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 - 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 ...

Group 1 - The Hong Kong stock market for innovative drugs is experiencing a correction, with the Hong Kong Stock Connect Innovative Drug ETF (520880) opening high but closing down 1.74%, with a trading volume exceeding 1.4 billion yuan [1] - Major constituent stocks are declining, with Yimeng Biotech-B down over 7%, China National Pharmaceutical Group down over 4%, and CSPC Pharmaceutical Group down over 3% [1] Group 2 - The Chief Executive of the Hong Kong SAR proposed the establishment of a "Greater Bay Area Clinical Trial Collaboration Platform" and a "Real-World Research and Application Center" to accelerate the approval and commercialization of innovative drugs [3] - The National Medical Products Administration announced an optimized clinical trial review and approval process, with eligible applications to be completed within 30 working days [3] Group 3 - Despite short-term market fluctuations, the long-term logic of the innovative drug industry remains strong, transitioning from quantity to quality, with a focus on profitable products and companies by 2025 [4] - The industry is witnessing a recovery in demand, continuous supply-side clearing, and a trend towards domestic substitution, with mergers and acquisitions helping companies grow stronger [4] - The innovative drug sector's sustainability is supported by ongoing trends of "innovation + internationalization," enhancing China's global competitiveness in innovative drugs [4] Group 4 - The Hong Kong Stock Connect Innovative Drug ETF (520880) is the first ETF tracking the Hang Seng Hong Kong Stock Connect Innovative Drug Select Index, focusing 100% on innovative drug research and development [5]

Core Insights - China Biopharmaceutical's self-developed innovative drug TQF3250, a GLP-1 receptor agonist, has received acceptance for clinical trial application from the National Medical Products Administration (NMPA) in China, aimed at treating type 2 diabetes [1][2] - TQF3250 is an oral small molecule GLP-1RA that selectively activates the cAMP-biased GLP-1R signaling pathway, effectively promoting insulin secretion while reducing β-inhibitory protein recruitment and receptor internalization, thereby extending the duration of drug efficacy [1] - Preclinical studies indicate that TQF3250 significantly improves glucose tolerance at doses as low as 1 mg/kg in mouse models, showing comparable efficacy to the similar drug Orforglipron [1] - In monkey models, TQF3250's no-observed-adverse-effect level (NOAEL) reached 24 mg/kg/day, with no significant cardiac or genetic toxicity risks identified, indicating good safety [1] Market Potential - Third-party statistics show that the global GLP-1RA market is expected to exceed $50 billion in 2024 and surpass $150 billion by 2031 [1] - The current GLP-1RA market is predominantly composed of injectable formulations, while TQF3250, as an oral capsule, presents multiple advantages: 1. Convenient administration, significantly enhancing patient compliance 2. Stability in storage, with the formulation showing stability for 24 months at 25ºC 3. Metabolic safety, primarily metabolized by CYP3A enzymes, resulting in low risk of drug interactions [1] Development Strategy - The company aims to accelerate the clinical development of TQF3250 to provide a more convenient and effective treatment option for patients with type 2 diabetes [2]

Core Viewpoint - China National Pharmaceutical Group (01177.HK) has received acceptance for the clinical trial application (IND) of its self-developed innovative drug TQF3250, a GLP-1 receptor agonist, from the National Medical Products Administration (NMPA) in China, aimed at treating type 2 diabetes [1]. Group 1 - TQF3250 is an oral small molecule GLP-1 receptor agonist that selectively activates the cAMP-biased GLP-1R signaling pathway [1]. - The drug effectively promotes insulin secretion while reducing the recruitment of β-inhibitory proteins and receptor internalization, thereby extending the duration of its efficacy [1].

Core Viewpoint - China Biopharmaceutical (01177) has received acceptance for the clinical trial application (IND) of its self-developed innovative drug TQF3250, a GLP-1 receptor agonist, intended for the treatment of type 2 diabetes [1][2] Company Summary - TQF3250 is an oral small molecule GLP-1 receptor agonist that selectively activates the cAMP-biased GLP-1R signaling pathway, effectively promoting insulin secretion while reducing β-inhibitory protein recruitment and receptor internalization, thereby extending the duration of drug efficacy [1] - Preclinical studies indicate that TQF3250 significantly improves glucose tolerance in mouse models at doses as low as 1 mg/kg, showing comparable activity to the similar drug Orforglipron, demonstrating high efficacy in glucose reduction [1] - In monkey models, the no-observed-adverse-effect level (NOAEL) for TQF3250 reached 24 mg/kg/day, with no significant cardiac or genetic toxicity risks identified, indicating good safety [1] Industry Summary - Third-party statistics show that the global market for GLP-1 receptor agonists is expected to exceed $50 billion in 2024 and is projected to surpass $150 billion by 2031 [1] - The current GLP-1 receptor agonist market is predominantly composed of injectable formulations, while TQF3250, as an oral capsule formulation, presents multiple advantages: 1. Convenient administration, significantly enhancing patient compliance 2. Stable storage, with the formulation showing stability for 24 months at 25°C 3. Metabolic safety, primarily metabolized by CYP3A enzymes, resulting in low risk of drug interactions [1] - Currently, there is only one approved oral GLP-1 receptor agonist globally, and the company aims to accelerate the clinical development of TQF3250 to provide a more convenient and effective treatment option for type 2 diabetes patients [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 TQF3250膠囊「GLP-1受體激動劑」臨床試驗申請獲NMPA受理 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TQF3250膠囊「GLP-1受體激動劑(GLP-1RA)」的新藥臨床試驗申請(IND)已獲 得中國國家藥品監督管理局(NMPA)受理，擬用於治療2型糖尿病。 TQF3250是一款口服小分子偏向型GLP-1RA，通過選擇性激活cAMP偏向的GLP-1R信號通路，高效 促進胰島素分泌，同時減少β－抑制蛋白募集和受體內吞，從而延長藥效持續時間。 臨床前研究顯示，在小鼠模型中，TQF3250在低至1 mg/kg的劑量下即可顯著改善糖耐量，其活性 與同類藥物Orforglipron相當，展現出高效降糖作用。在 ...