更新于：2024-12-14
Trastuzumab-DKST(Biocon Ltd.)
曲妥珠单抗生物类似药（Biocon）
更新于：2024-12-14
概要
基本信息
原研机构 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2017-12-01), |
最高研发阶段(中国)- |
特殊审评- |
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序列信息
Sequence Code 18481L
当前序列信息引自: *****
Sequence Code 44772H
当前序列信息引自: *****
关联
5
项与 曲妥珠单抗生物类似药（Biocon） 相关的临床试验Image-guided De-escalation of Neo-adjuvant Chemotherapy in HER2-positive Breast Cancer: the TRAIN-3 Study
This is a multicenter, single arm, phase II study evaluating the efficacy of image-guided de-escalating neoadjuvant treatment with paclitaxel, Herceptin® (trastuzumab), carboplatin, and pertuzumab (PTC-Ptz) in stage II-Ill HER2-positive breast cancer.
开始日期2019-02-27 |
申办/合作机构 |
Atezolizumab, Pertuzumab and Trastuzumab With Chemotherapy as Neoadjuvant Treatment of HER2 Positive Early High-risk and Locally Advanced Breast Cancer (APTneo)
n the present study the neoadjuvant approach with the anti-HER2 trastuzumab and pertuzumab combined with carboplatin and paclitaxel will be used to compare the Event-Free Survival (EFS) in regimens with and without atezolizumab. Following the neoadjuvant part of the study, after surgery all patients will continue to receive trastuzumab and pertuzumab to complete one year of anti-HER2 therapy. Similarly, patients allocated to receive atezolizumab will continue atezolizumab to complete one year In addition, several IHC and molecular assays will be performed before and during the period of chemotherapy administration and at surgery with the goal of defining a marker of efficacy to be later validated in a larger adjuvant setting.
开始日期2018-09-07 |
申办/合作机构 |
Pharmacokinetic Study Comparing Hercules, EU-approved Herceptin® and US-Licensed Herceptin® Administered as a Single Intravenous Infusion to Healthy Male Volunteers
The primary objective of this study was to demonstrate pharmacokinetic similarity of Mylan trastuzumab (Hercules) versus EU-approved Herceptin® and US-licensed Herceptin® and pharmacokinetic similarity of EU-approved Herceptin® versus US-licensed Herceptin® after 8 mg/kg as single dose administered as intravenous infusion over 90 minutes in healthy male subjects based on the equivalence criterion that AUC0-∞, AUC0-last, and Cmax least square mean ratios are bounded within the 90% confidence intervals, 80.00% - 125.00%. Three similarity assessments were performed, 1) Hercules vs. EU-approved Herceptin®, 2) Hercules vs. US-licensed Herceptin® and 3) EU-approved Herceptin® vs. US-licensed Herceptin®. Secondary objectives included further pharmacokinetic assessment of similarity of Hercules, EU-approved Herceptin® and US-licensed Herceptin® λz, tmax and t1/2 along with assessment of safety (including immunogenicity) and local tolerance.
开始日期2013-08-01 |
申办/合作机构 |
100 项与 曲妥珠单抗生物类似药（Biocon） 相关的临床结果
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100 项与 曲妥珠单抗生物类似药（Biocon） 相关的转化医学
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100 项与 曲妥珠单抗生物类似药（Biocon） 相关的专利（医药）
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16
项与 曲妥珠单抗生物类似药（Biocon） 相关的文献（医药）2024-09-01·Oncology and Therapy
Real-World Study of Adjuvant Biosimilar Trastuzumab-dkst for HER2-Positive Breast Cancer Treatment in a Brazilian Population
Article
作者: Matias, Danielli ; França, Bruno ; Fuzita, William ; Araújo, Márcia ; Magaton, Érida ; Brito, Natália ; Pimentel, Sâmio ; Tavares, Monique ; Castilho, Vivienne ; Gagliato, Debora ; Rocha, Cláudio ; Aleixo, Sabina ; Cardoso, Ana Carolina ; Reinert, Tomás
INTRODUCTION:
Biological monoclonal antibodies play a pivotal role in cancer treatment, with biosimilars significantly enhancing their accessibility. In Brazil's ethnically diverse setting, real-world evidence is crucial for assessing the effectiveness and applicability of these therapies in routine clinical practice.
METHODS:
We performed a multicentric, observational, prospective real-world study on biosimilar trastuzumab-dkst for adjuvant treatment of early HER2-positive breast cancer in Brazilian patients. Data were collected using a case-report form.
RESULTS:
Of the 176 recruited, we present data from the first 59 patients (mean age 51.7 ± 12.9 years) who had completed treatment with trastuzumab-dkst. The mean time from diagnosis to the first adjuvant treatment with trastuzumab-dkst was 5.5 ± 2.7 months. Of the patients, 59% of patients achieved at least a 30-month follow-up. The 31.7-month invasive disease-free survival rate (IDFS) was 94.5% (95% CI 83.9-98.2%) and median IDFS was not achieved, since only three patients had invasive disease recurrence. The overall survival rate was 100% until the last assessment. The observed adverse events were similar to those presented by other studies using biosimilar or reference trastuzumab. Four serious adverse events (8.5%) were observed. A reduction in left ventricular ejection fraction of at least 10% was observed in 16.9% of participants. There was no treatment interruption, and three participants (5.1%) had their trastuzumab-dkst dose reduced.
