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時間:2022-08-15 來源:本站 點擊:258次
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第一个国产新冠特效药获批 之后还必须打疫苗吗?******


12月8日,国家药监局官方网站发布消息,紧急准许腾盛华创药业技术性(北京市)有限责任公司新冠病毒感染中和抗体协同医治药品安巴韦单抗注射剂(BRII-196)及罗米司韦单抗注射剂(BRII-198)注册申请。

这也是在我国第一家获准的独立专利权新冠病毒感染中和抗体协同医治药品。

国家药品监督管理局依据《药品管理法》有关要求,依照药物尤其审批程序,开展紧急评审审核,准许以上2个药物协同用以医治轻形和通用型且伴随多次为超重型(包含住院治疗或身亡)高危要素的大人和青少年儿童(12—17岁,重量≥40kg)新式新冠病毒感柒(COVID-19)病人。在其中,青少年儿童(12—17岁,重量≥40kg)适用范围群体为附标准准许。

有关安巴韦单抗/罗米司韦单抗。

(BRII-196/BRII-198)。

据了解,安巴韦单抗和罗米司韦单抗是腾盛博药与深圳第三人民医院和北京清华大学协作从新式新冠病毒新冠肺炎(COVID-19)恢复期患儿中得到的单克隆中和抗体,尤其运用了生物技术技术性以减少抗原受体依赖感提高功效的风险性,并增加血液药物半衰期以得到更长久的治疗效果。

自三方协作,将安巴韦单抗/罗米司韦单抗协同疗法从起初的中和抗体分离出来与挑选快速推动到进行国际性3期临床研究,并最后在国家药品监督管理局获准,仅不上20个月的時间。

中和抗体疗法对突变株实际效果怎样?

据中国经济时报报导,腾盛博药的中和抗体疗法在4大洲、6个我国、111个临床研究组织开展的837例新冠新冠肺炎病人三期临床实验数据显示,该抗原组成药品可以减少78%的住院治疗和存活率,且给药组在医治28天之后完成零身亡,对照实验8例身亡。

除开临床研究的积极主动結果,事实上,在紧急获准以前,以上中和抗体疗法在临床医学治疗层面早已充分发挥了功效。对于我国发生的由“德尔塔”(Delta)突变株造成的新冠肺炎疫情,腾盛博药自2021年6月捐助了近3000人份的安巴韦单抗和罗米司韦单抗,涉及到广东、云南、江苏等13个省(自治州),救护了近900例病人,是这对中和抗体在单一我国病人感受总数较大的。

腾盛博药首席战略官大中华地区经理罗永庆表明,本次获准是根据日本国立大学环境卫生研究所(NIH)适用的ACTIV-2的3期临床研究,包含847例入组病人的关键前期及最后結果。最后数据显示,与对照组对比,安巴韦单抗/罗米司韦单抗协同疗法使临床医学进度高危的新冠门诊病人出院和致死风险性减少80%(中后期結果为78%),具备生态学独特性。与此同时,不管初期即開始进行医治(病症发生后5日内)或是后期才逐渐进行医治(病症发生后6至10日内)的试验者,住院治疗和存活率均明显减少,这为新冠病人带来了更长的医治潜伏期。

“安巴韦单抗/罗米司韦单抗协同疗法的获准,为我国产生了第一个新冠医治专用药。这一协同疗法在国际性多机构实验中呈现了出色的安全系数和防御性,是迄今已经在全球范畴内唯一进行了突变株病毒感染者治疗效果评定并得到最佳数据信息的抗体药物。”该协同疗法的关键产品研发者之一、北京清华大学中国身心健康与疾病研究所负责人张林琦专家教授表明,该抗原协同疗法为在我国抵御新冠肺炎疫情给予了全球一流的医治方式,为在我国甚至全世界疫情防控工作中作出了重大奉献。

针对当今备受关注的奥密克戎突变株是不是危害中和抗体疗法的实际效果,现阶段腾盛博药并未发布有关信息。

拥有新冠医治药品,疫苗还需要打吗?

