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重磅!君实PD-1价格和赠药方案正式公布,费用不到进口1/3!疗效出众

医药魔方 医药魔方 来源:医药魔方
2019-01-08
君实生物 PD-1
原文


国内首款自主研发的抗PD-1单抗——拓益(特瑞普利单抗注射液)于2018年12月17日获国家药品监督管理局批准上市,其公开临床数据引起全球关注。


研究结果显示,特瑞普利单抗单药治疗临床疗效显著,达到世界领先水平。其治疗既往接受全身系统治疗失败的不可切除或转移性黑色素瘤患者的客观缓解率(ORR)17.3%, 疾病控制率(DCR)57.5%,1年生存率69.3%。进口产品帕博利珠单抗在中国的临床试验中,其黑色素瘤开放性研究的公开数据为客观缓解率16.7%,疾病控制率38.2%,1年生存率50.8%。


因PD-1单抗产品研发及生成本较高,且我国之前没有自主产品,导致中国的患者至今只能被迫依赖于高昂的进口产品,往往因病致贫,不堪重负。随着热门电影《药神》的播出,更是把该类产品推上风口浪尖。良好的临床数据表现以及中国患者的巨大需求,让拓益的定价成为社会各界最为关注的焦点。


1、关于定价和慈善方案


现根据君实生物1月7日的官方消息,拓益的价格将定为7200元/240mg(支),合30元/mg,年治疗费用18.72万元。而同样适应症的进口产品帕博利珠单抗价格为17918元/100mg(支),合179元/mg,年治疗费用609212元(平均体重60kg计)。


这一定价其实早就有迹可寻,君实管理层上周在央视采访中已经表示,尽管拓益疗效显著,但是定价一定会争取惠及更多的患者,可能会是进口产品的1/3甚至更低。


此外,北京白求恩公益基金会宣布在全国发起“益路相伴——白求恩·拓益公益捐助项目”,为家庭困难或因病致贫而不能得到持续有效治疗的黑色素瘤患者提供药品援助,以求让更多患者获益。


根据基金会官方提供的项目方案,符合条件的患者使用4个周期拓益后可获4个周期的药品援助。初步估算,如该计划可覆盖一年或更长治疗周期,患者实际一年用药负担约为93600元。


特瑞普利单抗的价格远低于同类进口产品的定价,不到进口产品的三分之一。




君实生物的拓益以其远低于全球多个地区的PD-1产品售价,很大程度上缓解了该药品在中国的可及性问题,让更多的患者实际获益,减轻经济负担,缓解社会压力。


2、更多临床研究数据披露,疗效出众


作为新型重组人源化抗PD-1单抗,特瑞普利单抗与治疗靶点的亲和力和结合稳定性均达到国际先进水平,在体外和临床实验中展现了出色的抗肿瘤疗效和良好的安全性。


除了已经批准的“癌中之王”黑色素瘤,特瑞普利单抗在其他肿瘤方面的疗效表现也十分惊艳。如霍奇金淋巴瘤,早期临床实验中表现出的有效率高达88%,数值上超过目前有过报道的其他同类产品在该适应症方面的有效率。鼻咽癌、胃癌、食管癌、尿路上皮癌、肺泡软组织肉瘤等十多个瘤种也在开发当中。


同时,特瑞普利单抗的联合治疗也在探索当中。甚至在已获批的黑色素瘤适应症方面,特瑞普利单抗也不断刷新自己的纪录。针对国人中高发的粘膜黑色素瘤,特瑞普利单抗与血管生成抑制剂的联合治疗项目取得了全球性的突破,早期临床数据有效率超过60%。

 

君实特瑞普利单抗临床数据


关于PD-1


目前,肿瘤免疫治疗领域研究热点主要集中在抗程序性死亡因子1(ProgrammedDeath-1,PD-1)受体等免疫检查点抑制剂上,它和传统的化疗和靶向治疗不同,主要是通过克服患者体内的免疫抑制,重新激活患者自身的免疫细胞来杀伤肿瘤,是一种全新的抗肿瘤治疗理念。


