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]

（股 份 代 號：6955） 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） 自願性公告 本公司納武利尤單抗中國Ⅲ期臨床試驗完成所有患者入組 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 主開發的BA1104（納 武 利 尤 單 抗 注 射 液）在中華人民共和國（「中 國」）的Ⅲ期臨床 試 驗 已 完 成 所 有 患 者 入 組。BA1104開 發 進 度 領 先，為 國 內 首 個 開 展 Ⅲ 期 臨 床 試 驗的歐狄沃® （Opdivo®）生 物 類 似 藥。 納武利尤單抗是一種針對程序性細胞死亡1（「PD-1」）受體的人源化單克隆抗體 （IgG4亞 型），通 過 ...

Core Viewpoint - Despite significant business development (BD) agreements exceeding $10 billion, the stock prices of innovative pharmaceutical companies remain sluggish, indicating a disconnect between market expectations and actual performance [1][2]. Group 1: Market Performance - The Hong Kong Stock Connect innovative drug index has declined from over 1240 points on October 9 to 1110 points, reflecting a drop of approximately 10.5% [1][2]. - Notable companies like 信达生物 (Innovent Biologics) have seen their stock prices fall despite announcing major collaborations, with 信达生物's stock dropping 1.96% to 85.2 HKD per share on October 22 [2]. - Over the past month, the innovative drug sector has experienced a 16% decline from a peak of 1326 points on September 8, with several companies like 诺诚健华 (Nocera) and 康诺亚-B (CanSino) seeing stock drops exceeding 19% [2][4]. Group 2: Financial Performance - Many innovative drug companies have reported revenue growth, yet profitability remains a concern, with only four out of the listed companies achieving positive net profits [6][7]. - 康诺亚-B reported a staggering 812.1% year-on-year revenue increase, while other companies like 诺诚健华 and 信达生物 also showed significant revenue growth of over 40% [6][7]. Group 3: Industry Dynamics - The innovative drug sector is characterized by high competition and a high rate of project failure, with a significant percentage of BD agreements facing termination [8]. - The long-term outlook for the Chinese innovative drug industry remains positive, driven by an increase in BD transactions, although the market is becoming increasingly competitive [8][9]. - Analysts suggest that the recent stock price adjustments may be a result of previously overly optimistic expectations regarding BD agreements, and the market may be entering a phase of stabilization [10].

Core Viewpoint - The stock price of Bohan Biotech (06955) has declined over 30% since reaching a peak of HKD 19.90 on August 8, 2023, and is now facing pressure to maintain its position in the Hong Kong Stock Connect due to a decrease in average market capitalization [1][2] Group 1: Stock Performance - Bohan Biotech's average market capitalization has fallen to HKD 66.51 billion, approaching the HKD 57.45 billion threshold for potential removal from the Hong Kong Stock Connect [1] - The stock has been in a downward trend characterized by "price drop and volume shrinkage" since August, with significant trading volume declines observed [2][3] - Recent trading days have shown signs of stabilization, with the stock price touching the lower Bollinger Band and attempting a technical rebound [5] Group 2: Market Dynamics - The company has successfully commercialized biosimilars, which has been a key strategy for growth, but faces challenges due to centralized procurement policies [6][7] - The centralized procurement initiated on August 1, 2023, includes several monoclonal antibodies, directly impacting Bohan Biotech's products [7][8] - Bohan Biotech's flagship product, Bevacizumab (博优诺), faces intense competition with 11 approved biosimilars in the market, leading to price pressures [8][9] Group 3: Competitive Landscape - The sales performance of Bohan Biotech's products is under threat from established competitors, with significant market shares held by other companies [8] - The pricing strategy in response to centralized procurement may lead to a price war, impacting both Bohan Biotech and its competitors [9] - The regulatory environment for biosimilar procurement is evolving, with expectations for moderate price reductions rather than aggressive undercutting [9]

Core Viewpoint - The stock price of Bohan Biotech (06955) has declined over 30% since reaching a peak of 19.90 HKD on August 8, 2023, and is now facing pressure to maintain its status in the Hong Kong Stock Connect due to a decrease in average market capitalization [1][2] Group 1: Stock Performance - Bohan Biotech's average market capitalization has fallen to 6.651 billion HKD, approaching the Hong Kong Stock Connect exit threshold of 5.745 billion HKD [1] - The stock has been in a downward trend characterized by "price drop and volume shrinkage" since August, with significant trading volume declines observed [2][3] - On October 14, the stock price reached a low of 11.22 HKD, but there are signs of stabilization in the following trading days [1][5] Group 2: Market Dynamics - The company has faced challenges due to the introduction of centralized procurement for biosimilars, which could impact its valuation and market position [1][6] - Bohan Biotech's strategy of developing biosimilars has been crucial for its commercial success, but the centralized procurement poses a risk to its business model [6][7] - The centralized procurement initiated on August 1, 2023, includes several key monoclonal antibodies, directly affecting Bohan Biotech's products [7][8] Group 3: Competitive Landscape - Bohan Biotech's core product, Bevacizumab (博优诺®), faces intense competition with 11 approved biosimilars in the market, leading to price pressures [8][9] - The company has partnered with AstraZeneca for the exclusive promotion of Bevacizumab, but its market share remains low compared to competitors [8] - The pricing strategy post-procurement will be critical, as Bohan Biotech's pricing is competitive but may still struggle against established players [9]