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 | ...

Group 1 - The core point of the article is that Bohan Biotech (06955) has seen its stock price increase by over 4% following the completion of patient enrollment in the Phase III clinical trial for its drug BA1104 (Nivolumab injection) in China [1] - As of the report, Bohan Biotech's stock is trading at 10.48 HKD with a transaction volume of 45.98 million HKD [1] - BA1104 is the first biosimilar of Opdivo (Nivolumab) to enter Phase III clinical trials in China, indicating a significant milestone for the company [1] Group 2 - The Phase III clinical trial for BA1104 is a randomized, double-blind, multi-center study aimed at comparing the efficacy, safety, and immunogenicity of BA1104 combined with chemotherapy against Opdivo in patients with advanced or metastatic esophageal squamous cell carcinoma [1] - The results from the completed Phase I clinical trial show that BA1104 is highly comparable to Opdivo in terms of pharmacokinetics, safety, and immunogenicity, achieving all study endpoints [1] - The research results from the Phase I trial have been published in the international journal "BioDrugs," further validating the drug's development progress [1]

Core Viewpoint - The completion of patient enrollment in the Phase III clinical trial of BA1104 (Nivolumab injection) by the company marks a significant milestone, as it is the first biosimilar of Opdivo to enter Phase III trials in China [1][2] Group 1: Company Developments - BA1104 is a humanized monoclonal antibody targeting the PD-1 receptor, designed to enhance T-cell anti-tumor responses by blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2 [1] - The Phase III trial is a randomized, double-blind, multi-center study comparing the efficacy, safety, and immunogenicity of BA1104 with Opdivo in combination with chemotherapy for patients with advanced or metastatic esophageal squamous cell carcinoma [2] - The results of the completed Phase I trial indicated that BA1104 is highly comparable to Opdivo in terms of pharmacokinetics, safety, and immunogenicity, achieving all study endpoints [2] Group 2: Market Potential - The PD-1 inhibitors, including BA1104, represent a major advancement in cancer immunotherapy, with expanding clinical applications and significant market potential [2] - Opdivo is projected to generate approximately $9.3 billion in global sales in 2024 [2] - The Chinese antibody market based on PD-1/L1 is expected to reach 59.9 billion RMB by 2030, indicating substantial growth opportunities in this sector [2]

Core Viewpoint - The company has completed patient enrollment for the Phase III clinical trial of BA1104 (Nivolumab Injection) in China, making it the first biosimilar of Opdivo to enter Phase III trials domestically [1][2] Company Summary - BA1104 is a humanized monoclonal antibody (IgG4 subtype) targeting the programmed cell death protein 1 (PD-1) receptor, enhancing T-cell anti-tumor responses by blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2 [1] - The Phase III trial is a randomized, double-blind, multi-center study comparing the efficacy, safety, and immunogenicity of BA1104 combined with chemotherapy against Opdivo in patients with advanced or metastatic esophageal squamous cell carcinoma [2] - The completed Phase I trial results indicate that BA1104 is highly comparable to Opdivo in terms of pharmacokinetics, safety, and immunogenicity, achieving all study endpoints, with results published in the international journal "BioDrugs" [2] Industry Summary - PD-1 inhibitors represent a major approach in cancer immunotherapy, with ongoing breakthroughs in combination therapies and the synergistic development of diverse immunotherapies expanding their clinical application boundaries [2] - The global sales of Opdivo are projected to reach approximately $9.3 billion in 2024 [2] - According to a Frost & Sullivan report, the market size for PD-1/L1 antibodies in China is expected to reach 59.9 billion RMB by 2030 [2]

Core Viewpoint - The company announced the completion of patient enrollment for the Phase III clinical trial of BA1104 (Nivolumab Injection) in China, marking it as the first biosimilar of Opdivo® to enter Phase III trials domestically [1][2] Group 1: Product Development - BA1104 is a humanized monoclonal antibody targeting the PD-1 receptor, designed to enhance T-cell anti-tumor responses by blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2 [1] - The Phase III trial is a randomized, double-blind, multi-center study comparing the efficacy, safety, and immunogenicity of BA1104 combined with chemotherapy against Opdivo® in patients with advanced or metastatic esophageal squamous cell carcinoma [2] - The completed Phase I trial results indicate that BA1104 is highly comparable to Opdivo® in terms of pharmacokinetics, safety, and immunogenicity, achieving all study endpoints [2] Group 2: Market Potential - PD-1 inhibitors, including BA1104, represent a significant advancement in cancer immunotherapy, with expanding clinical applications and market potential [2] - Opdivo® is projected to generate global sales of approximately $9.3 billion in 2024 [2] - The antibody market in China based on PD-1/L1 is expected to reach RMB 59.9 billion by 2030, indicating substantial growth opportunities [2]