Tirzepatide: Phase 4 Clinical Trial Data Released

Eli Lilly and Company Announces Detailed Results from the Phase 4 SURPASS-EARLY Clinical Study. The study compared the efficacy and safety of tirzepatide versus an intensified conventional treatment regimen in adults with type 2 diabetes who were recently diagnosed and had inadequate glycemic control despite metformin therapy.Tirzepatide is a once-weekly dual agonist of the glucose-dependent insulinotropic polypeptide (GIP) receptor and the glucagon-like peptide-1 (GLP-1) receptor.

The results released this time show that,In patients with recently diagnosed type 2 diabetes, 2 years of treatment with tirzepatide achieved a greater reduction in glycated hemoglobin (HbA1c) compared with intensive conventional therapy.) decrease (-1.99% vs. -1.32%, P<0.001), and 60% of patients achieved normal levels (HbA1c <5.7%),The proportion in the conventional intensive therapy group was 24%, and these effects were sustained throughout the study period. Tirzepatide demonstrated significant superiority over conventional intensive therapy in reducing body weight and waist circumference, with a greater proportion of patients achieving ≥10% and ≥15% weight loss, accompanied by improvements in multiple metabolic parameters, including lipid profiles, β-cell function, and insulin sensitivity. The safety profile was consistent with previous studies, predominantly featuring mild to moderate gastrointestinal adverse events. The incidence of serious adverse events was comparable between the two groups (5.5% vs. 6.8%), and no severe hypoglycemia was reported. The discontinuation rate due to adverse events was low, at 4.5%.

Salanersen: Approved in the United StatesBreakthrough Therapy Designation Granted by the FDA

Biogen announced,The U.S. FDA Has Granted Breakthrough Therapy Designation to Salanersen for the Treatment of Spinal Muscular AtrophySalanersen is an intrathecally administered antisense oligonucleotide being developed for the treatment of SMA.Salanersen is designed to correctSMN2Splicing of pre-mRNA to increase SMN protein production. This drug employs novel chemical modifications and has the potential to achieve high efficacy with once-yearly dosing.

The FDA’s decision was based on Phase 1b clinical trial data for salanersen. In children with spinal muscular atrophy (SMA) who had previously responded poorly to gene therapy, researchers observed clinically meaningful improvements in motor function after initiating once-yearly salanersen treatment.and the slowing of neurodegeneration assessed by reduced neurofilament light chain (NfL) levels. In this study, salanersen was generally well tolerated.

Olepatide Injection: Marketing Application Submitted in China

Hansoh Pharma Announces Its Innovative Drug, Once-Weekly Subcutaneous Injection of the GLP-1/GIP Receptor Dual Agonist Olepatide InjectionNew Drug Application (NDA)Accepted by the National Medical Products Administration (NMPA) of China for long-term weight management in adults with obesity or overweight.Oleporatide (HS-20094) selectively activates GLP-1/GIP receptors, modulating metabolic pathways associated with appetite control, glucose metabolism, and energy balance, thereby exerting biological effects such as glycemic control and weight reduction.The drug is administered via subcutaneous injection once weekly. On June 2, 2025, Hansoh Pharma announced that it had entered into a licensing agreement with Regeneron Pharmaceuticals, granting Regeneron the exclusive global license (excluding mainland China, Hong Kong, and Macau) to develop, manufacture, and commercialize HS-20094.

According to Hansoh Pharma’s press release, in March 2026, the first Phase 3 clinical trial of olepatide in Chinese adult subjects with overweight or obesity (HS-20094-301) met its primary endpoint.At 48 weeks of orforglipron treatment, the mean weight reduction from baseline in subjects was up to 19.3%, and the proportion of subjects achieving a weight reduction of ≥5% was up to 97.2%.Studies have shown that the orforglipron treatment group demonstrated excellent gastrointestinal tolerability, with an average incidence of nausea <10% and vomiting <5%. Compared with published Phase 3 trial data for existing GLP-1 receptor agonist-based dual agonists, the incidence of gastrointestinal adverse events and the rate of treatment discontinuation were lower.

