[Reporter's view] Strategies for Trial & error/the evolution

In August, there was a lot of good news in the pharmaceutical and bio industry.

 

Hanmi and Yuhan, leading domestic pharmaceutical companies, announced the news of the signing of a global technology transfer contract for the new drug pipeline, revealing the potential of R&D.

 

The license agreements of domestic companies are developing.

 

Earlier this month, Hanmi transferred the global copyright of a new bio-drug to treat non-alcoholic steatohepatitis (NASH) to MSD in the US.

 

The scale of technology transfer is about ₩1 trillion.

 

The down payment without obligation to return is ₩10 million, and royalties based on sales after commercialization are separately received.

 

There is another reason that the industry gives a special meaning to this technology transfer contract.

 

This is because it is a pipeline (HM12525A) that was returned from Janssen just a year ago, a GLP-1-based dual agonist named Efinopegdutide.

 

The development process of Efinopegdutide was not easy.

 

In November 2015, Janssen signed a technology transfer contract worth $915 million for diabetes/obesity indications.

 

But the recruitment of patients was temporarily suspended in November of the following year.

 

The trial was restarted in June of the following year, but the rights were finally returned in July of last year.

 

At the time of copyright return, Janssen said, "As a result of analyzing two phase II clinical trials of type II diabetes patients with severe obesity, the weight loss goal was met, but the blood sugar control effect did not meet the internal standards." It can be said that it has proven enough to cure obesity.

 

Two clinical data released afterwards showed potential as a treatment for obesity.

 

Subjects who received the test drug showed significant weight loss after 12 weeks, and secured an efficacy and safety profile comparable to that of the blockbuster obesity treatment 'Saxenda'.

 

Kwon Se-chang, CEO of Hanmi Pharm, pointed to 'HM12525A' as a key task at the JP Morgan Healthcare Conference earlier this year, and declared that he would develop the world's first once-a-weekly administered obesity treatment drug.

 

Hanmi Pharm's management succeeded in regaining trust in the labscovery platform technology by signing a new technology transfer contract one year after operating the GLP-1-based dual agent rehabilitation project.

 

It is not the end that the technology has been returned, and it is an evaluation that it has proved its R&D efforts by signing a trillion unit contract with Big Pharma after 4 years.

 

The implications can also be found in the contract between Yuhan and Processa last week.

 

Yuhan has transferred the global copyright of the functional gastrointestinal disease treatment candidate 'YH12852' to Biotech Processa in the United States.

 

The total contract size is about ₩487.2 billion, and the down payment without a return obligation is $2 million.

 

The down payment is received in full from Processa, and $4.5 million worth of shares is included in the total amount of technology exports.

 

It is a small-scale biotech with little known contract partner, and there is no immediate cash inflow effect.

 

'YH12852' is a candidate substance for a synthetic new drug developed by Yuhan.

 

In 2013, Yuhan initiated a phase I clinical trial in Korea for healthy adults, confirmed the excellent effect of improving bowel movements, and conducted a phase II clinical trial on patients.

 

However, it has been pending for nearly two years without obtaining satisfactory results.

 

Processa is planning to enter phase II clinical trial by meeting with the US FDA early next year.

 

It made a turning point by handing over the new drug pipeline, which had not progressed in development since 2018, It showed that it is necessary to use selection, focus, and efficient strategies when using R&D strategies.

 

Korean pharmaceutical companies have experienced a lot of trial and error with a lot of expectations and bitter taste.

 

Numerous trials and errors have led to the evolution of new drug technology export strategies.

 

It is nice that domestic pharmaceutical bio companies started to pay attention to practical interests when signing global license agreements.