CONCLUSION:
Our study reinforces the existing pivotal data, underscoring the real-world efficacy and safety of biosimilar trastuzumab-dkst in the adjuvant treatment for early HER2-positive breast cancer. The preliminary long-term effectiveness and safety data we present further validate trastuzumab-dkst's role as a cost-saving alternative in oncological care. These findings have important implications for improving patient access to crucial treatments and for the more efficient use of healthcare resources.
CLINICALTRIALS:
GOV REGISTRATION:
NCT03892655.
2022-11-02·Immunopharmacology and immunotoxicology
Trastuzumab biosimilars vs trastuzumab originator in the treatment of HER2-positive breast cancer: a systematic review and network meta-analysis
Review
作者: Dong, Mei ; Liu, Tong ; Jin, Yao ; Liu, Duo
AIM:
Breast cancer is the most frequently diagnosed cancer in women and ranks second among causes for cancer related death in women. Trastuzumab originator (Herceptin) is a monoclonal antibody used as a standard treatment for breast and metastatic gastric cancer when the cancer cells over-express human epidermal growth factor receptor type 2 (HER2). As the patent of Trastuzumab has now expired, biosimilars are moving into the market. It is still controversial to chose which trastuzumab biosimilar has the best treatment of HER2-positive breast cancer patients. We conducted this network meta-analysis to explore the best trastuzumab biosimilar in the treatment of HER2-positive breast cancer patients.
METHODS:
PubMed, Cochrane library databases, China National Knowledge infrastructure (CNKI) and WanFang database up to November 2021 were systematically searched. The following search terms were used: 'trastuzumab originator', and 'trastuzumab biosimilar'. No language restriction was imposed. The reference lists of all retrieved articles were also reviewed to identify additional articles missed by using these search terms.
RESULTS:
We got 10 studies to conduct network meta-analysis to evaluate efficacy and serious adverse reactions among various trastuzumab biosimilars and trastuzumab originator. The overall response rate (ORR) and pathological complete response (pCR) of SB3 were worse than trastuzumab originator significantly, while the ORR and pCR of other trastuzumab biosimilars had not yet reached statistical differences compared with each other. The cumulative ranking curve (SUCRA) probability indicated that the ORR from best to worst was CT-P6, Herceptin, HLX02, PF-05280014, R-TPR-016, BCD-022, MYL-1401O, SB3, and the pCR from best to worst was PF-05280014, CT-P6, Herceptin, ABP-980, SB3. The serious adverse events (SAEs) of CT-P6 were more than Herceptin and MYL-1401O significantly, while the SAEs of other trastuzumab biosimilars had not statistical differences. The SUCRA probability indicated that the SAEs from best to worst was MYL-1401O, Herceptin, PF-05280014, SB3, HLX02, BCD-22, CT-P6.
CONCLUSION:
There was no statistical difference in both ORR and pCR of various trastuzumab biosimilars and Herceptin except SB3. The ORR and pCR of SB3 were worse than Herceptin. Both CT-P6 and PF-05280014 are better in the overall curative effect, but CT-P6 had the highest serious adverse reactions when compared with others. The PF-05280014 might be a better trastuzumab biosimilar in the treatment of HER2-positive breast cancer patients.
2022-02-01·Expert opinion on biological therapy3区 · 医学
Evaluation of physicochemical and biological properties of nonreconstituted MYL-1401O vials, reconstituted MYL-1401O suspension in vial, and diluted MYL-1401O suspension in infusion bags (0.9% saline) for extended duration
3区 · 医学
Article
作者: Subbarao, Malini ; Mathew, Zacharia ; Honnappa, Chethan Gejjalagere ; Bera, Arnab ; Goyal, Parag ; Patnaik, Uma Sankar ; Vats, Bhavesh ; Singh, Ankita ; Ghosh, Ranendu ; Parambath, Anusha Valiya ; Nair, Arya M. ; Sarkar, Anindya ; Ullanat, Rajesh ; Prakash Sadasivappa, Kirthi ; Jadav, Rahul Singh ; Babu, Moram Narendra ; Kabadi, Pradeep
BACKGROUND:
MYL-1401O; trastuzumab-dkst (Ogivri™; Mylan Inc.) is a biosimilar to the trastuzumab reference product (Herceptin®; Genentech, USA). Assessment of physicochemical stability and biological activity for the non-reconstituted, reconstituted, and infused solution over an extended, clinically relevant duration is critical for ensuring optimal patient outcomes and health resource utilization.
