Major Breakthrough: Johnson & Johnson, Pfizer, and AstraZeneca Secure Approvals for Multiple Blockbuster Drugs in China

Just now, NMPA released the drug approval certificate delivery information for April 25, 2025. This batch includes 104 approved acceptance numbers, with several重磅 new drugs and new indications approved for marketing.

Pfizer's Axitinib Tablets New Indication Approved for Marketing, specific indications have not been disclosed.

Public data shows that axitinib is an orally administered, potent and highly selective tyrosine kinase inhibitor that acts on vascular endothelial growth factor receptors 1, 2, and 3. By inhibiting the vascular endothelial growth factor receptor signaling system, it comprehensively halts tumor progression. The product was initially approved for marketing by the U.S. FDA in 2012 and received approval in China in 2015. Its first indication was for the treatment of adult patients with advanced renal cell carcinoma (RCC) who had failed prior treatment with either a tyrosine kinase inhibitor or cytokine therapy.

AstraZeneca's New Indication for Acalabrutinib Maleate Tablets Approved for Marketing, specific indications have not been disclosed.

Acalabrutinib is a second-generation selective BTK inhibitor independently developed by AstraZeneca. In November 2024, the acalabrutinib tablet formulation was approved for the first time in China for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Johnson & Johnson's Amivantamab Injection New Indication Approved for Marketing，In combination with carboplatin and pemetrexed, it is indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed during or after treatment with EGFR tyrosine kinase inhibitors.

Amivantamab is a fully human bispecific antibody targeting both EGFR and MET. This is the second lung cancer indication for amivantamab approved in China this year. Previously, in February, amivantamab was approved as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer carrying EGFR exon 20 insertion mutations.

Aosaikang Pharmaceutical's Riltekinib Tablets New Indication Approved for Marketing, for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have epidermal growth factor receptor (EGFR) exon 19 deletions (19DEL) or exon 21 substitution mutations (L858R).

Riociguat is an orally administered third-generation EGFR-TKI, launched in January 2025 for the treatment of adult patients with locally advanced or metastatic NSCLC who have experienced disease progression during or after prior EGFR TKI therapy and have been confirmed to carry the EGFR T790M mutation.

On September 30, 2024, Aosaikang and Innovent reached an exclusive commercialization collaboration for Liotinib. Innovent obtained the exclusive promotion and sales rights for the collaborative product in mainland China and will pay Aosaikang an upfront payment, registration milestones, and sales milestone payments as stipulated in the cooperation agreement.

NOCIONE's Orelabrutinib Tablets Approved for New Indication, first-line treatment for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

Orelabrutinib is an irreversible Bruton's tyrosine kinase (BTK) inhibitor developed by InnoCare Pharma for the treatment of lymphoma and autoimmune diseases. In December 2020, orelabrutinib was approved in China for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), as well as relapsed/refractory mantle cell lymphoma (MCL). In April 2023, orelabrutinib was approved for patients with marginal zone lymphoma (MZL) who have received at least one prior therapy.

Akeso's Evoxilimab Injection New Indication Approved for Marketing, as monotherapy for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with positive PD-L1 expression (PD-L1 TPS≥1%).

Ivonescimab is a PD-1/VEGF bispecific antibody. In May 2024, ivonescimab was approved for marketing for the first time, indicated for use in combination with pemetrexed and carboplatin as a second-line treatment for patients with locally advanced or metastatic non-squamous NSCLC who are positive for EGFR mutations and have progressed after EGFR-TKI therapy.

Junshi Biosciences' Toripalimab Injection Approved for New Indication, for first-line treatment of unresectable or metastatic melanoma.

Toripalimab, as the first domestically produced PD-1 monoclonal antibody approved for marketing in China, has been granted 12 indications in China, including melanoma, nasopharyngeal carcinoma, urothelial carcinoma/bladder cancer, esophageal squamous cell carcinoma, non-squamous non-small cell lung cancer, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, triple-negative breast cancer, liver cancer, and other indications.

Recordati China (a wholly-owned subsidiary of Recordati Group) submittedThe Marketing Approval of Pasireotide Pamoate Microspheres for Injection Granted, for the treatment of adult patients with acromegaly who are ineligible for surgery, not cured post-surgery, or inadequately controlled by another somatostatin analog.

Pasireotide pamoate is a second-generation somatostatin analog (SRL), and somatostatin is the physiological inhibitor of GH secretion. Previously, pasireotide pamoate has been approved by the European Medicines Agency (EMA) and the U.S. FDA for the treatment of adult patients with acromegaly.

Full approval information is as follows:

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