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中国生物制药(01177.HK):TQB2868“PD-1/TGF-β双功能融合蛋白”II期研究数据在2025年ASCO年会公布
格隆汇· 2025-05-29 12:30
在安全性方面,TQB2868联合方案安全耐受性良好,3级及以上不良反应发生率为52.5%(AG化疗方案 为68.1%-77%)。 集团正在就TQB2868联合方案的注册III期临床试验与中国国家药品监督管理局药品审评中心(CDE)进行 沟通。该方案有望成为免疫检查点抑制剂在胰腺癌的首个一线治疗方案,为胰腺癌患者的总生存期、生 活质量带来根本性改善。 TQB2868-ALTN-II-01是一项评估TQB2868联合安罗替尼与AG化疗(吉西他滨+白蛋白结合型紫杉醇) 一线治疗mPDAC的有效性和安全性的II期临床研究。 截至2025年1月,该研究已入组40例IV期mPDAC患者,其中36例可评估,初步数据显示:TQB2868联合 安罗替尼与AG化疗的客观缓解率(ORR)达63.9%,为AG化疗方案历史数据(23%-36%)的2-3倍;疾病控 制率(DCR)达100%,是AG化疗方案(62.3%)的1.6倍;中位无进展生存期(PFS)尚未达到,6个月PFS率达 86%,是AG化疗方案(43.2%)的2倍;中位总生存期(OS)尚未达到,预期有望超过1年。 格隆汇5月29日丨中国生物制药(01177.HK)公告,集团已 ...
中国生物制药:TQB2868联合方案在胰腺癌治疗中展现突破性疗效
快讯· 2025-05-29 12:22
中国生物制药公告,本集团在2025年美国临床肿瘤学会(ASCO)年会公布了TQB2868"PD-1/TGF-β双功能 融合蛋白"联合安罗替尼与化疗一线治疗转移性胰腺导管腺癌(mPDAC)的II期临床研究初步数据。截至 2025年1月,该研究已入组40例IV期mPDAC患者,其中36例可评估。初步数据显示,TQB2868联合安罗 替尼与AG化疗的客观缓解率(ORR)达63.9%,为AG化疗方案历史数据的2-3倍;疾病控制率(DCR)达 100%,是AG化疗方案的1.6倍;中位无进展生存期(PFS)尚未达到,6个月PFS率达86%,是AG化疗方案 的2倍;中位总生存期(OS)尚未达到,预期有望超过1年。在安全性方面,TQB2868联合方案安全耐受性 良好,3级及以上不良反应发生率为52.5%。本集团正在就TQB2868联合方案的注册III期临床试验与中 国国家药品监督管理局药品审评中心(CDE)进行沟通。 ...
中国生物制药(01177.HK):TQB2102"HER2双抗ADC"I期研究数据在2025年ASCO年会公布
格隆汇· 2025-05-27 09:44
截止2024年10月1日,该试验共纳入181例经治无标准治疗方案的晚期实体瘤患者,包括HER2阳性和 HER2低表达。研究结果显示,在有效性方面,6mg/kg及以上剂量组中,HER2阳性乳腺癌客观缓解率 (ORR)为51.3%,HER2低表达乳腺癌ORR为51.5%,HER2高表达(HER2免疫组化3+)结直肠癌ORR为 34.8%,HER2阳性胃或胃食管结合部腺癌ORR为70%。其中,HER2阳性乳腺癌伴脑转移亚组ORR为 70%,1例颅内病灶完全缓解;31%的乳腺癌受试者在T-DM1/DS-8201耐药後使用TQB2102治疗仍有 效。 目前,全球尚无双抗ADC药物获批上市。TQB2102在多个晚期恶性肿瘤中展现出显着的临床获益,且 ILD发生率低,实现了疗效和安全性的有效平衡。目前,TQB2102正在开展III期临床试验,有望重塑 HER2 ADC治疗格局。 在安全性方面,总人群中≥3级不良事件(AE)主要为中性粒细胞减少(21.7%)、白细胞计数降低(10.6%)、 贫血(8.9%)、血小板计数降低(6.1%)等。特别值得关注的是,仅出现1例(0.55%) 2级间质性肺病(ILD), 发生率远低於同类 ...
