Methylene Blue Enteric Delayed-release Tablets Landed The First Prescriptions In The Country

Conceptis is pleased to announce that the first prescriptions for the innovative drug Levulan® (Methylene Blue Enteric Delayed-release Tablets) have recently been issued nationwide, marking the first oral Methylene Blue Enteric-coated Extended-Release Tablets to be formally introduced into clinical application in China.

The methylene blue enteric delayed-release tablets are intended for enhanced visualization of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy.

Methylene blue enteric delayed-release tablets are an oral diagnostic drug that utilizes a proprietary multi-matrix (MMXTM) technology to deliver the active substance directly to the colon with localized controlled release.

As an enhancer dye, Methylene blue enteric delayed-release tablets increase the contrast between colorectal lesions and healthy mucosa. Results from a Phase III clinical study in China showed that the product significantly increased the detection rate of non-polypoid colorectal lesions (primary study endpoint), thereby increasing the detection rate of dangerous lesions such as non-polypoid adenomas (secondary endpoint).

In addition, Methylene blue enteric delayed-release tablets are taken during the bowel preparation step to ensure that colorectal staining has been completed at the time of colonoscopy, potentially streamlining the colonoscopy procedure while increasing the detection rate of colorectal lesions, resulting in a more efficient colonoscopy and higher screening benefit.

According to the diagnosis and treatment data of the Gastrointestinal Endoscopy Branch of the Chinese Medical Association, in 2012, gastrointestinal examinations were completed in China totalling about 28 million cases, of which 5.83 million were colonoscopies.

In 2019, gastrointestinal examinations were completed in China, totalling about 38.73 million cases, an increase of 34.62% compared with 2012.

The China Expert Consensus on Early Diagnosis and Treatment of Colorectal Cancer (2023 Edition) recommends that the age group for colorectal tumour screening in China is 40-74 years old.

According to the China Statistical Yearbook (2023), the total population aged 40-74 in China is 643.36 million.

With the popularization of early colorectal cancer screening in China, it is expected that the number of colonoscopy units in China will still have large room for growth in the future.

Prevention is better than cure, and early diagnosis and removal of lesions are crucial.

In the face of growing demand, the launch of Leafland® provides an innovative solution for colorectal screening and disease management in China.

Methylene blue enteric delayed-release tablets were approved by the European Medicines Agency (EMA) in August 2020 for commercialization in the European Union under the trade name Lumeblue®.

Conceptis acquired exclusive licensing rights to the product on December 3, 2020, from Cosmo Technologies Ltd., a wholly owned subsidiary of Cosmo Pharmaceuticals NV.

After Leflan® was approved in China in June this year, Cosmo Pharmaceuticals worked closely with all business segments to achieve rapid importation of the first batch of the product and actively collaborated with existing gastroenterology products and resources to promote the commercialization and academic promotion of the product in an orderly manner and to facilitate the landing of the first batch of prescriptions for Leflan®.

Up to now, five innovative medicines from Kangzhe Pharmaceuticals have been successfully approved in China and entered into clinical application.

This achievement demonstrates Conceptis’ ability to continue to promote the transformation of innovation while highlighting Conceptis’ commitment to be medically driven and to fulfil its social responsibility as a corporate citizen.

In the future, Kanzhe Pharma will continue to adhere to the patient-centred approach, efficiently promote the clinical development and commercialization of innovative products, enhance the accessibility and affordability of innovative drugs, and benefit more patients.

Note: DengYueMed provides the latest pharmaceutical news and health insights. For treatment guidance, please consult your doctor.

References:

1. Gastrointestinal Endoscopy Division of the Chinese Medical Association (CMA)

2. Early Diagnosis and Treatment Group of the Oncology Branch of the Chinese Medical Association. Chinese expert consensus on early diagnosis and treatment of colorectal cancer (2023 edition)[J]. Chinese Medical Journal, 2023, 103(48): 3896-3908. DOI: 10.3760/cma.j.cn112137-20230804-00164

3. National Statistical Office. (2023). China Statistical Yearbook-2023. Retrieved from https://www.stats.gov.cn/sj/ndsj/2023/indexch.htm

However, DengYueMed offers this information as a guide, not a substitute for professional medical advice. Consult your doctor before any treatment.