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 ...

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 安全性數據：3級及以上治療相關不良事件(TRAEs)主要包括中性粒細胞減少(23.3%)、白細胞減少 (20.6%)、貧血(8.2%)和低鉀血症(6.9%)等，總體耐受性良好。 乳腺癌是全球女性最常見的惡性腫瘤，2022年中國乳腺癌新發病例數約35.7萬例，死亡病例數約7.5 萬例[2]。其中，約45%-55%的乳腺癌為HER2低表達（即HER2 IHC 1+或2+/FISH-）。這類患者形成了 一個異質性群體，現有的常規靶向HER2療法對其臨床獲益有限，亟需新的治療手段改善預後[3-4]。 在乳腺癌治療領域，本集團已佈局HER2+、HER2低表達、HR+/HER2－及三陰性乳腺癌在內的全分 子分型，並系統覆蓋從新輔助、一線、二線及以上、到輔助治療的全病程治療階段，致力於為更多 患者提供新 ...

智通财经APP获悉，中国生物制药(01177)涨超3%，截至发稿，涨3.09%，报6.68港元，成交额1.49亿港 元。 消息面上，2月9日，中国生物制药发布公告，集团全资附属公司礼新医药科技(上海)有限公司(礼新医 药)自主研发的国家1类创新药维特柯妥拜单抗(研发代号：LM-302)"CLDN18.2 ADC"正在开展用于治疗 三线及以上CLDN18.2阳性的局部晚期或转移性胃及胃食管交界部腺癌的III期注册临床试验(LM302-03- 101)，已顺利完成患者入组。其中，LM302是全球首款完成注册III期临床试验入组的CLDN18.2 ADC药 物。 在2025年美国临床肿瘤学会(ASCO)年会上，礼新医药公布了LM-302联合特瑞普利单抗治疗胃癌的最新 研究数据：在41例疗效可评估的患者中，客观缓解率(ORR)为65.9%，疾病控制率(DCR)为 85.4%。其 中，在CLDN18.2表达≥25%的32例患者中，ORR达到71.9%，DCR达到96.9%。按PD-L1 表达分层分 析，PD-L1 CPS<1的患者ORR为63.3%，CPS≥1的患者ORR为77.8%。该研究表明，LM302联合治疗方案 ...

Core Viewpoint - China Biologic Products (01177) announced that its wholly-owned subsidiary, Lixin Pharmaceutical Technology (Shanghai) Co., Ltd., has initiated a Phase III registration clinical trial for its self-developed innovative drug, LM-302, targeting CLDN18.2-positive advanced gastric and gastroesophageal junction adenocarcinoma [1][2]. Group 1: Clinical Development - LM-302 is the first CLDN18.2 antibody-drug conjugate (ADC) to complete patient enrollment in a Phase III clinical trial globally [1]. - The drug specifically targets CLDN18.2-positive tumor cells, delivering a small molecule toxin to achieve precise tumor cell destruction [1]. - The ongoing Phase III trial focuses on patients with locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma who have received three or more prior lines of therapy [2]. Group 2: Clinical Results - At the 2025 American Society of Clinical Oncology (ASCO) annual meeting, Lixin Pharmaceutical reported that in 41 evaluable patients, the objective response rate (ORR) was 65.9% and the disease control rate (DCR) was 85.4% [2]. - Among 32 patients with CLDN18.2 expression ≥25%, the ORR reached 71.9% and the DCR was 96.9% [2]. - The study also indicated that for patients with PD-L1 CPS <1, the ORR was 63.3%, while for those with CPS ≥1, the ORR was 77.8% [2]. Group 3: Future Plans and Regulatory Status - In addition to the ongoing Phase III study, LM-302 is set to undergo another Phase III registration trial in China, focusing on first-line treatment for CLDN18.2-positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma [2]. - LM-302 has been included in the breakthrough therapy designation by the China National Medical Products Administration (NMPA) and has received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) [2]. Group 4: Company Strategy - Leveraging strong resources and industrial capabilities, Lixin Pharmaceutical is accelerating the clinical translation and commercialization of more innovative drugs, aiming to provide accessible treatment options for global cancer patients [3].