此次获批的拓益(特瑞普利单抗注射液)是由君实生物研制开发的新型重组人源化抗PD-1单抗,可通过封闭T淋巴细胞的PD-1,阻断其与肿瘤细胞表面PD-L1结合,解除肿瘤细胞对免疫细胞的免疫抑制,使免疫细胞重新发挥抗肿瘤细胞免疫作用而杀伤肿瘤细胞。


关于黑色素瘤


黑色素瘤在我国近年来呈现快速增长趋势,为发病率增长最快的恶性肿瘤之一,每年新发病例约20000例,死亡率也呈逐年快速上升趋势,已经成为严重危及我国人民健康的疾病之一。在治疗方面,一线治疗失败的黑色素瘤患者目前缺乏有效的标准治疗方案。


北京大学肿瘤医院副院长、中国临床肿瘤学会(CSCO)秘书长郭军教授参与和领导了拓益(特瑞普利单抗注射液)的注册临床研究工作,他表示:“近年来免疫治疗在多种肿瘤治疗领域均显示出令人惊喜的疗效,使得众多种肿瘤患者重新燃起了对生命的渴望,但高昂的价格仍然使许多中国患者望而却步。随着我国拥有自主知识产权的PD-1单抗拓益获批上市,价格及慈善计划的同时公布,中国的肿瘤患者将以年治疗费用低于10万价格得到目前国际最先进水平的免疫治疗。


君实生物的拓益(特瑞普利单抗注射液)用于既往接受标准治疗失败的局部进展或转移性黑色素瘤的治疗,其获批上市不仅填补了国产PD-1抑制剂的空白,还使更多中国患者有机会获得国际先进水平的肿瘤免疫治疗。黑色素瘤是拓益在国内获批的第一个适应症,未来,鼻咽癌、非小细胞肺癌、胃癌、食管癌、尿路上皮癌、肝癌等适应症也会陆续申请上市。目前,这些适应症正处于临床研究阶段。


机器翻译

The first self-developed anti-PD-1 monoclonal antibody in China — Tuoyi (Treprimumab Injection) was approved by the State Drug Administration on December 17, 2018, and its public clinical data has attracted global attention.

The results of the study showed that the clinical efficacy of teriplizumab monotherapy was significant, reaching the world's leading level.Its objective response rate (ORR) in patients with unresectable or metastatic melanoma who have failed prior systemic therapy 17.3%, disease control rate (DCR) 57.5%, 1-year survival rate 69.3%.Published data from an open-label study of melanoma in clinical trials of the imported product pabolizumab in China are objective response rates 16.7%, disease control rate 38.2%, 1-year survival rate 50.8%.

Because of the high R & D and generation of PD-1 monoclonal antibody products and the absence of independent products in China, patients in China have so far been forced to rely on high imported products, which are often impoverished and overwhelmed by illness.With the broadcast of the popular movie "Medicine God", it is pushing such products to the cusp.Good clinical data performance and the huge demand of Chinese patients have made the pricing of topologies the focus of attention in all sectors of society.

1, on pricing and charity programs

According to the official news of Junshi Bio on January 7, the price of the extension will be set at 7,200 yuan/240 mg (branch), 30 yuan/mg, and the annual cost of treatment 18.720,000 yuan.The price of the imported product of the same indication is 17918 yuan/100mg (branch), 179 yuan/mg, and the annual treatment cost is 609,212 yuan (average weight 60kg).

This pricing has long been available. Junshi management said in an interview with CCTV last week that despite the significant effect of topology, pricing will certainly strive to benefit more patients and may be 1/3 or less of imported products.

In addition, the Bethune Foundation for Public Welfare in Beijing announced the launch of the Bethune Tuoyi Public Welfare Donation Project to provide drug assistance to melanoma patients who are in family difficulties or who are impoverished due to illness and cannot receive sustained and effective treatment in order to benefit more patients.