新冠医治药品的发生,让大家看到了全世界抗疫的新的希望。

针对新冠医治药品和新冠疫苗的关联,张林琦专家教授曾注重,针对任意一个病症,防止全是第一关键的。“拥有药,也不接种疫苗了”是针对疫苗和药品中间存有认识错误观念。

Gebreselassie condemns mixing sports with politics******

ADDIS ABABA, Dec. 13 (Xinhua) -- Ethiopia's multiple Olympic gold medalist Haile Gebreselassie has strongly opposed attempts of some Western politicians and countries to disrupt the 2022 Winter Olympics with calls for a boycott.。

In a recent interview with Xinhua, Gebreselassie said the ongoing provocation by some Western politicians and countries to shun the upcoming Winter Olympics should be met seriously by the International Olympic Committee (IOC).。

"I see the move as unimportant and meaningless," said Gebreselassie, who has won two Olympic gold medals over 10,000 meters and four World Championship titles, among others.。

The veteran long-distance runner, who has also served as president of the Ethiopian Athletics Federation, underscored that recent boycott attempts would not have any meaningful impact on the Beijing Winter Olympics.。

"Do not get bothered," said Gebreselassie in his message to the organizers of the Beijing Winter Olympics.。

"The attempts [will] in no way affect the organizers, the people and the government of China.。

"The only way to bring the world together is [through] sport, especially the Olympics. I want to tell the politicians that they have to think twice, not once, before making such decisions, because this is sport," he added.。

Recalling the "amazing" 2008 Summer Olympics, Gebreselassie expressed his optimism that Beijing will host the upcoming Winter Olympics "in the most spectacular manner."

"As to my experience, I do not see many officials going to the Olympic Games. The Olympics need athletes, not officials," said Gebreselassie.。

Considered by many as one of the greatest long-distance runners of all time, Gebreselassie referred to the ongoing attempts to boycott the Beijing Winter Olympics as "old style."

"They would have succeeded had they been made during the previous era when there were Eastern and Western blocs," Gebreselassie said.。

He stressed that the Olympics should not be politicized and that Western countries must not mix sporting events with politics.。

"Water and oil do not mix, so sport and politics should not," Gebreselassie said, adding that the world should not give attention to such kinds of "silly activities" by the West.。

"Failing to do so will not be good for the international Olympic body," he warned.。

Noting the motto of the Beijing 2022 Olympic and Paralympic Winter Games has been set as "Together for a Shared Future," Gebreselassie commended the commitment of China in working together with the rest of the world for a better future. Enditem。

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西安市钟鼓楼博物馆3月23日恢复开放******

  3月22日12时13分,西安市钟鼓楼博物馆发布公告:根据西安市疫情防控工作统一安排,西安市钟鼓楼博物馆于2022年3月23日(星期三)恢复开放。

  疫情防控期间,钟鼓楼博物馆按照“限量、预约、错峰”的参观要求,每日接待人数不超过最大承载量75%。

  为持续做好疫情防控工作,保障游客安全,所有游客入馆参观时须测量体温、全程佩戴口罩,自觉保持1米以上安全距离,同时出示西安一码通(绿码)和通信大数据行程卡。

  博物馆暂不接待中、高风险等级地区所在市的游客及14日内有中、高风险等级地区所在市旅居史的游客。

  华商报记者 马虎振

  

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来源:华商网-华商报

编辑:方正

China's free trade port unveils opening******

HAIKOU, Nov. 16 (Xinhua) -- South China's Hainan Province plans to lock in three sectors, including duty-free shopping, international medical care and international education, in its drive to become an international tourism and consumption destination, according to its 2021-2025 development plan.。

The island province is a free trade port. The plan recently published sets the target for its tourist industry to contribute to 17.8 percent of its total economic growth by 2025.。

Efforts will be made in the Hainan Boao Lecheng International Medical Tourism Pilot Zone to introduce and cultivate a batch of high-end and professional medical institutions to promote the research progress on stem cell, immune cell and gene therapy, plus other new techniques in the biomedical sector.。

The medical pilot zone also encourages people from the countries joining the Regional Comprehensive Economic Partnership (RCEP) to come for treatment. By 2025, Lecheng is expected to attract about 500,000 people to receive medical service in Hainan, the plan noted.。

In regards to education, Hainan encourages overseas colleges and educational institutions to settle on the island.。

The number of international students in Hainan is expected to reach 10,000 by 2025. The province will also introduce about 15 international high schools and kindergartens and more than three overseas high-level universities and vocational colleges in science, agriculture and medicine by 2025.。

Last June, China released a master plan to build the southernmost province into a globally influential and high-level free trade port by the middle of the century. Enditem。

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