智通财经APP讯，中国生物制药(01177)发布公告，集团全资附属公司礼新医药科技(上海)有限公司(礼新 医药)自主研发的国家1类创新药维特柯妥拜单抗(研发代号：LM-302)"CLDN18.2 ADC"正在开展用于治 疗三线及以上CLDN18.2阳性的局部晚期或转移性胃及胃食管交界部腺癌的III期注册临床试验(LM302- 03-101)，已顺利完成患者入组。其中，LM302是全球首款完成注册III期临床试验入组的CLDN18.2 ADC 药物。 LM-302是一款靶向CLDN18.2的抗体偶联药物(ADC)，通过与CLDN18.2阳性肿瘤细胞特异性结合，并 经内吞作用进入细胞后释放小分子毒素，从而实现对肿瘤细胞的精准杀伤。作为潜在同类首创 (FIC)药 物，LM-302在胃癌、胰腺癌及胆道癌等多个消化道肿瘤中展现出良好的临床开发潜力，并有望为 CLDN18.2低表达和PD-L1低表达患者提供新的治疗选择。 在2025年美国临床肿瘤学会(ASCO)年会上，礼新医药公布了LM-302联合特瑞普利单抗治疗胃癌的最新 研究数据：在41例疗效可评估的患者中，客观缓解率(ORR)为65.9%，疾病控制率(DCR)为 ...

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，本集團全 資附屬公司禮新醫藥科技（上海）有限公司（「禮新醫藥」）自主研發的國家1類創新藥維特柯妥拜單抗（研 發代號：LM-302）「CLDN18.2 ADC」正在開展用於治療三線及以上CLDN18.2陽性的局部晚期或轉移 性胃及胃食管交界部腺癌的III期註冊臨床試驗(LM302-03-101)，已順利完成患者入組。其中，LM- 302是全球首款完成註冊III期臨床試驗入組的CLDN18.2 ADC藥物。 LM-302是一款靶向CLDN18.2的抗體偶聯藥物(ADC)，通過與CLDN18.2陽性腫瘤細胞特異性結合， 並經內吞作用進入細胞後釋放小分子毒素，從而實現對腫瘤細胞的精準殺傷。作為潛在同類首創 (FIC)藥物，LM-302在胃癌、胰腺癌及膽道癌等多個消化道腫瘤中展現出良好的臨床開發潛力，並有 望為CLDN18.2低表達和PD-L1低表達患者提供新的治療選擇。 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 ...

Investment Rating - The report indicates a positive outlook for the pharmaceutical sector, particularly for innovative drugs and companies expected to reach profitability in 2025 [1][9][15]. Core Insights - The innovative drug sector is anticipated to see significant growth due to the commercialization of core products and contributions from business development (BD) revenues, with companies like BeiGene, Innovent Biologics, and others expected to achieve profitability [1][9]. - The Pharma sub-sector is projected to experience a revenue growth rate of 15-20% in 2025, with notable companies such as Hansoh Pharmaceutical and China Biologic Products leading this growth [2][10]. - The CXO sector is also expected to report strong performance, with companies like WuXi AppTec forecasting substantial revenue and profit increases [3][11]. - The medical services sector is currently valued at historical lows, with a projected revenue growth of 13% for Genscript Biotech, highlighting the importance of monitoring industry changes [4][12]. Summary by Sections Innovative Drugs - Companies expected to achieve profitability in 2025 include BeiGene, Innovent Biologics, and others, driven by increased commercialization and BD revenues [1][9]. Pharma - Revenue growth of 15-20% is expected for leading companies such as Hansoh Pharmaceutical and China Biologic Products, with a significant boost anticipated for 3SBio due to a major BD deal with Pfizer [2][10]. CXO - WuXi AppTec is projected to achieve approximately 454.56 billion RMB in revenue, reflecting a year-on-year growth of about 15.84%, with adjusted net profits expected to rise significantly [3][11]. Medical Services - Genscript Biotech is expected to see a revenue increase of 13% in 2025, emphasizing the need to focus on overseas business expansion and AI integration in traditional medicine [4][12].

