Group 1 - The company announced the issuance of 1.5 million exchangeable preferred shares at a total subscription price of $150 million, equivalent to $100 per share, with the right to exchange for shares of Boan Biologics [1] - Upon full exercise of the exchange rights, Boan Biologics will no longer be a subsidiary of the company, which currently holds approximately 361 million shares of Boan Biologics, representing about 57.94% of its issued share capital [1] - The company has agreed to guarantee the issuer's obligations under the subscription agreement [1] Group 2 - The board believes that issuing exchangeable preferred shares will provide an immediate source of cash while maintaining strategic flexibility [2] - The exchange mechanism allows the company to monetize its investment in Boan Biologics over a longer period at a price above the current market level, which is expected to yield better results compared to bulk disposals at discounted prices [2] - Proceeds from the subscription will be used for general working capital purposes [2]

Group 1 - The core viewpoint of the news highlights the strong performance of the Hong Kong Stock Connect Innovative Drug ETF, which has gained 1.2% with a trading volume of 351 million yuan and a total fund size of 2.079 billion yuan as of November 10 [1] - Key performing stocks within the ETF include InnoCare Pharma-B, Bionet, and Ascletis Pharma, with respective gains of 5.4%, 4.43%, and 4.37% [1] - Conversely, stocks such as Kangzhe Pharmaceutical, MIRXES-B, and Innovent Biologics showed weaker performance, with declines of 1.28%, 0.94%, and 0.65% respectively [1] Group 2 - The innovative drug sector is identified as the largest investment opportunity in the pharmaceutical sector for 2025, with a focus on dual/multi-target drugs, chronic disease medications addressing unmet clinical needs, and ADCs [2] - There is a noted improvement in domestic and international innovative drug financing data, with an upward trend in CXO industry orders, indicating a potential recovery in valuations and performance [2] - The medical device sector is experiencing accelerated approvals for innovative products, such as the approval of the chest and abdominal aortic stent system by Xianjian Technology, which is expected to enhance long-term profit margins [2] Group 3 - The Hong Kong Stock Connect Innovative Drug ETF and its linked funds passively track the Hang Seng Hong Kong Stock Connect Innovative Drug Select Index, with the top ten weighted stocks including BeiGene, China Biologic Products, and Innovent Biologics [3]

Core Viewpoint - The company, 博安生物, has seen a stock increase of over 4% following the acceptance of its marketing authorization applications for two monoclonal antibody injections in the UK, indicating positive market sentiment and potential growth opportunities [1] Group 1: Product Development - 博安生物's BA6101 (60mg) and BA1102 (120mg) are key products in its global development strategy, targeting orthopedic and oncology fields respectively [1] - The company plans to submit marketing applications for these products to major international regulatory bodies including EMA, FDA, and PMDA [1] Group 2: Market Potential - There is a significant global market potential for 地舒单抗, with projected combined sales of Prolia and Xgeva reaching approximately $6.6 billion in 2024 [1] - The company has established a comprehensive quality management system that meets international standards to support the global commercialization of its products [1]

Core Viewpoint - The company, Boan Biotech (06955), has seen its stock rise over 4% following the acceptance of its marketing authorization applications for two monoclonal antibody injections in the UK, indicating positive market sentiment and potential growth opportunities in the orthopedic and oncology sectors [1] Group 1: Product Development - Boan Biotech announced that its self-developed monoclonal antibody injections, BA6101 (60mg) for orthopedics and BA1102 (120mg) for oncology, have received acceptance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for marketing authorization [1] - The company considers BA6101 and BA1102 as core products in its global development strategy and plans to submit applications to other international regulatory bodies, including the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan [1] Group 2: Market Potential - There is a broad market outlook for the monoclonal antibody, denosumab, due to extensive clinical demand and significant clinical value, with global sales for Prolia and Xgeva projected to reach approximately $6.6 billion in 2024 [1] - To support its global commercialization goals, the company has established a comprehensive quality management system that meets international standards in China, Europe, the United States, and Japan, ensuring quality assurance for denosumab and future biopharmaceuticals [1]

Core Viewpoint - The company has received acceptance for its marketing authorization applications for two monoclonal antibody injection products in the UK, indicating progress in its product pipeline and potential market expansion [1] Group 1: Product Development - The company has developed BA6101, a 60mg injection for orthopedic applications, and BA1102, a 120mg injection for oncology applications [1] - The acceptance of the marketing authorization applications by the UK Medicines and Healthcare products Regulatory Agency marks a significant milestone for the company's product offerings [1]

