Information for medical professionals only.
Internet Drug Information Service Certificate Number: (Lu)-non-commercial-2018-0066
Kexing Biopharm's clinical trial application accepted for "Pegylated Human Granulocyte Colony-stimulating Factor Injection"
Release date:2022 - 08 - 02
Another good news! One more clinical trial application accepted
On the evening of August 1, 2022, Kexing Biopharm Co., Ltd. (hereinafter referred to as "the Company" or "Kexing Biopharm") announced that it had just received the Notice of Acceptance, an administrative license document issued by the National Medical Products Administration (hereinafter referred to as "NMPA"), indicating that its clinical trial application for "Pegylated Human Granulocyte Colony-stimulating Factor Injection" was accepted.
Main Contents of Notice of Acceptance
1. Product Name: Pegylated Human Granulocyte Colony-stimulating Factor Injection
2. Application Item: clinical trial for registration of drugs produced in China
3. Acceptance No.: CXSL2200346G
4. Indications: This product is intended for patients with non-bone marrow cancer to reduce the incidence of infections manifested as febrile neutropenia when treated with myelosuppressive anticancer drugs that are prone to cause clinically significant febrile neutropenia.
5. Dosage Form: injection
The promotion of the R&D of Pegylated Human Granulocyte Colony-stimulating Factor Injection will help the Company further optimize the product portfolio, enrich the product pipelines, enhance the overall R&D capability, and build up the long-term profitability.
Pegylated Human Granulocyte Colony-stimulating Factor Injection
The Pegylated Human Granulocyte Colony-stimulating Factor Injection is a long-acting human granulocyte colony- stimulating factor (G-CSF) preparation, obtained by the conjugation of polyethylene glycol with G-CSF produced by gene recombination technology. It is a biosimilar to the innovator product Neulasta?, with its molecular structure, formula, strength and indications consistent with those of the latter.
Compared to human granulocyte colony-stimulating factor injection, Pegylated Human Granulocyte Colony-stimulating Factor Injection prolongs the half-life, so as to reduce the frequency of administrations and improve the medication compliance.
Share to:
Scan Code Consultation