Hutchmed (China) Limited Stock Price, News & Analysis

HUTCHMED has commenced a Phase III trial of HMPL-523, an investigational Syk inhibitor, for primary immune thrombocytopenia (ITP) in China. The trial began on October 27, 2021, enrolling approximately 180 adult patients. The study aims to evaluate the drug's efficacy, with the primary endpoint being the durable response rate. Previous Phase Ib data showed promising results, which will be further detailed at the upcoming American Society of Hematology Annual Meeting in December 2021. HUTCHMED retains global rights for HMPL-523, which is also being studied for other conditions.

HUTCHMED (Nasdaq/AIM: HCM; HKEX:13) has completed the sale of its indirect interest in Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited (HBYS) for approximately US$169 million in cash. This valuation represents about 22 times HBYS' adjusted net profit of US$7.7 million for 2020. HUTCHMED has received around US$127 million, with the remaining US$42 million expected from future dividends. The sale allows HUTCHMED to direct resources toward enhancing its Oncology/Immunology investments in China and globally.

HUTCHMED presented new clinical data for surufatinib and fruquintinib at the 24th CSCO Annual Meeting. The Phase II study of surufatinib with toripalimab in advanced neuroendocrine carcinoma showed a median overall survival of 10.3 months and a confirmed response rate of 23.8%. Meanwhile, a study on fruquintinib plus sintilimab demonstrated a 100% response rate in treatment-naïve patients and a 32% response rate in pretreated patients with advanced endometrial cancer. Regulatory discussions for potential pivotal studies in China are ongoing for both therapies.

HUTCHMED has launched the SURTORI-01 Phase III clinical trial to assess the efficacy and safety of surufatinib in combination with toripalimab for treating advanced neuroendocrine carcinoma (NEC). The first patient was dosed on September 18, 2021. The study aims to enroll approximately 200 patients and evaluate outcomes including overall survival and progression-free survival. Preliminary Phase II data revealed a 20% objective response rate and a 70% disease control rate, indicating potential for this treatment combination.

HUTCHMED announced the initiation of a Japan registration-enabling bridging study for surufatinib on September 15, 2021, aimed at treating advanced neuroendocrine tumors (NETs). This study follows the drug's previous approvals in China and regulatory progress in the U.S. and Europe. The study will recruit approximately 34 patients, assessing safety, tolerability, and efficacy. The NDA will include results from pivotal studies in Japan, complementing data from studies in the U.S. and China. Surufatinib is marketed in China as SULANDA®.

HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) announced that China's NMPA granted Breakthrough Therapy Designation to amdizalisib (HMPL-689), a selective PI3Kδ inhibitor, for treating relapsed or refractory follicular lymphoma (FL). This designation fast-tracks drug development and review, potentially leading to expedited approval for addressing unmet medical needs. Preliminary Phase Ib study results show that amdizalisib has a manageable toxicity profile and clinical activity in patients. Further data will be presented at the upcoming ESMO Congress on September 20, 2021.

HUTCHMED and AstraZeneca have launched the SANOVO Phase III study in China, evaluating the combination of ORPATHYS (savolitinib) and TAGRISSO (osimertinib) for first-line treatment in non-small cell lung cancer (NSCLC) patients with EGFR mutations and MET overexpression. The trial aims to compare the efficacy and safety of the combination against TAGRISSO alone, focusing on progression-free survival (PFS). This initiative follows significant results from previous studies, underscoring the potential of savolitinib in treating advanced solid tumors.

HUTCHMED (Nasdaq/AIM: HCM) announced that new analyses of its drug candidates will be presented at the 2021 ESMO Virtual Congress, taking place from September 16-21, 2021. Key studies include:

• Amdizalisib: Phase Ib results for relapsed/refractory lymphoma, presented on September 20, 2021.
• Savolitinib: Interim analysis of a biomarker-directed Phase II study in advanced non-small cell lung cancer available from September 13, 2021.
• Fruquintinib: Phase Ib/II study in advanced triple-negative breast cancer, also available from September 13, 2021.

HUTCHMED (HCM) announces its inclusion in the Shanghai-Hong Kong and Shenzhen-Hong Kong Stock Connect programs, effective September 6, 2021. This inclusion allows qualified Mainland Chinese investors direct access to HUTCHMED shares. The company is also now part of the Hang Seng Composite Index, a prerequisite for Stock Connect participation. CEO Christian Hogg expressed optimism about the new access for investors, which could enhance the trading volume and visibility of HUTCHMED's shares in the mainland market.