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Those suffering from metastatic colorectal cancer will soon have another option that could improve their survival rates and extend their lives. HUTCHMED’s partner, global pharmaceutical firm Takeda, has obtained approval from the US Food and Drug Administration to make FRUZAQLA™ (fruquintinib) available on the US market.

The drug has been approved for use in patients as part of a treatment protocol that gives them another chance when other treatments such as chemotherapy have proven ineffective. The development partnership with Takeda is part of a broader global partnership strategy. Achieving this watershed will trigger the delivery of sales royalties as well as a milestone payment as part of a deal that will total up to US$1.13 billion.  

HUTCHMED has passed key milestones to be accepted for review for use in the US and Europe. The fruquintinib New Drug Application has been accepted by the US Food and Drug Administration (FDA). The FDA has also granted priority review, with the Prescription Drug User Fee Act (PDUFA) date set for 30 November 2023. The Market Authorization Application in Europe has also been validated and accepted for regulator review by the European Medicines Agency. Results of the Phase III FRESCO‑2, a key study that supported the regulatory submissions, were published in The Lancet, one of the world’s most prestigious and well-respected medical journals.  

HUTCHMED has come to a licensing agreement with global pharmaceutical giant Takeda Pharmaceutical to further the global development, commercialisation and manufacture of fruquintinib outside of China. A US$400 million upfront payment and additional potential milestone payments could reach US$1.13 billion upon achieving regulatory, development and commercial sales milestones.  

HUTCHMED’s fruquintinib is now targeting second-line gastric cancer. A Phase III study, involving 703 patients, has shown a statistically significant impact in improving progression-free survival (PFS) when combined with another drug, paclitaxel. PFS is the length of time during and after the treatment of a disease wherein a patient lives with the disease but it does not get worse.

HUTCHMED has recently completed patient enrolment of ESLIM-01, the Phase III clinical trial of sovleplenib for the treatment of immune thrombocytopenia (ITP), an autoimmune disorder that can lead to increased risk of bleeding. ITP can often be serious and can have a significant, multifaceted impact on patients’ health and quality of life. Patients often become resistant to treatment over time and new treatment options are desperately needed. The drug has been granted Breakthrough Therapy Designation for ITP in China. It is also being studied for use in indolent non-Hodgkin’s lymphoma and multiple subtypes of B-cell malignancies.

HUTCHMED’s global Phase III registration trial of its colorectal cancer-fighting drug, fruquintinib, aims to gain the regulatory approvals needed to bring it to cancer patients around the world. A 14-country study is the next step in bringing new options to doctors and new hope to families struggling with cancer.  

Patient access to novel treatments just got easier in parts of China. HUTCHMED’s surufatinib (SULANDA® in China) has been approved in the Macau Special Administrative Region. This drug has benefited over 12,000 patients with neuroendocrine tumours in China.

HUTCHMED’s first in-licensed product tazemetostat (TAZVERIK®) has been approved for use in Hainan Boao Lecheng International Medical Tourism Pilot Zone under the Clinically Urgently Needed Imported Drugs scheme. TAZVERIK® is a first-in-class EZH2 inhibitor that has been approved by the US Food and Drug Administration (FDA) for the treatment of certain patients with follicular lymphoma and advanced epithelioid sarcoma, a type of blood cancer and soft-tissue cancer, respectively.  

Authorities in the Macau Special Administrative Region have approved the commercialisation of ELUNATE® (fruquintinib). ELUNATE® gained its first approval in Mainland China by the National Medical Products Administration (“NMPA”) in September 2018 for the treatment of metastatic colorectal cancer. It is estimated that more than 40,000 patients have benefited from this novel treatment since its launch. It is the first homegrown innovative oncology drug to be marketed in Macau based on NMPA approval.

A new wave of HUTCHMED innovation is also on the way. In January 2022, sovleplenib was granted Breakthrough Therapy Designation by the NMPA. The designation allows accelerated development of new drugs that treat life-threatening diseases or serious conditions which lack effective treatment options. Sovleplenib has demonstrated encouraging results in patients with immune thrombocytopenia (“ITP”), an autoimmune bleeding disorder that can often have a significant, multifaceted impact on patients’ health and quality of life. It is now being studied in a China Phase III trial on ITP, along with additional studies on lymphoma ongoing in China, the US and Europe.  

China’s National Reimbursement Drug List aims to make life-saving drugs accessible to citizens in Mainland China and has expanded the number of HUTCHMED medicines on the list. The latest to be included is SULANDA® (surufatinib), following its approval for the treatment of advanced pancreatic neuroendocrine tumours. This latest update of the list also renewed ELUNATE® (fruquintinib), first included in 2020, for the treatment of metastatic colorectal cancer.  

HUTCHMED is now a constituent stock in the FTSE Russell’s Global Equity Index Series (GEIS), including FTSE All-World, FTSE Global All Cap, FTSE Global Total Cap and FTSE Global Mid Cap Indexes. The GEIS monitors more than 16,000 stocks in over 70 countries representing 98% of global market cap, making it a key indicator of global stock market direction.  

HUTCHMED is the new brand for the innovative biopharmaceutical business formerly known as Hutchison China MediTech. The company recently launched a successful listing on the Stock Exchange of Hong Kong (adding to its London AIM and Nasdaq presence), under the venerable stock code 13, which had been held by Hutchison Whampoa. It is now included in over 10 indexes including the Hang Seng Composite Index, the main board listing in Hong Kong, in addition to the Hang Seng Healthcare Index, and the Hang Seng Hong Kong-Listed Biotech Index. Mainland investors also have access to the stock through the Shanghai-Hong Kong Stock Connect and Shenzhen-Hong Kong Stock Connect programmes.  

Orpathys® (savolitinib, for lung cancer) and Sulanda® (surufatinib, for neuroendocrine tumours) have both been approved for use and then launched in Mainland China this year. Both drugs are unique, novel therapies created by HUTCHMED. Orpathys® is the only targeted medicine approved for these biomarker-selected patients in the Mainland. Sulanda®’s two recent approvals make it the first-ever drug launched to counter neuroendocrine tumours regardless of tumour origin, and approvals are also being sought in major jurisdictions such as the US and Europe.  

HUTCHMED welcomes the approval of Surufatinib for the treatment of non-pancreatic neuroendocrine tumours. A 420-strong commercial team will now bring the drug – discovered and developed completely in-house – to doctors and patients across Mainland China to help fight cancer. It will be marketed under the brand name Sulanda®. The pharmaceutical innovator has also initiated a rolling submission of its New Drug Application to the US Food and Drug Administration.