On May 16, 2023, breakthroughs were recorded for Phase II clinical study of the selective JAK1 inhibitor LNK01001 cooperatively introduced by Simcere Pharmaceutical and Lynk Pharmaceuticals (Hangzhou) Co., Ltd. (hereinafter referred to as “Lynk Pharmaceuticals”) and it promises to be a safer and more effective treatment option for patients.
Rheumatoid arthritis (RA) is a common chronic, highly-disabling autoimmune disease that is recurrent and progressively aggravated, with its pathogenesis still unclear. Simcere Pharmaceutical (2096.HK) focuses strategically on treatment of autoimmune diseases because there are about 5 million RA patients in China and over 60% are in the active stage, with clinical treatment needs far from being met. For the moment, RA is still not curable and clinical treatment is undertaken primarily to control disease symptoms, slow down disease progression, reduce the rate of disability, and improve prognosis and the quality of life of patients.
On March 18, 2022, Simcere Pharmaceutical and Lynk Pharmaceuticals entered into a strategic business cooperation to introduce the selective JAK1 inhibitor LNK01001. According to the agreement, Lynk Pharmaceuticals is responsible for the development of LNK01001, and Simcere Pharmaceutical, after paying the consideration of full commercial rights, will receive exclusive commercial rights for LNK01001 in China for two indications of RA and ankylosing spondylitis and take charge of post-market promotion.
JAK1, an important member of the Janus kinase (JAKs) family of intracellular non-receptor tyrosine kinases, is closely associated with the development of various autoimmune diseases. Multiple JAK inhibitors have been on the market for autoimmune diseases and the JAK inhibitor market will reach $30.5 billion by 2030, predicted by Frost & Sullivan. LNK01001 is a highly selective JAK1 inhibitor that can selectively inhibit JAK1 without crossing over onto other JAK subtypes, particularly JAK2 enzyme. Preclinical data showed that LNK01001 was more selective and potentially safer than JAK inhibitors available on the market, promising to be a safer and more effective novel treatment option.
This study was a multi-center, randomized, double-blind, placebo-controlled Phase II clinical trial led by Professor Zeng Xiaofeng, the director of the Department of Rheumatology and Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences. The study showed that both low dose and high dose groups of LNK01001 improved patient conditions markedly and the efficacy exceeded all projected primary and key secondary endpoints after 12 weeks of treatment, showing statistically significant differences in efficacy compared with placebo. ACR20* rates of both low dose and high dose groups reached over 90% after 24 weeks of treatment. Additionally, the overall safety and tolerability of the investigational drug was very good. The majority of treatment-emergent adverse events (TEAEs) were mild, with no serious adverse advents (SAEs) reported in the investigational drug groups.
Simcere Pharmaceutical is excited about the significant therapeutic effects of LNK01001 in the treatment of patients with RA and looks forward to giving full play to respective strength in the cooperation with Lynk Pharmaceuticals to shorten the time-to-market, thus providing a safer and more effective treatment option for 5 million patients with RA in China.
[*] ACR20 response criteria
A 20% improvement in sore and swollen joint counts (28) and an improvement in the following 3 of 5 measures:
①VAS scores of subject accessed pain
②VAS scores of subject accessed general conditions
③VAS scores of investigator accessed general conditions
④Health Assessment Questionnaire (HAQ)
⑤Acute phase reactant (erythrocyte sedimentation rate or C-reactive protein)