reports
HUTCHMED Announces Positive CHMP Opinion for Fruquintinib in Previousl...
HUTCHMED Announces Positive CHMP Opinion for Fruquintinib in Previously Treated Metastatic Colorectal Cancer Received by Takeda — 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 (“”) (Nasdaq/AIM:HCM; HKEX:13) today announces that its partner (TSE:4502/NYSE:TAK) received noti...
HUTCHMED Highlights Data to be Presented at AACR Congress 2024
HUTCHMED Highlights Data to be Presented at AACR Congress 2024 HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., April 05, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“”) (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 differentiated menin-MLL inhibitor for t...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
HUTCHMED: Executing consistently on the road to breakeven
China commercial execution, the prospect of further approvals and launches globally and in China, plus a strong balance sheet means HUTCHMED is well positioned to achieve its goal of sustainable profitability from FY25. Having made significant progress during FY23, most notably with the FDA approval and US launch of first global product Fruzaqla (fruquintinib) in November 2023 (impressively generating $15.1m of in-market sales), its FY24 outlook is for continuing strong product revenue growth ac...
HUTCHMED and Innovent Jointly Announce NDA Acceptance in China for Fru...
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 — 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 (“”) (Nasdaq/AIM:HCM; HKEX:13) and Innovent Biologi...
HUTCHMED Announces Savolitinib sNDA Accepted in China for Treatment-Na...
HUTCHMED Announces Savolitinib sNDA Accepted in China for Treatment-Naïve or Previously Treated Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC — 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 (“”) (Nasdaq/AIM:HCM; HKEX:13) today announce...
HUTCHMED Initiates Registration Stage of the ESLIM-02 Phase II/III Tri...
HUTCHMED Initiates Registration Stage of the ESLIM-02 Phase II/III Trial of Sovleplenib for Warm Antibody Autoimmune Hemolytic Anemia in China HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., March 22, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“”) (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 w...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Trinity Delta Lighthouse: HUTCHMED
Trinity Delta view: HUTCHMED’s path to profitability continues to be supported by solid commercial execution in China, the prospect of additional approvals and launches in China and globally, and a solid balance sheet. Several pipeline assets could reach the market by 2025, including other global fruquintinib launches by Takeda (Europe and Japan regulatory decisions in advanced mCRC are anticipated in 2024); fruquintinib indication expansion in China (2L gastric cancer filed; potential 2024-25 f...
HUTCHMED Reports 2023 Full Year Results and Provides Business Updates
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 and SHANGHAI, China and FLORHAM PARK, N.J., Feb. 28, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“”, the “Company” or “we”) (Nasdaq/AIM:HCM; HKEX:13), the innovative, commercial-stage biopharmaceutical company, today...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Trinity Delta Lighthouse: HUTCHMED
Trinity Delta view: Fruquintinib’s commercial prospects are a key contributor to HUTCHMED’s path to profitability, which is supported by the growing traction and market share capture of its China oncology products, additional potential approvals and launches (by partner Takeda) of fruquintinib in international markets, and a solid balance sheet. Fruquintinib’s potential approval in a second indication in China (2L gastric cancer) as well as tiered royalties on annual net sales in Takeda’s market...
HUTCHMED Highlights Presentation of Phase III Data on Fruquintinib in ...
HUTCHMED Highlights Presentation of Phase III Data on Fruquintinib in Second-Line Gastric Cancer at ASCO Plenary Series Session HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Feb. 06, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“”) (Nasdaq/AIM:HCM; HKEX:13) today announces that data from FRUTIGA, HUTCHMED’s Phase III trial of fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric cancer in China, were presented at the American Society of Clinical Oncology (“ASCO”) Plenary Series Session on February 6, 2024. The full presentation can b...
HUTCHMED Announces that Inmagene Exercises Option to License Two Drug ...
HUTCHMED Announces that Inmagene Exercises Option to License Two Drug Candidates as Part of Strategic Partnership HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Feb. 02, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“”) (Nasdaq/AIM:HCM; HKEX:13) today announced that, Inmagene Biopharmaceuticals (“Inmagene”) has exercised options to license two drug candidates discovered by HUTCHMED, IMG-007 and IMG-004 (the “Options”) pursuant to the terms of the strategic partnership announced on January 11, 2021. Following the exercise of the Options and subject to receipt by HUTCHMED of o...
HUTCHMED to Announce 2023 Final Results
HUTCHMED to Announce 2023 Final Results HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Feb. 01, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“”) (Nasdaq/AIM: HCM; SEHK:13) will be announcing its final results for the year ended December 31, 2023 on Wednesday, February 28, 2024 at 6:30 am Eastern Standard Time (EST) / 11:30 am Greenwich Mean Time (GMT) / 7:30 pm Hong Kong Time (HKT). Analysts and investors are invited to join a conference call and audio webcast presentation with Q&A, conducted by HUTCHMED management. The English conference call and audio webcast will tak...
