HUTCHMED and Innovent Jointly Announce NDA Acceptance in China for Fruquintinib Combination with Sintilimab for the Treatment of Advanced Endometrial Cancer with Priority Review Status
HUTCHMED (China) Limited - American Depositary Shares (HCM)
NASDAQ:AMEX Investor Relations:
chi-med.com/investors/information-for-shareholders
Company Research
Source: GlobeNewswire
— NDA accepted and both fruquintinib and sintilimab granted Priority Review, following Breakthrough Therapy designation in July 2023 — — First regulatory filing for fruquintinib for use in combination with a leading immune checkpoint inhibitor — HONG KONG, SHANGHAI, China & FLORHAM PARK, N.J., April 02, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:?HCM; HKEX:?13) and Innovent Biologics, Inc. (“Innovent”) (HKEX:1801) today jointly announce that the New Drug Application (“NDA”) for the combination of fruquintinib and sintilimab for the treatment of patients with advanced endometrial cancer with pMMR1 or non-MSI-H2 tumors that have failed prior systemic therapy but are not candidates for curative surgery or radiation has been accepted and granted priority review by the China National Medical Products Administration (“NMPA”). The NDA is supported by data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase II stu
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News
- HUTCHMED Announces Positive CHMP Opinion for Fruquintinib in Previously Treated Metastatic Colorectal Cancer Received by Takeda [Yahoo! Finance]Yahoo! Finance
- HUTCHMED Announces Positive CHMP Opinion for Fruquintinib in Previously Treated Metastatic Colorectal Cancer Received by TakedaGlobeNewswire
- HUTCHMED Highlights Data to be Presented at AACR Congress 2024 [Yahoo! Finance]Yahoo! Finance
- HUTCHMED Highlights Data to be Presented at AACR Congress 2024GlobeNewswire
- Innovent and HUTCHMED Jointly Announce NDA Acceptance in China for Sintilimab Combination with Fruquintinib for the Treatment of Advanced Endometrial Cancer with Priority Review Status [Yahoo! Finance]Yahoo! Finance
HCM
Sec Filings
- 4/29/24 - Form 6-K
- 4/22/24 - Form 6-K
- 4/8/24 - Form 6-K
- HCM's page on the SEC website