Important Progresses of New Drugs Marketed in China in 2019

In the past 2019, lots of new drugs has been approved to be marketed in China which will make great impact on the Chinese pharmaceutical market. Here are some of the most important ones reported by En-CPhI.CN.

Imported Drugs:

1、Novartis’ CTL019 Applied for Clinical Trial in China to Officially Enter the Chinese Market

     Novartis filed a clinical trial application for CTL019 in China on Aug. 12, which has been accepted by the CDE. CTL019 is a breakthrough new CAR T-cell drug under Novartis, which is also the world’s first CAR T-cell therapy approved.

2、Novo Nordisk’s Recombinant Coagulation Factor Ⅷ Applied for Marketing Ahead of Chiatai Tianqing!

     Chiatai Tianqing previously completed the relevant Phase III clinical trial ahead of Novo Nordisk, however, Novo Nordisk filed the marketing application to the NMPA ahead of Chiatai Tianqing.

3、History of the "Sky-high Priced" Imported Drug to China: Nusinersen Injection

     Biogen announced on Feb.28, 2019 that SPINRAZA (nusinersen) has been approved by the China National Medical Products Association (NMPA) for the treatment of 5q spinal muscular atrophy (SMA), expanding the company’s presence in China.

4、A Blockbuster to Arrive in the Multiple Sclerosis Area of China！

     Novartis’ Fingolimod Hydrochloride has been approved in China as a disease-modifying therapy to treat adults and children, ages 10 and older, with relapsing forms of multiple sclerosis (MS).

5、The First Bladder Cancer Targeted Therapy Filed the Import Drug Clinical Trial Applications to Start the Road of Marketing in China

     The Erdafitinib Tablets developed by Janssen under J & J has recently been filed the import drug clinical trial applications in China, which have been accepted, to start the road of marketing of this blockbuster bladder cancer drug in China. It is expected to bring an innovative targeted therapy for Chinese bladder cancer patients.

Chinese Produced New Drugs:

6、Polyethylene Glycol Loxenatide! The First Chinese-produced Long-acting GLP-1R Agonist

     The blockbuster diabetes product: long-acting GLP-1 receptor agonist polyethylene glycol loxenatide (trade name: Fulaimei) of Hansoh Pharmaceutical has been marketed on May 7, 2019, which is indicated for type 2 diabetes and administered once every week. Polyethylene glycol loxenatide is the 3rd long-acting GLP-1 receptor agonist approved for marketing in China following exenatide microspheres (trade name: Bydureon) of AstraZeneca/3SBio and dulaglutide (trade name: Trulicity) of Eli Lilly.

7、The approval of Salubris’ Teriparatide is making waves again in the osteoporosis drug market in China

     The blockbuster diabetes product: long-acting GLP-1 receptor agonist polyethylene glycol loxenatide (trade name: Fulaimei) of Hansoh Pharmaceutical has been marketed on May 7, 2019, which is indicated for type 2 diabetes and administered once every week. Polyethylene glycol loxenatide is the 3rd long-acting GLP-1 receptor agonist approved for marketing in China following exenatide microspheres (trade name: Bydureon) of AstraZeneca/3SBio and dulaglutide (trade name: Trulicity) of Eli Lilly.

8、Shanghai Green Valley’s Class 1 New Drug for Alzheimer’s Disease Conditionally Approved for Marketing and Already Having the Registration Approval!

     The NMPA has conditionally approved the marketing registration application of Sodium Oligomannurarate Capsules (trade name: GV-971) to treat moderate to mild Alzheimer's disease (AD) and improve patients’ cognitive function. The NMPA requires the applicant to continue to study the pharmacological mechanism and the long-term safety and effectiveness, improve the oligosaccharide analysis method and submit relevant trial data on time after the marketing.

Antibody & Bisomilars:

9、Hot Battle! Which to be the Next "Hanlikang"? 

     Rituximab Injection (trade name: Hanlikang) developed by Henlius has been approved by NMPA for marketing on Feb. 22, 2019. It is the first biosimilar approved in China, and is an anti-CD20 monoclonal antibody mainly used to treat non-Hodgkin lymphoma.

     Its presence has formally started the era of biosimilars in China! The world of biosimilars in China is in hot battle.

10、Another Anti-PD-L(1) Monoclonal Antibody Filed the IND Application in China to Join the 40+ Applicants! Sales of Keytruda to Rank Second in the World in 2019

       The Chinese enterprise Jiangsu Hyamab Pharmaceutical Co., Ltd. applied for an anti-PD-L1 monoclonal antibody on Oct. 30, 2019 using IgG4kappa, S228P, ADCC weak and CDC weak, to join the 40+ Chinese applicants.

Related:  China has Entered the Era of Tumor Immunotherapy: Updates on the R&D Progress of Anti-PD-(L)1 Antibodies

11、Breaking News! China’s Humira Biosimilar Produced by Bio-Thera to be Marketed Soon

       On November. 7th, Bio-Thera Solutions, Ltd., a clinical-stage pharmaceutical company, Onannounced that the China National Medical Products Administration (NMPA) has approved QLETLI® (格乐立®) for all eligible indications of the reference product, Humira® (adalimumab), in China. 

12、Based on China to Go International: The Trastuzumab Biosimilar HLX02 Applied for Marketing

       According to the announcement of Henlius on Apr. 25, 2019, the marketing application of the trastuzumab HLX02 has been accepted by NMPA, with the acceptance No. of CXSS1900021 and the indications applied for being early-stage HER2+ breast cancer, metastatic breast cancer, and metastatic gastric cancer.

Related:  Biosimilars that have entered Phase III clinical trials

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