科伦博泰首个双载荷ADC SKB565获NMPA临床试验通知书

Kelun-Biotech Receives a Clinical Trial Notice for Its First Dual-payload ADC SKB565
CHENGDU, China, July 27, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) today 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 its novel dual-payload ADC drug, SKB565, for the treatment of advanced solid tumors. This marks the Company's first dual-payload ADC to enter the clinical stage.
SKB565 is developed using the Company's proprietary OptiDC™ platform. Featuring an innovative dual-payload design, SKB565 enables the direct delivery of toxins and immunomodulators, two kinds of payload with complementary mechanisms of action, to tumor tissue. Compared with conventional ADCs carrying only toxins, SKB565 has a dual antitumor mechanism: it precisely targets and kills tumors while activating the immune system within the tumor microenvironment to elicit an antitumor immune response, bringing enhanced and more durable antitumor efficacy. In preclinical studies, SKB565 demonstrated excellent antitumor activity and safety, with its outstanding therapeutic potential to support further clinical development.
Leveraging technological expertise and platform advantages in the ADC field, Kelun-Biotech has established a diversified pipeline of innovative molecules featuring high-value targets, differentiated designs, and global potential. Building on this foundation, the Company continues to advance its "ADC + IO" strategy—on one hand by actively exploring high-quality combination regimens, including multiple ongoing clinical studies evaluating ADCs in combination with PD-(L)1 monoclonal antibodies, as well as the PD-1/VEGF bispecific antibody SKB118 in combination with its proprietary ADC portfolio; on the other hand, the Company is advancing integrated drug design strategies by incorporating synergistic functional components into a single ADC molecule.
Dr. Michael Ge, CEO of Kelun-Biotech, said, " SKB565 is one of the core representative drugs of our integrated 'ADC + IO' strategy, leveraging the synergistic mechanism of its dual payloads to enhance efficacy and overcome drug resistance. Dual-payload ADCs are emerging as one of the key next-generation innovations in the ADC field. The advancement of SKB565 into clinical stage not only marks an important milestone in the achievements transformation of our technology platform, but also substantiates the continued deepening of our innovation capabilities in ADCs. We will actively advance the clinical development of novel drug conjugates such as SKB565, striving to deliver greater benefits to patients with cancer as soon as possible."
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