中国生物制药:贝莫苏拜单抗联合安罗替尼一线治疗鳞状非小细胞肺癌III期研究数据在2025年ASCO年会公布
智通财经· 2025-05-23 08:53
中国生物制药(01177)发布公告,该集团已在2025年美国临床肿瘤学会(ASCO)年会公佈了贝莫苏拜单抗 注射液联合化疗后序贯联合盐酸安罗替尼胶囊对比替雷利珠单抗注射液联合化疗用于晚期鳞状非小细胞 肺癌(sq-NSCLC)一线治疗的III期临床最新研究成果:试验组中位无进展生存期(mPFS)为10.12个月,与 对照组相比疾病进展风险降低36%。 2022年全球癌症数据统计显示,肺癌在全球和中国的发病率及死亡率居所有恶性肿瘤的第一位,其中非 小细胞肺癌(NSCLC)佔全部肺癌的80%-85%[2]。sq-NSCLC是NSCLC的主要亚型之一,约佔全部NSCLC 的30%[3]。sq-NSCLC患者可接受靶向治疗的靶点突变率不足10%,多数患者难以从靶向治疗中获益。 作为全球首个头对头PD-1单抗联合化疗取得阳性结果的随机双盲、安慰剂对照的III期临床研究,"贝莫 苏拜单抗联合化疗后序贯联合安罗替尼"方案或将改变现有治疗模式,为临床上治疗选择有限的晚期鳞 状非小细胞肺癌患者提供一个创新的一线治疗模式。 未来,本集团将凭藉自身的创新与商业化能力,推动创新产品加速走向全球市场,造福更多患者, 让"健康科技,温暖更 ...
中国生物制药12项临床研究入选ASCO“口头报告” “得福组合”头对头击败对比药物
中证网· 2025-05-23 04:04
公开信息显示,美国临床肿瘤学会年会是业内备受关注的临床肿瘤学会议,被认为是行业风向标,受到 全球医药行业和投资者关注。今年的ASCO年会上,中国研究者共计70余项原创研究入选口头报告,包 括诸多"First in Class""Best in Class"研究。其中,中国生物制药共有12项临床研究入选大会"口头报 告"环节,创下中国药企新纪录。 中证报中证网讯(记者孟培嘉)记者5月23日从中国生物制药获悉,一年一度的美国临床肿瘤学会(ASCO) 年会于当地时间5月22日公布入选研究摘要。其中,中国生物制药公司的"得福组合"(贝莫苏拜单抗+安 罗替尼胶囊)一线治疗局部晚期或转移性鳞状非小细胞肺癌(sq-NSCLC)Ⅲ期临床研究数据首次公布,中 位无进展生存期(PFS)为10.12个月,头对头击败对比药物。据悉,这也是业内首个对比免疫检查点(PD- 1)抑制剂联合化疗一线治疗鳞状非小细胞肺癌取得阳性结果的Ⅲ期临床研究。 报告作者及该项临床试验的主要研究者中国医学科学院肿瘤医院教授石远凯表示,贝莫苏拜单抗联合化 疗序贯联合安罗替尼方案突破了传统标准治疗瓶颈。安罗替尼已经积累了大量循证医学证据,在非小细 胞肺癌后线治 ...
启明创投邝子平:5年从0到30% 中国生物制药成为全球License-out新高地
新浪财经· 2025-05-19 07:09
专题:深交所2025全球投资者大会:新质生产力 投资中国新机遇——开放创新的深圳市场 炒股就看金麒麟分析师研报,权威,专业,及时,全面,助您挖掘潜力主题机会! 5月19日,在"新质生产力 投资中国新机遇——开放创新的深圳市场"主题引领下,2025全球投资者大会 于鹏城盛大启幕。启明创投创始主管合伙人邝子平出席首日论坛,并作《创投资本与新质生产力发展》 主旨演讲。 邝子平表示,中国的生物制药领域以更快的速度、更低的成本,创造世界最先进的新一代的生物医药的 制品。2024年全球的大药企License-in的30%来自于中国的优秀生物医药创业企业。对比而言,2019 年,这个数字是0。这里面有一个背景,即全球最大的跨国药企,有一部分新药通过内部研发获得,另 外很大一部分新药是通过外部的协作,包括从中小生物研发机构、生物研发企业购买专利。过去中国是 License-in,是海外先进医药的主要承接国,现在中国已经变成了License-out的主要发源地。 以下是演讲全文: 各位领导,各位嘉宾,各位同行,大家早上好。非常高兴今天有机会跟大家分享我对中国的新质生产 力,以及围绕新质生产力的投资机会的一些看法。我的主要观点有 ...
