Hutchmed (China) Limited Stock Price, News & Analysis

Inmagene Biopharmaceuticals has received FDA clearance for its investigational new drug (IND) application for IMG-004, a third-generation Bruton Tyrosine Kinase (BTK) inhibitor. This approval allows the drug to progress to Phase I clinical trials aimed at treating immunological diseases. The Phase I study will test safety, tolerability, and pharmacokinetics in healthy subjects. IMG-004 is designed for long-term treatment of inflammatory diseases and shows potential as a 'best-in-class' candidate based on preclinical findings. This marks Inmagene's third IND clearance in 2022.

HUTCHMED announced that the FDA issued a Complete Response Letter (CRL) for the New Drug Application of surufatinib, intended for treating pancreatic and extra-pancreatic neuroendocrine tumors (NETs). The FDA cited insufficient data to support approval and required a multi-regional clinical trial (MRCT) to represent US patient populations. Surufatinib, which received prior Fast Track and Orphan Drug designations, has proven effective in earlier trials in China, but its US access is now delayed. The company is engaging with the FDA to determine next steps.

HUTCHMED (HCM) has been added to the SEC's conclusive list under the Holding Foreign Companies Accountable Act (the Act), following its annual report filing on March 3, 2022. This designation could lead to delisting from Nasdaq in early 2024 unless compliance is achieved. The Company emphasizes that this update does not affect its operations and is committed to transparency and compliance with U.S. regulations. HUTCHMED continues to explore options to maintain U.S. listings, including potentially appointing an auditor outside China.

HUTCHMED (HCM) updates on its status under the Holding Foreign Companies Accountable Act (the Act). On March 8, 2022, the SEC provisionally identified HUTCHMED as a Commission-Identified Issuer. This designation could lead to the delisting of its American depositary shares from Nasdaq by early 2024 if its auditor remains non-inspected by the PCAOB for three consecutive years. The Company continues to monitor regulatory developments and evaluate strategic options amidst ongoing pressure from U.S. regulations.

HUTCHMED, listed as HCM, announced a $15 million milestone payment from AstraZeneca, triggered by the start of the Phase III SAFFRON study for ORPATHYS® in combination with TAGRISSO® for NSCLC patients. This brings AstraZeneca's total payments to HUTCHMED to $85 million out of a potential $140 million under their collaboration agreement. SAFFRON aims to enroll patients by mid-2022, following insights from the SAVANNAH study. The upcoming trial results will be shared at a scientific conference later in 2022.

HUTCHMED announces the retirement of CEO Christian Hogg, effective March 4, 2022, after 22 years with the company. Dr. Weiguo Su, previously Chief Scientific Officer, is appointed as the new CEO, bolstering leadership continuity. Dr. Su's tenure at HUTCHMED spans 17 years, during which he contributed to the in-house discovery of 12 oncology drug candidates, with three already approved. Hogg will transition to a strategic advisory role. His departure raises questions on continuity amidst ongoing management changes.

HUTCHMED reports a remarkable year in 2021, with oncology/immunology revenues soaring 296% to $119.6 million, driven by strong sales of ELUNATE®, SULANDA®, and ORPATHYS®. The company completed enrollment for the FRESCO-2 global Phase III study of fruquintinib and initiated multiple registration studies for ORPATHYS® in various cancers. With over $1 billion in cash, HUTCHMED plans to expand globally and launch new products. Total revenues rose 56% to $356.1 million, yet net loss increased to $194.6 million. Financial guidance for 2022 suggests oncology revenues between $160-$190 million.

HUTCHMED has received approval to market fruquintinib (ELUNATE^®) in Macau, marking it as the first homegrown innovative oncology drug based on clinical data from China. This approval follows updates to drug importation regulations in Macau. Originally approved for metastatic colorectal cancer in China in September 2018, fruquintinib shows potential for further clinical applications. HUTCHMED's COO expressed optimism about patient access to this drug in Macau and its promising safety profile in combination therapies.

HUTCHMED (Nasdaq/AIM: HCM; SEHK: 13) will announce its final results for the fiscal year ending December 31, 2021, on March 3, 2022, at 7:00 am EST. Following this, a conference call and audio webcast will commence at 8:00 am EST, featuring a Q&A session with management. HUTCHMED is a biopharmaceutical company dedicated to the development of targeted therapies and immunotherapies for cancer and related diseases. The company employs over 4,600 personnel, with a focus on advancing its oncology drug candidates.