中国生物制药(01177)发布公告，公司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LM-350"CDH17抗体偶联药物(ADC)"在澳洲开展的I期临床试验已顺利完成首例患者入 组，标志着这一创新疗法正式进入临床开发阶段。 LM-350是基于礼新医药新一代ADC技术平台LM-ADCTM开发的一款靶向CDH17的ADC，能够高度选 择性地结合CDH17，具有很强的内化能力。LM-350采用IgG1野生型构型，同时具备抗体依赖细胞介导 的细胞毒性作用(ADCC)活性。临床前研究显示，LM-350在多个异种移植模型中表现出显著的抗肿瘤活 性，尤其在对MMAE耐药或伊立替康耐药的结直肠癌细胞中效果突出。 CDH17在多种肿瘤侵袭转移中发挥重要作用，并在约99%的结肠癌、86%的胃腺癌、79%的食管腺癌、 50%的胰腺导管腺癌中高表达。消化道肿瘤(包括结直肠癌、胃癌、胰腺癌、食管癌等)是全球发病率和 死亡率最高的癌症种类之一，2022年全球新发患者数量超过400万人，存在巨大的尚未被满足的临床需 求。 本次临床研究为一项LM-350在晚期实体肿瘤患者中的安全性、耐受性、药代动力学特 ...

LM-350是基于礼新医药新一代ADC技术平台LM-ADC开发的一款靶向CDH17的ADC，能够高度选择性 地结合CDH17，具有很强的内化能力。LM-350采用IgG1野生型构型，同时具备抗体依赖细胞介导的细 胞毒性作用(ADCC)活性。临床前研究显示，LM-350在多个异种移植模型中表现出显著的抗肿瘤活性， 尤其在对MMAE耐药或伊立替康耐药的结直肠癌细胞中效果突出。 CDH17在多种肿瘤侵袭转移中发挥重要作用，并在约99%的结肠癌、86%的胃腺癌、79%的食管腺癌、 50%的胰腺导管腺癌中高表达。消化道肿瘤(包括结直肠癌、胃癌、胰腺癌、食管癌等)是全球发病率和 死亡率最高的癌症种类之一，2022年全球新发患者数量超过400万人，存在巨大的尚未被满足的临床需 求。 格隆汇9月25日丨中国生物制药(01177.HK)公告，公司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LM-350"CDH17抗体偶联药物(ADC)"在澳洲开展的I期临床试验已顺利 完成首例患者入组，标志着这一创新疗法正式进入临床开发阶段。 ...

Core Viewpoint - China Biopharmaceutical's subsidiary, Lixin Pharmaceutical Technology, has successfully completed the first patient enrollment in the Phase I clinical trial of its innovative drug LM-350, marking the entry of this therapy into clinical development [1][2] Group 1: Product Development - LM-350 is a Class 1 innovative drug developed based on Lixin's next-generation ADC technology platform, targeting CDH17 with high selectivity and strong internalization capability [1] - The drug utilizes an IgG1 wild-type configuration and exhibits antibody-dependent cellular cytotoxicity (ADCC) activity [1] - Preclinical studies have shown significant anti-tumor activity of LM-350 in various xenograft models, particularly in colorectal cancer cells resistant to MMAE or irinotecan [1] Group 2: Clinical Need and Market Potential - CDH17 is highly expressed in approximately 99% of colorectal cancers, 86% of gastric adenocarcinomas, 79% of esophageal adenocarcinomas, and 50% of pancreatic ductal adenocarcinomas, indicating its critical role in tumor invasion and metastasis [1] - Gastrointestinal tumors, including colorectal, gastric, pancreatic, and esophageal cancers, represent one of the highest incidence and mortality rates globally, with over 4 million new patients reported in 2022, highlighting a significant unmet clinical need [1]

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。 自願公告 LM-350「CDH17 ADC」完成澳洲I期臨床首例患者入組 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，本公司全 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LM-350「CDH17抗 體偶聯藥物(ADC)」在澳洲開展的I期臨床試驗已順利完成首例患者入組，標誌著這一創新療法正式進 入臨床開發階段。 LM-350是基於禮新醫藥新一代ADC技術平台LM-ADCTM開發的一款靶向CDH17的ADC，能夠高度選 擇性地結合CDH17，具有很強的內化能力。LM-350採用IgG1野生型構型，同時具備抗體依賴細胞介 導的細胞毒性作用(ADCC)活性。臨床前研究顯示，LM-350在多個異種移植模型中表現出顯著的抗 腫瘤活性，尤其在對MMAE耐藥或伊立替康耐藥的結直腸癌細胞中效果突出。 CDH17在多種腫瘤侵襲轉移中發揮重要作 ...

