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百奥泰与Intas Pharmaceuticals就BAT2506(戈利木单抗)深化在加拿大市...
Xin Lang Cai Jing· 2025-10-09 08:44
转自:百奥泰 Accord加拿大区总裁 Mike Reid表示:"在加拿大,随着社会对可持续医疗解决方案的需求持续增长,新 型生物类似药的引入不仅意味着临床治疗的新机遇,也展现出可观的经济价值。通过丰富治疗选择,并 有效降低省级药品计划、医院及患者所承受的成本压力,Accord致力于助力构建更具韧性的医疗体系。 此次与百奥泰的合作,正是我们履行这一承诺的体现。我们将携手加拿大医疗机构、监管机构及当局部 门,共同推动生物类似药及时、顺畅地惠及全国患者。" (来源:百奥泰) 百奥泰生物制药股份有限公司(上交所代码:688177)是一家位于中国广州,基于科学而创新的全球性 生物制药企业(以下简称"百奥泰"或"公司")。公司今日宣布已与Intas Pharmaceuticals(以下简 称"Intas")就BAT2506(一款参照欣普尼®戈利木单抗开发的生物类似药)深化在加拿大市场的合作。 Intas将拥有BAT2506在加拿大市场的独占的商业化权益。 根据协议条款,百奥泰将负责这款生物类似药的研发、生产以及商业化供应,Intas将通过其美国子公司 Accord BioPharma(以下简称"Accord")负责BA ...
复宏汉霖:HLX13一线治疗不可切除的肝细胞癌(HCC)患者的1期临床试验申请获美国FDA批准
Zhi Tong Cai Jing· 2025-09-29 09:24
复宏汉霖(02696)公布,近日,公司自主研发的伊匹木单抗生物类似药HLX13(重组抗CTLA-4全人单克隆 抗体注射液)(HLX13)一线治疗不可切除的肝细胞癌(HCC)患者的1期临床试验申请(IND)获美国食品药品 管理局(FDA)批准。公司拟于条件具备后于美国开展该国际多中心临床试验。 ...
复宏汉霖(02696.HK):伊匹木单抗生物类似药HLX13(重组抗CTLA-4全人单克隆抗体注射液)一线治疗不可切除的肝细胞癌(HCC)患者的临床试验申请获美国FDA批准
Ge Long Hui· 2025-09-29 09:08
Core Viewpoint - The company has received FDA approval for its self-developed biosimilar HLX13, intended for the first-line treatment of unresectable hepatocellular carcinoma (HCC) patients, and plans to conduct an international multi-center clinical trial in the U.S. [1] Group 1 - HLX13 is a biosimilar of ipilimumab, targeting multiple cancers including melanoma, renal cell carcinoma, colorectal cancer, HCC, non-small cell lung cancer, malignant pleural mesothelioma, and esophageal squamous cell carcinoma [2] - The mechanism of HLX13 involves blocking CTLA-4 to enhance immune response against tumors [2] - The clinical trial application for HLX13 in HCC was approved by the National Medical Products Administration in June 2023, and further approvals for other cancers were granted in November 2023 [2] Group 2 - In April 2025, the company signed a licensing agreement with Sandoz AG, granting exclusive rights for the commercialization of HLX13 in the U.S., certain European regions, Japan, Australia, and Canada [2]
复宏汉霖(02696)自主研发的帕博利珠单抗生物类似药HLX17在多种已切除实体瘤患者中开展的国际多中心1期临床研究于中国境内完成首例患者给药
Zhi Tong Cai Jing· 2025-09-26 10:10
据悉,HLX17是公司自主研发的帕博利珠单抗生物类似药,潜在适应症包括黑色素瘤、非小细胞肺 癌、食管癌、头颈部鳞状细胞癌、结直肠癌、肝细胞癌、胆道癌、三阴性乳腺癌、微卫星高度不稳定型 或错配修復基因缺陷型肿瘤、胃癌等原研药已获批的适应症。T细胞表达的PD-1受体与其配体PD-L1、 PD-L2结合,可以抑制T细胞增殖和细胞因子生成。部分肿瘤细胞的PD-1配体上调,通过这个通路信号 传导可抑制激活的T细胞对肿瘤的免疫监视。帕博利珠单抗是一种可与PD-1受体结合的单克隆抗体,可 阻断PD-1与PD-L1、 PD-L2的相互作用,解除PD-1通路介导的免疫抑制,包括抗肿瘤免疫应答,提高免 疫系统对肿瘤细胞的杀伤能力。2024年9月,HLX17的临床试验申请获国家药品监督管理局(NMPA)批 准。2025年9月,HLX17在多种已切除实体瘤患者中的1期临床试验申请(IND)获美国食品药品管理局 (FDA)批准。 智通财经APP讯,复宏汉霖(02696)公布,近日,公司自主研发的帕博利珠单抗生物类似药HLX17(重组 抗PD-1人源化克隆抗体注射液)(HLX17)在多种已切除实体瘤患者中开展的国际多中心1期临床研究于中 ...
