#China #Chengdu #Kelun-Biotech #Trastuzumab Botidotin #HER2-Positive BC

Kelun-Biotech Triumphs in Oncology with Trastuzumab Botidotin

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. has made significant strides in oncology with the approval of its innovative drug, trastuzumab botidotin (A166). This antibody-drug conjugate (ADC) has recently gained marketing authorization from the National Medical Products Administration (NMPA) in China for the treatment of adult patients suffering from unresectable or metastatic HER2-positive breast cancer (BC) who have previously undergone one or more anti-HER2 therapies.

This landmark approval stems from a rigorous multi-center, randomized Phase 3 clinical study dubbed KL166-III-06. This trial compared the efficacy and safety profile of trastuzumab botidotin against T-DM1 in patients who were diagnosed with HER2-positive, unresectable, or metastatic BC. The results indicated a statistically significant enhancement in progression-free survival (PFS), a primary endpoint evaluated via blinded independent central review (BICR).

Additionally, a beneficial trend towards improved overall survival (OS) in patients treated with trastuzumab botidotin has also been observed. The detailed findings from this groundbreaking study are set to be shared at the esteemed 2025 European Society for Medical Oncology (ESMO) Congress in Berlin, further emphasizing the drug's clinical promise.

Dr. Michael Ge's Enthusiasm for Progress

Dr. Michael Ge, the CEO of Kelun-Biotech, expressed his excitement regarding this development, stating, "We are thrilled to see our first HER2 ADC drug, trastuzumab botidotin, successfully approved for market. This marks a significant advancement in the treatment of HER2-positive breast cancer."

The drug's innovative formulation, designed to target the HER2 receptor effectively, fits perfectly into an evolving therapeutic landscape that aims to cater to patients needing alternative treatments amid drug resistance challenges.

Understanding HER2-Positive Breast Cancer

HER2-positive breast cancer represents 15-20% of all breast cancer cases and is known for its aggressive nature. Consequently, it poses a substantial risk to women's health globally. Current treatment guidelines primarily recommend trastuzumab and pertuzumab in the first-line treatment in conjunction with taxane-based chemotherapy. Patients who progress to second-line treatments typically use tyrosine kinase inhibitors (TKIs) or other ADCs such as T-DM1.

As treatment continues to evolve and improve, patients often face issues such as drug resistance or adverse effects, demonstrating an acute demand for safer therapeutic alternatives. Trastuzumab botidotin aims to satisfy this need through its distinguished safety profile and unique mechanism of action.

The Role of Trastuzumab Botidotin

Trastuzumab botidotin employs a linkage of an innovative cytotoxic agent, Duo-5, to a HER2 monoclonal antibody. This structure allows for specific targeting and internalization by tumor cells, releasing the potent toxin that effectively induces apoptosis in cancer cells. Additionally, it possesses antibody-dependent cell-mediated cytotoxicity (ADCC) properties, further enhancing its anti-tumor capabilities.

A New Era for Kelun-Biotech

Kelun-Biotech has positioned itself at the forefront of biopharmaceutical innovation, focusing on major disease areas including solid tumors and autoimmune disorders. With over 30 ongoing drug projects, it has been a trailblazer in the development and commercialization of biologics in China.

The approval of trastuzumab botidotin not only reflects the company's commitment to addressing unmet medical needs but also signifies a groundbreaking achievement in the field of oncology. This approval sets the stage for numerous future endeavors in combatting HER2-positive breast cancer and solidifies Kelun-Biotech’s reputation as a leader in innovative therapeutics. For more details on their ongoing projects, visit Kelun-Biotech's website.