HUTCHMED Receives ELUNATE® (fruquintinib) Marketing Approval in Hong K...
HUTCHMED Receives ELUNATE® (fruquintinib) Marketing Approval in Hong Kong for Treatment of Metastatic Colorectal Cancer — First medicine approved under new “1+” mechanism by HKSAR Government, providing an important treatment option to patients in Hong Kong — — ELUNATE® is the first oral targeted therapy approved in Hong Kong for metastatic colorectal cancer regardless of biomarker status or prior types of therapies in almost a decade — — Fruquintinib already approved in mainland China, Macau SAR and the United States — HONG KONG, SHANGHAI, China and FLORHAM PARK, N.J., Jan. 29, 20...
HUTCHMED Announces NDA Acceptance in China for Sovleplenib for the Tre...
HUTCHMED Announces NDA Acceptance in China for Sovleplenib for the Treatment of Primary Immune Thrombocytopenia with Priority Review Status — NDA accepted and granted Priority Review following its Breakthrough Therapy designation granted in January 2022 — — NDA is supported by data from successful Phase III ESLIM-01 trial in patients with adult primary immune thrombocytopenia who have received at least one previous therapy — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Jan. 10, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the...
HUTCHMED Announces Continued Inclusion of ELUNATE® (fruquintinib) and ...
HUTCHMED Announces Continued Inclusion of ELUNATE® (fruquintinib) and SULANDA® (surufatinib) in the National Reimbursement Drug List in China at Current Terms HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Dec. 13, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“”) (Nasdaq/AIM:HCM, HKEX:13) today announces that under the 2023 simple renewal mechanism of the China National Healthcare Security Administration (“NHSA”), on January 1, 2024 the updated National Reimbursement Drug List (“NRDL”) will continue to include ELUNATE® (fruquintinib) and SULANDA® (surufatinib) at the same t...
HUTCHMED Announces that it has Completed Enrollment of a Phase II/III ...
HUTCHMED Announces that it has Completed Enrollment of a Phase II/III Trial of Fruquintinib in Combination with Sintilimab for Advanced Renal Cell Carcinoma in China HONG KONG, Shanghai and FLORHAM Park, N.J., Dec. 12, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) (“”) today announces that it has completed enrollment of its Phase II/III trial of fruquintinib in combination with sintilimab as second-line treatment for locally advanced or metastatic renal cell carcinoma (“RCC”) in China. The study is a randomized, open-label, active-controlled study to evalu...
HUTCHMED Highlights Clinical Data to be Presented at 2023 ESMO Asia an...
HUTCHMED Highlights Clinical Data to be Presented at 2023 ESMO Asia and ESMO Immuno-Oncology Congresses HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Nov. 30, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“”) (Nasdaq/AIM:HCM; HKEX:13) today highlights that new clinical data from several ongoing studies with HUTCHMED investigational drug candidates fruquintinib, surufatinib and HMPL-295, which will be presented at the upcoming European Society for Medical Oncology (“ESMO”) Asia Congress, taking place on December 1-3, 2023 in Singapore, and the ESMO Immuno-Oncology Congress, ...
- Franc Gregori
- Lala Gregorek
- Philippa Gardner
Trinity Delta Lighthouse: HUTCHMED
Trinity Delta view: The FDA approval of fruquintinib (FRUZAQLA) for previously treated mCRC is a landmark achievement for HUTCHMED, and its pending launch will be the first of a HUTCHMED discovered and developed drug ex-China. Global fruquintinib sales are a key component of HUTCHMED’s path to profitability, which is supported by the growing traction and market share capture of its China oncology products, further potential approvals and launches (by partner Takeda) of fruquintinib in other inte...
HUTCHMED Announces that Takeda Receives U.S. FDA Approval of FRUZAQLA™...
HUTCHMED Announces that Takeda Receives U.S. FDA Approval of FRUZAQLA™ (fruquintinib) for Previously Treated Metastatic Colorectal Cancer — FRUZAQLA is the first targeted therapy approved in the U.S. for metastatic colorectal cancer regardless of biomarker status or prior types of therapies in more than a decade — — U.S. approval of FRUZAQLA triggers first milestone payment from Takeda of US$35 million and royalties on net sales — HONG KONG, SHANGHAI, China and FLORHAM PARK, N.J., Nov. 09, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) (“”) today announced...
HUTCHMED Highlights Clinical Data to be Presented at ESMO Congress 202...
HUTCHMED Highlights Clinical Data to be Presented at ESMO Congress 2023 HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Oct. 16, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated clinical data from several ongoing studies of fruquintinib, in combination with chemotherapies and/or immunotherapies, will be presented at the upcoming European Society for Medical Oncology (“ESMO”) Congress 2023, taking place on October 20-24, 2023 in Madrid, Spain. Details of the presentations are as follows: Abstract titlePresente...
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