复宏汉霖自主研发的帕博利珠单抗生物类似药HLX17在多种已切除实体瘤患者中开展的国际多中心1期临床研究于中国境内完成首例患者给药
Zhi Tong Cai Jing· 2025-09-26 09:54
本研究一项多中心、随机、双盲、平行对照的1期临床研究,旨在评估HLX17与KEYTRUDA(美国市售) 在多种已切除实体肿瘤(包括非小细胞肺癌、黑色素瘤或肾细胞癌)受试者中的药代动力学(PK)特徵、有 效性、安全性和免疫原性相似性。合格的受试者将按1:1的比例随机分配至A组和B组,A组受试者每3周 接受一次HLX17治疗;B组受试者前8个周期(24周)每3周接受一次KEYTRUDA治疗,随后转为接受 HLX17治疗,所有受试者持续接受治疗至随机化后12个月(约17个周期)或研究者评估的疾病复发、死 亡、开始新抗肿瘤治疗、出现不可耐受的药物毒性、撤回知情同意书或研究终止(以先发生者为準)。本 研究的主要研究终点为首次给药后从0到21天血清药物浓度-时间曲线下面积(AUC0-21d)以及第6次给药 后稳态下单个给药间隔内的血清药物浓度-时间曲线下面积(AUCss)。次要研究终点包括其他PK参数、 有效性、安全性和免疫原性。 复宏汉霖(02696)公布,近日,公司自主研发的帕博利珠单抗生物类似药HLX17(重组抗PD-1人源化克隆 抗体注射液)(HLX17)在多种已切除实体瘤患者中开展的国际多中心1期临床研究于中国 ...
国家医保局启动专项整治“百日行动”;新诺威仑卡奈单抗生物类似药获批临床
Mei Ri Jing Ji Xin Wen· 2025-09-25 23:15
Group 1: Regulatory Actions - The National Healthcare Security Administration (NHSA) has launched a "100-day action" to address prominent issues in medical insurance fund management, aiming to combat fraud and illegal activities related to the resale of medical insurance drugs [1] - The initiative reflects a zero-tolerance approach towards fraudulent practices, which may increase compliance pressure on medical institutions and pharmaceutical companies in the short term, while potentially purifying the industry ecosystem in the long run [1] Group 2: Company Developments - Hanyu Pharmaceutical plans to raise up to 968 million yuan (approximately 136 million USD) through a private placement to fund various projects, including the research and development of Semaglutide [2] - The approval of Lunacanab by XinNuoWei for clinical trials marks the first domestic biosimilar drug for Alzheimer's disease, which could enhance patient accessibility and alleviate financial burdens [3] - Baile Tianheng's ADC dual antibody, Iza-bren, has been included in the breakthrough therapy list by the National Medical Products Administration, which may expedite its market entry and positively impact the company's stock price [4] - Tainkang's subsidiary has received approval for clinical trials of CKBA cream for rosacea, filling a gap in the domestic market for innovative treatments in this area [5]
国家医保局启动专项整治“百日行动”;新诺威仑卡奈单抗生物类似药获批临床丨医药早参
Mei Ri Jing Ji Xin Wen· 2025-09-25 23:10
Group 1 - The National Healthcare Security Administration (NHSA) has launched a "100-day action" to crack down on fraudulent medical insurance practices, aiming to eliminate illegal activities such as the resale of returned drugs by designated institutions [1] - This initiative reflects a zero-tolerance approach towards fraud and is expected to increase compliance pressure on medical institutions and pharmaceutical companies in the short term, ultimately helping to purify the industry ecosystem [1] Group 2 - Hanyu Pharmaceutical plans to raise up to 968 million yuan (approximately 136 million USD) through a private placement to fund projects