目前国内除原研外，暂未有类似药获批上市 公司研发的帕博利珠单抗注射液为生物类似药。帕博利珠单抗原研产品(商品名：可瑞达?，Keytruda?) 由默沙东公司开发，是全球首个获批上市的PD-1抑制剂之一，已在全球范围内获批用于包括非小细胞 肺癌、黑色素瘤、头颈部鳞状细胞癌、食管癌、肝癌、胃癌、结直肠癌等在内的数十个重要肿瘤适应 症，临床价值得到广泛认可。 帕博利珠单抗是一种靶向程序性死亡受体-1(PD-1)的人源化单克隆抗体。PD-1 是免疫 T 细胞表面的一 种关键免疫检查点蛋白，肿瘤细胞可通过激活PD-1通路抑制 T 细胞的免疫活性，从而实现免疫逃逸。 帕博利珠单抗通过阻断PD-1与其配体 PD-L1/PD-L2 的结合，恢复 T 细胞的肿瘤杀伤功能，增强人体免 疫系统对抗肿瘤的能力。该药物作为免疫检查点抑制剂，已成为多种晚期恶性肿瘤的标准治疗方案之 一，革新了肿瘤治疗格局。 格隆汇12月16日丨华兰生物(002007.SZ)公布，近日公司参股公司华兰基因工程有限公司(以下简称"基因 公司")收到国家药品监督管理局签发的帕博利珠单抗注射液境内生产药品注册临床试验申请《受理通知 书》(受理号：CXSL2501 ...

Core Insights - The approval of the combination therapy of Bemarituzumab and Pembrolizumab marks the first and currently only perioperative treatment option for muscle-invasive bladder cancer (MIBC) patients who are not suitable for cisplatin-based chemotherapy, significantly improving survival outcomes compared to standard surgery [1][2] Group 1: Treatment Approval and Efficacy - The FDA has approved the combination of Bemarituzumab (an antibody-drug conjugate targeting Nectin-4) and Pembrolizumab (a PD-1 inhibitor) for neoadjuvant treatment in adult patients with muscle-invasive bladder cancer [1] - The approval is based on the pivotal Phase III EV-303 study, which demonstrated a 60% reduction in the risk of recurrence, progression, or death compared to surgery alone, and a 50% reduction in mortality risk [1][2] - The combination therapy is expected to redefine treatment standards for cisplatin-ineligible MIBC patients, addressing a long-standing unmet medical need [2][3] Group 2: Clinical Study Results - In the EV-303 study, the event-free survival (EFS) rate for the combination therapy group was 74.7%, compared to 39.4% for the surgery-only group, with a median EFS not yet reached for the combination group versus 15.7 months for the surgery group [2] - The overall survival (OS) data indicated a two-year survival probability of 79.7% for the combination group, compared to 63.1% for the surgery group, with a median OS not yet reached for the combination group versus 41.7 months for the surgery group [2] Group 3: Safety Profile - The safety profile of the combination therapy aligns with previous reports, with no new safety signals identified [3] - Common adverse reactions (≥20%) included laboratory abnormalities such as elevated blood glucose and hemoglobin levels, as well as fatigue and rash [3] - The incidence of grade 3 or higher adverse events was 71.3% in the combination therapy group compared to 45.9% in the surgery group [3] Group 4: Ongoing Research - The ongoing Phase III EV-304 study is evaluating the combination of Bemarituzumab and Pembrolizumab in the perioperative setting for cisplatin-eligible MIBC patients [4]

Core Viewpoint - The company Fuhong Hanlin (02696) has seen a significant stock price increase following the announcement that its innovative PD-1 inhibitor, H drug Surulitinib, has been officially included by the NMPA as a breakthrough therapy for gastric cancer treatment [1] Group 1: Company Developments - Fuhong Hanlin's H drug Surulitinib has been recognized as a breakthrough therapy by the NMPA for use in combination with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer [1] - The phase 3 clinical study for the H drug targeting this indication has met its primary endpoint, potentially offering patients improved survival benefits and quality of life [1] Group 2: Market Context - As of the announcement date, there are currently no targeted PD-1 monoclonal antibody drugs approved globally for neoadjuvant/adjuvant treatment of gastric cancer [1] - According to the latest IQVIA MIDAS data, the global sales for targeted PD-1 monoclonal antibody drugs are projected to reach approximately $45.704 billion in 2024 [1]

Group 1 - The core point of the article is that Fuhong Hanlin's innovative PD-1 inhibitor, H drug Surulitinib, has been officially included by the NMPA as a breakthrough therapy for gastric cancer, which could significantly improve patient survival and quality of life [1] - Fuhong Hanlin's stock rose over 6% in the afternoon trading session, with a current price of 66.95 HKD and a trading volume of 63.1355 million HKD [1] - The phase III clinical study for the H drug has met its primary endpoint, indicating its potential to replace postoperative adjuvant chemotherapy in the perioperative treatment of gastric cancer [1] Group 2 - As of the announcement date, there are no approved targeted PD-1 monoclonal antibody drugs for neoadjuvant/adjuvant treatment of gastric cancer globally [1] - According to IQVIA MIDAS data, the global sales of targeted PD-1 monoclonal antibody drugs are projected to reach approximately 45.704 billion USD in 2024 [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 - BeiGene reported a significant financial turnaround in the first half of 2025, achieving a total revenue of 17.518 billion yuan, a year-on-year increase of 46.03%, and a net profit of 450 million yuan, marking its first profit of the year [2][3]. Financial Performance - Total revenue for the first half of 2025 reached 17.518 billion yuan, up 46.03% year-on-year [2]. - Product revenue was 17.36 billion yuan, reflecting a growth of 45.8% [2]. - The company achieved a net profit of 450 million yuan, indicating a turnaround from previous losses [2]. Product Performance - The growth in product revenue was driven by sales of self-developed products, namely Brukinsa® (Zebutinib) and Tislelizumab, as well as increased sales from licensed products [2]. - Zebutinib's global sales reached 12.527 billion yuan, a 56.2% increase year-on-year, making it the leading BTK inhibitor in both the U.S. and global markets [2][3]. - In the U.S. market, Zebutinib sales amounted to 8.958 billion yuan, up 51.7% [3]. - In Europe, Zebutinib sales were 1.918 billion yuan, growing by 81.4% [3]. - In China, Zebutinib sales reached 1.192 billion yuan, an increase of 36.5% [3]. - Tislelizumab generated sales of 2.643 billion yuan, reflecting a 20.6% growth, primarily due to new indications being covered by insurance [3]. Research and Development - The company anticipates over 20 milestone advancements in blood cancers and solid tumors within the next 18 months [4]. - In the blood cancer sector, two products, BGB-16673 and Sotorasib, are in Phase 3 clinical trials [4]. - BGB-16673 is noted for its rapid clinical progress as a BTK degrader, showing potential for treating relapsed or refractory B-cell malignancies [4]. - Sotorasib has submitted applications for two indications in China and is expected to file for global accelerated approval in the second half of 2025 [4]. - The company is also developing multiple potential best-in-class products and combination therapies for key cancers, including breast, lung, and gastrointestinal cancers [4]. Stock Performance - As of August 29, BeiGene's A-share price closed at 278 yuan, marking a 12.55% increase and reaching a historical high [5].