FDA's CNPV Initiative Accelerates Approvals for J&J, Bayer and Others Amid Streamlined Drug Review Process

In 2025, the U.S. FDA launched a pilot program called the "Commissioner's National Priority Review Voucher (CNPV)," which significantly shortened drug review times from 10-12 months to just 1-2 months. Since then, several drugs have received special approval, covering areas such as gene therapy, orphan drugs, smoking cessation medications, and anticancer drugs.
 

November 20 News: AstraZeneca announced that the U.S. FDA has approved the oral MEK inhibitor Koselugo (selumetinib) for the treatment of adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). The approval was based on the results of the KOMET Phase III clinical trial, which showed an overall response rate of 20% in tumor size reduction among adult patients.
 

On November 19, the U.S. FDA approved Bayer's small molecule therapy Hyrnuo (sevabertinib) for the treatment of adult patients with locally advanced or metastatic non-squamous NSCLC. These patients must be confirmed by testing to carry HER2 (ERBB2) TKD activating mutations and have received prior systemic therapy. Sevabertinib is an orally administered reversible tyrosine kinase inhibitor (TKI) that potently inhibits mutant HER2 and EGFR, exhibiting high selectivity for mutant EGFR.
 

On November 6, Johnson & Johnson announced that the FDA had approved CAPLYTA® (Lumateperone) as an adjunctive therapy, to be used in combination with antidepressants for the treatment of major depressive disorder (MDD) in adults. Additionally, the FDA has also approved the subcutaneous formulation of Daratumumab, DARZALEX Faspro®, as a monotherapy for the treatment of adult patients with high-risk smoldering multiple myeloma.
 

Among them, CAPLYTA® is an oral, once-daily atypical antipsychotic drug. It is the first drug approved by the FDA for the treatment of adult bipolar I and II depression, either as an adjunctive therapy or monotherapy. DARZALEX Faspro is a subcutaneous formulation of the CD38-targeted antibody daratumumab, co-formulated with recombinant human hyaluronidase PH20; it is the first drug approved for the treatment of high-risk smoldering multiple myeloma.
 

It is reported that the CNPV program will provide a limited number of review vouchers to companies that align with U.S. national priorities. The review voucher can be tied to a specific investigational drug or set as "unassigned," allowing the biopharmaceutical company receiving the voucher to choose which new drug it will apply to. Companies holding the review voucher may still qualify for accelerated approval if their candidate drug meets the applicable legal requirements for expedited approval.
 

From the current perspective, under the promotion of this pilot program, U.S.-based manufacturing and companies aligned with its strategic interests are enjoying expedited review benefits. However, for Chinese pharmaceutical enterprises, the market space for similar new drugs going overseas in the future may be squeezed.
 

The industry suggests that Chinese pharmaceutical companies need to accelerate the diversified transformation of their global layout. They not only need to focus on drug efficacy but also delve into the policy directions and supply chain rules of target markets, balancing technological innovation, compliant production, and localized strategies. Only then can they enhance their ability to meet local regulatory and strategic requirements and better advance the process of international development.
 

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