京东健康与中国生物制药达成战略合作 全网首发新药德瑞妥®和得舒平®
证券日报网· 2025-05-07 13:48
Core Insights - JD Health and China National Pharmaceutical Group have signed a strategic cooperation agreement to enhance the accessibility of quality medical resources and promote health technology [1][2] - The partnership aims to launch innovative pharmaceutical products, including the first domestically approved tolvaptan patch and a sodium loxoprofen gel patch, through JD Health's online channels [1][2] Group 1: Strategic Partnership - JD Health and China National Pharmaceutical Group will collaborate in disease knowledge dissemination and new product launches [1] - The partnership is expected to leverage JD Health's online platform to improve public access to healthcare services [1][2] Group 2: Product Launches - JD Health will exclusively distribute the 2mg tolvaptan patch online, which is designed to alleviate symptoms of bronchial asthma and other obstructive airway diseases [1] - Another product, sodium loxoprofen gel patch, is the first in China to complete phase III clinical trials and is aimed at treating inflammation and pain from osteoarthritis and muscle injuries [1] Group 3: Market Trends - JD Health is positioned as the leading online health consumption platform, with e-commerce channels projected to account for 12.9% of the pharmaceutical retail market by 2024 [2] - The company employs a comprehensive "B2C + O2O + offline store" model to integrate supply chain, logistics, and medical resources effectively [2] Group 4: Future Collaboration - The partnership will expand to cover various disease areas, including oncology, rheumatology, and cardiovascular health, utilizing JD Health's internet hospital resources [2] - Both companies aim to transform authoritative medical knowledge into accessible content for the public, enhancing health education and chronic disease management [2]
中国生物制药与京东健康深化战略合作,借数字医疗打破信息壁垒
贝壳财经· 2025-05-07 08:43
Group 1 - The core viewpoint of the articles is the strategic partnership between China National Pharmaceutical Group and JD Health, aimed at enhancing the supply chain, retail channels, and innovative marketing models in the pharmaceutical sector [1][2] - The collaboration is seen as a key initiative to bridge the "last mile" in drug accessibility, leveraging digital healthcare to eliminate information barriers and geographical limitations, allowing patients to access quality medications more quickly [1] - The partnership will expand to cover various disease areas including oncology, rheumatology, surgery/pain management, liver disease, respiratory, cardiovascular, and endocrine disorders, utilizing resources from JD Health's internet hospital and expert doctors [1] Group 2 - China National Pharmaceutical Group launched two new products: Loxoprofen Sodium Gel Patch (brand name: Deshu Ping) and Torasemide Patch (brand name: Deruituo), with over 70 innovative drugs currently in development and plans to launch more than 50 innovative drugs in the next decade [2] - The collaboration will focus on three strategic directions: creating a "drug zone for all treatment areas," establishing an "innovative drug digital incubation platform," and innovating a comprehensive health management model that shifts from "passive treatment" to "proactive health management" [2] - The aim is to enhance patient health levels through a patient-centered service model, integrating medical education, medication guidance, and patient recruitment systems [2]
中国生物制药(01177) - 2024 - 年度财报
2025-04-29 09:43
Company Performance - The company reported a strong performance with a continuous presence in the top 50 global pharmaceutical companies for six consecutive years from 2019 to 2024[19]. - The company has been recognized as one of the top 50 best companies in Asia-Pacific by Forbes for three consecutive years from 2016 to 2018[16]. - The company recorded revenue of approximately RMB 28,866.16 million, representing a year-on-year growth of about 10.2% compared to RMB 26,199.41 million in the previous year[73]. - Gross profit was approximately RMB 23,529.94 million, an increase of about 10.9% from RMB 21,209.53 million in the previous year[73]. - Profit attributable to equity holders of the parent company was approximately RMB 3,499.83 million, reflecting a significant year-on-year increase of about 50.1%[74]. Financial Highlights - Total revenue for 2024 reached RMB 28,866,159 thousand, a 10.1% increase from RMB 26,199,409 thousand in 2023[26]. - Gross profit for 2024 was RMB 23,529,941 thousand, up from RMB 21,209,532 thousand in 2023, reflecting a gross margin improvement[26]. - Operating profit for 2024 was RMB 5,739,924 thousand, showing a significant increase compared to RMB 4,209,634 thousand in 2023[29]. - The company reported a net profit of RMB 6,364,682 thousand for 2024, compared to RMB 5,097,398 thousand in 2023, marking a 24.9% year-over-year growth[26]. - The total assets of the company reached RMB 65,408,069 thousand in 2024, up