最新动态
概要
2019年1月11日
Commencement of FiH Healthy Volunteer Study

The First-in-Human (FiH) healthy volunteer study to evaluate safety on the use of YQ23 has commenced on 11 Jan 2019. This study is mainly to assess the safety, tolerability and pharmacokinetics (PK - the amount of study drug in the blood) of ascending single dose of YQ23 in healthy male and female subjects. The clinical trial is conducted at a Phase 1 centre in UK and will enroll approximately 40 subjects.

2016年7月11日
Approval of Clinical Trial Application in HK

New β Innovation receives approval from the Hong Kong Department of Health (DoH) to proceed with a Phase 1 Clinical Trial (First-in-Patient) of YQ23 in patients with advanced tumors.

2016年3月21日
EMA Orphan Medicinal Product Designation

YQ23 has been granted the Orphan Medicinal Product Designation by the EMA for the treatment of oesophageal cancer.

2015年10月13日
Approval of Clinical Trial Application in UK

New β Innovation receives UK Medicines and Healthcare products Regulatory Agency (MHRA) approval to proceed with a Phase 1 Clinical Trial (First-in-Human) of YQ23 in healthy volunteers.

2014年11月19日
EMA Orphan Medicinal Product Designation

YQ23 has been granted the Orphan Medicinal Product Designation by the EMA for the treatment of hepatocellular carcinoma.

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