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乐城将独家引进日本最先进癌症治疗技术

这个是认证

凯迪海南

2022-06-27 17:00

19347 0 4

6月23日,中国生物科技服务发布公告称,旗下附属公司鹏博海南已和日本SHI(住友重机械工业株式会社)签署了相关合约,根据合约内容,鹏博海南将向SHI购买而SHI同意出售硼中子治疗设备,且SHI将向鹏博海南提供相关的技术顾问服务、硼中子治疗部件以及对设备的运营养护服务。该项目2023年底建设完成后安装设备,预计2024年开始运营。届时,海南博鳌BNCT项目中心将拥有中国第一台可提供商用化临床治疗服务的硼中子治疗设备,亦将成为中国第一个可提供硼中子俘获疗法的癌症治疗中心。

Sumitomo Heavy Industries, Ltd. and STELLA PHARMA CORPORATION have respectively entered into a sales contract for BNCT System, with China Biotech Services Holdings Limited, a company listed on The Stock Exchange of Hong Kong Limited, (Stock Code: 8037) and its subsidiary, Pengbo (Hainan) Medical Technology Co., Ltd. regarding the introduction of BNCT in Hainan Boao Lecheng International Medical Tourism Pilot Zone in China .
住友重工株式会和社斯特拉制药,分别与中国生物科技服务控股有限公司签订了 BNCT项目的合约,中国生物科技服务是香港联交所上市公司,(股票代码:8037)与其子公司鹏博(海南)医疗科技有限公司共同致力于在中国海南博鳌乐城国际医疗旅游先行区引进BNCT。

The Hainan Medical Tourism Pilot Zone is a special deregulated zone aimed at promoting medical tourism, with priority given to import of medical equipment and drugs.
海南博鳌乐城国际医疗旅游先行区是一个旨在促进医疗旅游的特别放松管制区,优先进口医疗设备和药品。

A distinctive feature of the Hainan Medical Tourism Pilot Zone is that, similar to Japan, the use of any medical equipment or drugs in China require prior testing via clinical trials before applications can be filed. However, unlike the normal process of obtaining approval from the regulatory authorities, this system will grant import licenses for medical equipment and drugs that have already been approved in other developed countries on the premise that they are clinically urgently needed at designated medical institutions, even if they have not yet been approved in China. This therefore allows the medical institutions not to conduct clinical trials and to use such medical equipment and drugs for clinical treatment.
海南博鳌乐城国际医疗旅游先行区的一个显特点是,与日本类似,在中国使用任何医疗器械或药品,都需要先通过临床试验进行检验,然后才能提出申请。但与正常的监管部门审批流程不同的是,该制度会在定点医疗机构临床急需的前提下,对已在其他发达国家获批的医疗器械和药品发放进口许可,即使它们尚未在中国获得批准。因此,允许医疗机构不进行临床试验,而将此类医疗设备和药物用于临床治疗。

This time, the only globally approved BNCT, combination of NeuCure® and Steboronine® will be introduced in China through this system.
此次,全球唯一获批的BNCT技术,包括NeuCure®和Steboronine®的组合将通过该项目引入中国。

Pengbo Co., Ltd. will obtain a Medical Institution Practicing License and establish a designated medical institution (hereinafter "BNCT center") in the Hainan Medical Tourism Pilot Zone. The land for the planned construction site has already been acquired, and the provision of BNCT is scheduled to start from FY2025 after the construction of the BNCT center and the installation of the BNCT system, "NeuCure®", are completed.
鹏博股份有限公司将取得《医疗机构执业许可证》,在海南医疗旅游试验区设立定点医疗机构(以下简称“BNCT中心”)。计划建设用地的土地已经获得,BNCT 中心建设和 BNCT 系统“NeuCure®”的安装完成后,计划从 2025年开始提供 BNCT。

The disease indicated for BNCT is "locally unresectable recurrent or unresectable advanced head and neck cancer" (hereinafter, "local head and neck cancer"), which is already approved in Japan. The total number of head and neck cancer patients in China is estimated to be around 140,000 per year. We will continue to develop BNCT as a new cancer treatment option for overseas patients who are waiting for it to be indicated as well.
BNCT的适应症为“局部不可切除的复发性或不可切除的晚期头颈癌”(以下简称“局部头颈癌”),已在日本获批。据估计,中国每年的头颈癌患者总数约为 140,000 人。我们将继续开发 BNCT 作为一种新的癌症治疗选择,供适应症患者,包括海外患者使用。

If a new indication for BNCT is approved in Japan in the future, the treatment will also be made available in the Hainan Medical Tourism Pilot Zone similar to local head and neck cancer. In addition, the real world data obtained at the BNCT center in the Hainan Medical Tourism Pilot Zone can be used to apply for approval in China if the management, research, analysis, and evaluation are conducted in accordance with relevant regulations. This will help us to promote BNCT in the Hainan Medical Tourism Pilot Zone and use it as a foothold to expand BNCT into China.

如果未来日本批准BNCT的新适应症,该治疗也将在海南博鳌乐城国际医疗旅游先行区提供,类似于当地的头颈癌。此外,在海南博鳌乐城国际医疗旅游先行区BNCT中心获得的真实世界数据,如果按照相关规定进行管理、研究、分析和评估,可用于在中国申请审批。这将有助于我们在海南博鳌乐城国际医疗旅游先行区推广BNCT,并以此为立足点将BNCT扩展到中国。

Boron-neutron capture therapy (BNCT) is a type of radiotherapy where the boron-containing drug for BNCT (Boron-10) is administered to cancer patients, which causes the selective uptake of boron (Boron-10) in cancer cells. A low-energy neutron beam is then irradiated on the cancerous area from outside the body. When the neutrons collide with the boron (Boron-10) in the cancer cells, nuclear fission occurs. This in turn generates alpha particles (helium nuclei) and lithium recoil nuclei (lithium nuclei) that damages cancer cells. These charged particles have a respective range of only about 9 µm and 4 µm in the body, which is approximately the size of a single cell. In theory, these characteristics allow us to selectively destroy cancer cells that have taken up boron (Boron-10) at the cellular level, with little to no damage to the surrounding normal cells.
硼中子俘获疗法 (BNCT) 是一种放射疗法,其中将用于 BNCT 的含药物 (Boron-10) 施用于癌症患者,导致癌细胞对硼 (Boron-10) 的选择性摄取。然后将低能中子束从体外照射到癌变区域。当中子与癌细胞中的硼(Boron-10)碰撞时,就会发生核裂变。这反过来又会产生的 α 粒子(氦核)和锂反冲核(锂核)损害癌细胞。这些带电粒子在体内的各自范围只有大约 9 µm 和 4 µm,大约是单个细胞的大小。从理论上讲,这些特性使我们能够选择性地破坏在细胞水平上吸收了硼 (Boron-10) 的癌细胞,而对周围的正常细胞几乎没有损伤。

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