from RMB 63,604,819 thousand in 2023[26]. Research and Development - Research and development expenses for 2024 amounted to RMB 5,089,203 thousand, an increase from RMB 4,402,973 thousand in 2023, indicating a focus on innovation[26]. - The company has established multiple R&D centers recognized by Jiangsu Province, focusing on oncology and other therapeutic areas[12]. - The company is actively involved in expanding its market presence and enhancing its product offerings through strategic R&D initiatives[11]. - The company has 70 innovative drugs in development, including 39 for oncology, 7 for liver diseases, 13 for respiratory diseases, and 6 for surgical/pain relief[102]. Product Portfolio and Innovations - The company has a diverse product portfolio, including various biopharmaceuticals and chemical drugs, with a strong market position in oncology, liver disease, respiratory, and surgical/pain relief[11]. - The company plans to launch new innovative products within the next five years, focusing on original innovation rather than imitation[38]. - The company received approval for 6 innovative products from the NMPA, including 4 Class 1 innovative drugs, achieving a revenue of RMB 12.06 billion from innovative products in 2024, a year-on-year increase of 21.9%[46]. - Revenue from new products launched within the last 5 years reached RMB 10.09 billion in 2024, reflecting a year-on-year growth of 25.4%[46]. Market and Strategic Initiatives - The company aims to become a leading global pharmaceutical enterprise, emphasizing innovation and patient service[11]. - The government has implemented policies to encourage pharmaceutical innovation, which is expected to positively impact the company's growth trajectory[44]. - The company is actively pursuing multiple indications for Gosorese, aiming to establish it as a key product in the oncology field[50]. - The company is focusing on clinical research to provide more academic evidence for the clinical use of its products[56]. Corporate Governance and Management - The board of directors focuses on overall corporate strategy and financial performance, emphasizing sustainable development[123]. - The company has established various committees, including an executive committee and an audit committee, to enhance board efficiency and oversight[125]. - The company emphasizes compliance with legal and regulatory requirements in its governance practices[133]. - The company has adopted a code of conduct for securities trading by directors and senior management, ensuring compliance with the standards set forth in the Listing Rules[162]. ESG and Sustainability - The company received an MSCI ESG rating of A for two consecutive years and improved its S&P CSA score to the top 4% in the global pharmaceutical industry[121]. - The company has implemented a carbon neutrality goal and pathway plan, with annual sustainable energy usage continuously increasing and carbon emission density decreasing[117]. - The company invested a total of RMB 60.11 million in community initiatives, with community service hours totaling 3,213 hours during the year[120]. - The company achieved a 96% pass rate in supplier ESG management self-assessments, identifying 13 key risks and achieving a 100% improvement plan formulation rate[120].
重塑慢性呼吸疾病管理 中国生物制药领跑透皮贴剂千亿赛道
证券时报网· 2025-04-29 03:36
Group 1 - Beijing Tide Pharmaceutical has launched its self-developed terbutaline patch (Derytuo) across major e-commerce platforms and offline pharmacies, marking it as the first domestically produced terbutaline patch in China [1] - The global transdermal drug delivery market is expanding at a compound annual growth rate (CAGR) of 5%, driven by an aging population and increasing chronic disease burden [1][3] Group 2 - The terbutaline patch utilizes innovative sustained-release technology to control the permeation rate, allowing for continuous absorption through the skin, thus overcoming traditional treatment limitations [2] - The patch is approved for patients aged 9 and above, with plans to extend its use to children under 9, potentially opening up the pediatric market [2] Group 3 - The global transdermal patch market is projected to grow from $7.88 billion in 2023 to $10.33 billion by 2029, with a CAGR of approximately 5% from 2024 to 2029 [3] - Beijing Tide has developed a comprehensive technology platform covering gel patches, hot melt adhesive patches, transdermal patches, and microneedle patches, establishing a fully controllable supply chain from raw materials to finished products [3][4] Group 4 - The company has successfully launched five patch products, including the first domestic non-steroidal anti-inflammatory gel patch, which has gained recognition among healthcare providers and patients [4] - With an annual production capacity of 330 million patches, Beijing Tide is accelerating the transformation of laboratory results into clinical value through partnerships with e-commerce platforms and educational content [4]