METHODS:
The physicochemical and biological stability of MYL-1401O was assessed in non-reconstituted vials stored at 25 °C ± 2 °C/60% ± 5% relative humidity (RH) for 6 months, reconstituted 21 mg/mL solution in vials stored at 2 °C to 8 °C for 10 days, and diluted in 0.9% saline-containing infusion bags at 0.3 mg/mL and 4.0 mg/mL stored for 77 days at 2 °C to 8 °C, plus an additional 2 days at 25 °C ± 2 °C/60% ± 5% RH.
RESULTS:
At all storage conditions tested, MYL-1401O was physicochemically and biologically stable for extended duration and under various temperature and humidity conditions.
CONCLUSIONS:
MYL-1401O retained its physicochemical and biological stability under different storage conditions, which supports advanced preparation of MYL-1401O, better efficiency, less wastage, and cost-savings for better patient management.
11
项与 曲妥珠单抗生物类似药（Biocon） 相关的新闻（医药）2024-10-22
·药渡
氨基观察-创新药组原创出品
作者 | 武月
风险这个东西，对于药企来说，应当最熟悉不过的。
根据BIO等组织发布的关于药物临床开发成功率的报告，在统计完9704个药物的1.27万个临床开发项目后，BIO发现，2011年至2020年十年间，药物开发项目从1期临床到获得FDA批准上市的成功率平均为7.9%，所需要的时间平均为10.5年。
对于国内药企来说，要面对的是比一生九死还要残酷的现实，因为还要面对出海的层层试炼。
但海外市场是更宽阔的大海，通过国际化让产品走向世界是每个药企的梦想。
那么，当药企厌恶风险之后呢？
相比自主出海，旱涝保收的对外授权模式，正在愈发受到青睐。包括一些不差钱、创新力也足够的传统大药企。
比如，恒瑞医药这艘大船在出海这条路上，正在调头。
相比当初野心勃勃推动“双艾组合”出海，恒瑞医药正在改变自己的出海战略。日前，在接受采访时，恒瑞医药副总经理张连山表示，现在每个产品都愿意寻求合作。
“我们改变策略，任何一个产品，在任何临床阶段，都会寻求跟海外合作开发。除了成本，对外合作也是一种去风险的模式。”
风险面前，野心退位。
这对于创新药行业，又意味着什么？
/ 01 /
出海大冒险
出海不仅是梦想，对于恒瑞医药来说，更是一次不得不进行的大冒险。
甚至于，在新的衡量标准下，有这样一种声音，出海成功与否，将是决定恒瑞医药能否保持“一哥”地位的关键。
的确，加速创新转型的恒瑞医药，走到一个十字路口。
一来，过去靠着国内市场，恒瑞医药对于海外市场的布局或许并不急迫。但在国内创新药内卷，药企纷纷出海寻找增量的情况下，国际化也被提到了更重要的高度。
而恒瑞医药，虽然早在2020年年报中就提出了“国际化”的方向，但过去几年，其国际化进展并不顺利。
二来，卡瑞利珠单抗已然落后，围绕PD-1的国际化，成为其必须拿下的一战。倘若这一搏成功，卡瑞利珠单抗也不是没有可能重回辉煌，更能改变其出海困局。
因此，恒瑞医药对于双艾组合（卡瑞利珠单抗+阿帕替尼）出海，寄予厚望。根据交易条款来看，恒瑞医药与合作伙伴双方Elevar合作，恒瑞医药实际负责管理海外临床试验，所有中国以外的研究费用由双方平摊。
并且，没有首付款，只有成功上市并达到一定销售额，恒瑞医药才能拿到里程碑款，最高为6亿美金；销售分成则与Elevar的净利润相关，比例在20.5%左右。
某种程度上，对于Elevar来说，这是一笔无风险的交易。而恒瑞医药之所以这样做，或许是出于对产品的信心，希望自己主导海外临床，加速上市，拿到高额的分成。毕竟，全球肝癌市场足够庞大。
去年2月份，恒瑞医药在调研中便表示，出海工作重点之一是双艾组合在海外的申报；5月，Elevar便提交了上市申请。
今年5月份，由于CMC及旅行限制等因素，FDA拒绝了双艾组合。5个月后，恒瑞医药宣布，已经重新向FDA递交了双艾组合的上市申请。
尽管三期临床结果发表在医学顶刊《柳叶刀》，但临床试验并不算完美。比如，83%的受试者都是亚洲人，试验中的白人占不足17%。这种情况，双艾组合能否成功获批尚不可知。
而眼下，恒瑞医药已经对出海策略做出了反思与调整。
在接受采访时，张连山表示，海外战略有所调整，现在每个产品都愿意寻求合作。
“过去卡瑞利珠单抗联合阿帕替尼组合的出海方式，放到现在，我们不会这么做，因为成本太大。
我们改变策略，任何一个产品，在任何临床阶段，都会寻求跟海外合作开发。除了成本，对外合作也是一种去风险的模式。过去国内企业跟海外公司达成过一些合作，所谓面临退货，其实这是很正常的，钱拿到，风险也去除了。
但是实事求是来看，并不是我们的每一个产品都有对外合作的机会。”
换句话说，恒瑞医药想出海，但不想继续冒险了。
/ 02 /
