Core Viewpoint - China Biologic Products (01177) has received acceptance from the National Medical Products Administration (NMPA) for the clinical trial application of its innovative drug TQB3122, a PARP1 inhibitor intended for the treatment of advanced malignant tumors [1] Group 1: Product Details - TQB3122 is a highly selective PARP1 inhibitor with the ability to penetrate the blood-brain barrier, demonstrating anti-tumor effects through a dual mechanism [1] - The drug competitively inhibits the catalytic activity of the PARP1 enzyme, blocking DNA single-strand break repair, and stabilizes the DNA-PARP complex to hinder replication fork progression [1] - Based on the principle of "synthetic lethality," TQB3122 selectively targets tumor cells with BRCA mutations or homologous recombination deficiencies [1] Group 2: Clinical Potential - Research indicates that TQB3122 shows significant efficacy across multiple tumor models and has outstanding distribution capabilities in brain tissue, making it a potential new option for treating intracranial tumors [1] - Currently, there are no approved drugs targeting the same mechanism globally, positioning TQB3122 as a novel therapeutic choice for patients with advanced solid tumors [1]

Core Viewpoint - China Biopharmaceutical's innovative drug TQB3122, a PARP1 inhibitor, has received acceptance for clinical trial application from the National Medical Products Administration (NMPA) in China, aimed at treating advanced malignant tumors [1] Group 1: Drug Development - TQB3122 is characterized by high selectivity and the ability to penetrate the blood-brain barrier, providing a dual mechanism for anti-tumor action [1] - The drug works by competitively inhibiting the catalytic activity of the PARP1 enzyme, blocking DNA single-strand break repair, and stabilizing the DNA-PARP complex to hinder replication fork progression [1] - TQB3122 selectively targets and kills tumor cells with BRCA mutations or homologous recombination deficiencies based on the principle of "synthetic lethality" [1] Group 2: Clinical Potential - Research indicates that TQB3122 shows significant efficacy across multiple tumor models and has outstanding distribution capabilities in brain tissue, making it a potential new option for treating intracranial tumors [1] - Currently, there are no approved drugs targeting the same pathway globally, positioning TQB3122 as a unique therapeutic candidate [1] - The company aims to explore the safety and efficacy of TQB3122 in advanced solid tumors, potentially providing new treatment options for patients worldwide [1]

Core Viewpoint - China Biopharmaceutical (01177) has received acceptance for the clinical trial application (IND) of its innovative drug TQB3122, a PARP1 inhibitor, from the National Medical Products Administration (NMPA) in China, aimed at treating advanced malignant tumors [1] Group 1: Drug Development - TQB3122 is a highly selective PARP1 inhibitor with the ability to penetrate the blood-brain barrier, utilizing a dual mechanism to exert anti-tumor effects [1] - The drug competitively inhibits the catalytic activity of the PARP1 enzyme, blocking DNA single-strand break repair, and stabilizes the DNA-PARP complex to hinder replication fork progression [1] - TQB3122 selectively targets and kills tumor cells with BRCA mutations or homologous recombination deficiencies based on the principle of "synthetic lethality" [1] Group 2: Clinical Potential - Research indicates that TQB3122 shows significant efficacy across multiple tumor models and has outstanding distribution capabilities in brain tissue, making it a potential new option for treating intracranial tumors [1] - Currently, there are no approved drugs targeting the same pathway globally, positioning TQB3122 as a novel therapeutic choice for patients with advanced solid tumors [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。 目前，全球尚無同靶點藥物獲批上市。本集團將探索TQB3122在晚期實體瘤中的安全性與療效，有 望為全球患者提供新的治療選擇。 承董事會命 中國生物製藥有限公司 主席 謝其潤 香港，二零二五年八月十一日 1 （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 TQB3122「PARP1抑制劑」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 主研發的創新藥TQB3122「PARP1抑制劑」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，擬用於治療晚期惡性腫瘤。 TQB3122是一款具有高選擇性和血腦屏障穿透能力的PARP1抑制劑，通過雙重機制發揮抗腫瘤作 用：一方面，競爭性抑制PARP1酶的催化活性，阻斷DNA單鏈斷裂修復；另一方面，通過 ...

