HUTCHMED Provides Update on Fruquintinib for Second-Line Gastric Cancer in China [Yahoo! Finance]
HUTCHMED (China) Limited - American Depositary Shares (HCM)
NASDAQ:AMEX Investor Relations:
chi-med.com/investors/information-for-shareholders
Company Research
Source: Yahoo! Finance
announces that it has voluntarily withdrawn its supplemental New Drug Application (“NDA”) in China for fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric or gastroesophageal junction adenocarcinoma and will evaluate a new route forward. Following an additional internal review of the current data package, in light of recent discussions with the National Medical Products Administration of China (“NMPA”), HUTCHMED has determined that the submission is unlikely to support an approval in China at this time. This supplemental NDA for fruquintinib was based on data from the Phase III FRUTIGA study, which was declared positive due to a statistically significant improvements in many clinically meaningful endpoints, including progression-free survival (“PFS”), which served as one of two primary endpoints. However, while an improvement was also observed in the second primary endpoint of median overall survival (“OS”), it was not statistically signific
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News
- HUTCHMED Highlights Clinical Data to be Presented at the 2024 ASH Annual Meeting and the 2024 ESMO Asia CongressGlobeNewswire
- HUTCHMED (China) Limited (NASDAQ: HCM) was upgraded by analysts at StockNews.com from a "hold" rating to a "buy" rating.MarketBeat
- HUTCHMED to Receive First Commercial Milestone Payment Following Over US$200 Million in FRUZAQLA® (fruquintinib) Sales by Takeda [Yahoo! Finance]Yahoo! Finance
- HUTCHMED to Receive First Commercial Milestone Payment Following Over US$200 Million in FRUZAQLA® (fruquintinib) Sales by TakedaGlobeNewswire
- HUTCHMED Announces that TAGRISSO® plus ORPATHYS® demonstrated high, clinically meaningful response rate in lung cancer patients with high levels of MET overexpression and/or amplification in SAVANNAH Phase II trialGlobeNewswire
HCM
Sec Filings
- 11/6/24 - Form 6-K
- 10/31/24 - Form 6-K
- 10/21/24 - Form 6-K
- HCM's page on the SEC website