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

HUTCHMED has launched a Phase Ib/II study of surufatinib in combination with BeiGene’s tislelizumab targeting advanced solid tumors in the U.S. and Europe. The first patient was dosed on March 23, 2021. This study aims to assess the drug combination's safety, tolerability, pharmacokinetics, and efficacy. It comprises two parts: Part 1 focuses on determining the recommended Phase II dose and/or maximum tolerated dose, while Part 2 evaluates antitumor activity in specific cancers, including neuroendocrine tumors and colorectal cancer. Details are available at clinicaltrials.gov (NCT04579757).

Hutchison China MediTech Limited (HUTCHMED) announced its 2020 financial results and updates on clinical developments. For 2021, they forecast consolidated revenues of $110-130 million, significantly up from $30.2 million in 2020. The company has expanded its oncology operations and achieved a 91% increase in sales of ELUNATE®. SULANDA® was launched in January 2021, generating $4.9 million in its first two months. The company seeks shareholder approval for a name change to HUTCHMED (China) Limited at the upcoming AGM. The net loss attributable to HUTCHMED for 2020 was $125.7 million, slightly above the $106.0 million loss in 2019.

Hutchison China MediTech Limited (HCM) will announce its final results for the fiscal year ending December 31, 2020, on March 4, 2021. The announcement will take place at 12:00 noon GMT, with a conference call and audio webcast scheduled for 1:00 pm GMT. Chi-Med is a biopharmaceutical company focused on the development of targeted therapies and immunotherapies for cancer and immunological diseases, boasting a portfolio of nine clinical drug candidates and a strong presence in China.

Hutchison China MediTech Limited (HCM) announced promising results from the Phase III SANET-p trial for surufatinib, a treatment for advanced pancreatic neuroendocrine tumors (NET). The study demonstrated a 51% reduction in the risk of disease progression or death compared to placebo. Median progression-free survival (PFS) was 10.9 months with surufatinib versus 3.7 months for placebo. Positive results were complemented by findings from the SANET-ep trial. The safety profile of surufatinib was manageable, with discontinuation rates of 10.6% for the treatment group.

Hutchison China MediTech Limited (HCM) announced that its New Drug Application for surufatinib, aimed at treating advanced pancreatic neuroendocrine tumors (NET), has been accepted by the China National Medical Products Administration (NMPA). The submission is supported by data from the successful SANET-p study, which demonstrated improved progression-free survival. Surufatinib has also received Fast Track Designation status from the FDA for both pancreatic and non-pancreatic NET. Chi-Med retains all global rights to surufatinib.

Hutchison China MediTech Limited (HCM) has commenced the Phase III FRESCO-2 study of fruquintinib for metastatic colorectal cancer, starting with the first patient dosed on September 3, 2020. This global trial will enroll around 130 sites across 10 countries, aiming for overall survival as the primary endpoint. The FDA previously granted Fast Track Designation for fruquintinib for this indication, with results from prior studies aiding a future New Drug Application. Fruquintinib, already marketed in China, targets VEGFR and shows promise for combining with other therapies.

Chi-Med (Nasdaq/AIM: HCM) has commenced a Phase II clinical study of HMPL-453, a selective inhibitor targeting FGFR in patients with advanced intrahepatic cholangiocarcinoma (IHCC). This single-arm, open-label study aims to assess the drug's efficacy and safety in patients with FGFR2 fusion who have not responded to prior treatments. Key metrics include objective response rate and survival rates. IHCC represents a significant health challenge, particularly in China, where it accounts for 10-20% of liver cancers. The global incidence of liver cancer was over 390,000 cases in 2018, highlighting the need for effective therapies.

Hutchison China MediTech Limited (HCM) announced that new analyses of surufatinib and fruquintinib will be presented at the ESMO Virtual Congress 2020 from September 17-21, 2020. Key presentations include a Phase III trial of surufatinib for advanced pancreatic neuroendocrine tumors (NCT02589821), scheduled for September 20. Additionally, a Phase 1/1b trial of fruquintinib in metastatic colorectal cancer will also be featured. Surufatinib is under review by the NMPA with plans for U.S. and European submissions in late 2020 and 2021, respectively.

Hutchison China MediTech Limited (HCM) announced receiving scientific advice from the EMA's CHMP regarding its drug, surufatinib, for treating advanced neuroendocrine tumors (NET). The positive feedback supports HCM's plans to submit a marketing authorization application (MAA) in 2021 following a U.S. FDA NDA submission. Surufatinib, an oral angio-immuno kinase inhibitor, demonstrates a dual mechanism targeting angiogenesis and immune response against tumors. HCM retains worldwide rights for surufatinib, enhancing its potential in the oncology market.