Hutchmed (China) Limited Stock Price, News & Analysis

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) 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) 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) 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.

Hutchison China MediTech Limited (Nasdaq/AIM: HCM) announced that the FDA has granted Fast Track Designation for fruquintinib, aimed at treating patients with metastatic colorectal cancer (mCRC) previously treated with standard chemotherapies. The ongoing Phase III FRESCO-2 study will start patient enrollment in mid-2020, with the potential for a New Drug Application contingent on positive results. Fruquintinib, already approved in China, is being positioned for broader markets, reflecting Chi-Med's commitment to cancer therapies.

Hutchison China MediTech Limited (HCM) announced that its joint venture, HBYS, will return its remaining land-use rights for a 30,000 square meter site in Guangzhou, China, to the local government. In exchange, HBYS will receive up to $95 million in cash compensation over the next year. The site will be rezoned for commercial and residential use, but this transition will not affect HBYS's ongoing operations, as it maintains manufacturing at a nearby facility and a larger factory in Bozhou, Anhui Province.

Hutchison China MediTech Limited (HCM) announced that the Independent Data Monitoring Committee (IDMC) has completed an interim data review of the FRUTIGA study for fruquintinib. The trial, which focuses on patients with advanced gastric adenocarcinoma, will continue based on preset criteria. Fruquintinib is an oral inhibitor targeting VEGFR, designed to minimize off-target toxicities. The FRUTIGA trial aims to evaluate its efficacy when combined with paclitaxel for second-line treatment in patients who didn't respond to initial chemotherapy. Additional global studies for colorectal cancer are also planned.