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  • Iftinitamab Deruxtecan Shows Clinically Meaningful Response in Extensive-Stage SCLC Patients: IDeate-Lung01 Phase 2 Trial Results

    Daiichi Sankyo and Merck announced positive Phase 2 IDeate-Lung01 trial results for ifinatamab deruxtecan (I-DXd) in previously treated extensive-stage small cell lung cancer (ES-SCLC). I-DXd demonstrated a 48.2% objective response rate (ORR) in patients who had progressed after platinum-based chemotherapy, with a median duration of response of 5.3 months. Notably, a second-line subset achieved a 56.3% ORR. Discussions with regulatory authorities are underway. The safety profile was consistent with prior observations.

    2025年9月7日
  • RH to Announce Second Quarter Fiscal 2025 Earnings on September 11, 2025

    RH (NYSE: RH) will release its second-quarter fiscal 2025 earnings on September 11, 2025, after market close. A letter from Chairman and CEO Gary Friedman and the full financial results will be available on the investor relations website at ir.rh.com. A live conference call and webcast will be held at 2:00 pm Pacific Time, offering further insights. Analysts will focus on supply chain, pricing, product performance, and expansion efforts. RH operates as a curator of design in the luxury lifestyle market.

    2025年9月7日
  • Osimertinib Plus Chemotherapy Shows Unprecedented Survival Benefit in EGFR-Mutated Advanced Lung Cancer

    The FLAURA2 Phase III trial demonstrated that TAGRISSO® (osimertinib) combined with chemotherapy significantly improved overall survival (OS) compared to TAGRISSO monotherapy in 1st-line EGFRm NSCLC. The combination therapy achieved a median OS of 47.5 months versus 37.6 months with monotherapy, reducing the risk of death by 23%. The safety profile was manageable, reinforcing TAGRISSO as a standard of care and backbone therapy across EGFRm lung cancer stages.

    2025年9月7日
  • Zidesamtinib Shows Promise in TKI-Pretreated ROS1+ NSCLC: ARROS-1 Data at WCLC 2025

    Nuvalent has initiated a rolling NDA submission to the FDA for zidesamtinib, a ROS1-selective inhibitor, for advanced ROS1-positive NSCLC patients previously treated with TKIs. The submission is supported by pivotal data from the ARROS-1 trial presented at WCLC 2025. Zidesamtinib has been granted RTOR designation, potentially accelerating its review. The drug is designed to overcome resistance mutations and improve treatment of brain metastases. Completion of the rolling submission is expected in Q3 2025. Nuvalent is also in discussion with the FDA regarding potential expansion of indications.

    2025年9月7日
  • Ivonescimab Plus Chemotherapy Shows Improving OS Trend in EGFRm NSCLC: HARMONi Trial Follow-Up

    Summit Therapeutics announced positive Phase III HARMONi trial data for ivonescimab plus chemotherapy in EGFR-mutated NSCLC patients who progressed after EGFR-TKI treatment. While the primary analysis showed a positive OS trend (HR=0.79, p=0.057), longer follow-up of Western patients demonstrated improved OS (HR=0.78, p=0.0332). North American patients showed a promising OS HR of 0.70. Ivonescimab’s safety profile was consistent with prior studies. A conference call will be held September 8, 2025, to discuss these findings.

    2025年9月7日
  • GlocalMe Showcases Award-Winning Connectivity Solutions at IFA 2025

    At IFA 2025, GlocalMe unveiled its “3-3-5 Digital Inclusion Framework” to address the global digital divide. This initiative focuses on bridging three gaps between carrier networks, local/international access, and human-pet connectivity. It’s powered by CloudSIM®, AI HyperConn®, and a positioning system, and realized through five product lines including Pet Network (PetPhone), Personal Mobile Network (eSIM Trio), Travel Network (Numen Air, MeowGo G40 Pro, G50 Pro), Life Network (UniCord Pro, RoamPlug), and Home Network (GuardFlex Pro). GlocalMe emphasizes both 5G and 4G coverage, leveraging AI to optimize connectivity performance and cost.

    2025年9月6日
  • BioMarin: Positive Phase 3 PALYNZIQ® Data in Adolescents with PKU Presented at ICIEM 2024

    BioMarin announced positive Phase 3 PEGASUS study results for PALYNZIQ® in adolescents (12-17) with PKU, presented at ICIEM 2025. PALYNZIQ demonstrated a 49.7% decrease in mean blood Phe levels compared to diet alone. A significant proportion of PALYNZIQ-treated participants achieved target Phe levels, with a safety profile consistent with adult patients. BioMarin plans to submit these data to global health authorities in the second half of 2025, seeking to expand PALYNZIQ’s indication to include adolescents.

    2025年9月6日
  • RYBREVANT® Plus LAZCLUZE® Overcomes Osimertinib Resistance in First-Line EGFR-Mutated NSCLC

    Johnson & Johnson’s Phase 3 MARIPOSA study reveals that first-line RYBREVANT® plus LAZCLUZE® significantly reduces EGFR- and MET-driven resistance in EGFR-mutated NSCLC compared to osimertinib. The combination demonstrates a lower incidence of MET amplification and EGFR mutations, potentially transforming disease biology. This chemo-free regimen has shown an overall survival benefit exceeding four years. These findings, presented at WCLC 2025, support the combination’s approval in multiple markets.

    2025年9月6日
  • Manulife and UpLink Name Winners of Asia Demographic Innovation Challenge

    Manulife and UpLink announced the winners of the “Innovating for Asia’s Demographic Future Challenge”, the second in a longevity-focused series. Ten ventures addressing financial resilience, healthy aging, and lifelong fulfillment in Asia’s changing demographic landscape were selected from over 85 submissions. Winners gain access to networking, partnerships, and visibility, with three top innovators receiving a share of CAD $200,000. The challenge highlights the urgent need for innovation to support Asia’s aging population, projected to be one in four over 60 by 2050.

    2025年9月5日
  • Hesai Group Announces Global Offering

    Hesai Group (HSAI) announced a global offering of 17 million Class B shares, including a Hong Kong public offering and an international offering, alongside a dual-primary listing on the Hong Kong Stock Exchange (“2525”). The maximum Hong Kong offer price is HK$228.00 per share. Cornerstone investors committed approximately US$148 million, representing about 29.8% of the initial offering. Proceeds will fund R&D, manufacturing, business expansion, and working capital. The dual-listing aims to diversify Hesai’s investor base and mitigate regulatory uncertainties.

    2025年9月5日