A Review of the Chinese-produced New Drugs Marketed in 2018

Sum up the past and look into the future. I’d like to sum up the Chinese-produced new drugs approved for marketing in 2018 and look into those that will soon be marketed in 2019.

Biological drugs accounting for half of the total

There was a total of 11 Chinese-produced new drugs approved for marketing in 2018, including 5 chemical drugs, 5 biological drugs, and 1 TCM by registration classification: the biological drugs accounted for half of the total. From the perspective of company, Hengrui topped with 2 marketed new drugs.

Click to view: Chinese-produced New Drugs Approved for Marketing in 2018

From the above we can see that the number of Chinese-produced new drugs marketed in 2018 was almost the same with previous years, but the quality was better and many indications were covered. All those new drugs are blockbuster drugs developed by the pharmaceutical enterprises and healthcare supply companies by spending a dozen years, and many of them are "first Chinese-produced". Let’s focus on several of them next.

First Chinese-produced anti-PD-1 antibody

Toripalimab Injection is the first Chinese-produced anti-PD-1 antibody marketed, which is used to treat patients with unresectable or metastatic melanoma who have failed systemic treatment previously. Furthermore, Junshi Biosciences is conducting clinical trials centering on many indications of the product, including nasopharyngeal cancer, gastric cancer, esophagus cancer, non-small cell lung cancer (NSCLC), malignant lymphoma, and hepatocellular carcinoma, etc. And Sintilimab of Innovent in the above table is the 2^nd Chinese-produced anti-PD-1 antibody marketed.

There have been 4 anti-PD-1 antibodies approved for marketing so far, separately being BMS’ Opdivo, MSD’s Keytruda, Junshi’s toripalimab, and Innovent’s sintilimab; and Hengrui and BeiGene are following them closely.

First Chinese-produced HCV DAA

The Danoprevir Sodium Tablets of Ascletis is the first Chinese-produced direct-acting antiviral (DAA) used to treat HCV. The drug belongs to the new generation of NS3/4A protease inhibitors. According to the results of the Phase III clinical trial completed in Mainland China, the drug showed a cure rate of 97% (SVR12) in genotype 1 non-cirrhotic patients and 100% in genotype 4 non-cirrhotic patients through a 12-week treatment duration.

First Chinese-produced long-acting anti-HIV drug

The new Class 1 biological drug: Albuvirtide independently developed by Frontier Biotechnologies is a gp41 inhibitor that is effective against the prevalent HIV-1 viruses and resistant viruses owing to its new molecular mechanism of action. It is used to treat HIV-1 infected people who have received antiviral treatment, and its administration of long-acting injection is an important supplement and improvement to the current oral therapeutic regimen. The drug is not only the first Chinese-produced anti-HIV drug, but also the world’s first long-acting HIV-1 fusion inhibitor that possesses global intellectual property. Details of the drug can be referred to in my previous article "Made in China—Albuvirtide, the World’s First Long-acting Anti-AIDS Drug, is Approved for Marketing".

Other new drugs also not to be taken lightly

Besides the above drugs, the 3 tinib drugs are also worthy of attention. Chiatai Tianqing’s anlotinib, Hengrui’s pyrotinib, and Hutchison MediPharma's fruquintinib are all much-anticipated blockbuster drugs. Details of them can be referred to previous articles in this official account: "Anlotinib, the ‘Most Heavyweight’ Class 1 New Drug of Chiatai Tianqing, Approved for Marketing", and "Big News! Fruquintinib, a Chinese-produced Blockbuster Class 1.1 New Anticancer Drug, Approved for Marketing".

In addition, Hengrui’s G-CSF—Mecapegfilgrastim Injection (referred to as 19K) was eventually approved in May 2018 after going through withdrawal of marketing application and reapplication for production. Details can be referred to my previous article "The Final Step! 19K, the RMB2 Billion+ Blockbuster New Drug that Walked the ‘Most Tortuous’ Way in History of Hengrui, to be Marketed Soon".

The Recombinant Cytokine Gene Derived Protein Injection of Genova Inc. is the first new drug of the company after 18 years of R&D, which is a therapeutic protein with broad-spectrum immune regulation functions and is used to treat chronic HBV. The drug has huge potential in terms of treatment of major human diseases associated with immune functions such as malignant tumors and autoimmune diseases. Pegylated Recombinant Interferon Variant Injection of Beijing Kawin is also a key new HCV drug launched by the company.

Avitinib may become the first Chinese-produced new drug marketed in 2019

I’ve sorted out the Chinese-produced new drugs to be marketed soon in 2019 based on public data, wherein, ACEA Pharma’s avitinib maleate, Hengrui Medicine’s Camrelizumab for Injection, and Hansoh’s Polyethylene Glycol Loxenatide Injection are expected to be marketed in 2019 Q1. In my opinion, avitinib, the first Chinese-produced third-generation EGFR TKI, may be the first Chinese-produced new drug marketed this year. Please refer to my previous article "Rival of Osimertinib: Avitinib, the First Chinese-produced Third-generation EGFR TKI, Has Received Priority Review for Production Application" for the details.

Clike to view: Chinese-produced new drugs to be marketed soon in 2019

About  the Author:    

Caicai, a Master of Pharmacy from Shanghai Jiaotong University, used to work in the Institute of Science and Technical Information. Currently as a practitioner in the drug surveillance system, she is good at interpreting industry regulations, pharmaceutical research developments, etc.

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