Warm congratulations to our parent company, Hiteck Bio, on the approval of its original Class 1 new drug, Saite (CPT), for market launch.

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According to the official website of the National Medical Products Administration, the parent company Wuhan Hiteck Biological Pharma Co., Ltd. (hereinafter referred to as “Hiteck Bio”) has applied for the approval of Epnamin for injection (brand name: Sha'ait®), which has been approved for marketing. The indication is for use in combination with thalidomide and dexamethasone for adult patients with relapsed or refractory multiple myeloma who have previously received at least two systemic treatment regimens.

Eptamin for Injection (brand name: Sha'ait®) is a recombinant circularly permuted human tumor necrosis factor-related apoptosis-inducing ligand (CPT), currently the only approved DR4/DR5 agonist (first-in-class) globally. The core technology underlying this product has been granted patent protection in multiple countries worldwide. CPT triggers intracellular caspase cascade reactions through the extrinsic apoptosis pathway, thereby exerting its antitumor effects. Currently, drugs targeting the same pathway are still in Phase I or II clinical trials overseas. The launch of Sha'ait® (CPT) will provide cancer patients with a new drug treatment option.

Multiple myeloma (MM) is a malignant disease characterized by the abnormal proliferation of clonal plasma cells. The number of newly diagnosed multiple myeloma patients worldwide continues to rise annually, making it the second most common malignant tumor of the hematological system. Despite significant progress in new drug development for multiple myeloma over the past decade, it remains an incurable hematological malignancy. Nearly all patients develop resistance to currently available anti-myeloma drugs, leading to disease recurrence. As the number of relapses increases, the prognosis for this patient population worsens, and treatment becomes increasingly challenging, characterized by greater difficulty in achieving remission and shorter remission durations. Therefore, there is an urgent need for more effective treatment options for relapsed or refractory multiple myeloma. Eptifibatide for injection (brand name: Sha'ait®) is currently the only approved DR4/DR5 agonist globally, with a completely different mechanism of action compared to previous drugs, offering patients a new treatment option.

Hiteck Bio will bring hope to patients with multiple myeloma and other cancers with its innovative new drug Sha'ait® (CPT), offering Chinese doctors a new treatment option to improve patient quality of life and contribute to the fight against disease. The company will steadfastly uphold its corporate mission of “respecting life and fearlessly innovating,” and practice its corporate values of “integrity, gratitude, professionalism, and progress,” striving to build Haitai Bio into a leading pharmaceutical company!

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