Johnson & Johnson, Kang Le Wei Shi File New Drug Applications; InnoCare's Class 1 New Drug Zurletrectinib Granted Priority Review

Apr 23, 2025 19:42 CST Updated 19:42

Johnson & Johnson

Medical Device R&D and Manufacturer

Health Guard

Recombinant Protein Drug Developer

InnoCare

Innovative Drug Developer

Health Guard's Trivalent HPV Vaccine Submits for Market Approval

TodayDay,CDEThe official website shows that Health Guard's recombinant trivalent human papillomavirus（16/18/58Type) vaccine (E. coli) marketing application accepted for the prevention ofHPV 16/18/58Type-related persistent infections and diseases such as cervical cancer.

It is worth noting that,This is the first domestically produced trivalent vaccine in China to have applied for marketing authorization.HPVVaccine.Previously3Month, the product has been included in the priority review list.Compared with the currently marketed bivalent or quadrivalentHPVVaccine, the trivalentHPVThe vaccine will expand the protection against cervical cancer for women in East Asia from70%Increase to78%。

Source: CDE Official Website

In October 2020, Health Guard launched the Phase III clinical trial of its trivalent HPV vaccine. In August 2024, the Independent Data Monitoring Committee (IDMC) of the product's Phase III efficacy clinical trial completed the interim analysis unblinding, primary efficacy endpoint evaluation, and safety assessment, with results meeting expectations.

Public information shows that Health Guard has completed the HPV vaccine industrialization base in Kunming, with a designed annual production capacity of 10 million doses of trivalent HPV vaccine and 30 million doses of nonavalent HPV vaccine.

InnoCare's Orelabrutinib Tablets Proposed for Priority Review

Today，CDEOfficial WebsiteDisplay, InnoCare's submission1New Drug Zholotinib Tablets: Marketing Application Proposed for Priority Review, Applicable to the Following ConditionsAdults and12Adolescent patients with solid tumors aged 12 years and above:Carrying neurotrophic tyrosine receptor kinase (NTRK) Fusion gene Patients with locally advanced, metastatic disease or for whom surgical resection may lead to serious complications, as well as those without satisfactory alternative treatments or who have failed previous treatments.

Public information shows,Zhuoletinib Tablets (zurletrectinib) is InnoCare's second-generation pan-TRKInhibitor, the listing application has been submitted onRecentlyObtainCDEAccepted.Intended to be developed for the treatment of those who have not receivedTRKInhibitor therapy, and the first generationTRKInhibitors Develop Resistance, CarryingNTRKPatients with advanced or metastatic solid tumors harboring fusion genes.

Screenshot source: CDE official website

According to relevant literature reports, NTRK fusion genes can be found in various types of adult and pediatric tumors. In some rare tumors, such as salivary gland cancer, secretory breast cancer, and infantile fibrosarcoma, the incidence of NTRK fusion exceeds 90%.

Johnson & Johnson's Nicallizumab Submitted for Marketing Approval in China

Today，CDEOfficial WebsiteDisplayJohnson & Johnson's Nicallinib Injection Submitted for Market Approval in China.Previously, the drug had been included in the priority review, applicable for treating generalized myasthenia gravis (gMG) that is seropositive for autoantibodies.gMG) Adult patients and adolescent patients (greater than12Years).

It is reported that,Nicalimab (Nipocalimab) is Johnson & Johnson through approximately65Billion-dollar AcquisitionMomenta PharmaceuticalsAn investigationalFcRnAntibody.2024Year8Month, the drug has been submitted for marketing in the United States, usedTreatmentFor Myasthenia Gravis.

Screenshot source: CDE official website

As an FcRn antibody, Nicalimab is designed to block FcRn with high affinity binding to reduce circulating immunoglobulin G (IgG) antibody levels (including autoantibodies and alloantibodies), while maintaining immune function without causing broad immunosuppression. Blocking the binding of IgG to FcRn in the placenta is also considered to prevent the transfer of maternal alloantibodies across the placenta to the fetus.

Editor: Zhang Song

Layout Editor: Yu Yuanze

Reviewed by: Ma Fei

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