HUTCHMED (China) Limited American Depositary Shares - HCM STOCK NEWS

HUTCHMED announces positive initial results from the Phase III FRUTIGA study for fruquintinib combined with paclitaxel in patients with advanced gastric or gastroesophageal junction adenocarcinoma. The study met the primary endpoint of statistically significant improvement in progression-free survival (PFS), although overall survival (OS) was not statistically significant. The drug demonstrated a favorable safety profile consistent with prior studies. Full results are pending detailed analysis and will be shared with the NMPA for potential NDA filing.

HUTCHMED has launched a Phase II/III trial for fruquintinib combined with sintilimab as a second-line treatment for locally advanced or metastatic renal cell carcinoma (RCC) in China, with the first patient dosed on October 27, 2022. This randomized, open-label study aims to assess the efficacy and safety of the combination against monotherapy options, with approximately 260 patients expected to enroll. The trial targets progression-free survival as the primary endpoint, addressing an unmet medical need in RCC treatment within China.

HUTCHMED has initiated a Phase II/III trial of sovleplenib for the treatment of warm antibody autoimmune hemolytic anemia (wAIHA) in China, with the first patient dosed on September 30, 2022. This randomized, double-blind, placebo-controlled trial aims to evaluate the drug's safety and efficacy, enrolling approximately 110 patients. Positive Phase II results could lead to a Phase III study. Sovleplenib targets spleen tyrosine kinase (Syk), potentially effective in treating wAIHA and other B-cell disorders. HUTCHMED retains worldwide rights to this investigational drug.

HUTCHMED has announced encouraging results from the FRESCO-2 trial, showing that fruquintinib significantly improves survival rates in patients with refractory metastatic colorectal cancer. The treatment reduced the risk of death by 34% (HR 0.66) and the risk of disease progression or death by 68% (HR 0.32). The median overall survival for patients on fruquintinib was 7.4 months compared to 4.8 months for those on placebo. A conference to discuss these findings will be held at the ESMO22 Congress on September 12, 2022.

HUTCHMED announced that its Phase 3 clinical trial, FRESCO-2, evaluating fruquintinib for treating refractory metastatic colorectal cancer (CRC), met its primary endpoint of overall survival. The results will be presented at the ESMO Congress 2022, with a conference call scheduled for September 12, 2022, to discuss the findings. The trial demonstrated significant improvements in overall and progression-free survival compared to placebo. Fruquintinib, already approved in China, shows promising potential for further development in various cancer therapies.

Inmagene Biopharmaceuticals and HUTCHMED announced the initiation of a global Phase I trial for IMG-004, a third-generation Bruton Tyrosine Kinase (BTK) inhibitor aimed at treating immunological diseases. The trial, which is a double-blind, randomized, placebo-controlled study, will assess safety, tolerability, pharmacokinetics, and pharmacodynamics. This marks Inmagene's second novel drug candidate entering clinical studies this year, with plans for an additional investigational new drug application expected in 2022.

HUTCHMED reported a 28% revenue increase to $202.0M for H1 2022, driven by a 113% surge in Oncology/Immunology sales to $91.1M. Key drivers include ELUNATE® ($50.4M), SULANDA® ($13.6M), and ORPATHYS® ($23.3M). The recently presented SAVANNAH data showed a 52% response rate in NSCLC patients. The company initiated six trials in 2022 and expanded its commercial team to 820 personnel. However, net loss increased to $162.9M, and cash reserves declined to $826.2M. Despite setbacks with surufatinib's FDA approval, HUTCHMED remains optimistic about its pipeline and revenue growth.

HUTCHMED (HCM) has initiated a bridging study for tazemetostat in China, with the first dose administered on July 29, 2022. This multicenter, open-label Phase II study targets relapsed/refractory follicular lymphoma (R/R FL) patients, focusing on those with EZH2 mutations. Tazemetostat, originally developed by Epizyme, is FDA-approved for specific cancer types. HUTCHMED collaborates with Epizyme to commercialize the drug in Greater China after recent approval in Hainan Province. The study aims to confirm tazemetostat's efficacy and safety in varied patient cohorts, addressing a significant oncology market need.

HUTCHMED has initiated a Phase I clinical trial in China for HMPL-A83, a novel anti-CD47 monoclonal antibody, aimed at treating patients with advanced malignancies. The first patient received the drug on July 15, 2022. This trial will assess safety, tolerability, and preliminary efficacy, marking HMPL-A83 as the company's thirteenth oncology drug candidate developed in-house. The drug shows potential for combination therapies and has demonstrated strong anti-tumor activity in preclinical studies.