The failure of Phase III clinical trials targeting the popular target TIGIT monoclonal antibody has once again put tumor immunotherapy on the radar this week. The pharma news review of this week from March 28 to April 1 covers a total of 25 pieces of news in 4 sections, including drug review, R&D, business, and listing.
NMPA
Marketing Application
1. On March 29, it was shown on the CDE official website that the new drug, Carglumic Acid Dispersible Tablets of Class 5.1, was declared for marketing and accepted. According to public information, it is a rare disease treatment product, which was initially approved overseas for hyperammonemia caused by N-acetylglutamate synthase (NAGS) deficiency.
2. On March 30, it was shown on the CDE official website that Merck's Tepotinib was declared for marketing in China. Tepotinib is a c-Met inhibitor researched and developed by Merck and was first approved for marketing in Japan in March 2020. The first c-Met inhibitor approved for marketing in China was Savolitinib of Hutchison Pharmaceuticals.
Approval
3. On March 30, Yangtze River announced that its generic drug of Sugammadex Sodium Injection had been approved for marketing, becoming the first specific binding neuromuscular block antagonist approved for marketing globally. Sugammadex Sodium is a water-soluble modified γ-cyclodextrin drug that specifically binds to muscle relaxants via physical encapsulation to reverse neuromuscular blockade.
Clinical
Application
4. On March 28, it was shown on the CDE official website that the JS116 of Junshi Biosciences was first declared for clinical use in China. This is the seventh new chemical drug declared by Junshi in China. JS116 is a small molecule irreversible covalent inhibitor of KRASG12C with a novel structure, which is used for treating patients with non-small cell lung cancer (NSCLC) caused by KRASG12C mutation.
5. On March 28, it was shown on the CDE official website that the clinical application of B7H4x4-1BB double-antibody of Harbour BioMed was accepted for the treatment of solid tumors in China. HBM7008 is a First-in-Class bispecific antibody that simultaneously targets tumor antigen B7H4 and T cell co-stimulatory molecule 4-1BB. It is the only bispecific antibody targeting these two targets in the world.
6. On March 29, it was shown on the CDE official website that the GB263T for Injection of Genor Biopharma was declared for clinical use for the first time. It is the first trispecific antibody for EGFR/c-Met/c-Met in the world and is indicated for non-small cell lung cancer (NSCLC). Currently, there are seven EGFR/c-Met antibody drugs under development worldwide, and only Johnson & Johnson’s Amivantamab has been approved by the FDA for marketing.
7. On March 30, it was shown on the CDE official website that the clinical application for WJ13404 Tablet jointly invested by Junshi Biosciences and Wigen Biomedicine was accepted. WJ13404 is an effective fourth-generation EGFR inhibitor with potent inhibitory activity against third-generation EGFR-insensitive acquired EGFR variants and a high degree of selectivity for wild-type EGFR.
Approval
8. On March 29, Sino Biopharm announced that a new drug of Class 1, FHND5071, was approved by NMPA for clinical trials in the treatment of advanced solid tumors. FHND5071 is a brand new selective inhibitor of transfection rearrangement (RET) and its Investigational New Drug application has been submitted to the FDA.
9. On March 29, Hengrui Medicine announced that the Investigational New Drug application of SHR8028 Eye Drops was approved, and the clinical trials will be carried out in the near future. SHR8028 Eye Drops is a CyclASol (0.1% cyclosporin A drug product) introduced by Hengrui Medicine from Novaliq for the treatment of dry eye disease. At present, the drug is undergoing Phase 3 clinical trials in China and the United States simultaneously.
10. On March 30, it was shown on the CDE official website that the ABSK043 Capsule declared by Abbisko Therapeutics received the implied license for clinical trial approval, and the proposed indication is malignant tumor. ABSK043 is an innovative oral small molecule PD-L1 inhibitor researched and developed by Abbisko Therapeutics. The results of preclinical research will be presented ...
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