厌恶风险
说起来，恒瑞医药的转变，同样始于2023年。
1月份，江宁军加入恒瑞医药，负责公司创新药国际化、临床研究和商务拓展工作。同时，由孙飘扬、张连山、江宁军组成战略决策小组，负责公司战略和研发决策。
2月起，恒瑞医药拉开了加速出海的序幕，包括EZH2抑制剂SHR2554、TSLP单抗SHR-1905、HER1/HER2/HER4靶向药物马来酸吡咯替尼、PARP1抑制剂HRS-1167、Claudin-18.2 ADC SHR-A1904被授权出去，总交易金额超40亿美元。
其中，其与默克就HRS-1167、SHR-A1904等管线，达成最高可达14亿欧元的BD交易。这也是恒瑞医药首次与MNC达成合作。
根据协议，恒瑞医药将获得1.6亿欧元的首付款、高至9000万欧元的技术转移费和行权费，及研发里程碑付款、销售里程碑付款，总额可能高达14亿欧元。
2023年之前，恒瑞医药对于出海合作，整体趋于谨慎，或者说保守；2023年之后，其一面推进双艾组合上市，一面加速调整出海策略。
那么，是什么促成了改变？
一方面，恒瑞医药转型创新的定力没有变过。近年来，其研发投入占营收比重都在20%以上。然而，需要指出的是，其在某些方面有些保守，比如发展BD的时机、节奏等。
简单来说，恒瑞医药的国际化形式上启动并不晚，但真正的国际化晚了。
另一方面，相比biotech，恒瑞医药显得有些“大而不精”。90多个管线在研，每年研发部申请近20个新分子，整体研发投入巨大，但每个分子在筛选优化、验证程度上并不高。
在研发上无法放开手脚投入，一个可想而知的原因是，恒瑞医药花的是自己卖药挣的钱，需要考虑收支平衡。
如果不考虑融资，药物高研发、高投入的前提应该是高回报。但在国内市场，这几乎难以做到，所以必须出海。
而对一哥来说，即使在海外完成了研发，其所擅长的销售模式，在海外也未必行得通。如百济神州一般，在不同的文化语境与监管要求下，要从头开始在海外建立一支完整的研发、注册和销售队伍，难度可想而知；更何况，现实的融资环境也不容许。
眼看自主出海难以推进的情况下，要打破出海困局，或许只有一条路可走，放开合作。
张连山曾坦言，“药物按照美国市场价格在中国卖，不是我们作为一家中国企业应当去做的事情。但我们不是一个慈善组织，是一个公司，做创新需要回报，我们需要给投资者回报、给员工发工资，所以必须要把产品拿到海外的价值市场。”
至于怎么拿到海外市场，他也说了：任何一个产品，在任何临床阶段，都会寻求跟海外合作开发。
因为，成本低、风险低。
而在交足“学费”后，恒瑞医药也摸索出一种新的出海形式。
通过技术入股，与海外资本一起攒局。
在降低风险的同时，还能锁定远期收益。
/ 03 /
大药企出海之辨
今年5月，恒瑞医药就GLP-1等产品组合的海外权益，授权给美国Hercules公司。
通过前期1.56亿元左右的研发投入，撬动总价60亿美元的交易，其中仅首付款便达到了1亿美元。除了首付款、里程碑等，恒瑞医药还将获得Hercules19.9%的股份。
即使后期临床失利，其也已经收到了保底的1亿美元。通过这种合作，减少了后期高昂成本投入，分散了研发风险，又通过股权，保留了未来获得收益的权利。
看上去，一举多得。只是，有得必有失。以license out交易的方式出海，或许也就意味着丧失了一次绝佳的出海练兵机会。
这种转变背后，很现实也很真实。“随着多款产品对外许可的实现，我们可以比较快地实现海外市场的回报，这非常重要。”张连山表示。
2024年上半年，恒瑞医药的创新药收入为66.12亿元，对外许可收入为1.6亿欧元。
不止恒瑞医药，包括翰森制药等大药企也选择了这条路。这或许意味着，大部分国内药企，还没有做好出海的准备，还需要更大的“野心”。
相比短期的收入，也有市场人士认为，恒瑞医药作为一哥，BD目标应该与biotech有根本不同。
中国药企必须走出去，中国也到了需要世界级药企的时刻。
而参考日本药企的崛起，对国内药企很有借鉴意义。
如今创新药企面临的困境，与80年代的日本药企相似。内卷+医保控费趋势下，让不少国内药企倍感焦灼。与此同时，国家正在大力鼓励真正的创新。这是挑战也是机遇。
面对持续的控费趋势，越来越多日本药企将眼光放到海外，踏上出海之路。而形式也不仅仅是旱涝保收的对外专利授权模式，还包括建立合资公司等，尤其后者。
武田制药出海的第一步，便是通过与海外药企建立合资公司。通过合资公司积攒了丰富的财富和经验后，武田制药开始只身一人奔赴全球化。1998年，其开始在美国建立自己的独立子公司进行药物销售，并通过不断并购海外优质药企，拓宽自身管线。
2020年，武田跻身全球药企前十，这也是亚洲药企最好的成绩。
除了武田，安斯泰来、盐野义等药企都曾通过与大药企创办合资药企来实现出海。相比于直接将海外权益卖出，这种方式虽然早期投入更大也更艰难，但也能帮助国内药企完成经验积累。
这些日本药企走出日本，底气与野心缺一不可。
回到国内来说，在寒冬中，绝大多数biotech并没有太多选择，只能通过license out活下去。但是，对于底气更足的传统大药企呢？
一方面，它们家底殷实，经得起折腾。截至今年6月末，翰森制药账上现金及金融资产共计234.97亿元；恒瑞医药拥有现金及金融资产232.85亿元。
这样的资金储备，足以支撑国内大药企的国际化脚步。
另一方面，它们的管线储备也足够。比如恒瑞医药，SHR-A1904临床进度居前，有望与其他选手在超越Claudin18.2 FIC这条路上，一争高下。
在今年ESMO会上，恒瑞医药首次公布了SHR-A1904的数据。在治疗胃或胃食管连接部癌的I期研究中，在基线和≥1 次基线后评估的患者中，6.0 mg/kg 剂量组中，ORR 和 DCR 分别为55.6%和88.9%；8.0 mg/kg剂量组中，ORR和DCR分别为36.7%和86.7%。
