HUTCHMED and Innovent Jointly Announce NMPA Conditional Approval for ELUNATE® (Fruquintinib) in Combination with TYVYT® (Sintilimab Injection) for the Treatment of Advanced Endometrial Can...
HUTCHMED (China) Limited - American Depositary Shares (HCM)
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chi-med.com/investors/information-for-shareholders
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Source: GlobeNewswire
— First regulatory approval for fruquintinib combination therapy with an immune checkpoint inhibitor — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Dec. 03, 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 ELUNATE® (fruquintinib) and TYVYT® (sintilimab injection) has been granted conditional approval in China for the treatment of patients with advanced endometrial cancer with Mismatch Repair proficient (“pMMR”) tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation. This approval follows the priority review status and breakthrough therapy designation by the National Medical Products Administration (“NMPA”) of China and marks the first regulatory approval for the combination of fruquintinib with a leading immune checkpoint inhibitor. The conditional appro
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News
- HUTCHMED to Receive Milestone Payment from Takeda following First European Reimbursement for FRUZAQLA® (fruquintinib)GlobeNewswire
- HUTCHMED Announces Breakthrough Therapy Designation in China for ORPATHYS® and TAGRISSO® Combination in Certain Lung Cancer Patients After Disease Progression on EGFR Inhibitor TherapyGlobeNewswire
- Innovent and HUTCHMED Jointly Announce NMPA Conditional Approval for TYVYT® (Sintilimab Injection) in Combination with ELUNATE® (Fruquintinib) for the Treatment of Advanced Endometrial Cancer [Yahoo! Finance]Yahoo! Finance
- Innovent and HUTCHMED Jointly Announce NMPA Conditional Approval for TYVYT® (Sintilimab Injection) in Combination with ELUNATE® (Fruquintinib) for the Treatment of Advanced Endometrial CancerPR Newswire
- Innovent and HUTCHMED Jointly Announce NMPA Conditional Approval for TYVYT® (Sintilimab Injection) in Combination with ELUNATE® (Fruquintinib) for the Treatment of Advanced Endometrial CancerPR Newswire
HCM
Sec Filings
- 12/13/24 - Form 6-K
- 12/12/24 - Form 6-K
- 12/3/24 - Form 6-K
- HCM's page on the SEC website