The popularity of the autoimmune track is still in full swing…
1. Transactions in autoimmune
- On July 15, Otsuka Pharmaceutical Co., Ltd. announced that it had signed an asset acquisition agreement with Cantargia. Under the agreement, Otsuka will pay Cantargia US$33 million upon closing, and Otsuka will obtain exclusive global rights to develop, manufacture, and commercialize CAN10 and related assets. CAN10 is a monoclonal antibody targeting IL-1RAP and is currently in a Phase I clinical trial (NCT06143371) evaluating its safety and tolerability in healthy subjects. Existing data demonstrate that CAN10 inhibits IL-1β and IL-36 signaling. Otsuka Pharmaceutical Co., Ltd. plans to continue developing CAN10 for the treatment of autoimmune diseases.
- On July 24, Novartis announced a collaboration with Matchpoint Therapeutics to jointly develop novel small molecule covalent inhibitors of targeted transcription factors for the treatment of inflammatory diseases. Under the agreement, Novartis will pay an upfront payment of US$60 million and up to US$1 billion in milestones, including option fees. Matchpoint Therapeutics’ ACE technology platform integrates machine learning, chemical proteomics, and compound libraries to screen for covalent small molecule inhibitors of elusive targets. This collaboration represents a significant expansion of Novartis’s presence in the field of autoimmune small molecule drugs.
- On July 28, Hengrui Medicine announced a collaboration agreement with GSK to jointly develop up to 12 innovative drugs. Under the terms of the agreement, GSK will pay Hengrui Medicine an upfront payment of US$500 million. If all options are exercised and all milestones are achieved, Hengrui could potentially receive up to approximately US$12 billion in total. These co-development projects will be rigorously selected and aim to expand GSK’s established pipeline in respiratory, autoimmune and inflammatory diseases, and oncology therapeutic areas. These projects include HRS-9821, an innovative PDE3/4 inhibitor currently in clinical development for the treatment of chronic obstructive pulmonary disease (COPD). This drug has demonstrated potent PDE3 and PDE4 inhibition in early clinical and preclinical studies, significantly enhancing bronchodilator effects and producing anti-inflammatory effects.
- On July 28, Inmagene Biopharmaceuticals announced the completion of its reverse merger with Ikena Oncology. The merged company was renamed ImageneBio, Inc. and listed on the Nasdaq. ImageneBio’s core asset is the OX40-targeting monoclonal antibody IMG-007, currently in a Phase 2b clinical trial for moderate-to-severe atopic dermatitis. Through this reverse merger and PIPE financing, ImageneBio has secured over $175 million in funding. This program is expected to provide differentiated treatment options for patients with atopic dermatitis and expand into other immune-related indications.
- On July 28, Bristol-Myers Squibb (BMS) and Bain Capital announced the formation of a new, independent biopharmaceutical company (NewCo) focused on developing novel therapies for autoimmune diseases to address significant unmet patient needs. The newly formed NewCo company has five immunology assets licensed from BMS and a $300 million financing commitment led by Bain Capital. The five immunology assets include: iiafimetoran (an oral, potential best-in-class TLR7/8 inhibitor currently in Phase 2 clinical trials for SLE); BMS-986322 (an oral TYK2 inhibitor that successfully established proof of concept in a positive Phase 2 trial for plaque psoriasis); BMS-986326 (a novel, potential best-in-class IL-2 fusion protein currently in Phase 1 clinical trials for SLE and atopic dermatitis); BMS-986481 (a Phase 1 biologic targeting the IL-18 pathway); and BMS-986498 (a Phase 1 biologic targeting the IL-10 pathway).