整体安全性尚可，患者可耐受，大多数AE为肿瘤化疗药物所常见，临床潜力可期。
翰森制药去年底对外授权的2款管线，都具有FIC潜力。其中，B7-H3靶点全球进入临床阶段药物共9款，翰森制药的HS-20093处于二期临床，进度全球第二；进入临床阶段的B7-H4 ADC仅4款，HS-20089进度全球第一。
如果它们不去尝试，属于我们的“中国罗氏”，又从何而来呢？
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临床1期医药出海
2024-09-24
·米内网
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米内网数据显示，2024第一季度中国零售药店终端（城市实体药店+网上药店）药品销售额超过950亿元，其中化学药占比超过50%，中成药占比超过40%，生物药占比超过8%。化学药TOP20中，抗ED药亮了，流感“神药”跌落；中成药TOP20中，11个独家品种霸榜，扬子江2大品种大涨；生物药TOP20中，单抗药物“称王”，重磅注射剂暴涨260%。
近年来中国零售药店终端药品（化药+生物药+中药）销售情况（单位：万元）来源：米内网格局数据库
化学药：抗ED药亮了，流感“神药”跌落
近年来，中国零售药店终端化学药销售额逐年上涨，2024年第一季度超过470亿元，占药品总销售额比重超过50%。
TOP20一级集团中，阿斯利康、拜耳、华润医药、晖致、赫力昂依次位列前五。从销售额增速看，阿斯利康、诺华、石药、辉瑞、豪森、齐鲁均超10%。
TOP20产品均为非独家产品，枸橼酸西地那非片、维生素D滴剂、葡萄糖酸钙锌口服溶液依次位列前三。其中，枸橼酸西地那非片以超12亿元领跑，维生素D滴剂、葡萄糖酸钙锌口服溶液均为营养素补充剂，分别属于维生素类、矿物质补充剂。
2024Q1中国零售药店终端化学药TOP20产品来源：米内网综合数据库
从销售额增速看，11个品种呈正增长，复方氨酚烷胺片、碳酸钙D3片(Ⅰ)涨幅均超过60%，其中复方氨酚烷胺片首次跻身TOP20产品；枸橼酸西地那非片、他达拉非片近年来持续正增长。9个负增长的品种中，磷酸奥司他韦颗粒、磷酸奥司他韦胶囊均为抗流感药，其中磷酸奥司他韦颗粒大幅下滑57.27%。
枸橼酸西地那非片、他达拉非片均为5型磷酸二酯酶的抑制剂，用于治疗男性性功能勃起障碍。近年来，上述2款抗ED药物在中国零售药店终端的销售额逐年上涨，2023年分别超过51亿元、28亿元。在品牌效应加持下，目前2款药物在零售药店的市场均由原研厂家占据主导地位。
近年来中国零售药店终端枸橼酸西地那非片、他达拉非片销售情况（单位：万元）来源：米内网格局数据库
中成药：11个独家品种霸榜，扬子江2大品种大涨
2024年第一季度中国零售药店终端中成药销售额超过390亿元，占药品总销售额比重超过40%。
TOP20一级集团中，华润医药、广药集团、国药集团、北京同仁堂、云南白药依次位列前五。从销售额增速看，扬子江药业、京都念慈菴总厂、福牌阿胶、济川药业均超20%。
TOP20产品中，阿胶以超15亿元蝉联榜首，安宫牛黄丸以超14亿元紧接在后，感冒灵颗粒以超10亿元排位第三。感冒灵颗粒、蒲地蓝消炎片、蓝芩口服液、苏黄止咳胶囊、蒲地蓝消炎口服液销售额增速分别达55.58%、60.32%、67.49%、70.81%、47.38%。
2024Q1中国零售药店终端中成药TOP20产品注：标红为销售额增速超10%来源：米内网综合数据库
11个为独家品种（含独家剂型），其中扬子江药业的蓝芩口服液及苏黄止咳胶囊、京都念慈菴总厂的京都念慈菴蜜炼川贝枇杷膏、漳州片仔癀药业的片仔癀、国药集团的急支糖浆、济川药业的蒲地蓝消炎口服液等品种涨幅均超过10%。
蓝芩口服液、苏黄止咳胶囊均为国家医保乙类品种，且均属于呼吸系统中成药。近年来，苏黄止咳胶囊在中国零售药店终端均以两位数的增速持续扩容，2023年突破6亿元，2024年第一季度大涨70.81%，全年销售额有望再创新高；蓝芩口服液的销售额则有所波动，2022-2023年均超11亿元，2024年第一季度大涨67.49%。
近年来中国零售药店终端蓝芩口服液、苏黄止咳胶囊销售情况（单位：万元）来源：米内网格局数据库
生物药：单抗药物“称王”，重磅注射剂暴涨260%
近年来，中国零售药店终端生物药销售额均以两位数的增速逐年上涨，2024年第一季度超过82亿元，占药品总销售额比重超过8%。
TOP20一级集团中，诺和诺德、罗氏、默沙东、康方生物、诺华依次位列前五。从销售额增速看，诺和诺德、康方生物、正大制药均超60%，其中正大制药涨超180%。
TOP20产品中，人血白蛋白稳居首位，销售额超过6亿元；司美格鲁肽注射液以超5亿元紧接在后，较2023年提升1个位次；帕博利珠单抗注射液以超4亿元排位第三。
2024Q1中国零售药店终端生物药TOP20产品来源：米内网综合数据库
从销售额增速看，12个品种同比增长超过10%，诺和诺德的司美格鲁肽注射液以260.67%的增速领跑，康方药业的卡度尼利单抗注射液涨幅达61.13%，注射用重组人凝血因子Ⅷ、信迪利单抗注射液涨幅均超过50%。
司美格鲁肽注射液是由诺和诺德研发的一款新型长效胰高糖素样肽-1(GLP-1)类似物，2021年4月获批进入中国市场，2023年在中国零售药店终端的销售额超过12亿元，2024年一季度同比增长260.67%。目前国内已有超过20家企业在布局司美格鲁肽生物类似药，其中杭州九源基因、丽珠集团新北江制药等企业的产品已报产在审。
近年来中国零售药店终端司美格鲁肽注射液销售情况（单位：万元）来源：米内网格局数据库
从药物类型看，20个产品中有15个为抗体药物，除了贝伐珠单抗注射液、注射用曲妥珠单抗、阿达木单抗注射液、利妥昔单抗注射液外，其余均为独家品种，包括4款国产创新药及7款进口原研药。
