Hengrui, Chia Tai Tianqing, and Fosun Pharma lead the IND application of Category 1 new drugs!

Before a new drug is finally launched, two administrative approvals are required: one is clinical research approval, which involves IND (Investigational New Drug) application; the other is the completion of clinical research registration and marketing (NDA application)

The number of Category 1 new drug applications in the IND reflects the reserve of mature innovative drug projects on the company's R&D line

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The number of applications has exploded, exceeding 1,000 for two consecutive years

Looking back at the IND applications for Category 1 new drugs in recent years, it can be found that the number of applications has grown rapidly since 2015.

In August 2015, the State Council issued the "Opinions on Reforming the Review and Approval System for Drugs and Medical Devices", proposing reform measures such as priority review, drug marketing authorization holders, project management, communication and expert advisory committees to encourage innovation

In October 2017, the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council issued the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices", which proposed to optimize the clinical trial approval process, accept overseas clinical trial data, and speed up the review of urgently needed drugs.

On July 27, 2018, the State Food and Drug Administration issued the "Announcement on Adjusting the Review and Approval Procedures for Drug Clinical Trials", which clearly proposed a 60-day clinical review time limit, and the clinical review speed was shortened from an average of 16 months to 60 days

After almost every major reform measure, the number of new Class 1 drugs applied for clinical applications will increase substantially once

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The number of chemical drug declarations is the largest, and the proportion is decreasing

The number of biological drug declarations is 31 times in 7 years

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The declaration of proprietary Chinese medicines broke the bureau, from 0 to 43

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Domestic enterprises are mainly reporting, and the growth rate is accelerated

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Anti-tumor and immunomodulatory agents account for nearly 70%

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Rapid growth in the number of common names declared

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These 10 domestic companies have the largest number of applications