According to the project protocol officially provided by the Foundation, eligible patients receive 4 cycles of pharmaceutical assistance after using 4 cycles of topologies.According to preliminary estimates, if the plan can cover a period of one year or more, the actual annual medication burden is about 93,600 yuan.

The price of terlizumab is much lower than the pricing of similar imported products, less than one-third of the imported products.

The benefits of Junshi Bio are much lower than the price of PD-1 products in many parts of the world, which greatly alleviates the problem of accessibility of the drug in China, allows more patients to actually benefit, reduces the economic burden, and relieves social pressure.

2. More clinical research data are disclosed, and the efficacy is outstanding

As a novel recombinant humanized anti-PD-1 monoclonal antibody, the affinity and binding stability of teriplizumab to therapeutic targets have reached the international advanced level, demonstrating excellent antitumor efficacy and good safety in vitro and in clinical trials.

In addition to the already approved "King of Cancer" melanoma, the efficacy of terlizumab in other tumors has also been stunning.Such as Hodgkin's lymphoma, early clinical trials showed an effective rate of up to 88%, numerically more than other similar products have been reported in this indication.More than a dozen tumor types such as nasopharyngeal carcinoma, gastric cancer, esophageal cancer, urothelial carcinoma, and alveolar soft tissue sarcoma are also under development.

At the same time, combination therapy with teriplizumab is also being explored.Even in terms of approved indications for melanoma, teriplizumab is constantly refreshing its record.In response to the high incidence of mucosal melanoma in China, a global breakthrough has been made in the combination therapy of teriplizumab and angiogenesis inhibitors, with an early clinical data efficiency of more than 60%.

Clinical data

About PD-1

At present, the research focus in the field of tumor immunotherapy is mainly focused on immune checkpoint inhibitors such as Programmed Death-1 (PD-1) receptors, which are different from traditional chemotherapy and targeted therapies, mainly by overcoming immunosuppression in patients and reactivating patients' own immune cells to kill tumors. It is a brand-new concept of anti-tumor therapy.

The approved topo (teriplizumab injection) is a novel recombinant humanized anti-PD-1 monoclonal antibody developed by Junshi Biological, which can block the binding of PD-L1 on the surface of tumor cells by blocking the PD-1 of T lymphocytes, relieve the immunosuppression of tumor cells on immune cells, and allow immune cells to regain anti-tumor cellular immunity and kill tumor cells.

About melanoma

Melanoma has shown a rapid growth trend in recent years in our country. It is one of the fastest growing malignant tumors in China. There are about 20,000 new cases each year, and the mortality rate is also rising rapidly year by year. It has become one of the diseases that seriously endanger the health of our people.In terms of treatment, melanoma patients who have failed first-line treatment currently lack effective standard treatment options.

Professor Guo Jun, Vice President of Cancer Hospital of Peking University and Secretary General of Chinese Society of Clinical Oncology (CSCO), participated in and led the registered clinical research work of Tuoyi (Treprimumab Injection). He said: "In recent years, immunotherapy has shown surprising results in a variety of cancer treatment areas, making many kinds of cancer patients re-ignited the desire for life, but the high price still makes many Chinese patients deterred.With the approval of the PD-1 monoclonal antibody with independent intellectual property rights in China, the price and charity plan are announced at the same time. Cancer patients in China will receive the most advanced level of immunotherapy in the world at an annual treatment cost of less than 100,000.

The topology of Junshi Bio (teriplizumab injection) is used for the treatment of locally advanced or metastatic melanoma that has previously failed standard therapy, and its approval for marketing not only fills the gap in domestic PD-1 inhibitors, but also gives more Chinese patients the opportunity to obtain internationally advanced levels of cancer immunotherapy.Melanoma is the first indication approved by Tuoyi in China. In the future, indications such as nasopharyngeal carcinoma, non-small cell lung cancer, gastric cancer, esophageal cancer, urothelial carcinoma, and liver cancer will also be applied for listing.At present, these indications are in the clinical research stage.

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