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 (Nasdaq/AIM: HCM; HKEX: 13) has initiated a Phase I study for HMPL-295, an oral ERK inhibitor targeting the RAS-MAPK pathway. The trial started on July 2, 2021, assessing HMPL-295's safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced malignant tumors. This study aims to establish the maximum tolerated dose and recommended Phase II dose. HUTCHMED retains all rights to HMPL-295 worldwide, marking a significant step in addressing resistance in cancer therapies.
HUTCHMED (HCM) will announce its interim results for the six months ending June 30, 2021, on July 28, 2021, at 12:00 noon BST. Analysts and investors are invited to participate in a conference call at 1:00 pm BST, which will be live-streamed on the company's website. As a biopharmaceutical company focused on cancer and immunological disease therapies, HUTCHMED has advanced multiple drug candidates into clinical studies, with three oncology drugs already approved. More details will be provided in the financial results announcement.
The U.S. FDA has accepted HUTCHMED's New Drug Application (NDA) for its novel oncology drug, surufatinib, aimed at treating pancreatic and extra-pancreatic neuroendocrine tumors (NETs). The target action date is set for April 30, 2022. Surufatinib, which has received both Fast Track and Orphan Drug designations, is HUTCHMED's first oncology drug to potentially be marketed outside of China. The NDA is supported by promising data from Phase III studies in China and will also assist in a forthcoming application to the European Medicines Agency (EMA).
HUTCHMED has successfully listed its ordinary shares on the Main Board of the Stock Exchange of Hong Kong (SEHK) under the stock code '13'. Following the closing of its primary offering, the company raised approximately HK$4.17 billion from the issuance of 104 million new ordinary shares. The gross proceeds will be utilized for advancing late-stage clinical programs, expanding product portfolio, and strengthening integrated capabilities. Notably, cornerstone investors subscribed for 61% of the Offer Shares. The final offer price was set at HK$40.10 per share.
HUTCHMED (HCM) has announced a global offering of 104 million new ordinary shares priced at HK$40.10 per share, equating to approximately US$25.82 per American depositary share (ADS). This offering aims to amass gross proceeds of around HK$4.17 billion. The funds will primarily support late-stage clinical programs and enhance commercialization capabilities. Trading is expected to commence on the Hong Kong Stock Exchange on June 30, 2021. An over-allotment option allows the issuance of up to an additional 15.6 million shares, enhancing the company's capacity for future growth.
HUTCHMED announced that its oral MET inhibitor, savolitinib, received conditional approval from China's NMPA for treating non-small cell lung cancer (NSCLC) patients with MET exon 14 alterations. This marks the first global regulatory approval for savolitinib. The approval was based on a successful Phase II trial demonstrating effective tumor response. A confirmatory study is required for full approval. HUTCHMED's CEO emphasized the significance of this milestone as part of their collaboration with AstraZeneca, dating back to 2011, to advance targeted cancer therapies.
HUTCHMED announces that surufatinib has received approval from the National Medical Products Administration in China for treating advanced pancreatic neuroendocrine tumors (pNETs), following a previous approval for extra-pancreatic neuroendocrine tumors (epNETs) in December 2020. The approval was based on positive results from the Phase III SANET-p trial, which showed a 51% reduction in the risk of progression or death. With surufatinib marketed as Sulanda, the company plans to expand its oncology treatment reach in China, where there are an estimated 300,000 NET patients.
HUTCHMED (HCM) announced its Hong Kong public offering alongside a global offering of 104 million new ordinary shares. The offering includes 13 million shares for the Hong Kong Public Offering and 91 million for international investors, with a maximum offer price set at HK$45.00 per share. Cornerstone investors, including The Carlyle Group and Canada Pension Plan, have committed to investing approximately HK$2.535 billion. Proceeds will primarily fund late-stage clinical programs and enhance commercialization capabilities. The Hong Kong Public Offering operates an electronic application process and runs from June 18 to June 23, 2021.
Innovent Biologics and HUTCHMED announced Phase 1b results for the combination of TYVYT® (sintilimab) and ELUNATE® (fruquintinib) in advanced colorectal cancer at the ASCO Annual Meeting. The study involved 44 patients with prior treatment failures, showing an objective response rate of 22.7%. Median progression-free survival was 5.6 months overall, with 6.9 months for the 5mg-intermittent dosage group. The safety profile was manageable, suggesting potential for future trials.
HUTCHMED (Nasdaq/AIM: HCM) will present updates on its ongoing studies of savolitinib, surufatinib, fruquintinib, and HMPL-306 at the ASCO21 Virtual Scientific Program from June 4-8, 2021. Key data will include analyses of savolitinib's efficacy in MET-driven metastatic renal cancer, interim results of surufatinib in neuroendocrine tumors, and preliminary findings on fruquintinib in advanced colorectal cancer. A corporate update will be provided in a call on May 26, 2021, at 9 a.m. EDT.