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]

8月11日，中国生物制药(01177)盘中下跌4.48%，截至10:10，报7.03元/股，成交3.03亿元。 本文源自：金融界 作者：行情君 截至2024年年报，中国生物制药营业总收入288.66亿元、净利润35.0亿元。 8月18日，中国生物制药将披露2025财年中报。 中国生物制药有限公司是一家创新研究和研发驱动型的医药集团，其主要业务包括医药研发、智能化生 产以及销售，主要产品包括多种生物药和化学药，特别在肿瘤、肝病、呼吸系统、外科/镇痛四大治疗 领域具有优势。公司自从2000年上市以来，在MSCI全球标准指数、恒生指数等多个指数中成为成分 股，连续六年入选《制药经理人》的"全球制药企业TOP50"，核心企业正大天晴药业集团、北京泰德制 药股份有限公司多年位列中国医药工业企业百强榜，公司产品收入占比逐年提升。 ...

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。 ...

（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-24C5「CEACAM5/4-1BB 雙抗」II期臨床試驗申請獲NMPA批准 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」）自主研發的創新藥LM-24C5 「CEACAM5/4-1BB雙抗」已獲得中國國家藥品監督管理局(NMPA)的臨床試驗批准，同意其在 CEACAM5陽性的晚期實體瘤患者中開展一項聯合其他抗腫瘤藥物的II期臨床試驗。 CEACAM5（癌胚抗原相關細胞黏附分子5）在多種實體瘤中高表達，包括非小細胞肺癌、結直腸癌和 胃癌等，使其成為一個極具前景的腫瘤治療靶點[1]。LM-24C5是禮新醫藥基於條件激活型4-1BB平台 開發的雙特異性抗體，通過特異性結合腫瘤細胞表面的CEACAM5和免疫細胞表面的4-1BB，將免疫 細胞特異性定向至腫瘤微環境，激活並增強其抗腫瘤活性。LM-24C5的獨特結構可以CEACAM5依 賴性方式選擇性激活4-1BB信號通路，避免非特異性外周免疫系 ...

Core Viewpoint - China National Pharmaceutical Group's self-developed drug TQ05105 (Ruxolitinib) has been included in the Breakthrough Therapy Designation (BTD) program by the CDE for the treatment of chronic graft-versus-host disease (cGVHD) [1][2] Group 1: Drug Development and Approval - Ruxolitinib is the fastest progressing JAK/ROCK dual small molecule inhibitor globally [1] - The company submitted a marketing application for Ruxolitinib to the CDE in July 2024, which has been accepted for the treatment of intermediate to high-risk myelofibrosis (MF) [1] - Currently, Ruxolitinib is undergoing a Phase III clinical trial for cGVHD in China and has been approved for a Phase II clinical trial in the United States [1] Group 2: Clinical Trial Results - The Phase Ib/IIa clinical results for Ruxolitinib were published in the top journal "Blood," involving 44 patients with moderate to severe steroid-refractory or dependent cGVHD [2] - No dose-limiting toxicities were observed, and there were no adverse events leading to discontinuation related to Ruxolitinib [2] - The best overall response rate (BOR) was 86.4%, with a 12-month failure-free survival rate (FFS) of 85.2% [2] - 88.6% of participants reduced their steroid dosage requirements, and 59.1% experienced improvement in cGVHD-related symptoms [2] - The company is accelerating the global clinical development of Ruxolitinib to provide better treatment options for patients worldwide [2]

智通财经APP讯，中国生物制药(01177)公布，该集团自主研发的罗伐昔替尼片"TQ05105 (JAK/ROCK抑 制剂)"已被中国国家药品监督管理局药品审评中心 (CDE)纳入突破性治疗药物程序(BTD)，用于慢性移 植物抗宿主病(cGVHD)的治疗。 异基因造血干细胞移植(allo-HSCT)是治疗恶性血液系统疾病的一种有效方式，而慢性移植物抗宿主病 (cGVHD)是allo-HSCT的主要并发症之一，发生率可达30%-70%。罗伐昔替尼的Ib/IIa期临床结果已发表 于国际血液学领域顶级期刊《Blood》：该研究共纳入44例中度或重度糖皮质激素难治性或依赖性 cGVHD患者，未出现剂量限制性毒性，且未发生与罗伐昔替尼相关导致停药的不良事件。最佳总体缓 解率(BOR)为86.4%，12个月无失败生存率(FFS)为85.2%，88.6%的受试者降低了对糖皮质激素剂量的需 求，59.1%的受试者cGVHD相关症状得到改善。 罗伐昔替尼是全球研发进度最快的JAK/ROCK双重小分子抑制剂。该集团已于2024年7月向CDE递交罗 伐昔替尼的上市申请并获受理，用于治疗中高危骨髓纤维化(MF)。目前，罗伐昔替尼正在 ...

Core Viewpoint - China Biologic Products (01177.HK) announced that its self-developed drug TQ05105 (a JAK/ROCK inhibitor) has been included in the Breakthrough Therapy Designation (BTD) program by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China for the treatment of chronic graft-versus-host disease (cGVHD) [1] Group 1 - TQ05105 is the fastest developing dual small molecule inhibitor of JAK/ROCK globally [1] - The company submitted a marketing application for TQ05105 to the CDE in July 2024, which has been accepted for the treatment of intermediate to high-risk myelofibrosis (MF) [1] - Currently, TQ05105 is undergoing a Phase III clinical trial for cGVHD in China, and has been approved to conduct a Phase II clinical trial in the United States [1] Group 2 - The Phase III clinical trial for TQ05105 in treating moderate to severe cGVHD is currently in the subject recruitment phase [1] - The company aims to accelerate the global clinical development of TQ05105 to provide better treatment options for patients worldwide as soon as possible [1]