November 6, 2026 — Simcere Pharmaceutical Group (02096) announced today that the New Drug Application (NDA) for zemprocitinib—an orally administered, highly selective, second-generation JAK1 inhibitor developed in collaboration with Lynk Pharmaceuticals (Zhejiang) Co., Ltd. ("Lynk")—for the treatment of moderate-to-severe active rheumatoid arthritis (RA) has been officially accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). This marks the second indication for zemprocitinib to enter the registration review stage in China.
The application is primarily supported by positive results from a multicenter, randomized, double-blind, placebo-controlled Phase III study conducted in China. Led by Professor Xiaofeng Zeng of Peking Union Medical College Hospital, the study enrolled 430 patients with moderate-to-severe active RA who had an inadequate response to or were intolerant of prior biologic disease-modifying antirheumatic drugs (bDMARDs). Results demonstrated that zemprocitinib achieved statistically significant improvements over placebo in both the primary and key secondary endpoints (p < 0.0001), with a favorable overall safety and tolerability profile.
Long-term follow-up data further confirmed the durability of treatment benefits. Among patients who continued treatment through Week 76, ACR20 and ACR50 response rates were maintained at 91.8% and 80.5%, respectively. The ACR70 response rate increased from 52.5% at Week 52 to 62.4% at Week 76.
Sustained improvements were also observed in disease activity, as measured by DAS28-CRP (≤ 3.2), and physical function, as measured by HAQ-DI (improvement ≥ 0.22).
Zemprocitinib is a highly selective, orally administered, second-generation JAK1 inhibitor independently developed by Lynk and is being advanced for the treatment of inflammatory and autoimmune diseases, including RA, atopic dermatitis (AD), and ankylosing spondylitis (AS). Under a collaboration established in March 2022, Simcere obtained exclusive commercialization rights to zemprocitinib for RA and AS in mainland China, Hong Kong, Macau, and Taiwan. In November 2026, the parties expanded their collaboration, granting Simcere exclusive commercialization rights for AD and other dermatological indications.
Dr. Aik Goh, Chief Medical Officer of Simcere, said: "Treatment options are very limited for patients with RA who have an inadequate response to biologic therapies. The Phase III clinical data for zemprocitinib have demonstrated significant clinical benefits in this patient population. We look forward to working closely with Lynk Pharmaceuticals to bring this JAK1 inhibitor, with best-in-class (BIC) potential, to patients as soon as possible."
Dr. Zhao-Kui (ZK) Wan, Founder and CEO of Lynk Pharmaceuticals, said: "The acceptance of the NDA for zemprocitinib for the treatment of rheumatoid arthritis marks an important milestone for the company. The 76-week data are encouraging, demonstrating that zemprocitinib achieved favorable efficacy not only in patients who had an inadequate response to prior biologic disease-modifying antirheumatic drugs (bDMARDs), but also showed positive treatment effects in patients who had previously received JAK inhibitors. We look forward to working closely with regulatory authorities to advance the product toward approval and bring its benefits to more patients."
About Simcere
Simcere Pharmaceutical Group Limited（02096）is a pharmaceutical company driven by innovation and focusing on four therapeutic areas including Neuroscience, Oncology, Autoimmune Diseases and Infectious Disease. We proactively explore areas with significant unmet needs, and our mission is 'For patients, for life'. Driven by our in-house R&D efforts and synergistic innovation, Simcere has established strategic cooperation partnerships with many innovative companies and research institutes.
About Lynk Pharmaceuticals
Lynk Pharmaceuticals is a clinical-stage innovative drug company focused on autoimmune and inflammatory diseases, committed to addressing unmet clinical needs through first-in-class innovation, developing differentiated small-molecule therapies, and providing superior oral alternatives to biologics. The company was founded by senior R&D leaders from Pfizer, MSD, and Johnson & Johnson, focusing on the JAK-STAT and expanding to TYK2 signaling pathways, and mastering targeted protein degradation.
The company combines AI-assisted drug design, comprehensive biological evaluation, and protein degradation technologies into an integrated innovative R&D platform spanning target discovery, molecular design, translational research, and clinical development to advance differentiated therapies for patients worldwide. To date, Lynk Pharmaceuticals has successfully developed and progressed multiple Class 1 new drug candidates and advanced multiple pipeline programs through internal research and development as well as global partnerships.