BOSTON, Mass. -- By Kim Chan-hyuk/Korea Biomedical Review correspondent -- In Korea, known as the cradle of the biosimilar industry with pioneers like Celltrion and Samsung Bioepis, there emerges another notable company making significant strides in the field of antibody-drug R&D. Prestige Biopharma Group, based in Singapore, has firmly established its presence in this domain.

Prestige Biopharma is developing not only biosimilars but pancreatic cancer antibody drugs and diagnostic kits. Prestige Biologics, a subsidiary specializing in contract development and manufacturing organization (CDMO) business, has established a 154,000-liter plant in Osong, North Chungcheong Province.

Prestige Biopharma Group, owning the two hottest business models -- biosimilars and CDMOs, installed an exclusive booth at the 2023 BIO International Convention (BIO 2023) in Boston, Mass., to engage with international clients.

Korea Biomedical Review conducted an interview with Lisa Soyeon Park, CEO of Prestige Biopharma Group, during BIO 2023 to learn more about the company's business plans, biosimilar development status, and future ambitions.

Question: How did Prestige Biopharma Group come to participate in BIO 2023?

Answer: BIO 2023 is one of the most attended and heavily promoted conferences for biotech companies. At the event, Prestige Biopharma will showcase to global clients its full value chain capabilities from antibody-drug R&D to production. We are scheduled to meet with many global partners.

In particular, We’re focusing on exploring opportunities for Prestige Biologics’ CDMO business, emphasizing that CDEMO is possible by adding an “E” (engineering) to CDMO. I am confident that we can supply customized services that are more flexible than existing CDMO services at a reasonable price.

Prestige Biologics has completed its Osong plant and is conducting aggressive sales activities. To date, the company has signed contracts for raw material testing, contract manufacturing of drug substance (DS), and contract packaging organization (CPO) orders.

Ultimately, the goal is to win large-scale supply contracts with multinational pharmaceutical companies. For now, Prestige Biologics is still a newcomer to them. We have been conducting independent sales activities since August last year. We will do our best to secure meaningful orders soon.

Q: What kind of activities will you be doing at BIO 2023?

A: We will participate in the Korea Biotech Partnership (KBTP 2023) event co-hosted by Korea BIO and the Korea Trade-Investment Promotion Agency (KOTRA), and conduct an IR pitch to 150 attendees, including overseas venture capitalists and those from Korean American Society in Biotech and Pharmaceuticals (KASBP). 

In particular, we will present PBP1510, a pancreatic cancer treatment candidate in our antibody drug pipeline, and a PAUF protein-based pancreatic cancer diagnostic kit under development. In addition, Prestige Biopharma will present its various antibody drug programs and R&D capabilities and explore investment and collaboration opportunities.

Q: We understand that you are planning to reapply for the European marketing authorization of HD201, a biosimilar of Herceptin, this year. What is the specific timing and strategy for the plan?

A: We had a preliminary meeting with the European Medicines Agency (EMA) in May. After reviewing the data related to the additional testing and analytical work, they did not raise any specific objections and gave a positive response that there is no problem with the marketing authorization application. We expect to submit the application in July.

The EMA's previous negative opinion was due to a difference of opinion on the setting of the analytical equivalence threshold, which they considered to be different for clinical and commercial batches. After withdrawing the application, we conducted additional testing and analyses to meet the equivalence analysis criteria desired by the CHMP, the EMA's Committee for Medicinal Products for Human Use.

In addition, we had a pre-marketing meeting with the U.S. Food and Drug Administration (FDA) on HD201 last month, which went well.

Q: Please share more about Prestige Biopharma's other biosimilar and antibody drug pipeline development and commercialization status.

A: Avastin biosimilar HD204 is in a global phase 3 clinical trial, and Humira biosimilar PBP1502 has been approved for a phase 1 study in Europe and the trial is ongoing. We plan to start a phase 3 study this year. We hope to file for approval in 2025.

PBP1510, a new antibody for pancreatic cancer, is in phase 1/2a in Europe and the U.S. In March, it was designated as a fast-track item by the FDA, which enabled simultaneous clinical development and license application preparation. In addition, various anti-cancer bispecific antibodies based on PAUF and CTHRC1 are in early development, and we are also working on developing new antibody drug platforms.

Q: Recently, you have accelerated the development of a pancreatic cancer diagnostic kit. What made you start developing it?

A: PAUF, the target protein of our new pancreatic cancer antibody PBP1510, is overexpressed in most pancreatic cancer patients. Therefore, detecting PAUF overexpression in the blood could lead to earlier detection of pancreatic cancer through regular screening. We aim to build an innovative pancreatic cancer treatment ecosystem with PAUF-based diagnostics, treatment, and prevention with PBP1510, an anti-PAUF antibody.

The pancreatic cancer diagnostic kit developed by Prestige Biopharma IDC is undergoing large-scale clinical sample analysis, and as soon as the initial results are available, we will consult with domestic and foreign regulatory authorities, and we expect to launch it as early as early next year.

Q: Lastly, please tell us about the future direction of the business.

A: Prestige Biologics has started its CDMO business in earnest this year with a record number of orders and track records. Our goals for the year are to secure orders through aggressive sales, improve profitability by preempting the CDMO market, and enhance shareholder value through stable growth.

Prestige Biopharma is also actively developing new biosimilars including PBP2102, a biosimilar of Keytruda whose patent is scheduled to expire in 2028, to secure future growth engines. 

Prestige Biopharma Group will strive to increase patient access to innovative new medicines under the group’s calling, "Innovation for Life.” Thanks to the efforts of all employees, R&D, commercialization, and business orders are progressing as expected. We look forward to receiving support for Prestige Biopharma Group's global journey.