Core Insights - The company has received acceptance for its marketing authorization applications for BA6101 and BA1102 in the UK, targeting the orthopedic and oncology fields respectively [1][2] Group 1: Product Details - BA6101 is a biosimilar to Prolia® and was approved in China in 2022, receiving positive feedback from doctors and patients during its clinical application [1] - BA1102 is a biosimilar to Xgeva® and is set to be approved in China in 2024 [2] Group 2: Indications and Applications - BA6101 aims to treat osteoporosis in postmenopausal women and high-risk men, significantly reducing the risk of vertebral, non-vertebral, and hip fractures [1] - BA1102 is intended for preventing skeletal-related events in adults with advanced malignancies and treating patients with giant cell tumors of bone [2] Group 3: Global Strategy and Market Potential - The company is pursuing international clinical and registration efforts for both products, planning submissions to EMA, FDA, and PMDA [2] - The global market for denosumab is promising, with projected combined sales of Prolia® and Xgeva® reaching approximately $6.6 billion in 2024 [2] - The company has established a quality management system compliant with international standards to support the global commercialization of denosumab and future biopharmaceuticals [2]

Core Viewpoint - The company has received acceptance for its marketing authorization applications for BA6101 and BA1102 in the UK, indicating a significant step in its global expansion strategy in the biopharmaceutical sector [1][2] Group 1: Product Information - BA6101 is a biosimilar to Prolia, approved in China in 2022, targeting osteoporosis treatment in postmenopausal women and men at high risk of fractures, as well as bone loss in prostate cancer patients undergoing hormone therapy [1] - BA1102 is a biosimilar to Xgeva, approved in China in 2024, aimed at preventing bone-related events in adults with advanced malignancies and treating patients with giant cell tumors of bone [2] Group 2: Market Potential - The global market for denosumab, represented by Prolia and Xgeva, is projected to reach approximately $6.6 billion in sales by 2024, highlighting the substantial commercial opportunity for the company's products [2] - The company is actively pursuing international clinical trials and regulatory submissions for BA6101 and BA1102 in various regions, including the EMA, FDA, and PMDA, to support its global commercialization goals [2] Group 3: Quality Assurance - The company has established a comprehensive quality management system that meets international standards to ensure the successful international launch of denosumab and future biopharmaceuticals [2]

Core Viewpoint - The company has received acceptance for its marketing authorization applications for BA6101 and BA1102 in the UK, indicating a significant step in expanding its product portfolio in the international market [1][2]. Group 1: Product Information - BA6101 is a biosimilar to Prolia, approved in China in 2022, and is aimed at treating osteoporosis in postmenopausal women and men at high risk of fractures, as well as bone loss in prostate cancer patients undergoing hormone therapy [1]. - BA1102 is a biosimilar to Xgeva, approved in China in 2024, targeting the prevention of skeletal-related events in adults with advanced malignancies and the treatment of giant cell tumors of bone [2]. Group 2: Market Potential - The global market for denosumab, represented by Prolia and Xgeva, is projected to generate approximately $6.6 billion in sales in 2024, highlighting the substantial commercial opportunity for the company's products [2]. - The company is actively pursuing international clinical trials and regulatory submissions for BA6101 and BA1102 to enhance their global market presence, including applications to EMA, FDA, and PMDA [2]. Group 3: Quality Assurance - The company has established a comprehensive quality management system that meets international standards to support the successful commercialization of denosumab and future biopharmaceuticals [2].

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 的全部或任何部份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。 Shandong Boan Biotechnology Co., Ltd. 山東博安生物技術股份有限公司 （於 中 華 人 民 共 和 國 註 冊 成 立 的 股 份 有 限 公 司） （股 份 代 號：6955） 自願性公告 本公司兩款地舒單抗注射液在英國的上市申請獲受理 山東博安生物技術股份有限公司（「本公司」）董事會（「董事會」）宣 佈，本 公 司 自 主研製的骨科領域的地舒單抗注射液60mg (BA6101)和腫瘤領域的地舒單抗注 射 液120mg (BA1102)的英國上市許可申請已獲得英國藥品和醫療健康產品管理 局(MHRA)受 理。 BA6101是Prolia（中文商品名：普羅力 ® ®）的生物類似藥，已於2022年作為首個國產 的地舒單抗注射液在中國獲批上市（中 文 商 品 名：博 優 倍®），在 近3年的臨床應 用 中 獲 得 ...

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年10月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 山東博安生物技術股份有限公司 呈交日期: 2025年11月5日 FF301 第 1 頁 共 10 頁 v 1.1.1 FF301 II. 已發行股份及/或庫存股份變動 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 06955 | 說明 | H股 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 622,333,694 | RMB | | 1 RMB | | 622,333,694 | | 增加 / 減少 (-) | | | 0 | | | RMB | | 0 | | 本月底結存 | | | 622,333,694 | RMB | ...