15 approvals to transfer up to 20 million

Recently, a total of 15 drug approvals have been transferred in accordance with the latest drug marketing license holder policy.

Recently, Kunyao Group Co.

The basic situation of the product

Drug name: Pregabalin oral solution

Specification: 2% (473ml:9460mg)

Indications: Post-herpetic neuralgia and fibromyalgia.

Pregabalin is a second-generation calcium channel modulator, which enhances its affinity with α2-δ subunits, and can relieve PHN, improve sleep and emotional disorders.

According to the sales data of chemical medicines in public hospitals in Chinese cities on Meinenet, the sales of pregabalin preparations were 140 million yuan in 2017 and increased to 433 million yuan in 2020, representing a compound annual growth rate of approximately 46%.

Overall transaction arrangement

This transaction will be carried out in two stages

In the first stage, Party B shall deliver all the technical data related to the agreed product and the 2% (100ml) pregabalin oral solution to be added as of the effective date of the agreement and the original drug registration certificate of the agreed product to Party A or Party A Confirmed related parties or third parties, and provide free training services and technical support for relevant technical personnel of Party A.

In the second stage, within 6 months from the effective date of this agreement, Party B shall assist Party A in applying and obtaining regulatory approval to change the marketing authorization holder of the agreed product to Party A, and sign any necessary documents.

Recent transfer of approval documents

▍Fangsheng Pharmaceutical acquired Sanhua Jiegu San for RMB 14.

On April 12, Fangsheng Pharmaceutical (603998.

Sanhua Jiegusan is a national exclusive variety.

Sanhua Pharmaceutical has entrusted its main product Sanhua Jiegu San to Fangsheng Pharmaceutical on October 29, 2019, and the remaining products have not been produced in recent years.

In order to save production costs and shorten the management radius, Fangsheng Pharmaceutical intends to dispose of Sanhua Pharmaceutical’s equity at an opportunity after receiving the ownership of Sanhua Jiegu San, in order to reduce solidified assets and improve asset utilization efficiency.

▍Hefei Cube, 38 million, acquisition of 13 approvals

Hefei Lifang Pharmaceutical Co.

According to the announcement, the total sales of these varieties in 2019 and 2020 will be 30.

Change of holder: The holder of the marketing authorization of the target drug is changed from Party B to Party A, and the original copy of the new drug registration approval is held by Party A;

Technology transfer: Party B transfers all existing technologies (production technology, preparation technology, formula technology, quality standards, technical secrets, etc.

It is worth noting that there was a fire in Hefei Lifang Pharmaceutical recently.

At around 9:20 am on April 21, 2021, a fire accident occurred in the warehouse of Hefei Lifang Pharmaceutical Co.
, Ltd.
located at No.
522 Wangjiang West Road, Hefei City.
After the fire broke out, the company immediately activated an emergency plan to quickly evacuate people to prevent the fire from spreading, and actively cooperated with firefighters to carry out extinguishing work.
The fire on the spot was effectively controlled and completely extinguished.
No casualties were found after confirmation on the spot.