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

HUTCHMED announced on May 3, 2021, the completion of a rolling submission of a New Drug Application (NDA) to the FDA for surufatinib aimed at treating pancreatic and extra-pancreatic neuroendocrine tumors (NETs). This marks HUTCHMED's first NDA in the U.S., following a successful launch in China. The submission is backed by data from two positive Phase III studies in China and a U.S. study. Fast Track and Orphan Drug designations were previously granted for surufatinib. An Expanded Access Protocol has also been initiated in the U.S. for patients with limited options.

Hutchison China MediTech Limited (HCM) has launched a registration-intent Phase II clinical trial for HMPL-689, a PI3Kδ inhibitor, targeting relapsed/refractory follicular lymphoma (FL) and marginal zone lymphoma (MZL). The study will enroll approximately 180 patients across 35 sites in China, focusing on the objective response rate (ORR) as its primary endpoint. Initial Phase Ib results indicated a favorable safety profile and clinical activity, supporting further development. This trial marks a significant step in HCM's global strategy for HMPL-689, connecting to the rising incidence of NHL.

Hutchison China MediTech Limited (HCM) announced a definitive agreement for a private placement of $100 million in shares at $30.5 per American Depositary Share (ADS) to Baring Private Equity Asia. CEO Christian Hogg anticipates significant growth in oncology revenues from its drug offerings, including ELUNATE® and SULANDA®, alongside the potential approval of savolitinib. The private placement will support ongoing research and the expansion of commercialization capabilities. Following the placement, HCM's total shares will be approximately 744.5 million.

HUTCHMED (Nasdaq/AIM: HCM) has launched two international Phase I trials for HMPL-306, a dual inhibitor targeting IDH1 and IDH2 mutations in advanced solid tumors and hematological malignancies. The trials, initiated on March 25, 2021, follow a prior study in China. Each trial will evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy. This marks HMPL-306 as HUTCHMED's sixth drug candidate in global clinical development, showcasing its expanding clinical presence.

HUTCHMED announced an agreement to sell its indirect interest in Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited for approximately $169 million. This sale enables HUTCHMED to focus on clinical development and market launches of its oncology and immunology assets. The cash received from this transaction is about 22 times HBYS' adjusted net profit of $7.7 million in 2020. The deal is subject to regulatory approval in China and is expected to close in mid-2021.

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.