AI Accelerates RNAi Therapy Design, Alnylam Enters R&D Collaboration

Alnylam Pharmaceuticals and Inceptive Nucleics Announce Strategic Collaboration to Accelerate Nucleic Acid-Based Drug DesignAlnylam Pharmaceuticals and Inceptive Nucleics have announced a strategic collaboration that combines Alnylam’s expertise in RNA interference (RNAi) with Inceptive’s foundation models and artificial intelligence (AI) capabilities to advance and accelerate the design of nucleic acid-based therapeutics. Inceptive specializes in developing models for sequence-based drugs, such as the RNAi therapies developed by Alnylam.

This collaboration aims to advance RNAi therapeutic design by modeling target mRNA, jointly exploring sequence space and novel chemical modifications to enhance potency and efficacy, and identifying the most promising therapeutic candidates in preclinical models for further development by Alnylam.The goal is to help Alnylam prioritize the screening of the most promising molecules and improve experimental efficiency.

Under the agreement, Inceptive will receive an upfront payment of $30 million (comprising cash and equity investment) and is eligible for preclinical, regulatory, and commercial sales milestone payments, with the total potential value of the collaboration reaching up to $2 billion.

Integrated Platform Accelerates Oligonucleotide Therapeutic Development

As an enabler of pharmaceutical innovation, WuXi AppTec leverages the synergistic advantages of its multi-business platforms to build an oligonucleotide drug R&D system covering drug discovery, mechanism of action studies, pharmacokinetic evaluation, and development and manufacturing, providing end-to-end support for partners.

WuXi Biology’s Platform for RNA Therapeutics Delivery System R&DWuXi Biology has established a systematic capability for evaluating targeted delivery systems, centered on the research and development of RNA therapeutic delivery platforms. It provides comprehensive support for RNA drug projects involving oligonucleotides, siRNA, and mRNA, ranging from delivery mechanism studies to functional validation. Additionally, the platform possesses the design and manufacturing capabilities for linear, circular, and self-amplifying mRNA.To address the critical challenges of delivery efficiency and tissue specificity in RNA therapeutic development, WuXi Biology has constructed an evaluation system encompassing both in vitro and ex vivo experiments. This system enables systematic analysis of the binding, uptake, and functional delivery efficacy of various delivery strategies at the cellular level. The platform can assess multiple delivery formats, including conjugate-based delivery systems and nanoparticle-based delivery systems, thereby helping partners gain a comprehensive understanding of the mechanisms of action of delivery systems at the cellular level and optimize the delivery efficiency of RNA therapeutics.

As the demand for treatments for central nervous system (CNS) diseases continues to grow, intrathecal administration of antisense oligonucleotide (ASO) drugs is emerging as a key therapeutic strategy to overcome the limitations of the blood-brain barrier. However, the development of such programs often faces challenges, including the complex matrices of cerebrospinal fluid (CSF) and brain tissue samples, low dosing levels, stringent requirements for distribution studies, and significant difficulties in developing bioanalytical methods. Leveraging its extensive experience in oligonucleotide bioanalysis, WuXi AppTec’s Drug Metabolism and Pharmacokinetics (DMPK) department has established comprehensive analytical capabilities for intrathecally administered ASOs. It provides integrated support ranging from method development and validation to preclinical sample analysis and pharmacokinetic profiling. The platform enables highly sensitive and selective quantitative analysis across various sample types, including CSF, plasma, spinal cord, and brain tissues. By employing diverse technical approaches such as hybridization assays and LC-MS/MS, it offers customized solutions for ASO molecules with different chemical modifications. Furthermore, the platform supports biodistribution studies, exposure-response relationship analyses, safety evaluations, and cross-species translational research, helping clients gain a more comprehensive understanding of candidate drug delivery and mechanism of action within the CNS. Backed by its integrated technological platform and project execution expertise, WuXi AppTec DMPK continues to empower global partners to accelerate the development of innovative oligonucleotide therapies for neurodegenerative diseases, rare neurological disorders, and other CNS indications.

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