-
Entinostat Tablets Approved for Marketing by China NMPA
2024-04-30
Recently, the Category I innovative drug Entinostat Tablets (Chinese trade name: 景助达) of Taizhou EOC Pharma Co. Ltd was approved for marketing by the National Medical Products Administration.
-
Iptacopan Hydrochloride Capsules Approved for Marketing by China NMPA
2024-04-30
Recently, the Category I innovative drug Iptacopan Hydrochloride Capsules (trade name: FABHALTA) of Novartis Pharma Schweiz AG was approved for marketing by the National Medical Products Administration with priority review and approval, which is applicable for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously received complement inhibitor therapy.
-
The 6th Asian Network Meeting was held
2024-04-25
On April 24, the 6th Asian Network Meeting (ANM) was held in a combination of online and offline sessions.
-
NMPA Announcement on the Matters Related to Optimizing the Application for Marketing and Registration of Drugs Manufactured Overseas and Marketed in China to be Transferred to Domestic Manufacturing
2024-04-23
To further optimize the foreign investment environment, promote the high-quality development in the pharmaceutical industry, improve the drug accessibility, and meet our people’s need, in accordance with the requirements of the Opinions on Further Optimizing the Foreign Investment Environment and Increasing the Efforts to Attract Foreign Investments (GF [2023] No. 11) issued by State Council, and the NMPA Announcement on Provisions for Post-approval Changes of Drugs (Interim) (No. 8, 2021), regarding the optimization of the application procedures for marketing and registration of drugs manufactured overseas and marketed in China to be transferred to domestic manufacturing, the relevant matters are hereby announced as follows.
-
Innovative TCM Qinwei Granules Approved for Marketing by China NMPA
2024-03-15
Recently, the Category 1.1 innovative traditional Chinese medicine (TCM) Qinwei Granules of Chengdu Huaxi Natural Medicine Co Ltd was approved for marketing by the National Medical Products Administration.
-
Tunlametinib Capsules approved with conditions for marketing by China NMPA
2024-03-15
Recently, the Category 1 innovative drug Tunlametinib Capsules (Chinese trade name: 科露平) of Shanghai KeChow Pharmaceuticals Co. Ltd was approved with conditions for marketing by the National Medical Products Administration with priority review and approval, which is applicable to patients with advanced melanoma containing anti-PD-1/PD-L1 treatment failure of the NRAS mutation.
