SCD Pharm confirms Eylea's US partner

The CEO In-seok Jeon "SCD411, selected after US and European companies after Japan"

A Global phase III study starts in the first half of this year, under development 24 weeks long acting formulation

Injectables such as insulin with S-Pass platform->Oral Type Challenge

Jeon In-seok, SCD Pharm’s CEO

In-seok Jeon, SCD Pharm’s CEO, said on the 18th that he had selected US and European partners for Eylea’s Biosimilar (SCD411).

 

Only Senju Pharmaceutical in Japan contracted SCD411.

 

According to CEO Jeon’s remarks, additional export announcements (disclosures, etc.) are imminent.

 

SCD411 is about to launch its global phase III study in the first half of this year.

 

In addition to SCD411, Jeon said, "We are developing oral diabetes drugs (insulin, GLP-1) and anticancer drugs (Enbrel and Herceptin) as oral drugs".

 

The reason why global pharmaceutical companies are having their eye on SCD411?

 

The CEO mentioned five things about SCD411 competitiveness.

 

Those five things are △ original formulation patents and overseas applications (US, JP, EU, etc.) △2000L CMO production line construction Completed pre-verification regarding IND △development of the same product line as the original △completed pre-validation of IND-related products such as quality, non-clinical, clinical, etc.

 

with each country's permit holders (outside Japan, Europe, and the US) △ development of the same product line as the original.

 

Jeon said, “The meaning of certification and securing the 2000L production facility is that it lowered the risk of quality equality during the scale-up process.

 

The cost competitiveness is more than three times cheaper than 500L, and That's the capacity to cover global demand.

 

Non-clinical studies were conducted with the global CRO Cobans, but some of them were delayed due to Cobans issues.

 

However, the delayed part was replaced with a three-phase preparation process, which minimized time leakage.

 

In particular, he emphasized the same product development sector as the original.

 

The CEO analyzed that the same vials products as Eylea and PFS (Pre-filled Syringe, Pre-filled Syringe) have been developed, 24 weeks long-acting (long-lasting) products are also under development and SCD Pharm is the only company with this lineup.

 

Following Japan, the US and European partners have been confirmed, and Eylea’s Biosimilar of the existing formulations is expected to start sales in U.S.A & Japan in 2023 and Europe in 2024.

 

'S-Pass Application', Injection → Oral Development 'Hidden Card' CEO Jeon also unveiled their future strategic projects for the first time.

 

The projects are about the non invasive glucose monitor, S-CHECK, oral development of injectable diabetes treatments such as insulin and GLP-1, and No Needle platform Biz development of injectable anticancer drugs such as Enbrel and Herceptin.

 

The CEO explained that S-CHECK proved similar to the blood glucose meter Roche’s Accu-Check.

 

There was no difference between the blood glucose meter and S-CHECK, non invasive glucose monitor.

 

He said that S-CHECK is 100% blood free, no additional calibration, no need to replace sensors and cartridges and will quickly replace the glucose meter market in the future.

 

It also shared the S-Pass platform, which converts injections into oral ones.

 

S-Pass platform is Nano Micelle + Protein Complex and the Advantages are △GI (gastrointestinal + small intestine) absorption (Quick Acting → Quick Onset) △ encapsulation (permeability and absorption increase) ) △digestion inhibition/high bioavailability(cost reduction and price competitiveness) △Avoiding FDA approved excipients and oils(Ease/permit and minimize side effects) △No antacids and surfactants (Minor side effects for long-term chronic patients) A related advantage is the lack of features for companies looking to develop oral injections.

 

SCD Pharm has filed a patent application for S-Pass last August.

 

The CEO Jeon said, "We are developing Diabetes treatment such as insulin and GLP-1 as well as anti-cancer drugs such as Enbrel and Herceptin as oral drugs using the S-Pass platform.

 

After that, it will be the cornerstone of growth of SCD Pharm after Eylea’s Biosimilar".