Welcome to our dedicated page for HUTCHMED (China) SEC filings (Ticker: HMDCF), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Our SEC filing database is enhanced with expert analysis from Rhea-AI, providing insights into the potential impact of each filing on HUTCHMED (China)'s stock performance. Each filing includes a concise AI-generated summary, sentiment and impact scores, and end-of-day stock performance data showing the actual market reaction. Navigate easily through different filing types including 10-K annual reports, 10-Q quarterly reports, 8-K current reports, proxy statements (DEF 14A), and Form 4 insider trading disclosures.
Designed for fundamental investors and regulatory compliance professionals, our page simplifies access to critical SEC filings. By combining real-time SEC filing updates, Rhea-AI's analytical insights, and historical stock performance data, we provide comprehensive visibility into HUTCHMED (China)'s regulatory disclosures and financial reporting.
HUTCHMED (China) Ltd (HCM) announced a global licensing deal with a GSK plc subsidiary for HMPL-A830, a first-in-class KRAS-EGFR Antibody-Targeted Therapy Conjugate (ATTC), excluding Mainland China, Hong Kong, Macau and Taiwan. HUTCHMED will receive a US$110 million upfront payment, plus potential development, regulatory and commercial milestone payments of up to US$1.185 billion, for a total of up to US$1.295 billion, as well as tiered royalties on the GSK subsidiary’s annual net sales. HUTCHMED retains full development and commercialization rights in Mainland China, Hong Kong, Macau and Taiwan.
HUTCHMED will run the global phase I program for HMPL-A830, which is expected to start in the second half of 2026, initially in colorectal, pancreatic and lung cancers; subsequent development and commercialization outside Greater China will be led by GSK’s subsidiary. The GSK subsidiary also receives a right of first negotiation on one earlier-stage ATTC candidate, while the upfront payment is payable at closing, subject to customary conditions including antitrust reviews.
HUTCHMED (China) Ltd (HCM) reports positive top-line results from the China Phase III SANOVO trial in treatment-naïve patients with locally advanced or metastatic EGFR-mutated, MET-overexpressing NSCLC. ORPATHYS® (savolitinib) plus TAGRISSO® (osimertinib) showed a statistically significant and highly clinically meaningful improvement in progression-free survival versus TAGRISSO® alone in both high-MET and intention-to-treat populations.
The combination also showed a very encouraging overall survival benefit as a secondary endpoint, with safety consistent with known profiles and no new safety findings. SANOVO randomized 326 patients 1:1 to TAGRISSO® plus ORPATHYS® or placebo, and HUTCHMED plans to share the data with regulatory authorities in China to support first-line use.
HUTCHMED (China) Limited reports an update concerning its Chairman and Non-executive Director, Dr Dan Eldar, under AIM Rule 17 Schedule 2(g). A former directorship held by Dr Eldar at S.D. Sight Diagnostics Ltd., an Israeli private medical device company, became relevant after that company entered insolvency proceedings in Israel.
Applications for insolvency proceedings for S.D. Sight were filed on 12 April 2026, with an order commencing proceedings issued on 24 May 2026 and a trustee appointed on 28 May 2026. Public information indicates proceedings involve about NIS3,057,876 (approximately US$1,019,292). Dr Eldar served as a director of S.D. Sight from 20 December 2018 to 18 March 2026, nominated by Hutchison Water Israel E.P.C Ltd, which invested about 9.98% in S.D. Sight.
HUTCHMED states that neither Hutchison Water Israel E.P.C Ltd nor S.D. Sight is part of the HUTCHMED Group, and the insolvency proceedings do not involve the Group or its businesses. The board expresses the view that this has no impact on the Group’s businesses and operations, and discloses the matter solely as a change of information regarding Dr Eldar.
HUTCHMED (China) Limited announced positive high-level results from the global Phase III SAFFRON trial in patients with EGFR-mutated non-small cell lung cancer whose disease progressed on TAGRISSO®. The study showed that combining ORPATHYS® (savolitinib) with TAGRISSO® (osimertinib) delivered statistically significant and clinically meaningful improvements in both progression-free survival and overall survival versus doublet platinum-based chemotherapy in MET-driven disease.
The trial enrolled 338 patients with high MET overexpression or amplification across 230 centers in 29 countries. The combination’s safety profile was consistent with the known profiles of each medicine, with no new safety findings. HUTCHMED and AstraZeneca plan to present the data at a medical meeting and share them with global regulators, supporting potential broader registrations of the ORPATHYS® plus TAGRISSO® regimen.
HUTCHMED (China) Limited reported H1 2026 revenue of $278.3 million, broadly in line with $277.7 million a year earlier. Oncology/Immunology consolidated revenue rose to $162.3 million, including $121.4 million from marketed oncology products, while distribution-focused Other Ventures revenue declined to $116.0 million.
