CHENGDU, China, July 27, 2026
Kelun-Biotech has announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for SKB565, the company’s first dual-payload antibody-drug conjugate (ADC), for the treatment of advanced solid tumors. The approval marks a significant milestone for Kelun-Biotech as SKB565 becomes the company’s first dual-payload ADC to enter clinical development, reinforcing its position among innovators developing next-generation targeted cancer therapies. Developed using the company’s proprietary OptiDC™ platform, SKB565 incorporates a unique dual-payload design that combines cytotoxic agents and immunomodulators within a single ADC molecule, enabling both direct tumor cell destruction and activation of the immune system inside the tumor microenvironment. This innovative approach is designed to overcome limitations associated with conventional single-payload ADCs by delivering stronger, longer-lasting anti-tumor responses while supporting the company’s broader “ADC + IO” strategy aimed at advancing precision oncology.
SKB565 Introduces Innovative Dual-Payload ADC Technology
Unlike traditional antibody-drug conjugates, which typically deliver only a single cytotoxic payload, SKB565 has been engineered with an advanced dual-payload mechanism capable of delivering both tumor-killing toxins and immune-activating molecules directly to cancer cells. Built on Kelun-Biotech’s proprietary OptiDC™ technology platform, the investigational therapy is designed to provide a dual antitumor mechanism, combining precise tumor targeting with activation of the body’s immune response within the tumor microenvironment. According to the company, this innovative molecular design has the potential to generate more durable therapeutic responses, improve treatment efficacy, and help overcome resistance commonly observed with existing ADC therapies. In preclinical studies, SKB565 demonstrated strong antitumor activity alongside a favorable safety profile, providing encouraging evidence supporting its progression into human clinical trials. The initiation of clinical development represents an important advancement in next-generation ADC innovation, an area experiencing rapid global investment across the oncology industry.
ADC + IO Strategy Strengthens Kelun-Biotech’s Oncology Pipeline
The advancement of SKB565 into the clinical stage further strengthens Kelun-Biotech’s expanding “ADC + IO” development strategy, which combines antibody-drug conjugates with immuno-oncology therapies to improve treatment outcomes across multiple cancer types. In addition to evaluating ADCs alongside PD-(L)1 monoclonal antibodies, the company is also investigating combinations involving its PD-1/VEGF bispecific antibody SKB118, while simultaneously developing integrated ADC molecules capable of delivering multiple synergistic therapeutic functions within a single drug. Company leadership emphasized that dual-payload ADCs represent one of the most promising next-generation technologies in oncology because they offer the opportunity to enhance efficacy while reducing the likelihood of drug resistance. Kelun-Biotech noted that SKB565 serves as one of the flagship programs demonstrating the successful translation of its proprietary technology platform into clinical development, validating years of investment in differentiated ADC research and expanding opportunities for future global collaborations.
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Clinical Milestone Highlights Growing Leadership in ADC Innovation
The approval of the IND application for SKB565 underscores Kelun-Biotech’s continued commitment to building one of the industry’s most comprehensive ADC development platforms. The company currently maintains more than 30 innovative drug programs, including multiple approved products, late-stage clinical candidates, and a broad pipeline of ADC and novel drug conjugate therapies targeting oncology, autoimmune disorders, and metabolic diseases. As demand continues to grow for precision oncology medicines, innovative dual-payload ADCs are increasingly viewed as an important evolution beyond conventional targeted therapies by combining multiple mechanisms of action within a single treatment. The clinical advancement of SKB565 highlights Kelun-Biotech’s expanding role in global cancer drug innovation while supporting the company’s mission to accelerate the development of transformative therapies capable of delivering meaningful clinical benefits for patients with advanced solid tumors worldwide.
Source: Kelun-Biotech press release
