Haitai Biotechnology’s Epunaiming for Injection Initiates Phase IV Clinical Trial for Indications in Multiple Myeloma

The Drug Clinical Trial Registration and Information Disclosure Platform shows that the post-marketing prospective, non-interventional clinical study evaluating the safety of epoaeinming for injection in patients with relapsed or refractory multiple myeloma by Wuhan Haitai Bio-Pharmaceutical Co., Ltd. has been initiated. The clinical trial registration number is CTR20261061, and the date of the first disclosed information is 2026-03-25.

This drug is in the form of a lyophilized powder for injection. The dosage and administration are as follows: inject approximately 4 ml of sterile water for injection, 5% glucose injection, or 0.9% sodium chloride injection into each vial of this product, gently agitate until completely dissolved. Add the dissolved drug solution to 250 ml of 5% glucose injection or normal saline, administer via intravenous infusion, once daily. Each dose is 10 mg/kg. Administer on days 1–5 of each treatment cycle. One treatment cycle is 4 weeks. The primary objective of this trial is to observe the long-term safety of epoaeinming for injection in patients with relapsed/refractory multiple myeloma. The secondary objective is to observe the safety risks related to nickel ions and residual kanamycin in patients with relapsed/refractory multiple myeloma, as well as the safety of epoaeinming treatment in patients with hepatic or renal impairment.

Epoaeinming for injection is a biologic product. Its indication is multiple myeloma. Multiple myeloma is a malignant proliferative disease of plasma cells, mainly characterized by bone pain, anemia, and impairment of renal function. Diagnosis relies on examinations such as bone marrow aspiration and immunofixation electrophoresis, and treatment is mainly based on chemotherapy and targeted therapy.

The primary endpoints of this trial include adverse events occurring during all treatment periods (TEAE) and serious adverse events (SAE), as well as vital signs, physical examination, and laboratory test indicators. The secondary endpoints include TEAE and SAE in patients with hepatic or renal impairment, nickel ion concentration (in blood and urine) and kanamycin concentration (in blood), drug adverse reactions related to nickel ions and kanamycin, and patient self-assessment results (the elderly hearing impairment screening questionnaire (HHIE-S) and the visual analog scale (VAS)).

Currently, the trial status is ongoing (not yet recruiting), and the target enrollment is 700 patients.

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