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一 | China's Ministry of Justice on Wednesday said that the European Union's (EU's) recent cross-border investigation into Chinese e-commerce giant JD.com under its Foreign Subsidies Regulation (FSR) has constituted unlawful extraterritorial jurisdiction. The ministry said in a statement that no organization or individual may comply with or assist in implementing the EU's unlawful extraterritorial jurisdiction measures. The ministry's statement came after the European Commission announced an investigation into JD.com's proposed takeover of German retailer Ceconomy in May. In the statement, the ministry said the conclusion followed an investigation conducted under China's rules on countering foreign states' unlawful extraterritorial jurisdiction measures, which were issued in April this year. According to the rules, the Chinese government has the authority to take countermeasures in response to extraterritorial jurisdiction measures by a foreign country that violate international law and the basic norms governing international relations and that harm China's sovereignty, security and development interests, or the legitimate rights and interests of Chinese citizens and organizations. In May, citing the same set of rules, the ministry said that the EU's probe into Chinese security check company Nuctech constituted unlawful extraterritorial jurisdiction. A spokesperson with the Ministry of Justice on Wednesday said the EU's probe, under the bloc's FSR effective since 2023, has arbitrarily demanded broad and unnecessary information located in China, which is a serious violation of the international rule of law. "China will resolutely take countermeasures in accordance with the law if the EU side were to insist on the wrong course," the spokesperson said. The spokesperson urged the EU to immediately correct its wrong practices, stop abusing the FSR as a tool, and foster a fair, impartial and predictable environment for companies investing and operating in the EU market.
。 8月26日消息,近期,莫德纳与默沙东联合研发的个性化mRNA癌症疫苗Intismeran三期临床传出积极结果,给无数饱受病痛折磨的患者带来了新的希望。 然而据华尔街投行William Blair测算,这款药的批发采购成本高达47.5万美元,约合人民币318万元,这无疑将劝退绝大多数病患,那么为何它会这么贵?
和可以大批量生产的普通疫苗不一样,这款属于一人一药的定制化疗法,是价格居高不下的核心原因。
据了解,每位患者需要先取出肿瘤组织做基因测序,解析独有的基因突变,依靠AI算法筛选可激活免疫的新抗原,再专门为这名患者设计、合成专属mRNA 序列,完成脂质纳米颗粒包裹以及全套GMP质量检测。 整套流程耗时6-9周,不存在规模化量产,相当于每一位患者都对应一套独立的生产流程,没有办法靠大批量生产摊薄成本,单患者直接生产成本就达到数十万美元。
同时mRNA 分子化学性质不稳定,生产、运输、存储都有严苛低温冷链要求,进一步抬高供应链开销。 从适用人群来看,现阶段该疫苗主要面向手术后的高危黑色素瘤患者,该病症属于相对小众癌种,全球每年新发病例三十余万,受众基数有限,同样的研发投入分摊到少量患者身上,进一步推高单位治疗成本。

二 | 值得注意的是,临床试验当中该疫苗不能单独使用,必须搭配高价PD-1药物K药联合治疗,如果算上联合用药,患者整体治疗负担还会继续增加。 此外还需说明,不少人存在认知误区,这款疫苗并非晚期癌症的救命特效药,它是术后辅助治疗手段,作用是清除体内微小残留病灶,降低癌症复发、转移风险,无法直接消灭已经形成的实体肿瘤。 业内表示,参考CAR-T细胞疗法的发展路径,未来随着自动化产线普及、抗原预测算法迭代、拓展更多癌种适应症,长期看价格存在下行空间,但就短期而言,高昂的成本,注定绝大多数普通患者难以负担,距离大范围普及还有很长的距离。

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