Lynk Pharmaceuticals Announces NMPA Acceptance of New Drug Application for Zemprocitinib in the Treatment of Rheumatoid Arthritis

SHANGHAI and HANGZHOU, China and BOSTON, Nov. 6, 2026 /PRNewswire/ -- Lynk Pharmaceuticals Co., Ltd. ("Lynk Pharmaceuticals"), a clinical-stage innovative drug development company focused on immune and inflammatory diseases, announced that the New Drug Application (NDA) for its core product, zemprocitinib capsules, for the treatment of moderate-to-severe active rheumatoid arthritis (RA) was formally accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) on November 4. This acceptance marks the advancement of zemprocitinib into the regulatory review stage for rheumatoid arthritis, with the potential to offer a new oral treatment option for patients with an inadequate response to biologics.

The NDA submission is supported by positive results from a randomized, double-blind, placebo-controlled Phase III clinical trial conducted across multiple centers in China. The study enrolled 430 adult patients with moderate-to-severe active RA who had an inadequate response or intolerance to prior biologic disease-modifying antirheumatic drugs (bDMARDs). The study demonstrated statistically significant efficacy advantages for zemprocitinib over placebo across the primary and key secondary endpoints (p<0.0001), with an overall favorable safety and tolerability profile.

Long-term follow-up data further confirm the sustained clinical benefit of zemprocitinib. Among patients receiving continuous treatment through Week 76, ACR20 and ACR50 response rates were maintained at 91.8% and 80.5%, respectively, while the ACR70 response rate increased to 62.4%. Additionally, zemprocitinib demonstrated durable and consistent efficacy in disease activity endpoints (DAS28-CRP ≤3.2) and physical function improvements (HAQ-DI improvement ≥0.22).

Differentiated Advantage: Clinical Value of a Highly Selective JAK1 Inhibitor

Zemprocitinib is a second-generation, highly selective oral JAK1 inhibitor with best-in-class potential. Compared with earlier-generation JAK inhibitors with lower selectivity, zemprocitinib has greater selectivity for JAK1, potentially reducing safety risks associated with off-target effects while maintaining efficacy. Preclinical and clinical study results have shown that zemprocitinib can potently inhibit multiple JAK1-related inflammatory signaling pathways in a dose-dependent manner. Across completed or unblinded clinical studies, zemprocitinib has demonstrated an overall favorable safety and tolerability profile, with rates of serious adverse events and adverse events of special interest (AESIs) comparable to those in the placebo group, as well as favorable laboratory safety parameters.

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 Zemprocitinib

Zemprocitinib is an investigational, highly selective, oral second-generation Janus Kinase 1 (JAK1) inhibitor currently being developed for inflammatory and autoimmune conditions, including rheumatoid arthritis, ankylosing spondylitis and atopic dermatitis. In addition to the NDA acceptance for RA, the NDA for zemprocitinib in moderate-to-severe atopic dermatitis was accepted for review by the CDE in April 2026. Lynk Pharmaceuticals has entered into a commercialization collaboration with Simcere to jointly advance the development and commercialization of zemprocitinib across rheumatology (rheumatoid arthritis, ankylosing spondylitis) and dermatology indications.

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.

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SOURCE Lynk Pharmaceuticals Co., Ltd.