [1] - The company plans to raise 2.45 billion yuan through the IPO, which will be allocated to new drug research and development projects as well as to supplement working capital [1]

Core Viewpoint - The announcement indicates that Shanghai Henlius Biopharma Co., Ltd.'s injectable SHR-1501 has been included in the list of potential breakthrough therapies by the National Medical Products Administration, with a public notice period of 7 days [1] Group 1: Product Information - SHR-1501 is a recombinant interleukin-15 fusion protein developed by the company, which, when used in conjunction with Bacillus Calmette-Guérin (BCG), can enhance immune response and synergistically combat tumors [1] - The primary indication for SHR-1501 is for patients with non-muscle invasive bladder cancer who do not respond to BCG treatment [1] Group 2: Financial Investment - The cumulative research and development investment for the SHR-1501 project has reached approximately 102 million yuan [1]

Core Insights - Recently, Dr. Wang Xingli, Co-President of Fosun Pharma and CEO of the Global R&D Center, visited the Shanghai headquarters of Ruizhi Pharmaceutical Technology Co., Ltd. for discussions [1] - The meeting focused on technological innovation in the biopharmaceutical R&D field and the development direction of new modality drugs, further deepening the cooperation consensus between the two companies [1] Company Collaboration - The visit signifies a strategic partnership aimed at enhancing collaboration in biopharmaceutical research and development [1] - Both companies are committed to exploring innovative solutions and advancing drug development processes [1]