Significantly Reduce Manufacturing Cost and Increased Local Production: SCG Cell Therapy Opens State-of-the-art Cell Therapy Manufacturing Facility and R&D Centre in Singapore

SCG Cell Therapy celebrates the opening of its new Cell Therapy Manufacturing Facility and R&D Centre,launching a new first-of-its-kind automatic cell therapy manufacturing system in Singapore,pioneering Singapore's Manufacturing 2030 Vision.

Facility will substantially increase local production capacity while significantly reducing the cost of cell therapy.

SINGAPORE,July 19,2023 -- SCG Cell Therapy Pte Ltd (SCG),a biotechnology company developing novel immunotherapies for infectious diseases and their associated cancers,has celebrated the official opening of its Cell Therapy cGMP Manufacturing Facility and R&D Centre at its headquarters in Singapore. With the support of the Singapore Economic Development Board (EDB),the new facility leverages and extends SCG's capabilities in advanced cell therapy manufacturing and off-the-shelf human-induced Pluripotent Stem Cell (iPSC) technology. The facility will supply cell therapy products to partner hospitals in Asia Pacific,North America,and Europe.

"Cell therapy has demonstrated the potential to revolutionize treatment for cancers and other life-threatening diseases. However,the high manufacturing costs and supply limitation are limiting patient access to the treatment",said Christy Ma,Chief Strategy Officer of SCG Cell Therapy.

Cell therapy list prices range from US$373,000 to US$475,000 (S$504,000 to S$640,000) depending on the specific drug and indication,and the demand outstrips supply.

In a report entitled "Bold Goals for U.S. Biotechnology and Biomanufacturing",the U.S. White House recently announced biotech-related "bold goals" to advance the development of cell therapy aiming to expand patient access to the treatments and decrease the manufacturing cost by 10-fold.[1]

Cell therapy manufacturing is often a complex process. It involves many handling steps of highly sensitive "living" cells under strictly controlled conditions. Transforming from the traditional open and manual processes,SCG employs its proprietary closed and automated cell therapy manufacturing technologies,providing advantages in reduced contamination and risk,greater product consistency and efficiency,increased scalability and lower cost.

"This advanced cell therapy manufacturing system reduces the amount of required cleanroom space by 80% per patient compared with manual manufacturing methods. It eliminates the labour-intensive procedures and improves throughput by a factor of ten. Overall,it is expected to reduce the per-patient manufacturing cost by up to 70%,making cell therapy an assessable and affordable treatment option for patients",Christy added.

In 2021,SCG collaborated with the Cell Therapy Facility of Singapore Health Sciences Authority (HSA-CTF) to validate its proprietary closed and automated cell therapy manufacturing system.[2] The system was accredited by Singapore Health Sciences Authority (HSA) and the U.S. Food and Drug Administration (FDA) for clinical trials.

"As part of Singapore's Manufacturing 2030 vision,we aim to position Singapore as a global business,innovation,and talent hub for advanced manufacturing. The biotechnology sector is an important flank of our strategy. Today,we have a thriving ecosystem comprising both local and global companies pursuing their ambitions in biotechnology from Singapore. SCG Cell Therapy is one of our promising local startups,developed its first cell therapy product,SCG101,with the support of agencies like the Health Sciences Authority (HSA) and the Agency for Science,Technology and Research (A*STAR). Headquartered in Singapore,and with teams in China and Germany,SCG Cell Therapy offers the entire drug development cycle - from research and development (R&D),GMP manufacturing,and clinical development to commercialisation. The cGMP facility will enable SCG Cell Therapy to further scale its operations. Its development augurs well for the growth of our biotech sector",said Ms Low Yen Ling,Minister of State,Ministry of Trade and Industry.

"In line with Singapore's advanced manufacturing initiatives,the opening of this facility set an important milestone of cell therapy manufacturing advancement in the region. As our broad pipeline of cell therapy products progresses to the market,we look forward to further expanding our commercial-scale manufacturing capabilities in Singapore to deliver high-quality and affordable treatment to meet patients' needs across Singapore,Asia-Pacific,and the world",said Frank Wang,Chief Executive Officer of SCG Cell Therapy.

"Apart from the cGMP facility,SCG Cell Therapy is also opening an R&D centre to facilitate the research of its pipeline of cell therapy product candidates. The opening of such R&D facilities will support the Government's vision and commitment to anchor Singapore as a global innovation node. At the national level,these efforts are guided by our Research,Innovation and Enterprise 2025 (RIE2025) masterplan. I look forward to seeing SCG Cell Therapy thriving amid our biotech ecosystem and advancing cell therapy technology to deliver breakthrough life-saving products to patients",Ms Low Yen Ling added.

About SCG Cell Therapy

SCG is a leading biotechnology company focusing on the development of novel immunotherapies in infections and its associated cancers. The company targets the most common cancer-causing infections: helicobacter pylori,human papillomavirus,and hepatitis B,and develops a broad and unique pipeline of T cell therapies,antibodies,and therapeutic vaccines against infections and to prevent and cure its associated cancers. Established and headquartered in Singapore,SCG combines regional advantages in Singapore,China and Germany,covering the entire value chain from innovative drug research and discovery,manufacturing,clinical development and commercialization. For more information about SCG,please visit us at www.scgcell.com.

Disclaimer:

This press release may contain forward-looking statements and information which are based on our current expectations and certain assumptions. Various known and unknown risks,uncertainties and other factors could lead to material differences between the actual future results,financial situation,performance of the company,development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise,among others,the research and development,the regulatory approval process,the timing of the actions of regulatory bodies and other governmental authorities,clinical results,changes in laws and regulations,product quality,patient safety,patent litigation,contractual risks and dependencies from third parties. With respect to pipeline products,SCG Cell Therapy Pte Lte does not provide any representation,warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. SCG Cell Therapy assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated.

References:

[1]Bold Goals for U.S. Biotechnology and Biomanufacturing. https://www.whitehouse.gov/wp-content/uploads/2023/03/Bold-Goals-for-U.S.-Biotechnology-and-Biomanufacturing-Harnessing-Research-and-Development-To-Further-Societal-Goals-FINAL.pdf

[2] SCG Cell Therapy Collaborates with the Cell Therapy Facility at Health Sciences Authority to Validate Processing Methods for T Cell Therapy Manufacturing.

https://www.hsa.gov.sg/announcements/press-release/scg-hsa-collaborates