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Overview of the Approval Trends of Pharmaceutical Products in the First Half of 2019

July 11, 2019 By Suyi

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

Overview of the Approval Trends of Pharmaceutical Products in the First Half of 2019

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



Linaclotide Capsules

Almac Pharma

Moderate to severe irritable bowel syndrome

Lurasidone Hydrochloride Tablets


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


Acute bacterial skin and skin structure infections (ABSSSI) in adults caused by designated susceptible bacteria

Nusinersen Sodium Injection


Infants, children and adults with spinal muscular atrophy, a rare inherited neuromuscular disease

Dacomitinib Tablets


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


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



Dulaglutide Injection

Eli Lilly

Type 2 diabetes

Secukinumab Injection


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


Elosulfase Alfa Injection



Denosumab Injection


Giant-cell tumor of bone

Herpes Zoster Vaccine (Recombinant, Adjuvanted) (CHO cells).


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



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


Benvitimod Cream

Guangdong Zhonghao


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


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


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’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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