2. The clinical progresses in Autoimmune
- On July 3, Legend Biotech registered its Phase 1 clinical trial of LUCAR-G19 for the treatment of autoimmune diseases on Clinicaltrials.gov. This Phase 1 trial plans to enroll 42 patients with relapsed or refractory autoimmune diseases and is expected to be initially completed in 2028. Indications covered in this Phase 1 trial include systemic lupus erythematosus, systemic sclerosis, ANCA-associated vasculitis, inflammatory myopathy, Takayasu arteritis, and IgG4-related disease. LUCAR-G19 is a non-gene-editing universal CAR-T technology platform independently developed by Legend Biotech. It utilizes endogenous TCR silencing technology to block complex formation by expressing proteins that specifically bind to TCR α/β subunits.
- On July 8, according to the China Center for Drug Evaluation (CDE) official website, AstraZeneca registered a Phase 1 clinical trial investigating AZD5492 for the treatment of autoimmune diseases. The trial aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD5492 following single-dose and step-wise dose escalation in adult subjects with systemic lupus erythematosus or idiopathic inflammatory myopathy. AZD5492 is the world’s first CD20/TCR/CD8 trispecific antibody. Its clinical trial application was submitted in China in August 2024 and it received its first clinical approval in October for the treatment of relapsed or refractory B-cell malignancies. In April 2025, the drug received further clinical approval in China for the treatment of systemic lupus erythematosus and idiopathic inflammatory myopathy, achieving a breakthrough from oncology to autoimmunity.
- On July 14, according to the official website of the CDE, Novartis’ gene therapy drug Zolgensma was proposed for priority review for the treatment of patients six months and older with spinal muscular atrophy (SMA) type 5q. Zolgensma is an adeno-associated virus (AAV) vector-based gene therapy developed by AveXis. Novartis acquired AveXis for $8.7 billion in 2018. The drug received its first FDA approval in May 2019 for the treatment of patients under two years of age with type 1 SMA. On July 15, according to the CDE official website, Huicun Medical’s HCL001 cell injection received clinical approval and plans to conduct research on the treatment of decompensated liver cirrhosis. HCL001 injection utilizes Huicun Medical’s proprietary small molecule chemical reprogramming technology to efficiently convert human hepatocytes into hepatic progenitor cells, which can directly differentiate into mature hepatocytes to supplement functional units. It also secretes growth factors such as HGF to promote liver tissue regeneration, achieving a dual effect of “cell replacement and microenvironment repair.”
- On July 15, Haisco Pharmaceutical announced that its clinical trial application for HSK47388 tablets had been approved by the FDA for the treatment of autoimmune diseases. Preclinical study results showed that HSK47388 inhibited inflammatory responses in rats in a dose-dependent manner, exhibited good tolerability, and had a wide safety window. This drug is a promising candidate for development and may offer a new treatment option for patients with autoimmune diseases.
- On July 22, Abivax announced positive Phase 3 results from two 8-week ABTECT induction trials of its core pipeline drug, obefazimod. In ABTECT-1 and ABTECT-2, obefazimod achieved placebo-adjusted response rates of 19.3% (p<0.0001) and 13.4% (p=0.0001), respectively, in patients with moderately to severely active ulcerative colitis. Obefazimod is a first-in-class, oral, small molecule miRNA-124 enhancer that selectively binds to and promotes the splicing of long noncoding RNAs, significantly increasing miR-124 expression. miR-124 can directly bind to STAT3 mRNA and inhibit its translational blockade, thereby blocking Th17 cell differentiation and reducing acute intestinal (or joint) inflammation. Obefazimod has demonstrated best-in-class potential and is expected to become a blockbuster product.
3. Trends of Autoimmune Companies
- On July 14th, the Hong Kong Stock Exchange announced that HUNAN MABGEEK BIOTECH’s IPO application had been accepted. MABGEEK BIOTECH focuses on the development of large-molecule drugs for autoimmune diseases. Its first pipeline drug, an IL-4R antibody, is in Phase III clinical trials, and subsequent pipeline drugs include TSLP antibodies, MASP-2 antibodies, IL-33 antibodies, and IL-1RA antibodies.
