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

HUTCHMED has initiated a Phase I clinical trial in China for HMPL-A83, a novel anti-CD47 monoclonal antibody, aimed at treating patients with advanced malignancies. The first patient received the drug on July 15, 2022. This trial will assess safety, tolerability, and preliminary efficacy, marking HMPL-A83 as the company's thirteenth oncology drug candidate developed in-house. The drug shows potential for combination therapies and has demonstrated strong anti-tumor activity in preclinical studies.

HUTCHMED announces positive interim results from the ongoing SAVANNAH Phase II trial of savolitinib combined with TAGRISSO® for EGFR-mutated NSCLC patients. The trial reported a 49% objective response rate (ORR) in patients with higher MET levels, suggesting improved efficacy for this subgroup. Overall, 32% of 193 evaluable patients showed a response, with a median duration of response of 8.3 months. The findings support the initiation of the SAFFRON Phase III study, aimed at comparing the combination treatment with current standard care. Safety profiles remained consistent with existing data.

Inmagene Biopharmaceuticals and HUTCHMED announced the dosing of the first participant in a global Phase I trial for IMG-007, a novel OX40 antagonistic monoclonal antibody targeting atopic dermatitis. The trial aims to assess IMG-007’s safety and efficacy in healthy volunteers and patients with moderate to severe atopic dermatitis. Dr. Jonathan Wang emphasized the milestone nature of this event, and experts from both companies expressed confidence in IMG-007's potential as a best-in-class treatment for immune diseases.

HUTCHMED (HCM) will announce its interim results for the six months ending June 30, 2022, on August 1, 2022, at 7:00 am EDT. A conference call and audio webcast will follow at 8:00 am EDT, inviting analysts and investors for a Q&A session with management. HUTCHMED is an innovative biopharmaceutical company committed to developing targeted therapies for cancer and immunological diseases, with a robust portfolio of 12 drug candidates. The call will be accessible via the company's website, with a replay available shortly after the event.

HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) has received approval for TAZVERIK^® (tazemetostat) in Hainan Province, China, to treat patients with epithelioid sarcoma (ES) and follicular lymphoma (FL). This approval allows patients early access to an innovative treatment under the Clinically Urgently Needed Imported Drugs scheme. TAZVERIK^® is part of HUTCHMED's strategic collaboration with Epizyme for development in Greater China. The company aims to further enhance patient access through registration-enabling studies in the region.

HUTCHMED has appointed Mr. Lefei Sun as a Non-Executive Director effective May 16, 2022, until the next annual general meeting. Mr. Sun, aged 42, brings extensive experience in capital markets, M&A, and business strategy from General Atlantic, where he leads China Healthcare. He has previously been a founding partner at Huatai Healthcare Investment Fund and held roles at Credit Suisse and McKinsey. His directorships include Adagene and he does not hold HUTCHMED shares. The Board expects Mr. Sun's expertise will enhance its strategic direction.

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.