Roche and KeChow to commercialise Zelboraf
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Roche and KeChow to commercialise Zelboraf

Shanghai Roche Pharmaceuticals and Shanghai KeChow Pharma, entered into a cooperation agreement to improve market access of Zelboraf in China.

  • By IPP Bureau | August 23, 2021

Zelboraf is an oral small molecule, selective BRAF inhibitor indicated for the treatment of patients with BRAF V600 mutation-positive advanced or inoperable melanoma. It is approved in more than 90 countries, and the first molecular-targeted oncology product approved by China's National Medical Products Administration (NMPA) for the treatment of patients with BRAF-V600E mutation melanoma.

Although melanoma is a rare malignant tumour in China, the mortality rate remains very high. The estimated incidence of melanoma in China was 0.4/100,000 in 1990 and 0.9/100,000 in 2017, an increase of more than 110% during this period. Approximately one-quarter of Chinese melanoma patients possess BRAF mutations. Advanced melanoma with activating BRAF mutations has been associated with an increased risk of death due to rapid disease progression.

Zelboraf specifically targets and blocks the activity of a mutated protein called BRAF, a molecule that helps regulate cell growth. Zelboraf interferes with abnormal BRAF signals to slow or stop out-of-control cell growth. Zelboraf is given orally with demonstrated efficacy and is well tolerated. In March 2017, Zelboraf was approved by NMPA and was successfully included in the NDRL in 2018.

The key objective of this cooperation agreement is to improve patients' access to Zelboraf in China. Adhering to "doing now what patients need next", Roche is a global leader in cancer treatments and is committed to exploring new cooperation models to accelerate new drug development to address key unmet medical needs. KeChow is committed to advancing best-in-class targeted therapies for the treatment of cancers and immune diseases by leveraging its extensive pharmaceutical R&D expertise. KeChow has dedicated significant resources to expand its core competencies in the research, development and commercialization of targeted oncology therapeutics. This cooperation will leverage the parties' expertise and dedicate resources to serve the unmet medical needs of Chinese melanoma patients.

"We are very excited to establish this collaboration with KeChow. The China market is a key part of Roche's global strategy. Roche has a long-term commitment to the China market and strives to deliver more first-class and differentiated drugs to China. We'd like to establish cooperation with emerging biopharmaceutical companies such as KeChow in China to accelerate the discovery and development of novel treatments as well as improve the accessibility of new medicines to Chinese patients," said Ms. Hong Chow, CEO of Roche Pharma China.

"We are very pleased to form this new cooperation with Roche, a global pioneer in pharmaceuticals and diagnostics. Roche is a leader in personalized healthcare and is the world's leading oncology biopharmaceutical company. KeChow is an emerging biotech focusing on advancing best-in-class small molecule oncology therapeutics by leveraging our extensive experience in drug discovery and development. Our lead product HL085, a novel ATP non-competitive MEK inhibitor, is currently in phase I/II clinical development in China and the United States. HL085 is designed to selectively target malignant tumours with RAF or RAS mutations, such as melanoma and NSCLC. We look forward to working closely with Roche to meet the unmet medical needs of Chinese melanoma patients in this cooperation agreement," said Dr. Tian Hongqi, Founder and Chairman of KeChow Pharma.

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