Core Viewpoint - China National Pharmaceutical Group's subsidiary, Chengdu Tianqing, has received approval for its biosimilar Adalimumab (Taibowei) in Algeria, providing affordable treatment options for patients with autoimmune diseases in Belt and Road Initiative countries [1][2] Group 1: Product Approval and Market Impact - The approval of Taibowei marks a significant step in meeting the growing demand for high-quality biosimilars in Algeria, a key market in North Africa [2] - Adalimumab is a critical drug for treating various autoimmune diseases, including rheumatoid arthritis and psoriasis [1] - The successful approval reflects the company's commitment to innovation and internationalization, aligning with the Belt and Road Initiative [2] Group 2: Regulatory and Quality Management - The development of biosimilars requires demonstrating high similarity in quality, safety, and efficacy to the reference drug, with China's regulatory framework evolving since 2015 [1] - As of 2024, over 20 biosimilars have been approved in China, with Taibowei being a successful example of this process [1] - The company has established large R&D and production bases in Jiangsu, with multiple production lines certified by EU cGMP and US FDA, emphasizing the importance of quality management [1] Group 3: Future Strategy and Collaboration - The company plans to deepen collaboration with local partners in Algeria to accelerate the commercialization of its products [2] - The firm aims to leverage its established technology platform and existing biosimilars to support further international expansion [2] - Future efforts will focus on innovation and meeting clinical needs in Belt and Road countries, contributing to the "Health Silk Road" initiative [2]

Core Viewpoint - China National Pharmaceutical Group (01177) experienced a decline of 4.48% in stock price, trading at 7.03 CNY per share with a transaction volume of 303 million CNY as of 10:10 AM on August 11 [1] Group 1: Company Overview - China National Pharmaceutical Group is an innovative research and development-driven pharmaceutical company, focusing on drug research, intelligent manufacturing, and sales [1] - The company specializes in various biological and chemical drugs, particularly excelling in four therapeutic areas: oncology, liver diseases, respiratory systems, and surgical/pain management [1] - Since its listing in 2000, the company has been included in multiple indices such as the MSCI Global Standard Index and the Hang Seng Index, and has been recognized in the "Top 50 Global Pharmaceutical Companies" by Pharmaceutical Manager for six consecutive years [1] Group 2: Financial Performance - As of the 2024 annual report, China National Pharmaceutical Group reported total revenue of 28.866 billion CNY and a net profit of 3.5 billion CNY [1] - The revenue contribution from the company's products has been increasing year by year [1] Group 3: Upcoming Events - The company is set to disclose its mid-year report for the fiscal year 2025 on August 18 [1]

Core Viewpoint - The biopharmaceutical industry in China is rapidly developing, with significant growth expected in market size from 257.65 billion yuan in 2018 to 454.17 billion yuan in 2024, and projected to reach 460 billion yuan by 2025 [1][6][4]. Group 1: Definition and Classification - Biopharmaceuticals are products used for prevention, treatment, and diagnosis, developed using principles from microbiology, biology, medicine, biochemistry, and biotechnology [2][4]. - The biopharmaceutical industry can be categorized into biopharmaceuticals, chemical drugs, and modern traditional Chinese medicine, with biopharmaceuticals further divided into blood products, recombinant proteins, vaccines, monoclonal antibodies, and cell therapy products [2]. Group 2: Current Development Status - The development of the biopharmaceutical industry is closely linked to innovations in biotechnology, with significant advancements since the 20th century [4][6]. - China's biopharmaceutical market is still in its early stages but is experiencing strong growth, with biopharmaceuticals becoming a crucial part of the pharmaceutical sector [6][4]. Group 3: Industry Chain - The upstream of the biopharmaceutical industry consists of raw materials, pharmaceutical equipment, and biotechnology, with raw materials primarily sourced from natural biological materials [8]. - The midstream involves the research and production of biopharmaceutical products, while the downstream focuses on sales channels to medical institutions, diagnostic agencies, research units, and consumers [8]. Group 4: Development Environment and Policies - Recent policies have supported and regulated the development of the biopharmaceutical industry, focusing on improving new drug pricing mechanisms, drug price governance, centralized procurement, and medical service standardization [10][12]. Group 5: Competitive Landscape - The biopharmaceutical industry is a strategic emerging industry in China, with notable companies including WuXi AppTec, HengRui Medicine, and BeiGene, among others [13][15]. - Various segments within the biopharmaceutical industry have seen the emergence of leading companies, such as vaccine producers and diagnostic reagent manufacturers [15][20]. Group 6: Development Trends - There is a strong emphasis on developing new vaccines and improving traditional vaccines to meet global health challenges [25]. - The industrialization of antibody drugs and protein drugs is advancing, with significant roles in treating various diseases [26][27]. - Research and product development in diagnostic and detection technologies for major diseases are increasingly utilizing nanomaterials for enhanced sensitivity and specificity [28].

