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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].

Summary of Gilead's Conference Call Company Overview - **Company**: Gilead Sciences - **Industry**: Biotechnology Key Points and Arguments Growth Strategy - Gilead is focusing on three core franchises: virology (HIV), oncology, and inflammation, with a strong emphasis on diversifying beyond virology [3][4] - The company has a robust balance sheet and cash flows, allowing for effective management of operating expenses and investment in growth opportunities [4][5] HIV and Lenacapavir Launch - The launch of lenacapavir for HIV PrEP is imminent, with a PDUFA date set for June 19 [7] - Gilead has been advocating for funding core HIV services, and discussions with the government have been positive regarding support for these programs [8] - Lenacapavir is reported to be 100% effective in preventing HIV, with high community awareness expected to drive uptake [9][10] - The target population for PrEP in the U.S. is approximately 1.2 million, with current users around 400,000, primarily men who have sex with men [13][14] - Gilead aims to improve compliance among current users and expand access to underserved communities [15][16] Reimbursement and Coverage - Gilead expects high insurance coverage for lenacapavir, similar to existing PrEP medications, with an anticipated 70-75% coverage within six months post-launch [22][23] - The company has various support systems in place for individuals with HIV, ensuring access to treatment [24][25] Pipeline and Innovation - Gilead has multiple long-acting HIV programs in development, including a once-a-year injection expected to be available by 2028 [27][28] - The company is also working on alternatives to its leading HIV treatment, Biktarvy, with several programs in various stages of development [32][34] Oncology Developments - Gilead presented significant data at ASCO for Trodelvy in treating triple-negative breast cancer, which could become the new standard of care [36][40] - The oncology business is currently generating over $3 billion annually, with Trodelvy contributing over $1 billion [44] - Gilead is expanding its oncology pipeline with ongoing trials in various cancer types, including lung cancer and multiple myeloma [45][46] Business Development and Future Outlook - Gilead plans to continue investing in late-stage research and development, with a focus on mid-stage acquisitions to complement its portfolio [55][57] - The company is committed to returning value to shareholders through dividends and share buybacks [58] Regulatory Environment - Gilead is actively engaging with the administration regarding potential policy changes, including the MFN executive order, emphasizing the need for a balanced approach to drug pricing [59][60] - The company believes it is less vulnerable to tariffs due to its significant U.S. presence and IP holdings [64][66] Additional Important Content - Gilead's long-term strategy includes exploring novel inflammation targets to complement its existing therapeutic areas [53] - The company is focused on maintaining a competitive edge in the biotechnology sector through innovation and strategic partnerships [54][66]

In February, the U.S. Food and Drug Administration (FDA) accepted Gilead Sciences, Inc.’s GILD New Drug Application (NDA) submissions for lenacapavir — the company’s twice-yearly injectable HIV-1 capsid inhibitor — for the prevention of HIV as pre-exposure prophylaxis (PrEP).What Happened: The FDA will review the applications under priority review and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 19, 2025.In June 2024, Gilead Sciences shared topline results from an interim ...

Gilead Sciences (GILD) Conference June 04, 2025 11:05 AM ET Speaker0 Good morning everyone. Welcome to our next panel discussion with Gilead Sciences. We have a couple of important members of the executive team from Gilead here up with us. To my left, Dietmar Berger, who's the new CMO, and I like to say running the hot seat of R and D in front of Wall Street to talk about obviously everything going on in the pipeline. As well as Cindy Paretti. She's Executive Vice President of Kite and runs everything at Ce ...