Kelun Biotech's PD-1 x VEGF bispecific antibody SKB118 new drug clinical trial application approved by CDE

On May 13, 2026, Sichuan Kelun Biotech Biopharmaceutical Co., Ltd. ('Kelun Biotech' or 'the Company', 6990.HK) announced that it had received a clinical trial notification 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) to treat advanced solid tumors.

In December 2025, Kelun Biotech entered into a strategic cooperation agreement with Crescent Biopharma ('Crescent') regarding SKB118/CR-001. Under this cooperation agreement, 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 that the U.S. Food and Drug Administration (FDA) had approved the IND application for SKB118/CR-001 to initiate its global ASCEND Phase I/II clinical trial (NCT07335497) targeting locally advanced or metastatic solid tumors. This study is ongoing and initially plans to enroll 290 patients.

Dr. Ge Junyou, CEO of Kelun Biotech, stated: 'We are delighted to see that the IND application for SKB118 in China has been smoothly approved, achieving synchronization between China and global clinical development. Since partnering with Crescent, both parties have efficiently driven the R&D of collaborative projects through close collaboration and complementary strengths. The company will actively explore the combination potential of SKB118 with its own ADC assets based on the ADC+IO strategy, maximizing the synergistic value of its product pipeline and expanding more treatment possibilities for cancer patients.'

About SKB118 (also known as CR-001)

SKB118 is a tetravalent bispecific antibody currently being developed for the treatment of solid tumors. It combines two complementary and proven mechanisms of action in oncology—PD-1 and VEGF blockade. Inhibition of the PD-1 checkpoint restores T-cell recognition and destruction of tumor cells, while VEGF blockade reduces blood supply to tumor cells and suppresses tumor growth. In preclinical studies, SKB118 demonstrated synergistic pharmacological effects by enhancing PD-1 binding and signal blockade in the presence of VEGF, showing robust anti-tumor activity. The anti-VEGF activity of SKB118 may also normalize blood vessels at tumor sites, potentially improving the accumulation and efficacy of combination therapies (e.g., with antibody-drug conjugates [ADCs]) in localized tumors.

About Kelun-Biotech

Kelun-Biotech Biopharmaceutical Co., Ltd. (referred to as 'Kelun-Biotech,' stock code: 6990.HK) is a majority-owned subsidiary of Kelun Pharmaceuticals, focusing on the research and development, production, commercialization, and international cooperation of innovative biotechnology drugs and small molecule drugs. The company targets unmet clinical needs globally and within China, with a primary focus on major disease areas such as oncology, autoimmune diseases, and metabolic disorders. It is building an international platform for drug research, development, and industrialization, striving to become a globally leading enterprise in the field of innovative drugs. The company currently has over 30 key innovative drug projects, among which four projects with eight indications have been approved for marketing, one project is at the NDA stage, and more than ten projects are in clinical trials. The company has successfully established OptiDC, an internationally recognized proprietary ADC and novel conjugate drug platform, with two ADC projects encompassing five indications approved for market launch, while multiple ADC or novel conjugate drug products are in clinical or preclinical research stages.

11K Views