格隆汇2月16日丨中国生物制药(01177.HK)发布公告，集团自主研发的国家1类创新药贝莫苏拜单抗（商 品名：安得卫®）新适应症已获得中国国家药品监督管理局(NMPA)的上市批准，用于在接受铂类药物 为基础的同步或序贯放化疗后未出现疾病进展的未携带已知表皮生长因子受体(EGFR)敏感突变或间变 性淋巴瘤激酶(ALK)重排的不可切除III期非小细胞肺癌(NSCLC)患者的治疗。 ...

Core Viewpoint - China National Pharmaceutical Group's innovative drug Bemosituzumab (brand name: Andevate) has received approval from the National Medical Products Administration (NMPA) for a new indication in treating unresectable stage III non-small cell lung cancer (NSCLC) patients who have not progressed after platinum-based chemotherapy [1] Group 1 - The approval is based on positive results from the R-ALPS study, which was presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting [1] - The study included patients with locally advanced or unresectable stage III NSCLC who had not progressed after synchronous/sequential chemoradiotherapy, comparing Bemosituzumab to a placebo [1] Group 2 - The median follow-up time was 19.4 months, with a median progression-free survival (PFS) of 9.69 months for the Bemosituzumab group compared to 4.17 months for the placebo group (HR=0.53, 95% CI 0.39-0.72, p<0.0001), indicating a 47% reduction in the risk of disease progression or death [2] - Subgroup analyses showed consistent benefit trends across various groups, demonstrating the broad applicability of this treatment [2] - Overall survival (OS) data is not yet mature, with median OS not reached, but a trend towards OS benefit was observed (HR=0.76, 95% CI 0.50-1.14) [2] Group 3 - The incidence of grade 3 or higher treatment-related adverse events (TRAEs) was 29.4% in the Bemosituzumab group compared to 19.7% in the placebo group [2] - Bemosituzumab is the third PD-L1 inhibitor approved in China for consolidation therapy after radical chemoradiotherapy for locally advanced or unresectable NSCLC [2] - The company aims to continue focusing on innovation in lung cancer treatment, developing a pipeline that covers multiple molecular subtypes and treatment scenarios to enhance patient survival benefits [2]

Core Viewpoint - China National Pharmaceutical Group's innovative drug Bemosituzumab (brand name: Andevate®) has received approval from the National Medical Products Administration (NMPA) for a new indication in treating unresectable stage III non-small cell lung cancer (NSCLC) patients who have not experienced disease progression after platinum-based chemoradiotherapy [1] Group 1 - The approval is based on positive results from the R-ALPS study, which was presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting [1] - The study included patients with locally advanced or unresectable stage III NSCLC who received either Bemosituzumab or a placebo as consolidation treatment until disease progression, with the primary endpoint being progression-free survival (PFS) assessed by blinded independent central review (BICR) [1] Group 2 - The median follow-up time was 19.4 months, with a median PFS of 9.69 months for the Bemosituzumab group compared to 4.17 months for the placebo group (HR=0.53, 95% CI 0.39-0.72, p<0.0001), indicating a 47% reduction in the risk of disease progression or death [2] - Subgroup analyses showed consistent benefit trends across various groups, demonstrating the broad applicability of this treatment [2] - Overall survival (OS) data is not yet mature, with median OS not reached, but a trend towards OS benefit was observed (HR=0.76, 95% CI 0.50-1.14) [2] Group 3 - The incidence of grade 3 or higher treatment-related adverse events (TRAEs) was 29.4% in the Bemosituzumab group compared to 19.7% in the placebo group [2] - Bemosituzumab is the third PD-L1 inhibitor approved in China for consolidation treatment after radical chemoradiotherapy for locally advanced or unresectable NSCLC [2] - The company aims to continue focusing on innovation in lung cancer treatment, developing a pipeline that covers multiple molecular subtypes and treatment scenarios to enhance patient survival benefits [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，概不對因本公告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。 （於開曼群島註冊成立之有限公司） 網站：www.sinobiopharm.com （股份編號：1177） 自願公告 • 中位隨訪時間19.4個月，貝莫蘇拜單抗組中位PFS為9.69個月，安慰劑組為4.17個月（HR=0.53， 95% CI 0.39-0.72， p<0.0001 ），患者疾病進展或死亡風險降低47%； • 預設的亞組分析（是否吸煙、前序治療方式為同步╱序貫）結果顯示，各亞組與意向性治療(ITT) 人群獲益趨勢一致，展現出該治療方案的廣泛適用性； 貝莫蘇拜單抗注射液非小細胞肺癌放化療後維持適應症獲批上市 中國生物製藥有限公司（「本公司」，連同其附屬公司統稱「本集團」）董事會（「董事會」）宣佈，本集團自 主研發的國家1類創新藥貝莫蘇拜單抗（商品名：安得衛® ）新適應症已獲得中國國家藥品監督管理局 (NMPA)的上市批准，用於在接受鉑類藥物為基礎的同步或序貫放化療後未出現疾病進展的未攜帶已 ...

