Huiyu Pharmaceutical (688553.SH): Lanreotide Acetate Sustained-release Injection (Prefilled) Receives Drug Registration Certificate
Huiyu Pharmaceutical (688553.SH) announced that the company recently received the Drug Registration Certificate approved and issued by the National Medical Products Administration for its product Lanreotide Acetate Sustained-release Injection (Prefilled). The approved Lanreotide Acetate Sustained-release Injection (Prefilled) is classified as a Category 4 chemical drug, reviewed and approved in accordance with the technical requirements for consistency in quality and efficacy with the reference product, and upon approval is deemed to have passed the generic drug quality and efficacy consistency evaluation.
Huiyu Pharmaceutical (688553.SH) announced that the company recently received the Drug Registration Certificate approved and issued by the National Medical Products Administration for its product Lanreotide Acetate Sustained-release Injection (Prefilled). The approved Lanreotide Acetate Sustained-release Injection (Prefilled) has a registration classification of Class 4 chemical drug, and was reviewed and approved in accordance with the technical requirements for consistency in quality and efficacy with the reference product. Upon approval, it is deemed to have passed the generic drug quality and efficacy consistency evaluation.
It is reported that Lanreotide Acetate Sustained-release Injection (Prefilled) is a high-barrier complex sustained-release injection. Its main indications are: for the treatment of acromegaly when blood growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels remain abnormal after surgery and/or radiotherapy, or when surgery and/or radiotherapy cannot be performed; for adult patients with unresectable, well-differentiated or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival; for adult patients with carcinoid syndrome: when receiving this product, the frequency of emergency treatment with short-acting somatostatin analogues can be reduced.
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