SCG Cell Therapy To Establish Cell Therapy Pilot cGMP Manufacturing Facility And R&D Centre In Singapore

SINGAPORE,Sept. 21,2022 --Singapore-based SCG Cell Therapy Pte Ltd (SCG),has announced todaythe establishment of a state-of-the-art cell therapy research and manufacturing hub in Singapore. With the support of the Singapore Economic Development Board (EDB),the hub comprises a pilot manufacturing facility and an R&D centre. SCG expects to begin construction in 2022 and anticipates it to be operational in 2023. SCG plans to hire up to 30 scientists,engineers,and managers locally.

The new Current Good Manufacturing Practice (cGMP) pilot facility will employ the latest sophisticated closed and automated cell therapy manufacturing technologies for cell therapy production,validated by the Cell Therapy Facility of Singapore Health Sciences Authority (HSA-CTF) and accredited by the U.S Food and Drug Administration (FDA). The site will facilitate research and development of SCG's growing pipeline of cell therapy product candidates,as well as provide regional and global supply capacity for product development and clinical trials.

The support from EDB gives SCG the capability and the certainty to leverage Singapore's local network and talent to fast-track the development of first-in-class cell therapy products,beneficial to both local and overseas patients.

"The growth potential of Asia's pharmaceutical markets is astounding. With the strong government investment and support over the past decades,Singapore has flourished into a leading biotech country with world-class research talent and infrastructure which are indispensable for the biomedical industry",said Frank Wang,Chief Executive Officer of SCG Cell Therapy.

"EDB's support strengthens our local capabilities to develop novel and affordable cell therapy for infection-associated cancers,which exert a heavy burden on the Asian population",he added.

Infection-related cancers remain a leading cause of cancer death in South-Eastern and Eastern Asia. This state-of-the-art centre will support global cell therapy production and clinical trials.

"Located in the heart of Asia,SCG strives to bring novel treatment options for this significant unmet need",said Peter Chen,Vice President of SCG. SCG's T-cell receptor (TCR) T cell therapy for hepatitis B (HBV) associated liver cancer – SCG101 is the first cell therapy product receiving clinical trial approval across the United States,Singapore and China.

"Lending our expertise in cell therapy and international presence across Singapore,China and Europe,this international hub in Singapore will increase our overall capacity and expand our ability to accelerate global clinical trials and product commercialization",he added.

"We are delighted that SCG Cell Therapy is setting up its research and manufacturing centre in Singapore. This is testament to Singapore's attractiveness as a global pharmaceutical hub to biotech start-ups," said Ms Elaine Teo,Senior Vice President,Investment Facilitation Division,Singapore Economic Development Board. "We look forward to seeing SCG Cell Therapy tap on our thriving biotech ecosystem to develop first-in-class cell therapy products and create exciting job opportunities in Singapore."

The global T-cell therapy market is expected to reach USD 20.3 billion by 2028,according to a new report by Grand View Research. Asia-Pacific is projected to witness the fastest compound annual growth rate.

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.

About SCG101

SCG101,an autologous T-cell receptor (TCR) T cell therapy,is an investigational cell therapy product that targets specific epitopes of hepatitis B surface antigen (HBsAg). It specifically designed to redirect T cells using virus-specific TCRs with high sensitivity and avidity selectively against dysfunctional infected and tumour cells. Preclinical studies of SCG101 demonstrated tumour inhibition and HBV cccDNA eradication. In 2022,SCG101 was granted clinical trial approvals by the U.S Food and Drug Administration (FDA),China National Medical Products Administration (NMPA) and Singapore Health Science Authority (HSA) for patient with HBV-related HCC. A Phase 1/2 clinical trial evaluating SCG101 is underway.