卡度尼利单抗是首个获批上市的国产双抗，也是全球首款获批的PD-1/CTLA-4双特异性抗体。该产品于2022年6月底获批上市，2023年在中国零售终端的销售额就突破10亿元，2024年一季度同比增长61.13%。
近年来中国零售药店终端卡度尼利单抗注射液销售情况（单位：万元）来源：米内网格局数据库
注：米内网《中国城市实体药店药品终端竞争格局》，统计范围是：全国地级及以上城市实体药店，不含县乡村药店；《中国网上药店药品终端竞争格局》，统计范围是：全国网上药店所有药品数据，包括天猫、京东等第三方平台及私域平台上所有网上药店药品数据；上述销售额均以产品在终端的平均零售价计算。
本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092
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2024-05-21
BRIDGEWATER, N.J. and BENGALURU, India, May 21, 2024 /PRNewswire/ --
Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced that the U.S. Food and Drug Administration (US FDA) has approved the Company's first-to-file application for Yesafili™ (aflibercept-jbvf), an interchangeable* biosimilar aflibercept. YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor used to treat several different types of ophthalmology conditions, is a biosimilar of its reference product EYLEA® (aflibercept).
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YESAFILI is intended for the treatment of neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV). It is highly similar to the reference product Eylea® (aflibercept). Data shows that YESAFILI has comparable quality, safety, and efficacy to Eylea®.
The FDA approval of YESAFILI as the first interchangeable biological product to Eylea is a significant milestone.
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The approval of YESAFILI marks Biocon Biologics' expansion into the ophthalmology therapeutic area in the United States following a steady track record of approval in Europe (September 2023) and the United Kingdom (November 2023) where it was the first biosimilar aflibercept to be approved. The Company has secured a launch date in Canada of no later than July 1, 2025, under the terms of a settlement agreement.
Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd.
, said: "The FDA approval of YESAFILI (aflibercept) as the first interchangeable biological product to Eylea is a significant milestone for Biocon Biologics marking our entry into Ophthalmology, a new therapeutic area in the United States. YESAFILI is approved for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy. This approval builds on our successful track record of bringing the first interchangeable insulin, SEMGLEE®, the first biosimilar Trastuzumab, OGIVRI®, and the first biosimilar Pegfilgrastim, FULPHILA®, to patients in the United States."
