HUTCHMED Provides Update on Fruquintinib for Second-Line Gastric Cancer in China
HUTCHMED (China) Limited - American Depositary Shares (HCM)
NASDAQ:AMEX Investor Relations:
chi-med.com/investors/information-for-shareholders
Company Research
Source: GlobeNewswire
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Aug. 30, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:?HCM; HKEX:?13) today announces that it has voluntarily withdrawn its supplemental New Drug Application (“NDA”) in China for fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric or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 primar
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News
- HUTCHMED Announces Appointment of Independent Non-executive Director and Member of Board Committee GlobeNewswire
- HUTCHMED (China) Limited (NASDAQ: HCM) was downgraded by analysts at StockNews.com from a "buy" rating to a "hold" rating.MarketBeat
- 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
HCM
Sec Filings
- 11/20/24 - Form 6-K
- 11/6/24 - Form 6-K
- 10/31/24 - Form 6-K
- HCM's page on the SEC website