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GSK 資訊
GSK 事件
AnaptysBio Announces GSK Receives FDA Approval for Jemperli
AnaptysBio (ANAB), a company focused on managing the financial collaborations for Jemperli with Tesaro, a GSK (GSK) company, and Quimilza with Vanda, announced that GSK has received U.S. Food and Drug Administration approval for Jemperli as the first and only immunotherapy for adults with stage II and III microsatellite instability-high/ mismatch repair deficient locally advanced rectal cancer. GSK plans to present full data from the AZUR-1 interim analysis as a late-breaking abstract at ESMO Congress 2026 in Madrid, Spain on October 25, AnaptysBio noted.
GSK's Jemperli Receives FDA Accelerated Approval for Advanced Rectal Cancer
GSK announced the Food and Drug Administration has approved Jemperli as "the first and only immunotherapy" for adults with stage II and III microsatellite instability-high/mismatch repair deficient locally advanced rectal cancer under the accelerated approval pathway. Tony Wood, Chief Scientific Officer, GSK, said:"Today, Jemperli becomes the first and only approved immunotherapy for adults in the US with MSI-H/dMMR locally advanced rectal cancer. For decades, treatment has relied on chemotherapy, radiation and surgery. This approval offers a new treatment approach and represents an important step towards more personalised care for these patients."
GSK Reports Positive Data for Small Cell Lung Cancer Drug
GSK announced the first global data for risvutatug rezetecan, its investigational B7-H3-targeted antibody-drug conjugate, in patients with relapsed extensive-stage small cell lung cancer, ES-SCLC. Results from the phase Ib dose-optimisation portion of the EMBOLD PanTumour-101 trial showed positive anti-tumour activity and a manageable safety profile, adding to recently reported positive phase III data in patients with SCLC in China. In the trial, Ris-Rez achieved a confirmed objective response rate, ORR, of 61% among evaluable patients at the 8 mg/kg dose, compared with 32% at the 6 mg/kg dose. These findings will be presented in a poster session at the European Society for Medical Oncology, ESMO, Congress 2026 in Madrid, Spain. Along with data from Hansoh's phase III ARTEMIS-008 study in SCLC, this data supported selection of the 8 mg/kg dose currently being evaluated in GSK's global phase III EMBOLD SCLC-301 study.
EU Sets 350,000 Annual Import Limit on Chinese Hybrid Vehicles
Catch up on the weekend's top five stories with this list compiled by The Fly: 1) The European Union will instill a 350,000-car limit per year for imports of Chinese hybrid vehicles, with the measure taking effect as soon as December 1, Alberto Nardelli and Jorge Valero of Bloomberg reports, citing a document outlining the plan seen by the journal. The cap will increase annually by 6% starting the second year of application. The cap will apply to all imports of hybrids. Publicly traded companies in the space include BYD (BYDDY), Geely (GELYF), Honda (HMC), Mercedes-Benz (MBGYY), Nissan (NSANY), Stellantis (STLA), Toyota (TM) and Volkswagen (VWAGY). 2) Amazon (AMZN) is in discussions to acquire Decart, an AI startup, in a deal that may be valued around $7B, Kate Clark and Lauren Thomas of The Wall Street Journal reports, citing people familiar with the matter. A deal could come soon if talks don't fall apart or another suitor doesn't emerge, the sources added. 3) Pennsylvania Governor Josh Shapiro and Department of Community and Economic Development, DCED, Secretary Rick Siger announced the Commonwealth has secured an over $800M investment from global biopharma company GSK (GSK) to expand its operations in Montgomery County. The expansion will create more than 300 new jobs over the next five years, retain approximately 4,500 existing full-time jobs across the Commonwealth, and continue growing Pennsylvania's life sciences industry. GSK is expanding its facilities in Upper Merion Township, with construction planned to begin in 2027. 4) Nvidia (NVDA) is in discussions to either acquire or increase its investment in Reflection AI, a US start-up, George Hammond, Michael Acton, George Steer, and Arash Massoudi of The Financial Times reports, citing people with direct knowledge of the matter. Discussions are currently in the early stages, and a deal could take different forms, the sources added. 5) AstraZeneca (AZN) announced results from the HICKORY Phase III trial showed that efzimfotase alfa, ALXN1850, did not achieve statistical significance but demonstrated a numerical improvement in the primary endpoint of Six-Minute Walk Test in adolescents and adults with hypophosphatasia, HPP, who had not been previously treated with Strensiq at week 25, compared to placebo. In the overall population, at week 25, efzimfotase alfa achieved a least squares mean difference of 17.05 metres change from baseline in the primary endpoint of 6MWT, compared to placebo.
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