Kwang Dong is continuing the business of Pomalyst

Celgene's market leading treatment for multiple myeloma, second challenge after Boryung

Prominence in the market with the launch of first generic, Afinitor

Kwang Dong

Kwang Dong is continuing the business of specializing anticancer drug first generics by challenging the patent for Celgene's multiple myeloma treatment 'Pomalyst' (Pomalidomide).

 

Recently, Kwang Dong is showing a prominence in the anticancer drug business by introducing the first generic drug for multiple myeloma treatment, Revlimid and breast cancer treatment, Afinitor.

 

According to the MFDS and the industry on the 13th, Kwang Dong requested a trial for a confirmation of passive rights scope to evade the formulation of Pomalyst (expired on July 21, 2030).

 

Earlier, on the 31st of last month, Boryung also filed a trial to confirm the scope of passive rights to the same patent.

 

Exclusivity generic drug, which grants market monopoly to drugs after successful patent challenge, applies to companies that have requested within 14 days of the initial request for trial.

 

After Boryung's initial request for judgment, other companies must file it by the 14th of this month for the condition to be established.

 

It is worth noting that Kwang Dong has succeeded in evading the patent of Celgene's other multiple myeloma treatment, Revlimid (Lenalidomide).

 

Kwang Dong confirmed the patent evasion by receiving a citation trial in the 2016 trial to confirm the passive scope of rights filed against the crystal-form patent of Revlimid .

 

Kwang Dong is the only pharmaceutical company that has succeeded in the patent challenge of Revlimid.

 

Kwang Dong has launched and sold the first generic drug 'Lenaldo' since 2018.

 

Last year, Lenaldo recorded sales of about ₩600 million based on IQVIA.

 

Kwang Dong was the first Korean company to challenge the patent for Novartis' breast cancer treatment drug 'Afinitor' and received a license for the first generic drug in March.

 

Through a long patent dispute with Novartis, Kwang Dong won the trial for invalidation of a patent for use earlier this month, and was granted a first generic drug.

 

Afinitor’s first generic 'Elinito', which was approved in March, is a drug imported from Synthon Chile Ltda.

 

in Chile.

 

It has obtained generic exclusivity right to the market by December 31 of this year.

 

In the case of generic for Afinito, only two companies of Kwang Dong and Samyang Biopharm were licensed, and generics for Revlimid were licensed only from Kwang Dong, Chong Kun Dang, Samyang Biopharm and Alvogen Korea were licensed.

 

It is relatively free from competition as there are few generic companies.

 

However, in the case of anticancer drugs, the original preference is high and the probability of using them in general hospitals is high.

 

Pomalyst, which has been challenged by Kwang Dong this time, is a drug that can be used in patients with multiple myeloma that do not respond to Revlimid.

 

The product lineup can be strengthened if Kwang Dong, which has the first generic for Revlimid, Lenaldo, succeeds in acquiring drugs that are generic for Pomalyst.

 

Multiple myeloma is one of the three major hematologic cancers with a high incidence, along with lymphoma and leukemia, and the market size of the drug has been increasing since the introduction of the target treatment, Revlimid.