CHENGDU, China, May 12, 2026
Kelun-Biotech announced that China’s Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for SKB118 (CR-001), a next-generation PD-1 x VEGF bispecific antibody being developed for the treatment of advanced solid tumors. The regulatory clearance represents a major milestone for Kelun-Biotech’s expanding immuno-oncology pipeline and supports simultaneous global clinical development of the therapy across China and international markets. SKB118 combines dual blockade of PD-1 immune checkpoint signaling and VEGF-mediated tumor angiogenesis, two of the most clinically validated pathways in modern oncology. The company believes the bispecific antibody has the potential to deliver synergistic anti-cancer activity while strengthening the effectiveness of combination therapies involving antibody-drug conjugates (ADCs) and other immunotherapies.
SKB118 Combines Immunotherapy and Anti-Angiogenic Mechanisms
According to Kelun-Biotech, SKB118 is a tetravalent bispecific antibody engineered to simultaneously target programmed cell death protein 1 (PD-1) and vascular endothelial growth factor (VEGF), integrating two complementary anti-cancer mechanisms into a single therapeutic molecule. PD-1 inhibition is designed to restore the immune system’s ability to recognize and destroy tumor cells by reactivating exhausted T cells, while VEGF blockade aims to suppress tumor blood vessel formation and inhibit cancer growth. The dual-targeting strategy has become one of the most promising approaches in immuno-oncology as researchers seek to improve response rates and overcome resistance associated with conventional checkpoint inhibitor therapies.
Kelun-Biotech reported that preclinical studies demonstrated strong anti-tumor activity and cooperative pharmacologic effects when both pathways were simultaneously inhibited. Researchers observed enhanced PD-1 binding and signaling blockade in the presence of VEGF, supporting the biological rationale behind the therapy’s bispecific design. The company also highlighted evidence suggesting that SKB118’s anti-VEGF activity may normalize tumor vasculature, potentially improving delivery and therapeutic activity of combination treatments such as antibody-drug conjugates (ADCs). This feature is considered strategically important because tumor vascular abnormalities often reduce penetration and efficacy of anti-cancer therapies within solid tumors.
The Chinese IND approval follows growing international development momentum for SKB118. In January 2026, Kelun-Biotech’s strategic partner Crescent Biopharma announced that the U.S. Food and Drug Administration (FDA) had cleared the IND application for SKB118/CR-001, enabling initiation of the global ASCEND Phase I/II clinical trial for patients with locally advanced or metastatic solid tumors. The ongoing study is expected to enroll up to 290 patients and will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of the therapy across multiple cancer types. The coordinated advancement of the program across China and the United States reflects increasing globalization of oncology drug development and rising collaboration between Chinese biotechnology firms and international clinical-stage companies.
Kelun-Biotech Expands ADC and Immuno-Oncology Strategy
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The SKB118 approval also reinforces Kelun-Biotech’s broader ADC plus immuno-oncology development strategy, which has become a central focus of the company’s global expansion efforts. In December 2025, Kelun-Biotech entered into a strategic collaboration agreement with Crescent Biopharma granting Kelun-Biotech exclusive rights to research, develop, manufacture, and commercialize SKB118 in Greater China, including Mainland China, Hong Kong, Macau, and Taiwan. Company executives stated that the collaboration allows both organizations to leverage complementary scientific and clinical development capabilities to accelerate advancement of the therapy globally.
Kelun-Biotech has rapidly emerged as one of China’s most active oncology biotechnology companies, particularly within the antibody-drug conjugate (ADC) sector. The company currently maintains more than 30 innovative drug programs spanning oncology, autoimmune disease, and metabolic disorders. According to the company, four projects covering eight indications have already received marketing approval, while multiple additional ADC and novel drug conjugate assets continue advancing through clinical development. Kelun-Biotech’s proprietary OptiDC™ platform is designed to support development of highly selective next-generation ADCs and novel drug conjugates with improved therapeutic index and tumor targeting.
Industry analysts believe combination strategies involving ADCs, checkpoint inhibitors, and bispecific antibodies may become increasingly important in oncology as companies pursue more effective multi-mechanistic treatment approaches capable of overcoming resistance in difficult-to-treat cancers. Kelun-Biotech executives stated that the company intends to actively explore combination regimens pairing SKB118 with its internal ADC portfolio to maximize synergistic therapeutic activity and expand treatment possibilities for patients with advanced solid tumors. As global investment in bispecific antibodies and next-generation immunotherapies continues accelerating, Kelun-Biotech aims to strengthen its position as a globally competitive innovator in precision oncology and targeted cancer therapeutics.
Source: Kelun-Biotech press release