CEACAM5(癌胚抗原相关细胞黏附分子5)在多种实体瘤中高表达，包括非小细胞肺癌、结直肠癌和胃癌 等，使其成为一个极具前景的肿瘤治疗靶点。LM-24C5是礼新医药基于条件激活型4-1BB平台开发的双 特异性抗体，通过特异性结合肿瘤细胞表面的CEACAM5和免疫细胞表面的4-1BB，将免疫细胞特异性 定向至肿瘤微环境，激活并增强其抗肿瘤活性。LM-24C5的独特结构可以CEACAM5依赖性方式选择性 激活4-1BB信号通路，避免非特异性外周免疫系统激活带来的毒性风险。 临床前研究表明，LM-24C5可诱导持久的抗肿瘤免疫记忆，并与其他免疫治疗药物具有协同效应，具有 成为同类首创(First-in-Class)免疫疗法的潜力。目前，LM-24C5正在美国开展I/II期临床试验。 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)自主研发的创新药LM-24C5 "CEACAM5/4-1BB双抗"已获得中国国家药品监督管理局(NMPA)的临 床试验批准，同意其在CEACAM5阳性的晚期实体瘤患者中开展一项联合其他抗肿瘤药物的II期临床试 验。 ...

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 创新药LM-24C5"CEACAM5/4-1BB双抗"已获得中国国家药品监督管理局(NMPA)的临床试验批准，同 意其在CEACAM5阳性的晚期实体瘤患者中开展一项联合其他抗肿瘤药物的II期临床试验。 CEACAM5(癌胚抗原相关细胞黏附分子5)在多种实体瘤中高表达，包括非小细胞肺癌、结直肠癌和胃癌 等，使其成为一个极具前景的肿瘤治疗靶点。LM-24C5是礼新医药基于条件激活型4-1BB平台开发的双 特异性抗体，通过特异性结合肿瘤细胞表面的CEACAM5和免疫细胞表面的4-1BB，将免疫细胞特异性 定向至肿瘤微环境，激活并增强其抗肿瘤活性。LM-24C5的独特结构可以CEACAM5依赖性方式选择性 激活4-1BB信号通路，避免非特异性外周免疫系统激活带来的毒性风险。 临床前研究表明，LM-24C5可诱导持久的抗肿瘤免疫记忆，并与其他免疫治疗药物具有协同效应，具有 成为同类首创(First-in-Class)免疫疗法的潜力。目前，LM-24C5正在美国开展I/II期临床试验。 ...

临床前研究表明，LM-24C5可诱导持久的抗肿瘤免疫记忆，并与其他免疫治疗药物具有协同效应，具有 成为同类首创(First-in-Class)免疫疗法的潜力。目前，LM-24C5正在美国开展I/II期临床试验。 格隆汇8月7日丨中国生物制药(01177.HK)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")自主研发的创新药LM-24C5"CEACAM5/4-1BB双抗"已获得中国国家药品监督管理局(NMPA)的临 床试验批准，同意其在CEACAM5阳性的晚期实体瘤患者中开展一项联合其他抗肿瘤药物的II期临床试 验。 CEACAM5(癌胚抗原相关细胞黏附分子5)在多种实体瘤中高表达，包括非小细胞肺癌、结直肠癌和胃癌 等，使其成为一个极具前景的肿瘤治疗靶点。LM-24C5是礼新医药基于条件激活型4-1BB平台开发的双 特异性抗体，通过特异性结合肿瘤细胞表面的CEACAM5和免疫细胞表面的4-1BB，将免疫细胞特异性 定向至肿瘤微环境，激活并增强其抗肿瘤活性。LM-24C5的独特结构可以CEACAM5依赖性方式选择性 激活4-1BB信号通路，避免非特异性外周免疫系统激活带来的毒性风险。 ...