Antengene Announces XPO1 Inhibitor Selinexor Prescribed for the First Time in the Pilot Zone of Hainan Province and Authorized to be Expanded Beyond the Pilot Zone for Outpatient Treatment

With the official release and implementation of the Overall Plan for the Construction of Hainan Free Trade Port, patient can now access global innovative medicines in mainland China. Recently, the global first-in-class selective inhibitor of nuclear export (SINE) compound, selinexor (XPOVIO®), was prescribed for the first time in mainland China at the Boao Super Hospital in Boao Lecheng Pilot Zone and has been authorized to be expanded beyond the Pilot Zone for the outpatient treatment of relapsed or refractory multiple myeloma (rrMM). Prescribing selinexor for the first time in China is a significant milestone in changing the hematological cancer treatment landscape in the country as it allows Chinese patients access to this novel antitumor therapy, similar to patients in other parts of the world.

Numerous media outlets including People's Daily, The Paper, and Hainan News of Hainan TV have reported on the first prescription and the Name Patient Program (NPP) inclusion of selinexor, in recognition of the clinical significance of having this novel therapy accessible to patients in China. Among these media outlets, People.cn stated: "the first patient with rrMM treated with selinexor in the Pilot Zone responded well to the therapy with his condition already stabilized. Selinexor achieves its antitumor effects by precision targeting the underlying oncogenic pathways, and has a special mechanism of action compared to other approved therapies. Through the rapid clinical adoption of selinexor in Lecheng, Boao, a much-needed new treatment option has been made available to patients with MM in China."

Previously, Antengene initiated a Named Patient Program (NPP) in Hong Kong, S.A.R., China for dozens of patients with rrMM and relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL). After being prescribed at the Boao Super Hospital for the first time, the use of selinexor in such patients will now be a part of real-world research in China.

Multiple Myeloma (MM) and Diffuse Large B-Cell Lymphoma (DLBCL) are two of the common types of hematological malignancies in the world. MM is a kind of plasma cell hematologic cancer. In recent years, with the availability of autologous stem cell transplantations and introductions of newer therapies such as lenalidomide, the conventional treatment of MM continues to evolve. Although significant progress has been made in treatment, MM is still incurable, mainly due to primary drug resistance and disease recurrence. In China, patients with MM face a range of challenges including late or missed diagnosis, as well as lack of effective treatment options for relapsed patients to improve overall survival. DLBCL is an aggressive hematologic malignancy that accounts for around 50%-60% of all lymphoma incidences. About half of patients with DLBCL fail to reach complete remission after receiving first-line treatments, and approximately 60% of patients with rrDLBCL lack effective treatment options.

As a first-in-class SINE compound XPO1 inhibitor, selinexor has been approved by U.S. food and drug administration (FDA) for the treatment of rrMM and rrDLBCL, and was included into five recommended regimens by the National Comprehensive Cancer Network (NCCN®) Guidelines for the treatment of hematological malignancies. Being an oral drug requiring low dosing frequency, selinexor has the advantages of ease of use and high patient compliance. Enabled by the Interim Provisions on the Administration of Imported Drugs of Urgent Need in Boao Lecheng International Medical Tourism Pilot Zone of Hainan Province, selinexor has successfully entered into clinical application in mainland China, and became the world's first XPO1 inhibitor accessible to patients both inside and outside the country, while being authorized to be used beyond the Pilot Zone for outpatient treatment. As the company that initiated this introduction of selinexor through a collaboration with the Boao Super Hospital and Hainan Chengmei Medicine Co., Ltd., Antengene has provided patients in mainland China a reliable and convenient program to access an urgently needed therapy.

Hongxia Yao, Director of Hematological Lymphoma Department of Hainan Cancer Hospital, said: "This prescription marks the first clinical application of selinexor at the Boao Super Hospital. It is a testament to a clinical breakthrough made possible by the supporting policies of the Boao Lecheng International Medical Tourism Pilot Zone, and benefit it brings to patients. This patient with rrMM has received multiple lines of therapy, and unfortunately failed all of the approved therapies in mainland China. The special policy in Hainan has brought renewed hope to this patient, giving him the early access to a novel therapy that has already been approved abroad and the possibility of bringing the drug's use beyond the Pilot Zone for outpatient treatment."

About Antengene

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading clinical-stage R&D driven biopharmaceutical company focused on innovative medicines for oncology and other life-threatening diseases. Antengene aims to provide the most advanced anti-cancer medicines to patients in the Asia Pacific Region and around the world. Since its establishment in 2017, Antengene has built a broad and expanding pipeline of clinical and pre-clinical stage assets through partnerships as well as in-house drug discovery, and obtained 13 investigational new drug (IND) approvals and submitted 5 new drug applications (NDA) in multiple markets in Asia Pacific. Antengene's vision is to "Treat Patients Beyond Borders". Antengene is focused on and committed to addressing significant unmet medical needs by discovering, developing and commercializing first-in-class/best-in-class therapeutics.