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

Hutchison China MediTech Limited (HCM) has commenced the Phase III FRESCO-2 study of fruquintinib for metastatic colorectal cancer, starting with the first patient dosed on September 3, 2020. This global trial will enroll around 130 sites across 10 countries, aiming for overall survival as the primary endpoint. The FDA previously granted Fast Track Designation for fruquintinib for this indication, with results from prior studies aiding a future New Drug Application. Fruquintinib, already marketed in China, targets VEGFR and shows promise for combining with other therapies.

Chi-Med (Nasdaq/AIM: HCM) has commenced a Phase II clinical study of HMPL-453, a selective inhibitor targeting FGFR in patients with advanced intrahepatic cholangiocarcinoma (IHCC). This single-arm, open-label study aims to assess the drug's efficacy and safety in patients with FGFR2 fusion who have not responded to prior treatments. Key metrics include objective response rate and survival rates. IHCC represents a significant health challenge, particularly in China, where it accounts for 10-20% of liver cancers. The global incidence of liver cancer was over 390,000 cases in 2018, highlighting the need for effective therapies.

Hutchison China MediTech Limited (HCM) announced that new analyses of surufatinib and fruquintinib will be presented at the ESMO Virtual Congress 2020 from September 17-21, 2020. Key presentations include a Phase III trial of surufatinib for advanced pancreatic neuroendocrine tumors (NCT02589821), scheduled for September 20. Additionally, a Phase 1/1b trial of fruquintinib in metastatic colorectal cancer will also be featured. Surufatinib is under review by the NMPA with plans for U.S. and European submissions in late 2020 and 2021, respectively.

Hutchison China MediTech Limited (HCM) announced receiving scientific advice from the EMA's CHMP regarding its drug, surufatinib, for treating advanced neuroendocrine tumors (NET). The positive feedback supports HCM's plans to submit a marketing authorization application (MAA) in 2021 following a U.S. FDA NDA submission. Surufatinib, an oral angio-immuno kinase inhibitor, demonstrates a dual mechanism targeting angiogenesis and immune response against tumors. HCM retains worldwide rights for surufatinib, enhancing its potential in the oncology market.

Hutchison China MediTech Limited (HCM) reported strong progress in its oncology pipeline, achieving three FDA Fast Track Designations and preparing NDAs for surufatinib and savolitinib in China. The company anticipates multiple drug launches in late 2020 and 2021, including surufatinib for NET and fruquintinib for CRC, which could drive significant growth. Revenue for H1 2020 rose to $106.8 million, up from $102.2 million in H1 2019, though the company reported a net loss of $49.7 million. The firm holds $281 million in cash, following a $100 million private placement.

Hutchison China MediTech Limited (HCM) announced that the China National Medical Products Administration granted Priority Review status for the New Drug Application of savolitinib, a treatment for non-small cell lung cancer (NSCLC) with MET Exon 14 mutations. This marks the first NDA filing for savolitinib globally. Lung cancer accounts for 37% of the world's cases in China, with MET Exon 14 mutations affecting an estimated 12,000 to 20,000 patients annually. The Priority Review process accelerates the evaluation of drugs with significant clinical value, ensuring quicker access to critical therapies.

Hutchison China MediTech Limited (HCM) and Eli Lilly have amended their 2013 License and Collaboration Agreement regarding the commercialization of Elunate® (fruquintinib) in China. Effective October 1, 2020, Chi-Med will enhance its role in local marketing and promotion, while Lilly retains exclusive commercialization rights. The agreement outlines a revenue-sharing model where Lilly will pay Chi-Med 70% to 80% of sales, subject to pre-agreed targets. Fruquintinib, an oral VEGFR inhibitor, is crucial for treating metastatic colorectal cancer (mCRC) and was previously approved in China in 2018.

Hutchison China MediTech Limited (HCM) has launched a Phase I study for its new drug candidate HMPL-306, targeting IDH1 and IDH2 mutations in patients with hematological malignancies. This multi-center trial aims to assess safety, pharmacokinetics, and efficacy, starting with a dose escalation phase. HMPL-306, the ninth oncology drug discovered in-house by Chi-Med, seeks to address acquired resistance seen in current treatments targeting IDH mutations. No dual inhibitors for these mutations are currently approved in the market, making this candidate potentially significant for cancer therapies.

Hutchison China MediTech Limited (HCM) announced a private placement of shares worth US$100 million to General Atlantic, reflecting a 10.4% premium to the 30-day volume weighted average price. The investment aligns with Chi-Med’s strategy to enhance its global oncology business, supported by FDA Fast Track Designations for key products. The deal includes a warrant for an additional US$100 million at a price of US$30.00 per ADS. Funds will support clinical development and commercialization efforts in China and globally, marking a significant endorsement of Chi-Med's growth prospects.