Core Insights - HUTCHMED will receive a US$10 million milestone payment from Takeda following the first national reimbursement recommendation for FRUZAQLA® (fruquintinib) in Europe for metastatic colorectal cancer [1][2] - FRUZAQLA® is the first novel oral targeted therapy approved in the EU for metastatic colorectal cancer in over a decade, with its European Commission approval granted in June 2024 [2][3] - The approval is based on the Phase III FRESCO-2 trial results, which demonstrated consistent benefits for patients treated with fruquintinib [3][6] Company Overview - HUTCHMED is an innovative biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [7] - The company has approximately 5,000 personnel, with a significant focus on oncology and immunology [7] - HUTCHMED's fruquintinib has been co-marketed in mainland China, Hong Kong, and Macau under the brand name ELUNATE® in collaboration with Eli Lilly and Company [6] Industry Context - Colorectal cancer (CRC) is the third most prevalent cancer globally, with over 1.9 million new cases and 900,000 deaths reported in 2022 [4] - In Europe, CRC accounted for approximately 538,000 new cases and 248,000 deaths in 2022, highlighting the significant unmet medical need in this area [4] - The approval and reimbursement of FRUZAQLA® represent a critical advancement in treatment options for patients with metastatic CRC, particularly given the poor outcomes associated with this condition [4][5]

Core Insights - HUTCHMED's combination therapy of ORPATHYS® and TAGRISSO® has received Breakthrough Therapy Designation from China's NMPA for treating advanced or metastatic EGFR mutation-positive NSCLC with MET amplification after progression on EGFR inhibitors [1][3] Company Overview - HUTCHMED is an innovative biopharmaceutical company focused on developing targeted therapies and immunotherapies for cancer and immunological diseases, employing approximately 5,000 personnel [15] - The company has a collaboration with AstraZeneca for the global development and commercialization of ORPATHYS®, with HUTCHMED leading development in China [12] Drug Development and Trials - The ongoing Phase III SACHI trial is evaluating the efficacy and safety of the ORPATHYS® and TAGRISSO® combination against standard platinum-based chemotherapy in NSCLC patients with MET amplification [2][8] - ORPATHYS® has been conditionally approved in China for patients with MET exon 14 skipping alterations and is included in the National Reimbursement Drug List since March 2023 [9] - The combination has shown promising results in previous studies, leading to the initiation of multiple Phase III trials, including SANOVO and SAFFRON [5][8] Disease Context - Lung cancer is the leading cause of cancer death, with NSCLC accounting for 80-85% of cases; approximately 30-40% of NSCLC patients in Asia have EGFR mutations [4] - MET amplification is a significant mechanism of resistance to EGFR TKIs, with 15-50% of patients experiencing disease progression post-osimertinib presenting with MET aberration [4][10]

Core Insights - The New Drug Application for the combination of fruquintinib and sintilimab has received conditional approval in China for treating advanced endometrial cancer patients with pMMR tumors who have failed prior systemic therapy and are not candidates for curative surgery or radiation [1][2][3] Company Insights - HUTCHMED and Innovent Biologics are collaborating on the development of fruquintinib and sintilimab, with HUTCHMED focusing on extending the clinical benefits of fruquintinib to a broader patient population [3][15] - Innovent aims to provide innovative treatment options that improve survival rates and quality of life for patients with advanced endometrial cancer [3][16] Clinical Study Insights - The approval was supported by data from the FRUSICA-1 study, which showed an objective response rate (ORR) of 35.6% and a disease control rate (DCR) of 88.5% for the combination therapy [2] - The median progression-free survival (PFS) and overall survival (OS) were reported at 9.5 months and 21.3 months respectively, indicating promising efficacy [2][3] Market Context - Endometrial cancer remains a significant global health challenge, with approximately 417,000 diagnoses and around 97,000 deaths reported in 2020 [6] - In China, there were an estimated 82,000 new cases of endometrial cancer in 2020, highlighting the unmet need for effective treatments in this area [6] Product Insights - Fruquintinib is a selective oral inhibitor of all three VEGF receptors, designed to inhibit tumor angiogenesis and enhance selectivity [7] - Sintilimab, marketed as TYVYT®, is a PD-1 monoclonal antibody that reactivates T-cells to kill cancer cells and has multiple approved indications in China [11][12]

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Nov. 28, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that following the contract renewal with the China National Healthcare Security Administration (“NHSA”), the updated National Reimbursement Drug List (“NRDL”) effective on January 1, 2025 will continue to include ORPATHYS® (savolitinib) at the same terms as the current two-year agreement. ORPATHYS® is an oral, potent, and highly selective MET tyro ...

— Launch follows approval by Japanese Ministry of Health, Labour and Welfare in September 2024 — — Milestone payment to be made to HUTCHMED from Takeda — — Fruquintinib already launched in several regions including the United States, Europe and China — HONG KONG, SHANGHAI & FLORHAM PARK, N.J., Nov. 21, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it will receive a milestone payment following the pricing approval and launch of FRUZAQLA® (fruqui ...

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Nov. 20, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED” or the “Company”) (Nasdaq/AIM:HCM, HKEX:13) today announces that Dr Chaohong Hu (Dr Mary Hu) is appointed as an Independent Non-executive Director and a member of the Technical Committee of the Company with effect from November 21, 2024. Dr Hu has over 20 years of experience in the development of therapeutic antibodies, antibody-drug conjugates, and vaccines. Throughout her career, she has d ...

SAN DIEGO, Nov. 08, 2024 (GLOBE NEWSWIRE) -- Shareholder rights law firm Johnson Fistel, LLP is investigating whether Paycor HCM, Inc. (NASDAQ: PYCR), any of its executive officers or others violated securities laws by misrepresenting or failing to timely disclose material adverse to investors. The investigation focuses on investors’ losses and whether they may be recovered under federal securities laws. What if I purchased PYCR securities? If you purchased securities and suffered losses on your investment ...

HONG KONG, SHANGHAI, and FLORHAM PARK, N.J., Nov. 05, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from the sovleplenib ESLIM-01 Phase III trial, as well as several investigator-initiated studies of compounds discovered by HUTCHMED will be presented at the American Society of Hematology (“ASH”) Annual Meeting taking place on December 7-10, 2024 in San Diego, USA, and the European Society for Medical Oncology (“ESMO”) Asia ...

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Oct. 31, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that it will receive a US$20 million milestone payment from its partner Takeda (TSE:​4502/​NYSE:​TAK), triggered by reaching over US$200 million in sales of FRUZAQLA® (fruquintinib) for metastatic colorectal cancer (“CRC”). CRC is the second most common cause of cancer-related deaths in the US. There are approximately 840,000 new cases of CRC each ...

Independent Data Safety and Monitoring Board Endorsed Dose Escalation and Broadening of Eligibility Criteria; Cohort 2 Now Enrolling Initial Data from Cohort 1 to be Reported in December 2024 Highlights Recently Presented Insights on Pediatric MYBPC3-associated HCM Disease Burden SOUTH SAN FRANCISCO, Calif., Oct. 17, 2024 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that add ...