With the second week of June coming to a close, let’s review the hot events of the pharmaceutical industry this week. The news involved 5 sections: approval, R&D, policies, transactions and listing that happened during June 8-12.
Approval
NMPA
1. Boehringer Ingelheim announced on June 8 that Nintedanib Esilate Soft Capsules (trade name: Ofev) has been approved by the NMPA for marketing, making it the first and currently the only drug for systemic sclerosis-associated interstitial lung disease (SSc-ILD) in China, which is the 2nd indication of the drug approved in China.
2. Yiling Pharmaceutical announced on June 8 that its marketing application for Yizhi Anshen Tablets has been accepted by the CDE, which is a new Chinese medicine developed according to the theoretical guidance of Chinese Eight-word Health Preservation for the pathogenesis and therapy of insomnia.
3. Roche’s clinical trial application for tiragolumab injection in China was accepted by the CDE on June 8. Tiragolumab is an anti-TIGIT monoclonal antibody. The preliminary clinical results have shown certain safety and anti-tumor effectiveness of anti-TIGIT antibody either as monotherapy or in combination with anti-PD-1/PD-L1 antibody, and especially the combination therapies hopefully exhibited synergistic enhancement effect. To date, there is no variety in its class approved in the world.
4. The clinical trial of MSD’s letermovir injection/tablets has been approved in China on June 8, which is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). The drug has been approved by the FDA for marketing in Nov. 2017, with the trade name: Prevymis, being the first drug approved to treat CMV in the U.S. in recent 15 years.
5. Hansoh’s marketing application for Class 4 generic drug Paliperidone Extended-Release Tablets (acceptance No.: CYHS1900200, CYHS1900201) has changed to “Under approval” on June 9, which is expected to be approved for marketing soon. Developed by J & J, the original drug of Paliperidone Extended-Release Tablets belongs to the second-generation antipsychotic drugs and was approved by the FDA for marketing in Dec. 2006 and by the NMPA for marketing in 2008. There is only the imported original drug in China. Hansoh will market the first generic.
6. According to the NMPA website on June 10, the marketing application for the contrast agent Iohexol Injection newly introduced by Hengrui in May has changed to the “Under approval” status and will be approved soon, while another contrast agent Iopamidol Injection introduced thereby simultaneously has been approved for marketing 1 month ago.
7. Roche’s marketing application for its new anti-influenza drug Baloxavir Marboxil Tablets (trade name: Xofluza) in China has been accepted by the CDE on June 10. Developed by the Japanese pharmaceutical enterprise Shionogi, Roche reached a cooperation agreement therewith in 2016 to be responsible for the R&D of the drug outside Japan and Taiwan, China Region of China, and ha...
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