HUTCHMED (China) Limited develops and commercializes targeted therapies and immunotherapies for cancer and immunological diseases through a China-based commercial organization and a global clinical pipeline. News for HCM centers on marketed oncology products such as FRUZAQLA and ELUNATE for fruquintinib, ORPATHYS for savolitinib, China regulatory actions, and partner-driven commercialization outside China.
Recurring updates also cover pipeline compounds including sovleplenib, HMPL-760 and HMPL-A580, clinical data presented at oncology meetings, and the company’s Antibody-Targeted Therapy Conjugate platform. Corporate items include annual results, product-license updates such as TAZVERIK in China, board and committee changes, and disclosures tied to HUTCHMED’s Nasdaq, AIM and HKEX listings and ADR structure.
HUTCHMED and AstraZeneca announced the initiation of the SACHI Phase III trial in China, studying ORPATHYS (savolitinib) combined with TAGRISSO (osimertinib) for EGFR mutation-positive NSCLC patients with MET amplification. The trial, which began on November 22, 2021, aims to assess the combination's efficacy against standard chemotherapy. Primary endpoint: median progression-free survival. This follows earlier promising results from TATTON studies. Savolitinib is already approved in China for specific NSCLC cases.
HUTCHMED (Nasdaq/AIM: HCM) announced updates on its ongoing studies of HMPL-523 and HMPL-306, presented at the 63rd ASH Annual Meeting from December 11-14, 2021. Key presentations include clinical data on HMPL-523, focusing on its safety and preliminary efficacy for treating primary immune thrombocytopenia, and initial results from a Phase I study on HMPL-523 in lymphoma patients. Additionally, a Phase I trial of HMPL-306 for advanced hematological malignancies is in progress. Both compounds aim to address significant oncology challenges, with HMPL-523 retaining global rights by HUTCHMED.
HUTCHMED and AstraZeneca have launched the global Phase III study SAMETA to evaluate savolitinib combined with IMFINZI for treating patients with MET-driven advanced papillary renal cell carcinoma (PRCC). The trial aims to show improved efficacy compared to existing treatments, with initial doses administered on October 28, 2021. Previous studies, like SAVOIR and CALYPSO, showcased promising results, with CALYPSO reporting a 57% response rate in patients with MET alterations. The primary endpoint is median progression-free survival.
HUTCHMED has commenced a Phase III trial of HMPL-523, an investigational Syk inhibitor, for primary immune thrombocytopenia (ITP) in China. The trial began on October 27, 2021, enrolling approximately 180 adult patients. The study aims to evaluate the drug's efficacy, with the primary endpoint being the durable response rate. Previous Phase Ib data showed promising results, which will be further detailed at the upcoming American Society of Hematology Annual Meeting in December 2021. HUTCHMED retains global rights for HMPL-523, which is also being studied for other conditions.
HUTCHMED (Nasdaq/AIM: HCM; HKEX:13) has completed the sale of its indirect interest in Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited (HBYS) for approximately US$169 million in cash. This valuation represents about 22 times HBYS' adjusted net profit of US$7.7 million for 2020. HUTCHMED has received around US$127 million, with the remaining US$42 million expected from future dividends. The sale allows HUTCHMED to direct resources toward enhancing its Oncology/Immunology investments in China and globally.
HUTCHMED presented new clinical data for surufatinib and fruquintinib at the 24th CSCO Annual Meeting. The Phase II study of surufatinib with toripalimab in advanced neuroendocrine carcinoma showed a median overall survival of 10.3 months and a confirmed response rate of 23.8%. Meanwhile, a study on fruquintinib plus sintilimab demonstrated a 100% response rate in treatment-naïve patients and a 32% response rate in pretreated patients with advanced endometrial cancer. Regulatory discussions for potential pivotal studies in China are ongoing for both therapies.
HUTCHMED has launched the SURTORI-01 Phase III clinical trial to assess the efficacy and safety of surufatinib in combination with toripalimab for treating advanced neuroendocrine carcinoma (NEC). The first patient was dosed on September 18, 2021. The study aims to enroll approximately 200 patients and evaluate outcomes including overall survival and progression-free survival. Preliminary Phase II data revealed a 20% objective response rate and a 70% disease control rate, indicating potential for this treatment combination.
HUTCHMED announced the initiation of a Japan registration-enabling bridging study for surufatinib on September 15, 2021, aimed at treating advanced neuroendocrine tumors (NETs). This study follows the drug's previous approvals in China and regulatory progress in the U.S. and Europe. The study will recruit approximately 34 patients, assessing safety, tolerability, and efficacy. The NDA will include results from pivotal studies in Japan, complementing data from studies in the U.S. and China. Surufatinib is marketed in China as SULANDA®.
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) announced that China's NMPA granted Breakthrough Therapy Designation to amdizalisib (HMPL-689), a selective PI3Kδ inhibitor, for treating relapsed or refractory follicular lymphoma (FL). This designation fast-tracks drug development and review, potentially leading to expedited approval for addressing unmet medical needs. Preliminary Phase Ib study results show that amdizalisib has a manageable toxicity profile and clinical activity in patients. Further data will be presented at the upcoming ESMO Congress on September 20, 2021.
HUTCHMED and AstraZeneca have launched the SANOVO Phase III study in China, evaluating the combination of ORPATHYS (savolitinib) and TAGRISSO (osimertinib) for first-line treatment in non-small cell lung cancer (NSCLC) patients with EGFR mutations and MET overexpression. The trial aims to compare the efficacy and safety of the combination against TAGRISSO alone, focusing on progression-free survival (PFS). This initiative follows significant results from previous studies, underscoring the potential of savolitinib in treating advanced solid tumors.