MS BioNTech WKN: A2PSR2 ISIN: US09075V1026 Forum: Aktien User: Thekla

Infos zu BNT323 in China: Die offizielle Bestätigung, dass BNT323 in China als DB1303 vom Partner DualityBio zur Zulassung beantragt wurde: A Phase 3 registrational trial (NCT06265428) is being conducted in China for trastuzumab pamirtecan versus T-DM1 in patients with HER2+ unresectable and/or metastatic BC previously treated with trastuzumab and taxane. As of September 5, 2025, the IDMC has reviewed the trial’s interim data and confirmed that this Phase 3 trial has achieved the primary endpoint of PFS as evaluated by BICR relative to the T-DM1 control arm. Leveraging these positive interim analysis results, we have submitted the BLA for trastuzumab pamirtecan in this indication to the CDE of the NMPA. A multi-site, non-randomized, open-label, global Phase 1/2 clinical trial (NCT05150691) is being conducted to evaluate trastuzumab pamirtecan in patients with advanced/unresectable, recurrent, or metastatic HER2-expressing solid tumors. A potential registrational cohort with HER2-expressing (IHC3+, 2+, 1+ or ISH-positive) patients with advanced/recurrent endometrial carcinoma has completed enrollment. We and BioNTech expect data from this cohort in 2026. BioNTech is continuing discussions with the FDA and plans to file a potential BLA for trastuzumab pamirtecan in second or subsequent line HER2-expressing (IHC3+, 2+, 1+) advanced/recurrent EC in 2026, subject to regulatory feedback. Quelle: Board Meeting von heute bei DualityBio - Im Protokoll steht vieles (auch zu BNT327) Der BLA ab Seite 20. https://tinyurl.com/BNT323China

Infos zu BNT323 in China: Die offizielle Bestätigung, dass BNT323 in China als DB1303 vom Partner DualityBio zur Zulassung beantragt wurde: A Phase 3 registrational trial (NCT06265428) is being conducted in China for trastuzumab pamirtecan versus T-DM1 in patients with HER2+ unresectable and/or metastatic BC previously treated with trastuzumab and taxane. As of September 5, 2025, the IDMC has reviewed the trial’s interim data and confirmed that this Phase 3 trial has achieved the primary endpoint of PFS as evaluated by BICR relative to the T-DM1 control arm. Leveraging these positive interim analysis results, we have submitted the BLA for trastuzumab pamirtecan in this indication to the CDE of the NMPA. A multi-site, non-randomized, open-label, global Phase 1/2 clinical trial (NCT05150691) is being conducted to evaluate trastuzumab pamirtecan in patients with advanced/unresectable, recurrent, or metastatic HER2-expressing solid tumors. A potential registrational cohort with HER2-expressing (IHC3+, 2+, 1+ or ISH-positive) patients with advanced/recurrent endometrial carcinoma has completed enrollment. We and BioNTech expect data from this cohort in 2026. BioNTech is continuing discussions with the FDA and plans to file a potential BLA for trastuzumab pamirtecan in second or subsequent line HER2-expressing (IHC3+, 2+, 1+) advanced/recurrent EC in 2026, subject to regulatory feedback. Quelle: Board Meeting von heute bei DualityBio - Im Protokoll steht vieles (auch zu BNT327) Der BLA ab Seite 20. https://tinyurl.com/BNT323China