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HUTCHMED Announces Positive CHMP Opinion for Fruquintinib in Previously Treated Metastatic Colorectal Cancer Received by Takeda
Newsfilter· 2024-04-26 12:30
— If approved in the European Union, fruquintinib will be the first novel targeted therapy for metastatic colorectal cancer regardless of biomarker status in over a decade — — Positive opinion based on results from FRESCO-2 Phase III clinical trial — HONG KONG, SHANGHAI, China and FLORHAM PARK, N.J., April 26, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) today announces that its partner Takeda (TSE:​4502/​NYSE:​TAK) received notification that the Committee for M ...
HUTCHMED Highlights Data to be Presented at AACR Congress 2024
Newsfilter· 2024-04-05 08:30
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., April 05, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the upcoming American Association of Cancer Research ("AACR") Annual Meeting 2024, taking place on April 5-10, 2024 in San Diego, California. Initial preclinical data will be presented for HMPL-506, a novel, highly potent and differentiate ...
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
Prnewswire· 2024-04-02 05:00
ROCKVILLE, Md. and SUZHOU, China, April 2, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, and HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) today jointly announce that the New Drug Application ("NDA") for the combination of sintilimab and fruquin ...
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
Newsfilter· 2024-04-02 04:30
— 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") f ...
HUTCHMED Announces Savolitinib sNDA Accepted in China for Treatment-Naïve or Previously Treated Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC
Newsfilter· 2024-03-28 00:00
— Oral presentation at the European Lung Cancer Congress 2024 of Phase IIIb data demonstrating median PFS of 13.7 months and median OS not reached in treatment-naïve patients — — If approved, would confirm 2021 conditional approval and expand indication to more patients — HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., March 27, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the supplemental New Drug Application ("sNDA") for savolitinib, ...
HUTCHMED Initiates Registration Stage of the ESLIM-02 Phase II/III Trial of Sovleplenib for Warm Antibody Autoimmune Hemolytic Anemia in China
Newsfilter· 2024-03-22 00:00
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., March 22, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated the registration stage of the Phase II/III clinical trial of sovleplenib in adult patients with warm antibody autoimmune hemolytic anemia ("wAIHA") in China. This follows positive data from the proof-of-concept Phase II stage of the trial and subsequent consultation with the China National Medical Products Administratio ...
HUTCHMED(HCM) - 2023 Q4 - Earnings Call Transcript
2024-02-28 18:25
HUTCHMED (China) Limited (NASDAQ:HCM) Q4 2023 Results Conference Call February 28, 2024 7:30 AM ET Company Participants Mark Lee - Senior Vice President of Corporate Management & Communications Dr. Wei-Guo Su - CEO, Chief Scientific Officer Johnny Cheng - CFO Zhenping Wu - Executive Vice President of Pharmaceutical Science & Manufacturing Michael Shi - Executive VP, Head of R&D and Chief Medical Officer Conference Call Participants Louise Alesandra Chen - Cantor Fitzgerald & Co Alec Warren Stranahan - Bank ...
HUTCHMED Reports 2023 Full Year Results and Provides Business Updates
Newsfilter· 2024-02-28 11:30
Revenue grew 97% (102% CER) to US$838 million, with net income of US$101 million First U.S. FDA approval of our self-developed medicine, FRUZAQLA™ (fruquintinib) Sovleplenib for ITP accepted for NDA review in China, with Priority Review status and Breakthrough Therapy designation HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Feb. 28, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ("HUTCHMED", the "Company" or "we") (Nasdaq/AIM:​HCM; HKEX:​13), the innovative, commercial-stage biopharmaceutical co ...
HUTCHMED(HCM) - 2023 Q4 - Annual Report
2024-02-27 16:00
Exhibit 99.1 HUTCHMED Reports 2023 Full Year Results and Provides Business Updates Revenue grew 97% (102% CER) to US$838 million, with net income of US$101 million First U.S. FDA approval of our self-developed medicine, FRUZAQLA™ (fruquintinib) Sovleplenib for ITP accepted for NDA review in China, with Priority Review status and Breakthrough Therapy designation Hong Kong, Shanghai & Florham Park, NJ — Wednesday, February 28, 2024: HUTCHMED (China) Limited (“HUTCHMED”, the “Company” or “we”) (Nasdaq/AIM:HCM; ...
HUTCHMED(HCM) - 2023 Q4 - Annual Report
2024-02-27 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark one) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF ...