June 2026 Sees Surge in Imported Drug Approvals as Multinational Pharma Giants Secure New Indications in China

　　【Pharmaceutical Network | Industry Trends] In June 2026, the National Medical Products Administration centrally approved the market launch of numerous innovative drugs. Among them, multinational pharmaceutical companies such as Eli Lilly and Johnson & Johnson intensively announced approvals for innovative drugs and new indications.
 

Recently, the National Medical Products Administration approved the marketing of etlunsegib tosylate tablets (brand name: INLURIYO), a Class 1 innovative drug submitted by Eli Lilly. The specific treatment regimens include two options: monotherapy or combination therapy with abemaciclib.
 

This drug is indicated as monotherapy for adult patients with locally advanced or metastatic breast cancer that is estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, and harboring estrogen receptor 1 (ESR1) mutations, who have previously received endocrine therapy; it is also indicated in combination with abemaciclib for adult patients with locally advanced or metastatic breast cancer that is ER-positive, HER2-negative, and harboring ESR1 mutations, who have previously received endocrine therapy.
 

On June 22, Zebec® (niraparib and abiraterone acetate tablets), an innovative therapeutic drug under Johnson & Johnson, was officially approved by the National Medical Products Administration for use in combination with prednisone or prednisolone in adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) harboring germline and/or somatic BRCA2 mutations.
 

This approval is based on the positive results from the Phase III AMPLITUDE study. Compared with current standard-of-care regimens, Zebeike® in combination with prednisone and androgen deprivation therapy (ADT) significantly prolonged radiographic progression-free survival (rPFS), reducing the risk of disease progression or death by 54%. Additionally, this regimen significantly delayed time to symptomatic progression (TSP), lowering the risk of symptomatic progression by 59%.
 

On June 15, Servier China announced that its innovative targeted therapy, Tivoso (ivosidenib tablets), has officially received approval from the National Medical Products Administration (NMPA) for a new indication. It is indicated for use in combination with azacitidine for the treatment of newly diagnosed acute myeloid leukemia (AML) patients with susceptible isocitrate dehydrogenase-1 (IDH1) mutations who are aged ≥75 years or have comorbidities that preclude the use of intensive induction chemotherapy.
 

Previously, Tolvudex was approved in China for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) harboring IDH1 mutations. In addition, the combination regimen of this drug with azacitidine has also been approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of adult patients with newly diagnosed AML harboring IDH1 mutations who are ineligible for intensive chemotherapy.
 

On June 15, Bristol Myers Squibb China announced that Sotyktu® (deucravacitinib tablets) had been approved by the National Medical Products Administration for adult patients with active psoriatic arthritis (PsA) who have had an inadequate response to or intolerance of prior disease-modifying antirheumatic drugs (DMARDs).
 

Deucravitinib Tablets are an oral, highly selective TYK2 allosteric inhibitor, representing a novel class of small-molecule oral targeted therapies. The approval of this new indication is primarily based on the positive results from two global Phase 3 clinical trials, POETYK PsA-1 and POETYK PsA-2, which confirmed the efficacy and safety of Deucravitinib Tablets (6 mg, once daily, orally) in treating adult patients with active psoriatic arthritis (PsA).
 

On June 8, the National Medical Products Administration officially approved Teva Pharmaceutical’s fremanezumab injection (Aimovig) for the preventive treatment of migraine in adults.
 

Fremanezumab Injection is a monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) ligand. Among the currently marketed CGRP monoclonal antibodies, this drug is a subcutaneous injection offering two optional dosing regimens: “once monthly” or “once quarterly.” It is reported that the drug has been approved for marketing in more than 45 countries worldwide.
 

　　Disclaimer: Under no circumstances shall the information contained herein or the opinions expressed constitute investment advice for any person.