Matt Erick, Chief Commercial Officer of Advanced Markets, Biocon Biologics Ltd
, said: "Biosimilars are crucial for making healthcare more affordable and accessible. YESAFILI will offer ophthalmologists an important new option for patients impacted by macular degeneration and diabetic retinopathy, from a company with a long history of delivering high-quality, science-driven medicines, solely focused on the development and commercialization of biosimilars."
There are 19.8 million Americans living with age-related macular degeneration (AMD) in the United States.1 In the U.S., sales of aflibercept were approximately $5.89 billion in 2023.2
Biocon Biologics is a leading global company offering a large portfolio of monoclonal antibodies, insulins, and conjugated proteins. It has achieved several "firsts" in the industry including the first to receive approval in the United States of a biosimilar trastuzumab (OGIVRI®, trastuzumab-dkst) and a biosimilar pegfilgrastim (FULPHILA®, pegfilgrastim-jmdb). Serving over 5.5M patients annually, Biocon Biologics has a comprehensive portfolio of in-market and in-development biosimilar products across multiple therapies, including four in the United States and six in Canada, with a robust pipeline of 20 biosimilar assets spanning multiple therapy areas.
1 Rein DB, Wittenborn JS, Burke-Conte Z, Gulia R, Robalik T, Ehrlich JR, Lundeen EA, Flaxman AD. Prevalence of Age-Related Macular Degeneration in the United States in 2019. JAMA Ophthalmology.
Published Online: November 3, 2022 at: . Accessed April 29, 2024.
2 Regeneron Fourth Quarter and Full Year 2023 Financial and Operating Results. February 2, 2024.
* An interchangeable product (IP) is a biological product that is approved based on data demonstrating that it is highly similar to an FDA-approved reference product (RP) and that there are no clinically meaningful differences between the products; it can be expected to produce the same clinical result as the RP in any given patient; and if administered more than once to a patient, the risk in terms of safety or diminished efficacy from alternating or switching between use of the RP and IP is not greater than that from the RP without such alternation or switch. Interchangeability of YESAFILI has been demonstrated for the condition(s) of use, strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.
About YESAFILI:
The approval for YESAFILI (aflibercept-jbvf) was based on a comprehensive package of analytical, nonclinical and clinical data, which confirmed that YESAFILI is highly similar to Eylea®. In a Phase 3 INSIGHT Study, YESAFILI was compared with Eylea® in patients with Diabetic Macular Edema. Study demonstrated that there were no clinically meaningful differences between YESAFILI and Eylea in terms of pharmacokinetics, safety, efficacy, and immunogenicity.
INDICATIONS AND USAGE:
YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with:
Neovascular (Wet) Age-Related Macular Degeneration (AMD)
Macular Edema Following Retinal Vein Occlusion (RVO)
Diabetic Macular Edema (DME)
Diabetic Retinopathy (DR)
WARNINGS AND PRECAUTIONS:
YESAFILI is contraindicated in patients with Ocular or periocular infection, Active intraocular inflammation and Hypersensitivity to aflibercept.
Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately.
Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection.
There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.
Please refer to full Prescribing Information for YESAFILI for more information. To report SUSPECTED ADVERSE REACTIONS, contact Biocon Biologics at 1-833-986-1468 or FDA at 1-800-FDA-1088 or .
About Biocon Biologics Limited:
Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Ltd., is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives by enabling affordable access to high quality biosimilars for millions of patients worldwide. It is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes.
BBL has integrated the acquired global biosimilars business of its long-standing partner Viatris, which is a historic milestone in its value creation journey. Biocon Biologics has commercialized eight biosimilars in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. The Company has a pipeline of 20 biosimilar assets across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases. It has many 'firsts' to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, BBL is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website: ; Follow us on Twitter: @BioconBiologics and LinkedIn: Biocon Biologics for company updates.
Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: ; Follow-us on Twitter: @bioconlimited for company updates.
Forward-Looking Statements: Biocon
This press release may include statements of future expectations and other forward-looking statements based on management's current expectations and beliefs concerning future developments and their potential effects upon Biocon and its subsidiaries/ associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or any of our subsidiaries/associates assume any obligation to update any particular forward-looking statement contained in this release.
YESAFILI™ is a trademark of a Biosimilars Newco Limited, a Biocon Biologics Ltd. company.
OGIVRI® and FULPHILA® are registered trademarks of Biosimilars Newco Limited, a Biocon Biologics Ltd. company.
All other trademarks, registered or unregistered, are the property of their respective owners.
SOURCE Biocon Biologics Ltd.
