Recent Articles in Trials & Approvals

Shanghai Tyligand Bioscience has dosed the first patient in a US Phase I/II trial of a small molecule candidate that targets KRAS G12D mutant solid tumors. The candidate, TSN1611, is a highly selective and orally bioavailable small molecule that targets the KRAS G12D mutation, engaging both the ON-state (GTP-bound) and OFF-state (GDP-bound) of KRAS G12D. TSN1611 has demonstrated in vivo anti-tumor activity with a durable response across multiple animal models, along with potential to penetrate the brain. Tyligand is approved to start similar China trials. More details....

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Suzhou Innovent Biologics said its NDA for IBI311, a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody, was accepted for review in China to treat Thyroid Eye Disease (TED). Innovent is the first company to file an NDA in China for an anti-IGF-1R antibody aimed at TED, an autoimmune disease that causes progressive inflammation and damage to tissues around the eyes. IBI311 is a biological drug with a novel mechanism of action. Innovent expects the candidate will be approved as a first-line therapy for TED, which does not have an effective therapy currently. More details....

Stock Symbol: (HK: 01801)

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Yantai’s RemeGen (HK: 9995: SHA: 688331) announced that two China Phase III trials for Telitacicept (RC18) have completed enrollment, one for IgA nephropathy and the other for primary Sjögren's syndrome (pSS). Telitacicept is a proprietary novel fusion protein aimed at treating autoimmune diseases. It targets two cell-signaling molecules critical for B-lymphocyte development: B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL) that reduces B-cell mediated autoimmune responses implicated in several autoimmune diseases. Telitacicept was granted China approval for systemic lupus erythematosus in 2023. More details....

Stock Symbols: (HK: 9995: SHA: 688331)

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Beijing InnoCare Pharma has completed the enrollment process in a China Phase II trial of ICP-488, a potential psoriasis therapy. ICP-488 is a TYK2 (tyrosine kinase 2) JH2 allosteric inhibitor. The trial enrolled 129 patients who were randomized to one of three treatment groups in a 1:1:1 ratio: a 6mg once-daily group, a 9mg once-daily group, and a placebo group, for 12 consecutive weeks of treatment. By binding the JH2 domain, ICP-488 blocks the signal transduction of IL-23, IL-12, type 1 IFN and other inflammatory cytokines. More details....

Stock Symbols: (HK: 09969; SHA: 688428)

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Suzhou Ractigen Therapeutics reported that a China IND was approved for RAG-17 as a therapy for Amyotrophic Lateral Sclerosis (ALS). RAG-17 is a therapeutic siRNA designed to suppress the SOD1 gene in ALS patients with pathogenic mutations. Of the more than 50 genes associated with ALS, SOD1 gene mutations account for approximately 20% of the cases. Using Ractigen's proprietary SCAD™ delivery platform, RAG-17 combines siRNA with an accessory oligonucleotide to improve efficacy in central nervous system tissues. In preclinical studies, RAG-17 showed the ability to improve motor function and prolong survival. More details....

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