SHANDONG XINHUA (00719.HK): Received the approval notice for the supplementary application of Ipatasertib tablets.

On May 9, Gelonghui reported that SHANDONG XINHUA (00719.HK) announced that it recently received the approval from the National Medical Products Administration for the supplemental application approval notice for Ipatasertib tablets, permitting the transfer of the supplemental application by the marketing authorization holder. The indication for Ipatasertib tablets is diabetic neuropathy. This product falls under category B of the National Essential Medical Insurance, Work Injury Insurance, and Maternity Insurance Pharmaceutical Directory. According to relevant statistics, the sales of Ipatasertib tablets in public Medical Institutions in China amounted to approximately 1.803 billion yuan in 2023.

Gelonghui FinanceMay 9 16:34

Shandong Xinhua Pharmaceutical (000756.SZ): Received the approval notification for the supplementary application of Ipalbid tablets.

Globe News on May 9th丨Shandong Xinhua Pharmaceutical (000756.SZ) announced that it recently received the "Approval Notice for Supplementary Application for Pharmaceutical" issued by the National Medical Products Administration for Epafusitab Tablets (hereinafter referred to as "this product"), approving the transfer of the supplementary application for the marketing license holder of this product. The change of the marketing license holder for this product has been approved, and the company becomes the marketing license holder for this product.

Gelonghui FinanceMay 9 16:29

AI empowers the FDA! Drug approvals hit the 'fast-forward' button, and a large number of pharmaceutical companies may welcome a 'Gold' period.

The USA Food and Drug Administration (FDA) announced an accelerated plan on Thursday to fully implement AI applications across all subsidiary institutions by June 30, aiming to significantly expedite the approval process for new pharmaceuticals.

Zhitong FinanceMay 9 10:49

Lobbyist groups warn that Trump's drug pricing proposal could lead to a loss of 1 trillion dollars for the pharmaceutical industry.

Lobbying groups warn that USA President Donald Trump's new pharmaceutical pricing proposal could result in losses of up to 1 trillion dollars for pharmaceutical companies over the next decade.

Zhitong FinanceMay 7 12:00

Trump wants to impose tariffs on Pharmaceuticals: Pharmaceutical companies are busy stockpiling, and the import volume in the USA surged in March.

① The volume of Pharmaceutical imports in the USA surged in March, as pharmaceutical companies stockpiled products in anticipation of potential tariffs; ② A report released by the US Department of Commerce on Tuesday showed that the total value of Pharmaceutical imports in March exceeded 50 billion USD, equivalent to 20% of the total Pharmaceutical imports for the entire year of 2024.

cls.cnMay 7 08:41

The Pacific Securities: The Sector's profits improved significantly in Q1, and the pharmaceutical industry is expected to see a rapid increase in concentration.

The trend of increasing concentration in the pharmaceutical industry and the strong becoming stronger is expected to continue to strengthen.

Zhitong FinanceMay 6 14:05