China in‑market oncology sales reached $279.8 million, up 19%, led by ELUNATE® up 41% and SULANDA® up 45%; FRUZAQLA® global in‑market sales were $185.4 million, helped by ex‑US growth of about 70% and launches or approvals in 41 countries. Net income attributable to HUTCHMED was $15.9 million versus $455.0 million in H1 2025, when results included a $477.5 million gain on an equity divestment.
The company highlighted regulatory momentum, including China approval of savolitinib for MET‑amplified third‑line gastric cancer and NMPA priority‑review NDAs for sovleplenib (ITP and wAIHA) and fanregratinib (FGFR2‑positive ICC). It reiterated 2026 Oncology/Immunology revenue guidance of $330–$450 million and ended June 30, 2026 with $1.37 billion in cash, cash equivalents and short‑term investments.
HUTCHMED (China) Limited reports that China’s National Medical Products Administration has granted conditional approval for ORPATHYS® (savolitinib) to treat locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with MET amplification after at least two prior systemic treatments.
ORPATHYS® is described as the first selective MET inhibitor approved in China for this MET‑amplified gastric cancer population, which the company cites as an estimated 4–6% of gastric cancer cases, or about 18,000 patients annually. The approval is based on a pivotal Phase II study that met its primary endpoint, with an independently reviewed objective response rate of 32.3% and a disease control rate of 63.1% as of the October 8, 2025 data cut‑off.
HUTCHMED (China) Limited has scheduled the announcement of its interim results for the six months ended June 30, 2026 for Thursday, July 30, 2026 at 7:00 am Eastern Daylight Time, 12:00 noon British Summer Time and 7:00 pm Hong Kong Time. Management will host two webcast presentations with Q&A: an English webcast on July 30, 2026 at 8:00 am EDT, 1:00 pm BST and 8:00 pm HKT, and a Putonghua webcast on July 31, 2026 at 8:30 am HKT (1:30 am BST and 8:30 pm EDT on July 30, 2026). The live and replay webcasts and presentation materials will be accessible via the company website. HUTCHMED is described as an innovative, commercial-stage biopharmaceutical company focused on targeted therapies and immunotherapies for cancer and immunological diseases, with three medicines marketed in China and one also approved in the US, Europe and Japan.
HUTCHMED (China) Limited filed a blocklisting six monthly return covering its share option schemes for the period from December 29, 2025 to June 28, 2026. The company reports activity under both its 2015 and 2026 HUTCHMED Share Option Schemes.
Under the 2015 scheme, 7,500 ordinary shares of US$0.1 each were issued during the period, leaving 45,768,368 shares available but not yet issued or allotted at the period end. The 2026 scheme was increased by 43,616,756 ordinary shares, all of which remain unissued at the end of the period.
The filing also notes that a total of 872,335,120 ordinary shares of US$0.1 each were in issue at the end of the period, providing context for the scale of these share option arrangements.
HUTCHMED (China) Limited reported pivotal Phase II results for its FGFR inhibitor fanregratinib in patients with advanced intrahepatic cholangiocarcinoma (ICC) harboring FGFR2 fusions or rearrangements. In this single-arm, multi-center trial across 53 sites in China, all patients had received prior systemic therapy, including chemotherapy and, for most, immunotherapy.
The study met its primary endpoint with an Independent Review Committee–assessed objective response rate of 42.5%, and a disease control rate of 83.9%. Responses occurred quickly, with a median time to response of 1.4 months, and showed durability, with median duration of response and progression-free survival both at 6.9 months. Median overall survival reached 16.6 months, suggesting meaningful benefit in a difficult-to-treat population.
Fanregratinib showed a manageable safety profile typical of selective FGFR inhibitors. Grade 3 or higher drug-related adverse events occurred in 48.3% of patients, mainly liver enzyme elevations and palmar-plantar erythrodysesthesia, but treatment discontinuations due to drug-related events were limited to 2.2%, and no treatment-related deaths were reported. Supported by these data, a New Drug Application for fanregratinib in this indication has been accepted and granted priority review by China’s National Medical Products Administration.
HUTCHMED reports detailed Phase III ESLIM-02 results for its oral Syk inhibitor sovleplenib in adults with warm antibody autoimmune hemolytic anemia (wAIHA) in China. The study met its primary endpoint, with a durable hemoglobin response in 66% of sovleplenib patients versus 15% on placebo between weeks 5–24.
Overall response rate, defined by meaningful hemoglobin improvement without rescue therapy, was 70% for sovleplenib versus 22% for placebo, and use of rescue therapy and blood transfusions was markedly lower in the treatment arm. Median time to response was shorter and duration of response longer with sovleplenib, and subgroup data in patients previously treated with rituximab remained favorable.
Sovleplenib showed a favorable safety profile, with Grade ≥3 treatment-emergent adverse events in 43% of patients versus 59% on placebo and no treatment-related deaths or discontinuations in the sovleplenib arm. Supported by ESLIM-02, a New Drug Application for sovleplenib in wAIHA has been accepted and granted priority review, following earlier Breakthrough Therapy Designation in China.