#China #Chengdu #Kelun-Biotech #Tagitanlimab #SKB315

Kelun-Biotech's Revolutionary ADC Receives Approval

In a significant advancement in cancer therapy, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. has been granted approval from the National Medical Products Administration (NMPA) in China for its investigational new drug application for SKB315. This novel CLDN18.2-directed antibody-drug conjugate (ADC) is to be used in combination with tagitanlimab, an anti-PD-L1 monoclonal antibody. This therapy is aimed at treating patients with gastric cancer and gastro-esophageal junction cancer (GC/GEJC) as a first-line treatment option.

Overview of SKB315

SKB315 represents an innovative approach in treating advanced solid tumors. It utilizes a humanized monoclonal antibody directed at CLDN18.2, a target that is prominently expressed in select cancers. The ADC leverages a unique payload-linker, allowing for effective delivery and action at the tumor site. Prior studies on SKB315 in patients with CLDN18.2-expressing tumors, like pancreatic ductal adenocarcinoma, have shown promising results, setting the stage for this combination therapy.

The latest approval from the NMPA, issued on June 11, 2025, enables Kelun-Biotech to commence clinical trials that explore the synergistic effects of SKB315 and tagitanlimab. This combination is expected to address challenges posed by tumor heterogeneity, potentially enhancing patient outcomes in terms of survival and response rates.

About Tagitanlimab

Tagitanlimab, the first PD-L1 monoclonal antibody approved for the first-line treatment of nasopharyngeal carcinoma (NPC), plays a critical role in this therapeutic strategy. Approved for marketing in China, tagitanlimab is already in use in combination with cisplatin and gemcitabine for treating recurrent or metastatic NPC. It has also demonstrated efficacy when used alone for patients who have previously undergone chemotherapy.

The combination of SKB315 and tagitanlimab is anticipated to create a streamlined pathway for improving treatment protocols in GC/GEJC. Clinical trials in progress will assess how effectively this combination counteracts the aggressive nature of these cancers.

Rationale Behind the Combination

Contemporary cancer therapies are increasingly embracing combination strategies, particularly those that employ immune checkpoint inhibitors like PD-L1 inhibitors. Research has shown that these combinations can lead to a `synergistic effect`, where the combined action of both agents results in a greater efficacy than when administered independently.

This innovative combination therapy aims to enhance the body's immune response against cancer while inhibiting tumor growth. By targeting different aspects of the cancer's biology—through both direct cytotoxicity of the ADC and immune modulation from tagitanlimab—Kelun-Biotech hopes to improve survival outcomes for patients.

Kelun-Biotech's Commitment to Innovation

Kelun-Biotech has positioned itself at the forefront of biopharmaceutical innovation. With a keen focus on developing therapies for critical disease areas, the company actively conducts research in solid tumors, autoimmune disorders, inflammatory diseases, and metabolic conditions. Its mission is anchored in meeting unmet medical needs, both within China and internationally.

With over 30 innovative drug projects underway and the establishment of a proprietary ADC platform, OptiDC™, Kelun-Biotech is gaining recognition as a leader in the field of targeted therapies. The company is dedicated to advancing its projects, with three already approved for marketing, while others continue through various stages of clinical development.

Kelun-Biotech's innovative spirit reflects its commitment to enhancing treatment options and delivering hope to cancer patients worldwide. The recent approval of SKB315 in combination with tagitanlimab marks not only a significant milestone for the company but also a hopeful perspective for patients with gastric cancer worldwide.

For more information, visit Kelun-Biotech.