With the first half of 2019 to pass soon, according to Xanda Data V3.5 (Xanda.cn) on the products approved by NMPA, imported new drugs are based on clinically imperative marketed drugs, and approvals of generic drugs are being accelerated.

Approval of imported new drugs
From the perspective of indication, diabetes drugs account for the largest number. Many products are approved according to clinically imperative overseas new drug, such as Elosulfase Alfa Injection, Denosumab Injection, and Herpes Zoster Vaccine (Recombinant, Adjuvanted) (CHO cells).
Product name | Company | Indication |
Linaclotide Capsules | Almac Pharma | Moderate to severe irritable bowel syndrome |
Lurasidone Hydrochloride Tablets | Bushu | Adults with schizophrenia |
Sitafloxacin Tablets | Daiichi Sankyo | Community-acquired pneumonia and urinary tract infections |
Metformin and Empagliflozin Tablets (Ⅰ), (Ⅲ), (Ⅳ), (Ⅴ), (Ⅵ) | Boehringer Ingelheim | Type 2 diabetes |
Tedizolid Phosphate Tablets, Tedizolid Phosphate for Injection | Bayer | Acute bacterial skin and skin structure infections (ABSSSI) in adults caused by designated susceptible bacteria |
Nusinersen Sodium Injection | Biogen | Infants, children and adults with spinal muscular atrophy, a rare inherited neuromuscular disease |
Dacomitinib Tablets | Pfizer | Single drug used for locally advanced or metastatic NSCLC (non-small cell lung cancer) with confirmed EGFR (epidermal growth factor receptor) exon 19 deletion or exon 21 L858R substitution mutations |
Ceftazidime and Avibactam for Injection | Pfizer | Complicated urinary tract infections (cUTI) and complicated urinary tract infections (cUTI), including kidney infection (pyelonephritis), in adults who have limited or no alternative treatment options |
Glecaprevir and Pibrentasvir Tablets | AbbVie | HCV |
Dulaglutide Injection | Eli Lilly | Type 2 diabetes |
Secukinumab Injection | Novartis | Psoriasis, psoriatic arthritis, and ankylosing spondylitis |
Recombinant Human Growth Hormone for Injection | Novo Nordisk | Deficiency of growth hormone in adults or children, Turner syndrome, and growth disorder caused by chronic kidney disease |
Insulin Degludec and Insulin Aspart Injection | Novo Nordisk | Diabetes |
Elosulfase Alfa Injection | BioMarin | Mucopolysaccharidosis |
Denosumab Injection | Amgen | Giant-cell tumor of bone |
Read More
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