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 |
Herpes Zoster Vaccine (Recombinant, Adjuvanted) (CHO cells). | GSK | Prevention of herpes zoster (HZ) and HZ associated complications |
The original drug of Bivalirudin for Injection has finally been marketed according to Class 5.1 drug, while its first generic has already been marketed in China since 2014 by Hansoh.
Chinese new drugs approved
Product name | Company | Indication |
Camrelizumab for Injection | Jiangsu Hengrui | Relapsed/refractory classical Hodgkin lymphoma patients who have received at least second-line systematic chemotherapies |
Polyethylene Glycol Loxenatide Injection | Jiangsu Hansoh | Diabetes |
Benvitimod Cream | Guangdong Zhonghao | Psoriasis |
Fructus Cnidii Total Coumarins and Cream | Guangdong HST | Improvement of psoriasis pathological changes, with strong anti-inflammatory, antiallergic and antipruritic effects |
Octafluoropropane-filled Human Albumin Microspheres for Injection | Xiamen Lizhuo | Contrast-enhanced ultrasound |
First generics /biosimilars first marketed in China
Product name | Enterprise |
Tadalafil Tablets | Changchun Haiyue |
Apixaban Tablets | Jiangsu Hansoh |
Vildagliptin Tablets | Jiangsu Hansoh |
Saxagliptin Tablets | Jiangsu Aosaikang |
Lacosamide Tablets | Jiangxi Qingfeng |
Levetiracetam Extended-Release Tablets | Shenzhen Salubris |
Entecavir Tablets | Beijing Baiao |
Sodium Bicarbonate Ringer's Injection | Jiangsu Hengrui |
Trimetazidine Dihydrochloride Modified Release Tablets | Qilu Pharmaceutical |
Compound Ipratropium Bromide Solution for Inhalation | Joincare |
Rituximab Injection | Shanghai Henlius |
Lamivudine and Tenofovir Disoproxil Fumarate Tablets | Anhui Biochem |
Multiple Electrolytes Injection (Ⅴ) | Inner Mongolia Baiyi |
Lysozyme Eye Drops | Shenyang Sinqi Pharmaceutical |
Chiatai Tianqing is the manufacturer that has received many generic drug approvals in 2019: besides first generics, it has been among the first three approved for Lenalidomide Capsules, Apixaban Tablets, Gefitinib Tablets, and Ambrisentan Tablets.
Qilu’s Lenalidomide Capsules has also been approved in 2019. Lenalidomide Capsules is highly likely to become one among the second batch of "4+7" product list. Qilu pharmaceutical’s Vildagliptin Tablets is the second Chinese-produced Vildagliptin Tablets approved in China.
Among the Chinese generic drug manufacturers, Sichuan Huiyu’s Docetaxel Injection, Guangdong HEC Pharm’s Olmesartan Medoxomil Tablets, Guangdong China Resources Shunfeng’s Hydrotalcite Chewable Tablets, and Jiangsu Vanguard’s Olopatadine Hydrochloride Tablets have been the first products approved according to the new Class 4 since 2016; Chengdu Brilliant’s Ketorolac Tromethamine Injection has been the first product approved according to the new Class 3 since 2016.
Zhejiang Jingxin has marketed the 10mg Rosuvastatin Calcium Dispersible Tablets according to the old Class 5 in 2019. According to the "4+7" tender rules, it’s difficult to separately group dispersible tablets and common tablets.
In terms of imported generic drug, Yuhan Corporation, a South Korean company, has been approved for the Voglibose Tablets. The approval of imported generic drugs is gradually accelerated.
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