Core Viewpoint - The BD (Business Development) transactions in China's innovative pharmaceutical sector have surged, with upfront payments exceeding 30 billion RMB from January to August 2025, surpassing the financing amounts in the primary market during the same period. This trend has led to a second peak in market capitalization for innovative drug companies [1]. Group 1: BD Market Dynamics - The BD transactions have significantly influenced the stock market and propelled several innovative drug companies to new market capitalization heights [1]. - Recent controversies surrounding U.S. administrative orders and clinical data disputes for some overseas drugs have created uncertainty in the BD market, leading to mixed sentiments among market participants [1]. - A notable increase in local BD transactions has been observed, with many biotech companies actively seeking BD partnerships, indicating a competitive landscape [6][10]. Group 2: Company Strategies and Advantages - China Biopharmaceutical has positioned BD transactions as a core strategy, with a strong pipeline of over 100 clinical products and a focus on high-quality, cost-effective therapies [5][6]. - The company has invested nearly 30 billion RMB in innovative drug development since 2015, enhancing its competitive edge in the BD landscape [6]. - The company aims to complete its first BD transaction by the end of the year, reflecting optimism about its ongoing progress [5]. Group 3: Industry Trends and Future Outlook - The current BD wave is seen as a pivotal moment for China's innovative drug sector, with expectations for continued growth and increased transaction volumes in the coming years [10][19]. - The U.S. government's recent focus on BD transactions is expected to have limited impact on the overall market, as multinational corporations (MNCs) continue to benefit from engaging in BD deals with Chinese companies [11][15]. - The trend of Chinese companies becoming more competitive in the global market is attributed to their strong innovation capabilities and efficient clinical trial processes [26][29]. Group 4: Clinical Development and Regulatory Environment - MNCs are increasingly interested in early-stage clinical trials conducted in China due to the high efficiency and lower costs associated with these trials [13][11]. - The regulatory environment in China is evolving, with a focus on supporting innovative drug development and enhancing the commercial viability of new therapies [19][32]. - The collaboration between local companies and MNCs is expected to foster knowledge transfer and improve global operational capabilities in clinical development and sales [23][39].

Core Insights - Chinese biopharmaceutical companies are becoming significant players in both global and domestic M&A markets, accounting for 14% of all agreements in the first half of 2025 [3][4]. - The trend of "China-to-China" mergers is emerging, exemplified by the acquisition of Lixin Pharmaceutical by a Chinese biopharmaceutical company [3][8]. M&A Activity - In the first half of 2025, the number of licensing agreements from Chinese companies increased to 14%, up from 8% in 2024, with a notable rise in clinical-stage asset transactions [4]. - Clinical-stage drugs accounted for 42% of all licensing transactions, second only to preclinical assets [4]. - The average upfront payment for licensing agreements from Chinese companies exceeded $100 million, reaching a historical high of 40% in such transactions [5]. Licensing Trends - Chinese biopharmaceutical companies are increasingly favored for licensing agreements, with 87% of disclosed drug types in agreements involving Chinese licensors being biopharmaceuticals, compared to 51% outside China [4][5]. - The average total deal size for licensing agreements from Chinese companies reached $180 million, significantly higher than the $100 million average for other regions [5]. Notable Transactions - A significant transaction involved Merck and Kelun Pharmaceutical, valued at $9.3 billion for seven antibody-drug conjugates, marking a trend of increasing high-value licensing agreements with Chinese firms [5]. - The acquisition of Lixin Pharmaceutical for up to $951 million is a landmark deal in the "China-to-China" M&A landscape, allowing the acquirer to control Lixin's innovative pipeline [8].

