Kexing Biopharm’s Biologics License Application for Long-Acting G-CSF Candidate GB-K02 Accepted for Review

SAN DIEGO, Oct. 16, 2026 (GLOBE NEWSWIRE) -- Kexing Biopharm (688136.SH) recently announced that it has received a Notice of Acceptance from China’s National Medical Products Administration (NMPA) for the biologics license application (BLA) for GB-K02, its self-developed PEGylated human granulocyte colony-stimulating factor (G-CSF) injection.

A Complementary Portfolio of Short- and Long-Acting G-CSF Products

Kexing Biopharm has established a strong presence in the G-CSF market with WHITE-C^®, its short-acting human G-CSF injection, supported by an established brand and mature sales channels. As treatment options evolve toward longer-acting formulations, the Company has developed GB-K02 to complement its existing product. GB-K02 is intended for patients with non-myeloid malignancies receiving myelosuppressive anti-cancer therapy. It is designed to reduce the risk of infection associated with febrile neutropenia (FN).

By extending the drug’s half-life, GB-K02 may reduce dosing frequency compared with traditional short-acting products, potentially improving treatment adherence. It is also intended to help prevent FN and shorten the duration of Grade 3 and Grade 4 neutropenia.

If approved, GB-K02 would join WHITE-C^® to form a differentiated portfolio of long- and short-acting G-CSF products, strengthening Kexing Biopharm’s position in this therapeutic area.

Building a Differentiated Oncology Pipeline

Cancer treatment is often accompanied by neutropenia, erythropenia and thrombocytopenia. These adverse reactions may limit treatment intensity, disrupt scheduled courses of therapy and, in some cases, lead to serious infections. G-CSF therapy is one option for managing neutropenia, a common complication of cancer treatment. As cancer care advances and greater emphasis is placed on patients’ quality of life, long-acting G-CSF offers the convenience of less frequent dosing and may help patients stay on schedule with their treatment.

In recent years, Kexing Biopharm has advanced multiple research and development programs across oncology, autoimmune diseases and antiviral therapies. In addition to GB-K02, its oncology pipeline includes GB18, a GDF-15-targeted candidate for cancer cachexia currently in Phase I clinical development. Kexing Biopharm is also advancing several innovative antibody programs, including GB25 for colorectal cancer and GB23 and GB27 for solid tumors, further strengthening its diversified oncology pipeline.

Kexing Biopharm’s in-licensed products for international markets—including albumin-bound paclitaxel, bevacizumab and sorafenib tosylate tablets—have received marketing approvals in several countries, broadening its oncology portfolio across multiple indications.

Acceptance of the GB-K02 BLA marks a key step toward potential commercialization and, if approved, would further diversify Kexing Biopharm’s product portfolio.

Media contact: 
Kexing Biopharm 
Zheng Haiyan 
zhenghaiyan@kexing.com 
https://www.kexingbiopharm.com/