FDA Approves Kelun-Biotech's New ADC Drug SKB518 IND

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., based in Chengdu, China, has recently achieved a significant milestone in its drug development efforts. The company announced that it has received clearance from the United States Food and Drug Administration (FDA) for its investigational new drug (IND) application, allowing the commencement of clinical trials for its pioneering ADC drug, SKB518. This announcement follows prior approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in June 2024, which approved the IND application for SKB518 targeting advanced solid tumors. Currently, Phase 1 of the clinical trial for SKB518 is underway in China.

SKB518 stands out as an innovative antibody-drug conjugate (ADC) with a potentially first-in-class target, underpinned by the company's proprietary intellectual property rights. Developed using Kelun-Biotech’s "OptiDCTM" platform, SKB518 has shown promising results in preclinical studies, indicating both efficacy and a favorable safety window. This novel drug aims to offer a new treatment avenue for individuals suffering from advanced solid tumors, an area where treatment options are often limited.

Kelun-Biotech is a subsidiary of Kelun Pharmaceutical and is listed on the Hong Kong Stock Exchange under the symbol 6990.HK. As a company, Kelun-Biotech specializes in the research, development, manufacturing, and commercialization of innovative biological and small molecule drugs. The company is particularly focused on addressing major disease areas such as solid tumors, autoimmune conditions, inflammatory diseases, and metabolic disorders. By building a global platform for drug development and industrialization, Kelun-Biotech seeks to meet the unmet medical needs both in China and worldwide.

The company is working towards establishing itself as a leading player in the global field of innovative drugs. Currently, Kelun-Biotech has more than 30 innovative drug projects in various stages of development. Three of these projects have already been approved for marketing, one is in the New Drug Application (NDA) stage, and over ten other projects are in the clinical trial phase. A key component of their research portfolio includes their proprietary ADC platform, OptiDC™, which is recognized as one of the leading platforms globally. Within this framework, Kelun-Biotech has one ADC project approved for marketing and another in the NDA stage, while multiple projects are either in clinical trials or preclinical research.

Kelun-Biotech’s focus on building a diversified and robust pipeline is indicative of its commitment to innovation and addressing critical health challenges. The IND clearance from the FDA for SKB518 not only highlights the company’s progress in developing innovative therapies but also marks an essential step towards its aspirations of becoming a global leader in the pharmaceutical industry. As Kelun-Biotech advances its portfolio, its efforts are poised to have a significant impact on the treatment landscape for various diseases, offering hope to patients with limited options.