Investment accounts
Adult accounts
Child accounts
Choosing Fidelity
Choosing Fidelity
Why invest with us Current offers Fees and charges Open an account Transfer investments
Financial advice & support
Fidelity’s Services
Fidelity’s Services
Financial advice Retirement Wealth Management Investor Centre (London) Bereavement
Guidance and tools
Guidance and tools
Choosing investments Choosing accounts ISA calculator Retirement calculators
Share dealing
Choose your shares
Tools and information
Tools and information
Share prices and markets Chart and compare shares Stock market news Shareholder perks
Pensions & retirement
Pensions, tax & tools
Saving for retirement
Approaching / In retirement
Approaching / In retirement
Speak to a specialist Creating a retirement plan Taking tax-free cash Pension drawdown Annuities Investing in retirement Investment Pathways
Hutchmed gets tazemetostat new drug application approved in China
(Sharecast News) - Hutchmed China announced on Thursday that the China National Medical Products Administration (NMPA) has accepted its new drug application (NDA) for tazemetostat, granting it priority review for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).
The AIM-traded firm said tazemetostat, developed by Epizyme, an Ipsen company, is a first-in-class methyltransferase inhibitor of EZH2.
It was already approved by the US Food and Drug Administration (FDA) for certain patients with R/R FL and advanced epithelioid sarcoma (ES) under the FDA's accelerated approval programme.
Additionally, the drug was approved by the Japan Ministry of Health, Labour and Welfare for specific R/R FL patients.
Hutchmed's strategic collaboration with Epizyme was focussed on the research, development, manufacturing, and commercialisation of tazemetostat in China, Hong Kong, Macau, and Taiwan.
The NDA in China was supported by data from a multicentre, open-label, phase two bridging study conducted in China, along with clinical studies by Epizyme outside of China.
Tazemetostat had been available in the Hainan Boao Lecheng International Medical Tourism Pilot Zone since May 2022 under the 'Clinically Urgently Needed Imported Drugs' scheme, for certain ES and FL patients consistent with the FDA-approved label.
The drug received approval in Macau in March last year, and in Hong Kong in May this year.
At 1434 BST, shares in Hutchmed China were down 1.13% at 270.9p.
Reporting by Josh White for Sharecast.com.
Share this article
Related Sharecast Articles
Important information: This information is not a personal recommendation for any particular investment. If you are unsure about the suitability of an investment you should speak to one of Fidelity’s advisers or an authorised financial adviser of your choice. When you are thinking about investing in shares, it’s generally a good idea to consider holding them alongside other investments in a diversified portfolio of assets. Past performance is not a reliable indicator of future returns.
Award-winning online share dealing
Search, compare and select from thousands of shares.
Expert insights into investing your money
Our team of experts explore the world of share dealing.
Policies and important information
Accessibility | Conflicts of interest statement | Consumer Duty Target Market | Consumer Duty Value Assessment Statement | Cookie policy | Diversity, Equity & Inclusion | Doing Business with Fidelity | Diversity, Equity & Inclusion Reports | Investing in Fidelity funds | Legal information | Modern slavery | Mutual respect policy | Privacy statement | Remuneration policy | Security | Statutory and Regulatory disclosures | Whistleblowing policy
Please remember that past performance is not necessarily a guide to future performance, the performance of investments is not guaranteed, and the value of your investments can go down as well as up, so you may get back less than you invest. When investments have particular tax features, these will depend on your personal circumstances and tax rules may change in the future. This website does not contain any personal recommendations for a particular course of action, service or product. You should regularly review your investment objectives and choices and, if you are unsure whether an investment is suitable for you, you should contact an authorised financial adviser. Before opening an account, please read the ‘Doing Business with Fidelity’ document which incorporates our client terms. Prior to investing into a fund, please read the relevant key information document which contains important information about the fund.
This website is issued by Financial Administration Services Limited, which is authorised and regulated by the Financial Conduct Authority (FCA) (FCA Register number 122169) and registered in England and Wales under company number 1629709 whose registered address is Beech Gate, Millfield Lane, Lower Kingswood, Tadworth, Surrey, KT20 6RP.
