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

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.

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.

Hutchison China MediTech (HCM) and BeiGene announced a clinical collaboration to evaluate the efficacy of combining HCM’s drug candidates, surufatinib and fruquintinib, with BeiGene’s tislelizumab for treating various solid tumors. The trials will take place in the U.S., Europe, China, and Australia. Both companies will support drug supply and development efforts. Tislelizumab aims to reduce negative effects on T effector cells, while fruquintinib enhances kinase selectivity to reduce off-target toxicities. Surufatinib is also under NDA review in China.

Hutchison China MediTech Limited (HCM) announced new analyses of savolitinib, surufatinib, and fruquintinib, to be presented at the ASCO20 Virtual Scientific Program from May 29-31, 2020. The company will hold a conference call on June 1 to discuss results. Key studies include a Phase II study of savolitinib for non-small cell lung cancer and a Phase III trial comparing savolitinib with sunitinib for renal cell carcinoma. Surufatinib's efficacy in neuroendocrine tumors will also be highlighted, reflecting HCM's commitment to innovative cancer therapies.