BOSTON, Mass. -- By Lee Han-soo/Korea Biomedical Review correspondent -- Samyang Holdings Biopharm Group said it would open a production base for biodegradable suture yarns with an annual production capacity of 100,000 kilometers of yarns in Hungary on June 13.

Hungary was considered an optimal production base thanks to its zero tariffs and convenient logistics within the EU, said Samyang Biopharm USA President Helen Cho during a press conference on the sidelines of the 2023 BIO International Convention in Boston, Mass., on Wednesday, local time. 

"Notably, Europe is a key region that supplies 30 percent of the world's suture yarn exports," she said.

According to Cho, biodegradable suture yarns play a vital role in Samyang's medical device business, constituting approximately 45 percent of the total sales of Samyang Holdings Biopharm Group.

"We mainly focus on the global market, as exports account for 95 percent of biodegradable suture yarn sales," she said. 

Last year, the company supplied more than 190 companies in 45 countries with yarns worth about $50 million, maintaining the top spot in the global yarn market.

The company's capabilities in biodegradable materials accumulated over 20 years have recently led to its entry into the aesthetic plastic surgery market.

In 2020, Samyang Holdings Biopharm Group first launched the lifting thread Croquis​, which is a biodegradable suture used in thread lifting procedures to improve skin elasticity and wrinkles, in the global market.

To expand into the aesthetic surgery market, the company has developed a Lafullen, a polycaprolactone (PCL).

Earlier on May 25, the Korean headquarters had announced a partnership agreement with Hangzhou Yxintent, a Chinese medical device and aesthetics company, to export Lafullen to China.

Under the accord, Yxintent will conduct clinical trials and licensing of Lafullen in China and will exclusively market Lapulen in China once licensing is completed.

Samyang Holdings will supply finished products worth approximately 100 billion won ($$75.4 million) over five years.

Anticancer drugs lead Samyang's pharma biz

Cho said that Samyang Holdings Biopharm Group's pharmaceutical business is centered on anticancer drugs.

Genexol, a paclitaxel-based lung and breast cancer drug launched in 2001, has held the top spot among domestic paclitaxel-based anticancer drugs since 2017 with a share of more than 50 percent, she said. 

"The company is comprising a portfolio of anticancer drugs centered on Genexol, including six types of solid tumors and six types of hematologic cancers. It will also induce prescription expansion through securing new indications and entering large hospitals."

Samyang Holdings Biopharm is also planning to expand the anticancer business into the global contract development and manufacturing organization (CDMO) market.

The Daejeon Pharmaceutical Plant, which currently has an annual production capacity of 900,000 vials, is expanding its capacity to produce 5 million vials of cytotoxic anticancer injectables, including 4 million vials of liquid injectables (glass containers for injection) and 1 million vials of freeze-dried injectables.

The plant is being expanded to meet U.S. current good manufacturing practice (cGMP) standards and is equipped with an isolator system to keep workers and manufacturing processes completely separate, she added.

Seeking global licensing agreements

Cho said the company wants to license out new drug development technologies to global pharmaceutical companies.

"We are developing new drugs with the goal of entering the global market, and the company's R&D center in Pangyo, Gyeonggi Province, focuses on developing gene therapies utilizing its self-developed drug delivery platform, SENS," she said.

SENS, short for Stability Enhanced Nano Shells, is a drug delivery platform for nucleic acid therapeutics such as siRNA (short interfering ribonucleic acid) and mRNA (messenger ribonucleic acid) and biopharmaceuticals such as anticancer viruses by enhancing stability compared to the existing DDS platform.

"Biopharmaceuticals are easily degraded in the human body and are harder to absorb into cells than synthetic drugs," the president of the U.S. offshoot said. "To be effective, biopharmaceuticals must have a delivery vehicle that can deliver the drug to the target organ in the body without damage and pass through the cell membrane into the cell. This is why drug delivery vehicles are important for biopharmaceutical development."

Recently, interest in the SENS platform has increased, and open innovation is expanding in all directions, she added.

In April of this year, Samyang Holdings signed a strategic partnership agreement with LG Chem to apply Samyang Holdings' proprietary drug delivery system technology to develop mRNA-based anticancer drugs.

Samyang Holdings will provide LG Chem with its own mRNA delivery system NanoReady technology and related compositions, and LG Chem will combine them to discover innovative new mRNA-based drugs with maximized anticancer efficacy.

"Recently, the most popular delivery technology is lipid nanoparticle (LNP), which has been used to develop mRNA coronavirus vaccines," she said. "This method is characterized by encapsulating and protecting the mRNA with a fatty capsule, which accumulates in the liver and causes hepatotoxicity in the body. Research is focused on overcoming these limitations."

SENS is a delivery vehicle that overcomes the disadvantages of LNPs by being composed of polymers in addition to lipids, she added.

The U.S. head stressed that unlike LNPs, which are mainly delivered to the liver, SENS can be used to deliver drugs directly to specific organs such as the liver, lungs, and spleen, resulting in better therapeutic effects.

"It also has lower liver toxicity than LNPs, making it suitable for developing treatments for rare diseases that require repeated administration over a long period," she said.