Hutchmed (China) Limited Stock Price, News & Analysis

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.

HUTCHMED announces positive interim results from the ongoing SAVANNAH Phase II trial of savolitinib combined with TAGRISSO® for EGFR-mutated NSCLC patients. The trial reported a 49% objective response rate (ORR) in patients with higher MET levels, suggesting improved efficacy for this subgroup. Overall, 32% of 193 evaluable patients showed a response, with a median duration of response of 8.3 months. The findings support the initiation of the SAFFRON Phase III study, aimed at comparing the combination treatment with current standard care. Safety profiles remained consistent with existing data.

Inmagene Biopharmaceuticals and HUTCHMED announced the dosing of the first participant in a global Phase I trial for IMG-007, a novel OX40 antagonistic monoclonal antibody targeting atopic dermatitis. The trial aims to assess IMG-007’s safety and efficacy in healthy volunteers and patients with moderate to severe atopic dermatitis. Dr. Jonathan Wang emphasized the milestone nature of this event, and experts from both companies expressed confidence in IMG-007's potential as a best-in-class treatment for immune diseases.

HUTCHMED (HCM) will announce its interim results for the six months ending June 30, 2022, on August 1, 2022, at 7:00 am EDT. A conference call and audio webcast will follow at 8:00 am EDT, inviting analysts and investors for a Q&A session with management. HUTCHMED is an innovative biopharmaceutical company committed to developing targeted therapies for cancer and immunological diseases, with a robust portfolio of 12 drug candidates. The call will be accessible via the company's website, with a replay available shortly after the event.

HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) has received approval for TAZVERIK^® (tazemetostat) in Hainan Province, China, to treat patients with epithelioid sarcoma (ES) and follicular lymphoma (FL). This approval allows patients early access to an innovative treatment under the Clinically Urgently Needed Imported Drugs scheme. TAZVERIK^® is part of HUTCHMED's strategic collaboration with Epizyme for development in Greater China. The company aims to further enhance patient access through registration-enabling studies in the region.