Review progress of the first batch of clinically imperative overseas new drugs

I’ve specially updated the review progress of the first batch of clinically imperative overseas new drugs on Dec. 10, 2018, for details of which please refer to "Update on Review Progress of the First Batch of Clinically Imperative New Drugs: Many Drugs Approved for Marketing through Streamlined Review". Based on this article, certain noteworthy developments recently will be updated below. (Read more on: Global Innovative Drugs Speeding up to Enter China with the Help from Policies)

There is a total of 40 drugs in the first batch of clinically imperative drugs, wherein, 4 drugs have been successively approved for marketing, such as the rare disease drug Nusinersen; and a noteworthy drug in the batch is Eli Lilly’s Olaratumab for soft tissue sarcoma. CDE undertook the marketing application therefor on Dec. 10, 2018, and its handling status is now "Under approval".

However, after the drug was accelerated approval for marketing in 2016, its subsequent confirmatory trial ANNOUNCE, NCT02451943 failed to reach the endpoint. According to Eli Lilly’s 2018 financial report, sales of Lartruvo reached USD304 million in 2018, and Eli Lilly has stopped the promotion of the drug. FDA and EMA have announced that 1. Lartruvo (olaratumab) should not be given to new patients with soft tissue sarcoma; 2. Patients who are currently receiving the drug should consult with doctors and other professionals about whether to remain on the treatment.

Clinical benefits of Lartruvo (olaratumab) should also continue to be monitored and assessed after it is accelerated to be approval for marketing in China.

Predictably, more drugs will be approved for marketing via such channel in the future, and the inclusion into the list of clinically imperative new drugs will greatly accelerate the marketing process, specifically:

1. Those filed marketing applications need to be supplemented some data (such as ethnic differences study data, and research and risk control after marketing);

2. Those filed IND applications may be changed to marketing applications, with relevant data supplemented;

3. Those not applied in China may directly be filed marketing applications.

The above review and approval channel specially set for pharmaceutical products in the said list will undoubtedly improve the access to innovative drugs in China, showing that China is warmly embracing global innovative drugs.

Related:

Global Innovative Drugs Speeding up to Enter China with the Help from Policies

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