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China Drug Approvals | 2024 | iPharmaCenter

Updated: May 15

May 13, 2024

Eisai's Fycompa was approved for generalized tonic-clonic seizures

Approved in China for the supplementary management of main generalized tonic-clonic seizures, Eisai has gained authorization for its internally developed anti-seizure medication, Fycompa (perampanel hydrate), in patients aged 12 and above with epilepsy.

Fycompa, a pioneering anti-seizure medication, originated from Eisai’s research facilities in Tsukuba. This medication acts selectively as a noncompetitive antagonist of AMPA receptors, aiming to mitigate neuronal over-excitation linked with seizures by modulating glutamate activity at AMPA receptors situated on postsynaptic membranes.

Initially sanctioned in China for adjunctive therapy of partial-onset seizures (with or without secondary generalization) in patients aged 12 and above with epilepsy in September 2019, Fycompa garnered further approval in July 2021. This subsequent approval extended its utility to encompass both monotherapy and adjunctive therapy for partial-onset seizures in epilepsy patients aged 4 and above, thus broadening its spectrum of assistance to epilepsy patients in China.

Approximately 9 million individuals in China are estimated to suffer from epilepsy, with 30% to 40% of them inadequately managing their seizures with existing anti-seizure medications. Primary generalized tonic-clonic seizures, among the most severe manifestations of epileptic episodes, pose significant threats of harm to patients and rank as one of the principal risk factors contributing to sudden unexpected death in epilepsy (SUDEP). With this recent expansion of indications, Fycompa can now serve as an adjunctive therapy for primary generalized tonic-clonic seizures in China.

Eisai places a particular emphasis on neurology, including epilepsy, within its therapeutic pursuits. As a healthcare enterprise dedicated to human well-being, Eisai is committed to advancing its mission of delivering "seizure freedom" to a broader spectrum of epilepsy patients. The company remains steadfast in its dedication to addressing the multifaceted requirements of patients with epilepsy and their families while augmenting the benefits afforded to them.


NMPA approved Novartis' iptacopan for paroxysmal nocturnal hemoglobinuria

The National Medical Products Administration recently greenlit the introduction of iptacopan Hydrochloride Capsules, a Class 1 innovative medication developed by Novartis Pharmaunder the trade name Feheda. This approval, facilitated through the priority review process, marks a significant step forward in the treatment landscape for adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously undergone complement inhibitor therapy.

Iptacopan hydrochloride functions by binding to factor B (FB) within the complement alternative pathway. It modulates the cleavage of C3, regulates downstream effector production, and dampens the amplification of the terminal pathway. This mechanism enables control over C3b-mediated extravascular hemolysis and terminal complement-mediated vascular hemolysis, thereby addressing internal hemolysis. The introduction of this variant offers a fresh therapeutic avenue for adult patients grappling with paroxysmal nocturnal hemoglobinuria.


April 30, 2024

NMPA approved Entinostat for HR+/HER2-negative breast cancer

The National Medical Products Administration (NMPA) has granted approval for the introduction of Entinostat Tablets, a Class 1 innovative medication developed by Taizhou Yiteng Jingang Pharmaceutical Co., Ltd., under the trade name Jingzhuda. This approval marks a significant advancement in the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor-2 (HER-2)-negative breast cancer in patients who have experienced relapse or progression following prior endocrine therapy.

Entinostat tablets function as histone deacetylase (HDAC) inhibitors, selectively targeting class I and class IV HDACs. By inhibiting cell proliferation, promoting terminal differentiation, inducing apoptosis, and exerting anti-tumor effects, these tablets offer a promising therapeutic approach. The introduction of Entinostat provides a novel treatment avenue for individuals with hormone receptor (HR)-positive, human epidermal growth factor receptor-2 (HER-2)-negative locally advanced or metastatic breast cancer, enhancing the spectrum of available treatment options.


January 02, 2024

Beyfortus was approved in China for Preventing RSV Disease in Infants

AstraZeneca and Sanofi's Beyfortus (nirsevimab), a long-acting monoclonal antibody, has received official approval in China for its role in preventing lower respiratory tract infection (LRTI) caused by the respiratory syncytial virus (RSV) in newborns and infants. This approval encompasses infants entering or during their initial RSV season, and Beyfortus is expected to be accessible in the forthcoming 2024-2025 RSV season.

Beyfortus marks a significant breakthrough as the first preventive solution approved to safeguard a broad infant population from RSV. This includes protection for healthy term-born infants, preterm infants, and those with specific health conditions that make them susceptible to severe RSV disease.

The nod of approval from The National Medical Products Administration (NMPA) is grounded in the results of three pivotal late-stage clinical trials of Beyfortus and an extensive local clinical development initiative. Across all clinical endpoints, a single dose of Beyfortus consistently demonstrated efficacy against RSV lower respiratory tract disease (LRTD) for five months, aligning with the typical RSV season.

RSV is a prevalent and highly transmissible seasonal virus and stands as the leading cause of LRTD, including bronchiolitis and pneumonia, in infants. It is also a major contributor to hospitalizations among all infants, with a significant portion of hospital admissions for RSV affecting healthy term-born infants. China, identified as a country with elevated RSV infection rates, underscores the significance of Beyfortus approval in this region.

Before securing approval in China, Beyfortus gained regulatory clearance in the European Union in October 2022 for preventing RSV LRTD in newborns and infants during their initial RSV season. The United States Food and Drug Administration approved it in July 2023, backed by the unanimous recommendation from the Antimicrobial Drugs Advisory Committee in June 2023. Ongoing reviews of regulatory applications are also underway in Japan and various other nations.



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