including the development of Semaglutide, which is part of the GLP-1 drug class with significant market potential [2] - If the fundraising is successful, it will accelerate the company's GLP-1 drug development process and enhance its production capacity for peptide raw materials [2] Group 3 - XinNuoWei announced that its subsidiary received approval for clinical trials of Lecanemab, a monoclonal antibody drug for treating Alzheimer's disease, marking it as the first domestic biosimilar of this drug to gain clinical approval [3][4] - The approval of this biosimilar is expected to improve patient accessibility and alleviate financial burdens, as current treatments for Alzheimer's are predominantly high-priced products from multinational companies [4] Group 4 - Baillie Tianheng's ADC dual antibody drug, Iza-bren, has been included in the list of breakthrough therapies by the National Medical Products Administration (NMPA) for treating advanced or metastatic urothelial carcinoma that has failed previous treatments [5] - This designation is likely to expedite the drug's market entry and could positively impact the company's stock price in the short term [5] Group 5 - Tainkang's subsidiary has received approval for clinical trials of CKBA cream for the treatment of rosacea, a first-class innovative drug in China for this condition [6][7] - The approval of this innovative drug could fill a gap in the domestic market for rosacea treatment, presenting considerable market potential if clinical trials demonstrate its efficacy [7]
石药集团:仑卡奈单抗注射液在中国获临床试验批准
Zhi Tong Cai Jing· 2025-09-25 10:34
石药集团(01093)公布,该集团开发的仑卡奈单抗注射液已获中华人民共和国国家药品监督管理局批 准,可在中国开展临床试验,为国内首个获得临床许可的仑卡奈单抗注射液生物类似药。 该产品是一种重组抗人β淀粉样蛋白单克隆抗体,为乐意保的生物类似药,按照治疗用生物制品3.3类申 报,适用于治疗由阿尔茨海默病引起的轻度认知障碍和阿尔茨海默病轻度痴呆。 该产品的研发遵循生物类似药相关研究指南。药学及非临床研究结果显示,该产品与原研参照药在质 量、安全性和有效性方面高度相似,支持开展后续临床研究。 ...
石药集团(01093) - 自愿公告 - 仑卡奈单抗注射液在中国获临床试验批准
2025-09-25 10:27
(股份代號:1093) (於香港註冊成立之有限公司) 自願公告 侖卡奈單抗注射液在中國獲臨床試驗批准 石 藥 集 團 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 」)欣 然 宣 佈,本集團開發的侖卡奈單抗注射液(「該產品」)已獲中華人民共和國國家藥品監督管理局 批 准 , 可 在 中 國 開 展 臨 床 試 驗 , 為 國 內 首 個 獲 得 臨 床 許 可 的 侖 卡 奈 單 抗 注 射 液 生 物 類 似 藥。 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,並明確表示概不就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。 CSPC PHARMACEUTICAL GROUP LIMITED 石 藥 集 團 有 限 公 司 該產品是一種重組抗人b澱粉樣蛋白單克隆抗體,為樂意保®的生物類似藥,按照治療用生 物製品3.3類申報,適用於治療由阿爾茨海默病引起的輕度認知障礙和阿爾茨海默病輕度痴 呆。 該產品的研發遵循生物類似藥相關研究指南。藥學及非 ...
新诺威(300765.SZ):控股子公司仑卡奈单抗注射液获得药物临床试验批准通知书
Ge Long Hui A P P· 2025-09-25 08:48
格隆汇9月25日丨新诺威(300765.SZ)公布,控股子公司石药集团巨石生物制药有限公司(简称"巨石生 物")于近日收到国家药品监督管理局核准签发的关于仑卡奈单抗注射液的《药物临床试验批准通知 书》,将于近期开展临床试验。该产品是一种重组抗人β淀粉样蛋白单克隆抗体药物,为乐意保®的生 物类似药,按照治疗用生物制品 3.3 类申报,适用于治疗由阿尔茨海默病引起的轻度认知障碍和阿尔茨 海默病轻度痴呆,为国内首家获得临床许可的仑卡奈单抗注射液生物类似药。该产品的研发遵循生物类 似药相关研究指南。药学及非临床研究结果显示,该产品与原研参照药在质量、安全性和有效性方面高 度相似,支持开展后续临床研究。 ...