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国家药监局公布5起“清源”行动违法违规案例丨21健讯Daily
Group 1 - Fujian Quanzhou has launched an instant settlement model for basic medical insurance funds to improve settlement efficiency and alleviate financial pressure on designated medical institutions [1] - The instant settlement reform establishes an efficient mechanism of "daily payment + monthly settlement" by compressing the settlement cycle and increasing payment frequency [1] Group 2 - Shanghai Pharmaceuticals announced that its subsidiary in Thailand received approval from the Thai FDA for the registration of Pregabalin capsules, which are used to treat various types of neuropathic pain and as an adjunct therapy for epilepsy [3] - Gilead Sciences announced that the FDA approved its injectable HIV-1 capsid inhibitor Yeztugo for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV infection in adults and adolescents weighing 35 kg or more [4] Group 3 - Haizheng Pharmaceutical plans to establish a joint venture for synthetic biology with its wholly-owned subsidiary, with a registered capital of 350 million yuan, aiming to support the professional and large-scale development of its synthetic biology business [6] - Nuo Vision announced a plan to repurchase shares worth between 5 million and 10 million yuan for employee stock ownership plans, with a repurchase price not exceeding 30 yuan per share [7] - Tiankang Biological's subsidiary Tiankang Pharmaceutical has completed the counseling acceptance for its public stock issuance and listing on the Beijing Stock Exchange [8] Group 4 - Baike Biological received approval from the National Medical Products Administration for clinical trials of its influenza virus split vaccine, which aims to provide new vaccination options for individuals aged 60 and above [10] - Dizhi Pharmaceutical announced the completion of patient enrollment for its global Phase III clinical study of its lung cancer targeted drug, which compares its drug with platinum-based chemotherapy for advanced non-small cell lung cancer [11] Group 5 - The FDA announced the launch of the "Commissioners National Priority Voucher" program to expedite new drug review times from approximately 10-12 months to 1-2 months for eligible companies [12] - Shengnuo Biological expects a net profit increase of 254% to 332% year-on-year for the first half of 2025, driven by strong performance in its peptide raw material business [12]
36氪晚报|阿里国际站:6月至今平台订单同比大涨42%;B站推出动画短剧激励政策
3 6 Ke· 2025-06-19 11:51
日发精机:意大利MCM公司申请破产 36氪获悉,日发精机发布公告,鉴于下属全资子公司Machining Centers Manufacturing S.p.A(简称"意大 利MCM公司")因持续亏损,无法偿还到期债务且已出现流动性不足的情形,为维护公司及公司股东的 合法权益,公司董事会同意意大利MCM公司申请破产事项。意大利MCM公司的资产、业务均在境外, 与公司国内的业务、财务相对独立,申请破产不会对公司国内主营业务产生重大影响,不会对公司的持 续经营产生重大影响。 迪士尼中国携手上海美术电影制片厂推出动画宣传短片系列《疯狂动物城:动物城日与夜》 36氪获悉,迪士尼中国宣布与上海美术电影制片厂达成特别合作,邀请四位中国动画导演,以《疯狂动 物城》的故事为原点,巧妙运用偶(定格)、水墨、二维、剪纸等四种中国传统美术动画技法,推出动 画宣传短片系列《疯狂动物城:动物城日与夜》。四支完整短片预计将于2025年11月于全国各大社交及 视频平台发布,观众可免费观看。 B站推出动画短剧激励政策 大公司: 36氪获悉,B站发布了动画短剧的扶持政策"觉醒计划",该计划面向UP主、MCN和动画短剧相关公 司,提供30%至10 ...
艾滋病流行即将终结?这一药物在美国获批上市
第一财经· 2025-06-19 03:48
Core Viewpoint - Gilead's HIV-1 capsid inhibitor, Yeztugo (lenacapavir), has been approved by the FDA as a pre-exposure prophylaxis (PrEP) to reduce the risk of HIV infection in adults and adolescents weighing at least 35 kg, marking a significant advancement in HIV prevention strategies [1][2]. Group 1: Drug Approval and Efficacy - Yeztugo is the first HIV prevention drug that requires administration only twice a year [2]. - In clinical trials (PURPOSE 1 and PURPOSE 2), over 99.9% of participants maintained an HIV-negative status, with PURPOSE 1 showing a 100% reduction in infection rates among cisgender women and PURPOSE 2 showing a 99.9% reduction among men who have sex with men, transgender men, transgender women, and non-binary individuals [2]. Group 2: Mechanism of Action - Lenacapavir works by binding directly to the HIV capsid protein subunits, regulating the stability and transport of the capsid, thereby preventing HIV from entering human cells and inhibiting multiple critical steps in the viral lifecycle [2][3]. - This multi-stage mechanism distinguishes lenacapavir from other approved antiretroviral drugs and shows no known cross-resistance with existing medications [2]. Group 3: Market Context and Future Implications - Prior to this approval, lenacapavir had not been authorized for pre-exposure prophylaxis in other countries, although it had been approved for treating multi-drug resistant HIV in the EU and the US [3]. - The introduction of a biannual dosing regimen could significantly improve adherence among high-risk populations who struggle with daily medication, potentially leading to a further decline in HIV prevalence if widely adopted [3].