Four Innovative Drugs Approved in China on the Same Day, Including Xuanzhu Biopharma's Diloroak Tablets

　　【Pharmaceutical Network Industry DynamicsAccording to the news on the website of the National Medical Products Administration on August 22, four innovative drugs were approved for marketing on the same day, from XZenith Biopharm, Wuhan Institute of Biological Products Co., Ltd., etc.
 

On August 22, the website of the National Medical Products Administration (NMPA) announced that XZenith Biopharm's Class 1 innovative drug Deruoak Tablets (brand name: Xuanfening) has been approved for marketing. This drug, as a monotherapy, is indicated for the treatment of patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not been treated with anaplastic lymphoma kinase (ALK) inhibitors. The approval of this drug provides patients with a new treatment option.
 

Diloac has four core advantages, including rapid onset, excellent tumor suppression intensity, long-lasting relief, and significant survival benefits. In Phase III clinical trials, Diloac demonstrated significantly superior efficacy compared to both first-generation and second-generation ALK inhibitors already on the market, and showed potent inhibitory activity against resistant mutations.
 

Industry insiders stated that the approval and market launch of XZenith Biopharm's Dilorak tablet is not only a significant milestone in XZenith Biopharm’s innovative drug pipeline but also provides a breakthrough treatment option for Chinese patients with ALK-positive non-small cell lung cancer (NSCLC). Data shows that in 2024, there will be 91,200 Chinese ALK-positive NSCLC patients, expected to reach 121,700 by 2032, with a compound annual growth rate (CAGR) of 3.7%; In 2024, the market size of ALK inhibitors in China is approximately 4.7 billion yuan, predicted to increase to 8.9 billion yuan by 2032, with a CAGR of 8.3%.
 

On August 22, the website of the National Medical Products Administration (NMPA) also announced that the NMPA had approved, through the priority review and approval process, the oral hexavalent reassortant rotavirus attenuated live vaccine (Vero cell) (brand name: Wushengerlunbao) submitted by Wuhan Institute of Biological Products Co., Ltd. for market launch. The vaccine is indicated for the prevention of acute gastroenteritis in infants and young children caused by rotavirus serotypes G1, G2, G3, G4, G8, and G9. The vaccine is administered orally and is suitable for infants aged between 6 weeks and 36 weeks.
 

It is reported that rotavirus is the main pathogen causing severe diarrhea in children under 5 years old worldwide. As a hexavalent rotavirus vaccine, the approval and market launch of Wuhan Institute of Biological Products' "Wushenger Lunbao" will provide more comprehensive immune protection for infants and young children in China and globally. It can effectively reduce the incidence of severe rotavirus diarrhea and build a stronger immune barrier for infants and young children, safeguarding the healthy growth of children.
 

In addition, on August 22, the website of the National Medical Products Administration (NMPA) showed that the Class 1 innovative drug Atrasentan Hydrochloride Tablets, submitted by Novartis Pharma Schweiz AG, was conditionally approved for marketing through the priority review process. This product is indicated for reducing proteinuria in adult patients with primary immunoglobulin A nephropathy (IgA nephropathy) who are at risk of rapid disease progression. Generally, these patients have a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g. The approval of this drug provides patients with a new treatment option.
 

On the same day, the injectable drug Dato-DXd (brand name: Dazhuo You), submitted by Daiichi Sankyo Europe GmbH, was also approved for marketing by the National Medical Products Administration (NMPA) in China. It is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer who have previously received endocrine therapy and at least one line of chemotherapy in the advanced disease setting. The approval of this product provides a new treatment option for relevant patients.
 

Four Innovative Drugs Approved in a Single Day, Demonstrating Strong Support for Innovative Drug Development and Enhanced Efficiency in Drug Review and Approval Processes. The launch of these innovative drugs will bring benefits to patients in their respective fields and further promote the development of China's pharmaceutical industry.
 

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