China’s Genor Biopharma Co., Ltd (HKG: 6998) has announced that the National Medical Products Administration (NMPA) has declined its New Drug Application (NDA) for geptanolimab, a programmed-death 1 (PD-1) inhibitor, for the treatment of recurrent/refractory peripheral T-cell lymphoma (PTCL). The drug, which was under development to treat a range of solid tumor types, had previously received priority review status for its NDA in July 2020. The reasons for the rejection were not disclosed by the company, but it stated that “other clinical studies and overall candidate development will not be affected.”
Ongoing Clinical Studies for Geptanolimab
Genor Bio’s website indicates that geptanolimab is also being assessed in various other cancer types, including cervical cancer, rare sarcoma, primary mediastinal large B-cell lymphoma, and EGFR positive non-small cell lung cancer, as well as metastatic colorectal cancer in combination with fruquintinib. The continued development of geptanolimab for these indications reflects the company’s commitment to expanding its oncology pipeline.
Genor Bio’s Market Performance and Leadership Changes
Founded in 2007, Genor Bio has only one product approved for market, its biosimilar version of Johnson & Johnson’s Remicade (infliximab), known as GB242. The company debuted on the Hong Kong Stock Exchange in October 2020, but its share price has been on a downward trajectory since, with the company’s market cap currently standing at only HKD 911 million (USD 92 million). In a significant leadership change, Zhou Xinhua, the founder of Genor Bio, resigned from his position as group president and executive director in April of this year.-Fineline Info & Tech
