On January 14, 2020 GenScript Biotech Corp., a leading global biotechnology group and a pioneer in the field of gene synthesis, reported held its inaugural "Global Forum on Cell & Gene Therapy and the Booming China Market," during the JP Morgan Healthcare Conference week, attracting hundreds of industry leaders, investors and others to address the challenges and opportunities in this innovative field (Press release, GenScript, JAN 14, 2020, View Source [SID1234553191]).
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"As an industry, we are on the brink of achieving some extraordinary breakthroughs in cell and gene therapy for cancer and other diseases," said GenScript Biotech CEO Frank Zhang, PhD. "Four gene and cell therapies have recently been approved by the FDA, bringing new hope to patients, and this is only the beginning. Our vision is to make cancer a chronic or curable disease rather than a deadly one, and to transform the treatment of cancer, autoimmune and other diseases by leveraging the advantages of cell and gene therapy."
While significant advances are being made, the Forum also tackled some of the more pressing challenges, such as mitigating treatment side effects, improving treatment efficacy in solid tumors and scaling up manufacturing. Panelists from Kite Pharma, GE Healthcare Life Sciences, Ziopharm Oncology, Oxford Biomedica, Genethon, CARsgen Therapeutics, J&J Innovation Asia Pacific, the American Society of Gene & Cell Therapy, Loncar Investment, Lilly Asia Ventures, and many others participated in the event.
In the U.S. alone, the U.S. Food and Drug Administration is expected to approve 40-60 cell and gene therapies by 2030. During a panel discussion focused on regulatory issues, experts considered what regulators will need to do to keep up with the rapid pace of innovation, the new hospital-based regulatory pathway in China, how to ensure quality through the manufacturing process, and the challenges and opportunities that come with regulatory harmonization among different countries.
China continues to attract significant attention from industry and investors and is poised to grow even more. During his welcoming remarks, Zhang noted China’s emergence as a global economic leader, with a projected $1.1 trillion spend on healthcare this year, as well as the growing disease burden in China. By 2030, an estimated 4.3 million Chinese will be diagnosed with one of the 14 major cancers, according to research from IMS Health. Panelists addressed issues such as the amount of capital required to achieve scale in China, and advantages of the market in China.
"The drug development business is changing rapidly and China is at the fore in a number of ways," Zhang said. "Biotech and pharma companies do not need or desire to have the infrastructure to scale their drugs through commercialization. With lower costs, China is a natural place for companies to contract out costly development and manufacturing to organizations that have the expertise and experience to collaborate with them through the entire discovery to development lifecycle."
For its part, GenScript has put significant resources into its Contract Development and Manufacturing Organization (CDMO) business to meet the increasing demand. In 2018, the company officially launched its biologics CDMO segment, and last year opened a new GMP compliant biologics research center. GenScript is also leading the way in cell therapy through its antibody discovery service and plasmid and virus production capabilities.
In December 2017, Legend and Janssen, a Johnson & Johnson business, entered into a worldwide collaboration and license agreement to develop, manufacture and commercialize LCAR‐B38M (JNJ‐4528) in multiple myeloma. The companies are advancing this investigational B-cell maturation antigen (BCMA) targeted chimeric antigen receptor (CAR) T-cell therapy in previously treated patients with the disease. Clinical trials are ongoing in both the U.S. and China and the therapy has received orphan drug designation and breakthrough treatment designation from the FDA in the U.S. and PRIME designation from the European Medicines Agency.
GenScript is one of only a few Chinese companies to have a significant presence during JPM week. Based on the success of this year’s Forum and the interest in cell and gene therapy, GenScript will host its second annual Forum with influential leaders on the topic again next year during JPM week at the San Francisco Grant Hyatt.