Group 1 - The core viewpoint of the article is that China Biologic Products (01177) has completed the enrollment of subjects for the Phase III clinical trials of two drugs, TQB2102 and LM302 [1] - LM302 is noted as the world's first CLDN18.2 antibody drug complex to complete subject enrollment in Phase III registration clinical trials, potentially providing new treatment options for patients [1] - Bank of America Securities has set a target price of HKD 8.6 and reiterated a "Buy" rating for the company [1]

Core Viewpoint - Bank of America Securities reports that China Biologic Products (01177) has completed patient enrollment for Phase III clinical trials of two drugs, TQB2102 and LM302, with LM302 being the first CLDN18.2 antibody drug conjugate to complete such enrollment globally, potentially offering new treatment options for patients [1] Group 1 - China Biologic Products has completed patient enrollment for Phase III clinical trials of TQB2102 and LM302 [1] - LM302 is noted as the world's first CLDN18.2 antibody drug conjugate to finish Phase III registration clinical trial enrollment [1] - Bank of America Securities sets a target price of HKD 8.6 and maintains a "Buy" rating for the stock [1]

Core Viewpoint - Bank of America Securities reports that two drugs from a Chinese biopharmaceutical company, TQB2102 and LM302, have recently completed patient enrollment for Phase III clinical trials, with LM302 being the first CLDN18.2 antibody-drug conjugate to complete this phase globally, potentially offering new treatment options for patients [1] Group 1 - The two drugs, TQB2102 and LM302, have completed patient enrollment for Phase III clinical trials [1] - LM302 is noted as the world's first CLDN18.2 antibody-drug conjugate to complete Phase III registration clinical trial enrollment [1] - The target price for the company is set at HKD 8.6, with a reiterated "Buy" rating [1]

TQB2102是集团自主研发的新一代HER2双表位双特异性抗体偶联药物(ADC)，通过三项核心技术创 新，实现疗效与安全性的优化平衡：1. 双表位靶向设计：抗体端采用非对称型结构设计，同时结合 HER2的ECD II/IV结构域，可显著提升对肿瘤细胞的选择性及药物内吞效率，从而增强抗肿瘤活性。2. 可裂解连接子：采用酶裂解型连接子，能够高效裂解释放毒素，并具备"旁观者效应"，清除周边异质性 肿瘤细胞，扩大杀伤范围。3. 优化的药物抗体比(DAR)：DAR值稳定控制在5.8-6.0，搭配拓扑异构酶I (Topo I)抑制剂毒素，在提升疗效的同时降低毒副作用。以上核心技术的结合，突破了传统HER2单抗及 单靶点ADC的局限，使TQB2102在HER2低表达肿瘤治疗中展现出显著潜力。 格隆汇2月10日丨中国生物制药(01177.HK)发布公告，集团自主研发的国家1类创新药TQB2102"HER2双 抗ADC"正在开展一项"评价注射用TQB2102对比研究者选择的化疗在HER2低表达复发╱转移性乳腺癌 中有效性和安全性的随机、开放、平行对照的III期临床试验(TQB2102-III-01)"，近期已完成全部受试者 入 ...

智通财经APP讯，中国生物制药(01177)发布公告，集团自主研发的国家1类创新药TQB2102"HER2双抗 ADC"正在开展一项"评价注射用TQB2102对比研究者选择的化疗在HER2低表达复发╱转移性乳腺癌中 有效性和安全性的随机、开放、平行对照的III期临床试验(TQB2102-III-01)"，近期已完成全部受试者入 组。 TQB2102是集团自主研发的新一代HER2双表位双特异性抗体偶联药物(ADC)，通过三项核心技术创 新，实现疗效与安全性的优化平衡： 1.双表位靶向设计：抗体端采用非对称型结构设计，同时结合 HER2的ECD II/IV结构域，可显著提升对肿瘤细胞的选择性及药物内吞效率，从而增强抗肿瘤活性。 2. 可裂解连接子：采用酶裂解型连接子，能够高效裂解释放毒素，并具备"旁观者效应"，清除周边异质性 肿瘤细胞，扩大杀伤范围。 3.优化的药物抗体比(DAR)：DAR值稳定控制在5.8-6.0，搭配拓扑异构酶I (Topo I)抑制剂毒素，在提升疗效的同时降低毒副作用。 以上核心技术的结合，突破了传统HER2单抗及单靶点ADC的局限，使TQB2102在HER2低表达肿瘤治 疗中展现出显著潜力 ...

在2025年美国临床肿瘤学会(ASCO)年会上，集团公布了TQB2102用于HER2低表达晚期乳腺癌的Ib期临 床研究结果，显示出良好的疗效与安全性： 疗效数据：在既往接受过多线治疗(中位晚期系统性治疗4线，中位姑息性化疗2线)的HER2低表达患者 中，总体客观缓解率(ORR)为53.4%(39/73)，其中7.5mg/kg组的ORR达到58.3%(21/36)。值得注意的是， 即使在既往接受过ADC治疗并进展的患者中，仍有44.4%的患者经TQB2102治疗后获得缓解。 安全性数据：3级及以上治疗相关不良事件(TRAEs)主要包括中性粒细胞减少(23.3%)、白细胞减少 (20.6%)、贫血(8.2%)和低钾血症(6.9%)等，总体耐受性良好。 在乳腺癌治疗领域，集团已布局HER2+、HER2低表达、HR+/HER2-及三阴性乳腺癌在内的全分子分 型，并系统覆盖从新辅助、一线、二线及以上、到辅助治疗的全病程治疗阶段，致力于为更多患者提供 新的治疗选择。 中国生物制药(01177)发布公告，集团自主研发的国家1类创新药TQB2102"HER2双抗ADC"正在开展一 项"评价注射用TQB2102对比研究者选择的 ...