Kelun-Biotech Secures Approval for Tagitanlimab in New Indication

Kelun-Biotech's Tagitanlimab Achieves Marketing Approval

Kelun-Biotech Biopharmaceutical Co., Ltd. has received significant news about the marketing authorization of its innovative drug tagitanlimab. This programmed cell death ligand 1 (PD-L1) directed monoclonal antibody is now approved to be used in combination with cisplatin and gemcitabine, specifically for the treatment of patients suffering from recurrent or metastatic nasopharyngeal cancer (NPC).

Clinical Study Highlights

The approval from the National Medical Products Administration (NMPA) relies on a comprehensive phase III clinical trial. This randomized, double-blinded, placebo-controlled study assessed the combined efficacy and safety of tagitanlimab when used alongside standard chemotherapy treatments. Led by Professor Shi Yuankai of the Cancer Hospital Chinese Academy of Medical Sciences, the study confirms the potential of this therapy to enhance patient outcomes.

Impressive Results in Patient Survival

According to the findings, data suggested that patients treated with tagitanlimab, cisplatin, and gemcitabine might experience enhanced progression-free survival (PFS) rates. The study showed that the median PFS for the drug combination was notably superior, with an impressive reduction in the risk of disease progression and mortality by 53%. The objective response rate (ORR) for this combination was 81.7%, compared to 74.5% for baseline chemotherapy.

Double the Duration of Response

Moreover, the results indicated that the median duration of response (DoR) for tagitanlimab was significantly longer — 11.7 months versus only 5.8 months for those in the control group. While median overall survival (OS) data is still being gathered, early trends suggest a favorable improvement for patients receiving the experimental therapy.

Second Indication Approved for Tagitanlimab

This marks the second indication for tagitanlimab, having previously gained approval for monotherapy in cases where patients experienced failure after prior treatments. Such recognition reinforces the drug's potential impact on treating NPC patients in different scenarios.

Leadership's Vision for the Future

Kelun-Biotech's CEO, Dr. Micheal Ge, expressed enthusiasm regarding this advancement, emphasizing the significance this new approval holds for patients battling NPC. He stated that this achievement reflects the company's dedication not just to scientific innovation but also fulfilling unmet clinical needs effectively.

Commitment to Continued Innovation

Looking into the future, Kelun-Biotech is determined to expand its research and development efforts, aiming to provide additional therapeutic options that can optimize patient care and enhance quality of life. The company is deeply invested in addressing critical medical needs on a broader scale.

About Kelun-Biotech

As a holding subsidiary of Kelun Pharmaceutical, Kelun-Biotech is focused on the R&D, manufacturing, and commercialization of advanced biological drugs and small molecules. The company is particularly dedicated to tackling major disease areas such as solid tumors, autoimmune conditions, and metabolic disorders. With over 30 innovative drug projects underway, Kelun-Biotech strives to lead in the innovative drug space while establishing a strong global presence in drug development.

Frequently Asked Questions

What is tagitanlimab used for?

Tagitanlimab is a PD-L1 monoclonal antibody used in combination with cisplatin and gemcitabine for treating recurrent or metastatic nasopharyngeal cancer.

What are the benefits of using tagitanlimab?

Tagitanlimab has been shown to improve progression-free survival, response rates, and duration of response compared to traditional chemotherapy.

Who led the clinical studies for tagitanlimab?

Professor Shi Yuankai of the Cancer Hospital Chinese Academy of Medical Sciences was the principal investigator for the clinical study assessing tagitanlimab.

Is tagitanlimab approved for other indications?

Yes, in addition to its recent approval for combination therapy, tagitanlimab was previously approved as a monotherapy for patients who were unsuccessful after 2L+ chemotherapy.

What is Kelun-Biotech's mission?

Kelun-Biotech aims to address unmet medical needs globally by advancing innovative therapies in various major disease areas.

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