Recently, across ChinaBallMorePeptideAnd FewNucleosideAcid (TIDES）LeadDomain WelcomeComeSeriesInExpandGSK announced that two pivotal Phase 3 clinical trials of bepirovirsen, an investigational antisense oligonucleotide (ASO) therapy developed in collaboration with Ionis Pharmaceuticals for the treatment of chronic hepatitis B (HBV) infection, have both met their primary endpoints. Sanofi announced that its innovative lipid-lowering small interfering RNA (siRNA) therapy, inclisiran sodium injection, has been officially approved by the National Medical Products Administration (NMPA) of China.ThisWenWillSectionSelectA brief introduction to some of the key advancements, onlyFor readers' reference.

BepirovirsPublishData from two Phase 3 clinical trials

GSK announced that bepirovirsen, an investigational ASO therapy developed in collaboration with Ionis Pharmaceuticals, has achieved positive results in two pivotal Phase 3 clinical trials, B-Well 1 and B-Well 2, for the treatment of chronic HBV infection.Positive Results。Both trials met their primary endpoints. Bepirovirsen demonstrated a statistically and clinically significant rate of functional cure.GSK Plans to Initiate Global Regulatory Submission in the First Quarter of 2026.

Bepirovirsen is an investigational ASO therapy with a triple mechanism of action, designed to recognize and disrupt the genetic components (i.e., RNA) of the hepatitis B virus, potentially enabling the patient's immune system to regain control over the viral infection.Bepirovirsen can inhibit viral DNA replication in the body, reduce HBsAg levels in the blood, and activate the immune system, thereby increasing the chance of achieving a sustained response.GSK Obtains Authorization for Bepirovirsen from Ionis Pharmaceuticals and Collaborates on Its Development; Bepirovirsen Previously Granted Breakthrough Therapy Designation by the U.S. FDA.

Plethran Sodium Injection: Approved for Marketing in China

Sanofi announces that the innovative drug Plasilan Sodium Injection has been officially approved by the NMPA.On the basis of dietary control, it is used to reduce triglyceride levels in adult patients with familial chylomicronemia syndrome (FCS).On August 1, 2025, Sanofi announced that it had signed an asset purchase agreement with Visirna Therapeutics, a subsidiary of Arrowhead Pharmaceuticals, to obtain the rights to develop and commercialize the investigational drug Puluosilan Sodium Injection in Greater China.

Plecanatide sodium is an siRNA therapy that inhibits the production of apolipoprotein C-III (APOC3).APOC3 is a protein produced by the liver that slows down the breakdown and clearance of triglycerides, raising triglyceride levels. Volanesorsen sodium significantly lowers triglyceride levels by continuously inhibiting APOC3 expression. FCS is a hereditary disease associated with high triglyceride levels.Plerixafor Sodium Injection can reduce fasting triglyceride levels by 80% from baseline and decrease the incidence of acute pancreatitis by 80% compared to placebo in FCS patients, with only four doses required per year in clinical studies.

Previously, the U.S. FDA has approved the use of volanesorsen sodium injection as an adjunct to dietary therapy for reducing triglyceride levels in adult patients with FCS. In December 2025, the FDA also granted volanesorsen sodium injection a Breakthrough Therapy Designation for severe hypertriglyceridemia (sHTG), which is expected to further expand its therapeutic management scope and benefit more patients.

Rusfertide: Submission of NDA to the U.S. FDA

Takeda and Protagonist Therapeutics Announce Submission of New Drug Application (NDA) to U.S. FDA for Rusfertide for the Treatment of Adults with Polycythemia Vera (PV). Rusfertide, a potential “first-in-class” investigational peptide mimetic of the natural hormone hepcidin, has been granted Orphan Drug Designation and Fast Track Designation by the U.S. FDA.

This NDA submission is primarily based on the 52-week data from the Phase 3 VERIFY study.The study met its primary endpoint and all four key secondary endpoints, showing that rusfertide provided durable and stable hematocrit control and significantly improved pre-specified patient-reported outcome measures.These data highlight the potential of rusfertide to transform the treatment paradigm for PV, alleviating the burden of frequent phlebotomy for patients.

DA-1726: Publication of Phase 1b Clinical Trial Data

MetaVia Announces Positive Phase 1 Clinical Trial Results for Its Investigational Peptide Therapy DA-1726DA-1726 is a novel oxyntomodulin (OXM) analog that functions as a dual agonist of GLP-1R and GCGR, reducing body weight by suppressing appetite and increasing energy expenditure.DA-1726 is designed for once-weekly subcutaneous injection and is under development for the treatment of obesity and metabolic dysfunction-associated steatohepatitis (MASH).

The results announced this time show,Patients receiving DA-1726 experienced significant early weight loss, a marked reduction in waist circumference, notable improvement in blood glucose control, and a significant decrease in liver stiffness, with both safety and tolerability being excellent.Specifically, by Day 54, the patients' average waist circumference decreased by 9.8 cm (p=0.006); there was a significant direct effect on the liver, with liver stiffness measured by vibration-controlled transient elastography (VCTE) reduced by 23.7%; fasting blood glucose significantly decreased by 12.3 mg/dL, demonstrating potent blood sugar improvement; robust weight loss was also achieved, with an average weight reduction of 9.1%, approximately 21.2 pounds (about 9.6 kilograms).

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