Jiangsu Hengrui Pharmaceuticals Co., Ltd. is dedicated to discovering novel medicines and developing innovative therapies to address the unmet medical needs of patients around the world. During clinical development of new therapies, clinical trials are designed and conducted; eligible patients with cancer or other diseases can be enrolled into the trials and access the investigational products. Hengrui’s pipeline and ongoing clinical trials can be found through our website https://www.hengrui.com/en/index.html or an online clinical research database https://www.clinicaltrials.gov.

We are currently conducting early phase clinical trials of SHR-A2009, a novel antibody-drug conjugate directed against human epidermal growth factor receptor 3. The clinical trials are underway in patients with advanced solid tumors including non-small cell lung cancer.

We understand some patients may not be eligible for our clinical trials but wish to access the potential new therapies through expanded access. Expanded access, also known as “compassionate use” sometimes, per FDA’s introduction, is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. Further details about expanded access can be found at https://www.fda.gov/news-events/public-health-focus/expanded-access.

At this time, however, we could not offer expanded access use of SHR-A2009 beyond the clinical trials. By concentrating the resources on clinical trials to obtain regulatory approval, we aim to make our new therapy available to the broader patient population around the world as early as possible.

Pursuant to the 21st Century Cures Act, Hengrui may revise this policy at any time.