Roche and KeChow Reach a Cooperation Agreement

SHANGHAI,Aug. 20,2021 -- On August 2,2021,Shanghai Roche Pharmaceuticals Co.,Ltd. (hereinafter referred to as "Roche Pharma China" or "Roche") and Shanghai KeChow Pharma,Inc. (hereinafter referred to as "KeChow Pharma" or "KeChow") entered into a cooperation agreement to improve market access of Zelboraf® in China. Under this collaboration,KeChow will promote Roche's Zelboraf® in China.

Zelboraf® is an oral small molecule,selectiveBRAFinhibitor 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 tumor in China,the mortality rate remains very high[1]. 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 of time[2]. 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 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 inthe NDRL in 2018.

The key objective of this cooperation agreementis 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 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 theunmet medical needs ofChinese 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'dlike 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 accessibility of new medicines to Chinese patients," said Ms.Hong Chow,CEO of Roche Pharma China.

"We are very pleased to form this newcooperationwith 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 therapeuticsby 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 tumors 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,Founderand Chairman of KeChowPharma.

References:

[1] Chinese guidelines for diagnosis and treatment of melanoma 2018 (English version),National Health Commission of the People's Republic of China; Chin J Cancer Res. 2019 Aug; 31(4): 578–585.

[2] Int. J. Cancer. 2019 Oct; 147,692–701.

About Roche

Roche is a leading global biotechnology company headquartered in Switzerland with a history of 125 years. Combining our unique advantages in the fields of pharmaceuticals and diagnostics,we are committed to advancing science and improving people's lives through personalised healthcare. Established in 1994,as the first multinational pharmaceutical company setting up operations in Zhangjiang Hi-Tech Park,Roche Pharma China provides Chinese patients with breakthrough medicines in multiple key therapeutic areas,including oncology,infectious diseases and transplantation,and immunology diseases. So far it has 24 medicines covering 8 therapeutic areas in China. Among multinational pharma companies,Roche takes the lead in building and upgrading a complete pharma value chain covering early research,late phase product development,manufacturing and commercialisation. Meanwhile,Roche continues to work with the government,medical institutions and NGOs to explore innovative modes of cooperation and benefit more Chinese patients through a series of influential and sustainable initiatives.

About KeChow

Shanghai KeChow Pharma,Inc. is a clinical-stage biotech focusing on differentiated small molecule therapeutics for cancer. The company was founded by Dr. Hongqi Tian in 2014,and is headquartered in Shanghai Zhangjiang Pharmaceutical Valley.Since its inception,KeChow is committed to accelerate the discovery,development and commercializationof novel small molecule therapeutics through scientific innovation and by leveraging extensive pharmaceutical expertise from the management team. The company has a science driven corporate culture and is specialized in the development of best-in-class innovative therapeutics to address unmet medical needs of patients around the world.

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