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

HUTCHMED (HCM) has submitted a New Drug Application (NDA) to the FDA for fruquintinib, an oral VEGFR inhibitor for refractory metastatic colorectal cancer (CRC). Supported by Phase III FRESCO-2 data, the submission shows a 34% reduction in death risk. The NDA is part of global regulatory efforts, with submissions in Europe and Japan planned for 2023. Fruquintinib, launched in China since 2018, has proven effective in improving patient outcomes and is now positioned for commercialization outside China thanks to a partnership with Takeda.

HUTCHMED announced the closing of an exclusive license agreement with Takeda Pharmaceutical for the development and commercialization of fruquintinib outside of China. HUTCHMED will receive an upfront payment of US$400 million, with potential additional payments of up to US$730 million based on milestones and royalties. Fruquintinib targets refractory metastatic colorectal cancer and has shown a solid clinical profile, with plans for marketing authorization submissions in the U.S., Europe, and Japan in 2023. The agreement aims to enhance treatment options for cancer patients globally.

HUTCHMED (HCM) announced on March 13, 2023, that it has no exposure to Silicon Valley Bank (SVB) or SVB UK Limited, confirming it holds no cash deposits or securities with these institutions. This statement assures investors regarding the company’s financial stability amid recent banking sector turmoil. HUTCHMED, a biopharmaceutical firm focused on cancer and immunological treatments, employs approximately 5,000 personnel, with a substantial portion dedicated to oncology and immunology. The company's drugs are now commercially available in China, further solidifying its market presence.

HUTCHMED announced a landmark licensing agreement with Takeda for fruquintinib, with potential proceeds of up to $1.13 billion plus royalties, reinforcing its global strategy. The company reported a 20% revenue increase to $426.4 million in 2022, driven by a 37% rise in oncology/immunology revenues, totaling $163.8 million. Notable product performances included ELUNATE® with a 32% increase in sales, and SULANDA® showing a 178% surge. The company aims for sustainable growth, maintaining a substantial cash balance of $631 million to support future developments and pioneering clinical trials.

HUTCHMED has completed patient enrollment for its Phase II trial of amdizalisib in relapsed or refractory follicular lymphoma (FL), enrolling 108 patients across 35 sites in China. The trial, which has primary and secondary endpoints focusing on response rates and survival metrics, aims to assess the safety and efficacy of amdizalisib. The last patient was enrolled on February 24, 2023, and topline results are expected in the second half of 2023. A positive outcome may lead to a marketing authorization application in China. HUTCHMED retains worldwide rights to amdizalisib, a selective PI3Kδ inhibitor.

HUTCHMED (HCM) will announce its final results for the year ended December 31, 2022, on February 28, 2023, at 3:30 am EST. An invitation is extended to analysts and investors for a subsequent conference call and audio webcast at 8:00 am EST the same day. Management will host the Q&A session following the presentation, which will be available for download prior to the call. HUTCHMED focuses on the development and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases, employing over 5,000 personnel globally. Its first three oncology drugs are already approved in China.

Takeda Pharmaceutical has secured an exclusive licensing agreement with HUTCHMED for the development and commercialization of fruquintinib outside China, Hong Kong, and Macau. Fruquintinib, an inhibitor targeting VEGFR-1, 2, and 3, is aimed at treating refractory metastatic colorectal cancer (CRC). Takeda will pay HUTCHMED $400 million upfront, with potential additional payments of up to $730 million based on regulatory and sales milestones. The drug has shown promise in clinical trials and received Fast Track designation from the FDA. This partnership aims to enhance Takeda's oncology portfolio and expand treatment options for CRC patients.

HUTCHMED has entered an exclusive license agreement with Takeda Pharmaceutical for the global development and commercialization of fruquintinib outside China, receiving up to US$1.13 billion, including US$400 million upfront. The deal aligns with HUTCHMED's strategy to enhance profitability and broaden its market reach. Fruquintinib, already approved in China, shows promise in treating refractory metastatic colorectal cancer (CRC), as demonstrated by successful Phase III trial results. Marketing submissions in the U.S., Europe, and Japan are expected in 2023. This partnership is anticipated to accelerate HUTCHMED's growth and extend its cash runway.

HUTCHMED announced that its drug ORPATHYS (savolitinib) has been included in the National Reimbursement Drug List (NRDL) in China, effective March 1, 2023. This inclusion allows access for patients with non-small cell lung cancer (NSCLC) who have MET exon 14-skipping alterations and have not responded to platinum-based chemotherapy. ORPATHYS is the first selective MET inhibitor approved for this indication. The NRDL update has added a total of 23 oncology drugs, reflecting the government's focus on improving drug affordability. The collaboration between HUTCHMED and AstraZeneca continues to enhance treatment options for patients in need.