The NL002 project has received approval for Phase III clinical trials.

Category:

2012-03-08


Our company’s independently developed NL002 project recently received the Phase III clinical trial approval from the National Medical Products Administration (Approval No.: 2012L00474).


The NL002 project is a novel drug belonging to the therapeutic biological products category 1+9. It is a newly engineered variant of natural human interleukin-11. Its clinical indication is thrombocytopenia induced by cancer chemotherapy, and its effective dose is 7.5 μg/kg. Results from the Phase II clinical study show that this product (7.5 μg/kg), at one-third the dose of the positive-control drug (25 μg/kg), achieves the same therapeutic effect. Moreover, the incidence of adverse reactions is significantly lower than that observed with the positive-control drug. Thus, NL002 is a safe and effective medication with excellent development potential.


Currently, under the leadership of Principal Investigator Professor Song Santai and Director Wu Shikai (307th Hospital of the PLA), this project is actively preparing for the pre-trial activities. The trial is expected to be officially launched in May.

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