Core Viewpoint - China Biologic Products (01177) announced that its wholly-owned subsidiary, Lixin Pharmaceutical Technology (Shanghai) Co., Ltd., has successfully completed the first patient enrollment in the Phase I clinical trial of its self-developed innovative drug LM-2417, a NaPi2b/4-1BB bispecific antibody, marking the entry of this innovative therapy into clinical development [1][2] Group 1 - LM-2417 is developed based on Lixin Pharmaceutical's self-researched conditionally activated 4-1BB platform, specifically binding to NaPi2b on tumor cells and 4-1BB on immune cells, enhancing anti-tumor effects through precise activation of immune cells in the tumor microenvironment [2] - NaPi2b is encoded by the SLC34A2 gene and is highly expressed in various malignancies, including high-grade serous ovarian cancer, fallopian tube cancer, primary peritoneal cancer, thyroid cancer, breast cancer, and non-squamous non-small cell lung cancer, while having limited distribution in normal tissues, making it a promising target for anti-tumor therapy [1][2] - Preclinical data indicate that LM-2417 can induce durable anti-tumor immune memory and shows significant synergistic effects when combined with other immunotherapy drugs, positioning it as a potential First-in-Class immunotherapy [2] Group 2 - The clinical study is an open-label, dose-escalation, and dose-expansion Phase I/II trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of LM-2417 as a monotherapy or in combination with other anti-tumor drugs in patients with advanced malignant solid tumors [2] - The company aims to rapidly advance the clinical research of this project, looking forward to providing new options for immunotherapy clinical use for patients [2]

Core Viewpoint - China National Pharmaceutical Group's subsidiary, Lixin Pharmaceutical Technology, has successfully completed the first patient enrollment in the Phase I clinical trial of its innovative drug LM-2417, marking the entry of this therapy into clinical development [1][2]. Group 1: Product Development - LM-2417 is a dual-specific antibody targeting NaPi2b and 4-1BB, developed using Lixin Pharmaceutical's proprietary conditionally activated 4-1BB platform [2]. - The mechanism of LM-2417 allows for precise activation of immune cells in the tumor microenvironment, enhancing anti-tumor effects while potentially reducing non-specific immune activation toxicity [2]. - Preclinical data indicate that LM-2417 can induce durable anti-tumor immune memory and shows significant synergistic effects when combined with other immunotherapy drugs [2]. Group 2: Clinical Research - The ongoing clinical study is an open-label, dose-escalation, and dose-expansion Phase I/II trial assessing the safety, tolerability, pharmacokinetics, and preliminary efficacy of LM-2417 as a monotherapy or in combination with other anti-tumor drugs in patients with advanced malignant solid tumors [2]. - The company aims to expedite the clinical research process to provide new immunotherapy options for patients [2].

格隆汇9月23日丨中国生物制药(01177.HK)宣布，公司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LM-2417"NaPi2b/4-1BB双特异性抗体"在中国开展的I期临床试验已顺 利完成首例患者入组，标志着这一创新疗法正式进入临床开发阶段。 本次临床研究为一项注射用LM-2417单药或联合其他抗肿瘤药物在晚期恶性实体肿瘤患者中的安全性、 耐受性、药代动力学特徵以及初步疗效的开放标签、剂量递增和剂量扩展的I/II期临床研究。集团将继 续快速推进项目的临床研究，期待早日为患者带来免疫治疗临床用药新选择。 LM-2417是礼新医药基於其自主研发的条件激活型4-1BB平台开发的一款NaPi2b/4-1BB双抗，能够特异 性结合肿瘤细胞表面的NaPi2b及免疫细胞表面的4-1BB。该机制可实现免疫细胞在肿瘤微环境中的精准 激活，从而增强抗肿瘤效应。与传统4-1BB激动剂不同，LM-2417通过NaPi2b依赖性方式选择性激活4- 1BB信号通路，有望显著降低非特异性免疫激活引发的毒性风险。 临床前数据表明，LM-2417不仅能诱导持久的抗肿瘤免疫记忆，还在与其他免疫治疗药物 ...

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 LM-2417「NaPi2b/4-1BB雙特異性抗體」完成中國I期臨床首例患者入組 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，本公 司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LM-2417 「NaPi2b/4-1BB雙特異性抗體」在中國開展的I期臨床試驗已順利完成首例患者入組，標誌著這一創新 療法正式進入臨床開發階段。 NaPi2b由SLC34A2基因編碼，屬於II型鈉依賴性磷酸鹽轉運蛋白SLC34家族成員之一，在機體磷酸鹽 穩態調控中發揮重要作用。NaPi2b在高級別漿液性卵巢癌、輸卵管癌、原發性腹膜癌，以及甲狀腺 癌、乳腺癌和非鱗狀非小細胞肺癌等多種惡性腫瘤中呈高表達，而在正常組織中分佈有限，因此被 ...