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LNK01001 dosed to first patient for treatment of rheumatoid arthritis in the Phase III clinical study

Release time:2023-12-20

On December 20, 2023, Simcere Pharmaceutical Group Ltd. (HKEX:2096; “Simcere”) and Lynk Pharmaceuticals (Hangzhou) Co., Ltd., (“Lynk Pharmaceuticals”) announced that LNK01001, a highly selective JAK1 inhibitor jointly developed by Simcere and Lunk Pharmaceuticals, has been dosed to first patient in a Phase III clinical study for the treatment of rheumatoid arthritis (RA).

This study is a randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of LNK01001 in the treatment of moderate to severe active RA patients with inadequate response or intolerance to bDMARDs. It is led and conducted by Professor Zeng Xiaofeng from Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, with assistance from Simcere in multiple clinical study sites across China.

LNK01001 has previously undergone three phase II clinical studies in patients with RA, ankylosing spondylitis (AS), and atopic dermatitis (AD). To date, LNK01001 has been administered to more than 800 subjects for three indications worldwide, including approximately 100 subjects and more than 600 subjects in the Phase I clinical trial in Australia and China, respectively.

All the completed Phase II clinical studies have met their respective primary and secondary clinical endpoints and no relevant adverse reactions for JAK inhibitors, such as major adverse cardiovascular events, thrombosis, serious infections, or malignant tumors, were observed.


About Lynk Pharmaceuticals

Lynk Pharmaceuticals, a clinical stage company, was founded in 2018 by senior drug R&D experts and executives from Pfizer, Merck and Johnson & Johnson. Lynk Pharmaceuticals is dedicated to the discovery and development of innovative drugs for the treatment of cancer, as well as immune and inflammatory diseases. Driven by a higher goal, Lynk Pharmaceuticals aims to be a market leader to address unmet medical demands by the development of innovative therapies. To date, Lynk Pharmaceuticals has independently developed a number of Class I clinical innovative new drugs and launched a number of clinical studies globally.

For more information, please visit: www.lynkpharma.com