Core Viewpoint - The article discusses a significant breakthrough in the treatment of systemic sclerosis (SSc) through the use of an iPSC-derived CD19/BCMA CAR-NK cell therapy, QN-139b, which has shown promising results in a patient with refractory diffuse cutaneous systemic sclerosis (dcSSc) [2][4][10]. Group 1: Research and Development - Systemic sclerosis is characterized by vascular abnormalities, immune activation, and progressive tissue fibrosis, presenting challenges in clinical treatment due to limited drug efficacy and high disease heterogeneity [2]. - The study published in Cell highlights the first successful clinical translation of iPSC-derived CAR-NK therapy in a patient with dcSSc, marking a global first in this area [3][4]. - QN-139b targets both CD19 and BCMA to eliminate pathogenic B cells and plasma cells, developed using a high-throughput gene editing technology platform [6]. Group 2: Clinical Application - A 36-year-old female patient with a 20-year history of severe dcSSc was treated with QN-139b, receiving a total of four doses [8][9]. - After six months of follow-up, the patient exhibited significant clinical improvement, including a notable decrease in autoantibodies and a reduction in the modified Rodnan skin score (mRSS) [9][10]. - The therapy demonstrated good overall safety, with no significant adverse effects reported during the treatment period [9][10]. Group 3: Expert Opinions - Professor Xu Huji, leading the clinical team, emphasized the strong research capabilities and technological platform of Qihang Biotech, expressing confidence in the partnership [12]. - Academician Pei Gang highlighted the innovative advancements in universal off-the-shelf cell therapies, indicating a new direction for treating autoimmune diseases [12][14]. - Dr. Yang Luhan, CEO of Qihang Biotech, expressed satisfaction with the clinical outcomes and reiterated the company's commitment to providing better solutions for patients with autoimmune diseases [13][14].

Core Viewpoint - The research highlights a significant breakthrough in the use of allogeneic CAR-T cell therapy for treating autoimmune diseases, specifically refractory systemic lupus erythematosus (SLE), demonstrating long-term remission and safety [2][3][4]. Group 1: Research Findings - The study published in Cell reported the successful use of allogeneic CD19-targeted CAR-T cells (TyU19) in treating refractory immune-mediated necrotizing myopathy and diffuse cutaneous systemic sclerosis, achieving long-term remission [1]. - In a subsequent study published in Med, the same CAR-T cell therapy was shown to effectively treat three patients with refractory SLE, leading to significant reductions in serum autoantibodies and achieving clinical remission as defined by the SRI-4 standard [3][6][7]. - The therapy demonstrated good tolerance, with no occurrences of graft-versus-host disease (GvHD), cytokine release syndrome (CRS), or immune effector cell-associated neurotoxicity syndrome (ICANS) reported during the study [9][10]. Group 2: Methodology and Safety - The clinical trial involved three patients with severe refractory SLE, where CAR-T cells were infused at a dose of 1 million cells per kilogram, and safety was assessed through the monitoring of potential adverse events [5][6]. - The CAR-T cells showed robust in vivo proliferation, peaking on day 14 post-infusion, and effectively eliminated B cells from the patients, leading to a significant decrease in B cell counts [6][9]. - The study utilized a low-intensity lymphocyte-depleting regimen, and even without pre-treatment lymphocyte clearance, TyU19 exhibited remarkable therapeutic efficacy, indicating a new potential pathway for treating autoimmune diseases [11].

Core Viewpoint - The biopharmaceutical sector is experiencing growth driven by innovation and increasing domestic demand, with significant developments in various therapeutic areas and technologies [1][2][3]. Group 1: Market Performance - The Biopharmaceutical ETF (512290) opened with a gain of 1.40% [1]. - The CS Biomedicine Index (930726), which the ETF tracks, reflects the overall performance of listed companies in the biopharmaceutical, medical device, and healthcare service sectors in China [1]. Group 2: Industry Developments - The biopharmaceutical sector is witnessing a recovery in exports, with Q1 2025 pharmaceutical exports reaching $26.632 billion, a year-on-year increase of 4.39%, and exports to the U.S. growing by 9.6% [2]. - Companies like Maiwei Biotech are advancing differentiated innovation in R&D, with key clinical studies underway for core products [1][2]. - New products in the biopharmaceutical space, such as the C-reactive protein testing kit by New Industry Biotech, are enhancing the company's product line [1]. Group 3: Innovation and Growth Potential - The global market for gout treatment is projected to reach 1.42 billion patients by 2030, with significant opportunities for new drugs targeting URAT1 [2]. - The cell therapy sector is making strides with universal CAR-T technologies showing breakthroughs in efficacy and cost-effectiveness [2]. - The medical device sector is transitioning from manufacturing to intelligent manufacturing, with new technologies like pulsed field ablation (PFA) improving surgical safety and efficiency [3].