AZ, Sanofi, and GSK Secure Consecutive New Drug Approvals in China

Dec 17, 2025 19:36 CST Updated 19:36

Sanofi

Pharmaceutical Manufacturer

GSK

Pharmaceutical R&D Manufacturer

Cytokinetics

Developer of Muscle Activators and Muscle Inhibitors

CORXEL

Developer of Oral Small Molecule Cardiac Myosin Inhibitors

Sanofi's BIC New Drug Approved for Marketing in China

12Month17Day, SanofiPublication of AnnouncementAnnounce, Afuketai (Aficamten, Trade Name: Xing Shu Ping) has been approved for marketing in China, for the treatment of New York Heart Association (NYHA) Cardiac Function ClassificationⅡ-ⅢObstructive Hypertrophic Cardiomyopathy （HCM）Adult patients, to improve motor function and symptoms. Previously, the drug received breakthrough therapy designations in both China and the U.S., and its marketing application in China was included in the priority review category, allowing for rapid approval.

Source of screenshot: Sanofi Official WeChat

Public information shows,Aficamten(Research and Development Code:CK-274) is a new generation of selective small molecule cardiac myosin inhibitors, which improve the therapeutic index and pharmacokinetic properties of the drug through comprehensive chemical optimization, reducing the number of force-generating cross-bridges of active myosin in each cardiac cycle, thereby inhibiting excessive myocardial contraction associated with hypertrophic cardiomyopathy.

It is reported that,The drug was first developed byCytokineticsCompany R&D,2020Year7Month, CORXEL andCytokineticsReached a cooperation and obtained the Greater China rights to the drug, which was still in clinical trials at that time.ⅠR&D PeriodStage。

Previously,AficamtenZengReceived by multipleMNCFavor, Bayer in2024Year11In the same year, the Japanese rights to the drug were introduced in China, while Sanofi12In the month, a cooperation with CORXEL was reached, obtaining the rights for Greater China.

GSK's Ultra-Long-Acting New Drug Approved for Marketing

Local time12Month16Day,GSKAnnouncing the United StatesFDADemoglitazar has been approved (Depemokimab，Exdensur) is launched as an add-on maintenance treatment drug for patients with severe asthma of the eosinophilic phenotype, suitable for12Adult and adolescent patients aged and above.

The press release noted that this is the first and currently the only ultra-long-acting biologic approved for the treatment of severe asthma patients with an eosinophilic phenotype, with a dosing regimen of twice a year.

Source of Screenshot:GSKOfficial Website

Public information shows,Demochizumab is a targetedIL-5Monoclonal antibody.IL-5 Yes2Key cytokines in type inflammation.2Type 2 inflammation can usually be identified through blood eosinophil counts and is also a significant driving factor in various diseases. In patients with refractory asthma, the majority exhibit this type of inflammation, which can easily lead to acute exacerbations and an increased risk of hospitalization. Up to...85%TheCRSwNPThe patient also experienced2Type inflammation, and closely related to the severity of the disease and symptom presentation.

This approval is mainly based onSWIFT-1AndSWIFT-2Two itemsⅢPhase ClinicalTestPositive results.

SWIFT-1AndSWIFT-2For52Week, Randomized, Double-blind, Placebo-controlled, MulticenterⅢPhase clinical trial, which evaluatedDepemokimabEfficacy and Safety as an Adjunctive Therapy for Patients with Eosinophilic Asthma.

The results showed that both trials met the primary endpoints. In52Within the week, compared with placebo,SWIFT-1AndSWIFT-2In the study, Dermoqimab significantly reduced the risk of asthma attacks in patients with severe asthma.58%（HR=0.42，95% CI：0.30–0.59，p<0.001) and48%（HR=0.52，95% CI：0.36–0.73，p<0.001）。

In addition, the trial also met the secondary endpoint. Patients receiving dermokine monoclonal antibody treatment required hospitalization and/Or the incidence of worsening conditions requiring emergency visits (respectively1%And4%) Lower than the placebo group (respectively8%And10%) A pre-specified pooled analysis of the two trials showed that, compared with placebo, the risk of clinically significant deterioration requiring hospitalization or emergency treatment was reduced in patients.72%（HR=0.28，95% CI：0.13–0.61，p=0.002). In these trials, domagrozumab was well-tolerated, with the incidence and severity of side effects in patients similar to those receiving placebo.

AstraZeneca's New Autoimmune Drug Approved for Subcutaneous Formulation

12Month16Recently, AstraZeneca announced its subcutaneous injectable biologicSaphnelo（Anifrolumab, Avuliyu Monoclonal Antibody Subcutaneous Injection) has been approved in the EU as a pre-filled injection pen for systemic lupus erythematosus (SLE) Subcutaneous self-administration in adult patients as a supplement to standard therapy.

The press release pointed out that the convenient subcutaneous injection method is expected to enable more patients to benefit.SaphneloThe same clinical benefits of intravenous infusion.

Screenshot source: AstraZeneca official website

Public information shows,SaphneloIs the world's first approved targetedⅠType I Interferon PathwaySLETargeted therapeutic drugs, can be used withⅠType Interferon (IFN) Receptor Subunit1Combine, thereby blockingⅠType I Interferon Activity.ⅠType interferon, such asIFN-α、IFN-βAndIFN-κ, which is involved in the regulation andSLECytokines of the relevant inflammatory pathways.

Previously, the drug was2021Year7Obtained for the first time inFDAApproved for the treatment of moderate to severeSLEAdult patients, and2021Year9Month,2022Year2Later in the month, it was successively approved for marketing in Japan and the EU. Since its approval, the sales of Afliyulimab have been on the rise.2024Global sales reached4.74billion dollars, a significant increase year-over-year69.29%。2025Achievements in the First Three Quarters of the Year4.83Billion USD, Year-over-Year Growth47%。