Investment Rating - The report maintains a positive outlook on the pharmaceutical sector, indicating an "Overweight" rating for the industry, suggesting it will outperform the overall market [1]. Core Insights - The report highlights that the commercialization of innovative drugs, combined with licensing income, is expected to lead to profitability for several companies in 2025, including BeiGene, Innovent Biologics, and others [1][9]. - The Pharma sub-sector is projected to achieve a revenue growth rate of 15-20% in 2025 for companies like Hansoh Pharmaceutical and China Biologic Products, with a significant revenue increase expected for 3SBio due to a major business development deal with Pfizer [2][10]. - The CXO sector is also expected to show strong performance, with companies like WuXi AppTec forecasting a revenue increase of approximately 15.84% and a net profit growth of about 102.65% in 2025 [3][11]. - In the medical services sector, the report notes that valuations are at historical lows, with a projected revenue growth of 13% for GuoShengTang in 2025, emphasizing the importance of overseas business expansion and AI integration in traditional Chinese medicine [4][12]. Summary by Sections Innovative Drugs - The report anticipates that several innovative drug companies will reach profitability in 2025 due to increased commercialization and business development income [9][15]. Pharma - The Pharma sub-sector is expected to see a revenue growth of 15-20% in 2025 for key players, with 3SBio projected to achieve over 100% growth due to a significant partnership with Pfizer [2][10]. CXO - WuXi AppTec is expected to report a revenue of approximately 454.56 billion RMB in 2025, with a net profit growth of around 102.65% [3][11]. Medical Services - GuoShengTang is projected to have a revenue growth of 13% in 2025, with a focus on overseas acquisitions and AI applications in traditional medicine [4][12].

Core Viewpoint - The Hong Kong Innovative Drug ETF (159567) has shown a slight increase in performance, with a closing rise of 0.79% and a trading volume of 849 million yuan on February 6, 2024 [1]. Group 1: Fund Overview - The Hong Kong Innovative Drug ETF (159567) was established on January 3, 2024, with an annual management fee of 0.50% and a custody fee of 0.10% [1]. - As of February 5, 2024, the fund's total shares stood at 10.244 billion, with a total size of 7.906 billion yuan, reflecting a 2.36% decrease in shares and a 0.13% increase in size since December 31, 2023 [1]. Group 2: Liquidity and Trading Activity - Over the last 20 trading days, the cumulative trading amount for the ETF reached 21.573 billion yuan, with an average daily trading amount of 1.079 billion yuan [1]. - Since the beginning of the year, the ETF has recorded a cumulative trading amount of 29.237 billion yuan over 25 trading days, averaging 1.169 billion yuan per day [1]. Group 3: Fund Management - The current fund manager is Ma Jun, who has managed the fund since its inception, achieving a return of 56.50% during the management period [1]. Group 4: Top Holdings - The top holdings of the Hong Kong Innovative Drug ETF (159567) include: - CSPC Pharmaceutical Group (10.44% holding, 108 million shares, market value of 825 million yuan) [2] - BeiGene (9.91% holding, 4.8299 million shares, market value of 782 million yuan) [2] - CanSino Biologics (9.72% holding, 7.52 million shares, market value of 768 million yuan) [2] - China Biologic Products (9.66% holding, 13.7 million shares, market value of 763 million yuan) [2] - Innovent Biologics (9.53% holding, 10.9295 million shares, market value of 753 million yuan) [2] - Other notable holdings include 3SBio, Hansoh Pharmaceutical, and Kelun-Biotech [2].