上市批准临床3期并购临床结果生物类似药
100 项与 曲妥珠单抗生物类似药（Biocon） 相关的药物交易
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研发状态
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 胃癌 | 加拿大 | 2019-05-01 | |
| 早期乳腺癌 | 欧盟 | 2018-12-12 | |
| 早期乳腺癌 | 冰岛 | 2018-12-12 | |
| 早期乳腺癌 | 列支敦士登 | 2018-12-12 | |
| 早期乳腺癌 | 挪威 | 2018-12-12 | |
| HR阳性乳腺癌 | 欧盟 | 2018-12-12 | |
| HR阳性乳腺癌 | 冰岛 | 2018-12-12 | |
| HR阳性乳腺癌 | 列支敦士登 | 2018-12-12 | |
| HR阳性乳腺癌 | 挪威 | 2018-12-12 | |
| 转移性乳腺癌 | 欧盟 | 2018-12-12 | |
| 转移性乳腺癌 | 冰岛 | 2018-12-12 | |
| 转移性乳腺癌 | 列支敦士登 | 2018-12-12 | |
| 转移性乳腺癌 | 挪威 | 2018-12-12 | |
| 转移性胃癌 | 欧盟 | 2018-12-12 | |
| 转移性胃癌 | 冰岛 | 2018-12-12 | |
| 转移性胃癌 | 列支敦士登 | 2018-12-12 | |
| 转移性胃癌 | 挪威 | 2018-12-12 | |
| HER2阳性转移性乳腺癌 | 欧盟 | 2018-12-12 | |
| HER2阳性转移性乳腺癌 | 冰岛 | 2018-12-12 | |
| HER2阳性转移性乳腺癌 | 列支敦士登 | 2018-12-12 |
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临床结果
临床结果
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分期
评价
查看全部结果
| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
N/A | 193 | 蓋淵膚獵築淵積鏇襯繭(鹹憲遞餘衊網餘願窪餘) = 蓋選鬱鏇範糧積鹹衊憲 蓋獵鏇糧餘糧獵襯廠觸 (顧襯鹹廠繭餘憲獵繭網 ) | 积极 | 2023-05-12 | |||
Referent Trastuzumab | 蓋淵膚獵築淵積鏇襯繭(鹹憲遞餘衊網餘願窪餘) = 衊蓋蓋醖廠鹹窪壓衊顧 蓋獵鏇糧餘糧獵襯廠觸 (顧襯鹹廠繭餘憲獵繭網 ) | ||||||
Pubmed 人工标引  | N/A | 早期乳腺癌 新辅助 | 136 | 夢淵網膚壓遞鬱鹽網鬱(獵積鏇蓋築網餘積顧願) = 壓鬱憲積廠顧遞膚鏇製 膚遞選顧廠積醖鬱齋鬱 (膚蓋築觸窪獵築淵壓獵 ) | 不佳 | 2022-06-11 | |
夢淵網膚壓遞鬱鹽網鬱(獵積鏇蓋築網餘積顧願) = 繭餘繭齋鹽鹹衊壓範積 膚遞選顧廠積醖鬱齋鬱 (膚蓋築觸窪獵築淵壓獵 ) | |||||||
临床3期 | 500 | taxane+trastuzumab-dkst | 遞餘觸觸壓艱壓膚淵夢(膚糧壓淵蓋製憲窪醖蓋) = 鹽壓製艱選鹹鑰簾淵廠 選襯選壓鏇網夢選憲艱 (鹽膚壓襯窪遞選醖夢遞 ) 更多 | 相似 | 2019-06-02 | ||
taxane+trastuzumab | 遞餘觸觸壓艱壓膚淵夢(膚糧壓淵蓋製憲窪醖蓋) = 積糧襯艱簾築築鬱網窪 選襯選壓鏇網夢選憲艱 (鹽膚壓襯窪遞選醖夢遞 ) 更多 | ||||||
临床3期 | 500 | 壓獵願憲窪顧網蓋艱齋(積網簾艱繭鏇網構願獵) = 願壓醖構醖鏇艱鹽醖鑰 築積鹹齋廠鬱蓋壓鑰淵 (鑰選膚鹽窪糧膚夢鹹艱 ) 更多 | 积极 | 2018-06-01 | |||
壓獵願憲窪顧網蓋艱齋(積網簾艱繭鏇網構願獵) = 淵網築築繭觸壓廠獵積 築積鹹齋廠鬱蓋壓鑰淵 (鑰選膚鹽窪糧膚夢鹹艱 ) 更多 | |||||||
临床3期 | 458 | taxane+trastuzumab biosimilar | 糧窪淵淵鬱艱膚範積觸(窪淵築齋範衊廠簾簾選) = 鹹願觸顧顧廠簾窪淵糧 鹹廠網鏇齋齋鹽鹹夢製 (積網製簾獵觸廠鏇獵襯, 63.62 ~ 75.51) 更多 | 相似 | 2017-01-03 | ||
taxane+Trastuzumab | 糧窪淵淵鬱艱膚範積觸(窪淵築齋範衊廠簾簾選) = 衊選鹽壓鏇壓廠選餘遞 鹹廠網鏇齋齋鹽鹹夢製 (積網製簾獵觸廠鏇獵襯, 57.81 ~ 70.26) 更多 |
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