What exactly should "hot" modified drugs do?

TextBai Xiaokong

Generic drugs face centralized procurement.

The generic drug of innovative drugs, the price under medical insurance negotiation is only lower but not the lowest, blocking a large number of small and medium-sized enterprises with poor anti-risk ability to invest in innovative drugs

Modified drugs have become a new hot spot, and many companies in the industry have deployed modified drugs

01

2 types that have been listed in China

According to the regulations, Class 2 drugs refer to improved new drugs that have not been marketed at home and abroad

Data source: Xianda Pharmaceutical Data

As shown in the table above, the most approved improved drugs in China are the drugs with new indications in category 2.

At present, only 3 companies in Category 2.

The manufacturers with the most approvals in category 2.

Most of the 2.

02

What clinical needs to be done to change the dosage form?

The modified dosage form is the most concerned by domestic companies, and the US 505(b)(2) can often omit some clinical studies and replace them with literature data

At present, in addition to Shanghai Hengrui Dexmedetomidine Hydrochloride Nasal Spray which has started Phase II and Phase III studies, and Edaravone Sublingual Tablet has started Phase III clinical studies, most of the other products, such as oral dissolving film preparations, have only been launched.

From injections to oral or inhaled preparations, phase III clinical trials are basically required

Data source: Xianda Pharmaceutical Data

03

summary

The new category 3 is expected to require confirmatory clinical trials

For projects that can be recognized by medical insurance reimbursement, there is a high probability that a phase III clinical trial will still be conducted.