Kelun-Biotech Receives Investigational New Drug Approval from CDE for SKB118, a PD-1 x VEGF Bispecific Antibody

CHENGDU, China, May 12, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) announced that it has received a clinical trial notice from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) approving the Investigational New Drug (IND) application for PD-1 x VEGF bispecific antibody SKB118 (also known as CR-001) for the treatment of advanced solid tumors.

In December 2025, Kelun-Biotech and Crescent Biopharma ("Crescent") entered into a strategic collaboration for SKB118/CR-001. Under the collaboration, Crescent granted Kelun-Biotech exclusive rights to research, develop, manufacture and commercialize SKB118/CR-001 in Greater China (including Mainland China, Hong Kong, Macau, and Taiwan). In January 2026, Crescent announced the regulatory clearance of the IND application for SKB118/CR-001 by the U.S. Food and Drug Administration (FDA) to initiate its global ASCEND Phase I/II clinical trial (NCT07335497) for the treatment of locally advanced or metastatic solid tumors. The trial is ongoing and expected to initially enroll up to 290 patients.

Dr. Michael Ge, CEO of Kelun-Biotech, stated: "We are pleased to see the approval of the IND application for SKB118 in China, which marks the simultaneous advancement of clinical development in China and globally. Since entering into the collaboration with Crescent, we have worked closely and leveraged complementary advantages with each other to efficiently drive the R&D of the collaborative product candidates. Based on our ADC+IO strategies, we will actively explore the potential of combining SKB118 with our proprietary ADC assets to unlock the synergistic value of our portfolio and expand more treatment possibilities for cancer patients."

About SKB118 (also known as CR-001)

SKB118 is a tetravalent bispecific antibody being developed for the treatment of solid tumors that combines two complementary, validated mechanisms in oncology via a blockade of PD-1 and VEGF. PD-1 checkpoint inhibition is aimed at restoring T cells' ability to recognize and destroy tumor cells, and blocking VEGF is intended to reduce blood supply to tumor cells and to inhibit tumor growth. In preclinical studies, SKB118 demonstrated cooperative pharmacology with increased binding to PD-1 and signal blockade in the presence of VEGF as well as robust anti-tumor activity. SKB118's anti-VEGF activity may also normalize the vasculature at the tumor site, which has the potential to improve the localization and effectiveness of combination therapies, such as in combination with antibody-drug conjugates (ADCs).

About Kelun-Biotech

Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical, which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects with 8 indications have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects with 5 indications approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://en.kelun-biotech.com/

SOURCE Kelun-Biotech