03 February, 2021
JW Therapeutics and Thermo Fisher Scientific Announce CAR-T Partnership in China
Companies join forces in cell therapy applications and commercial-scale manufacturing
Shanghai, China, February 3, 2021 -- JW Therapeutics, a leading cell therapy company in China, has signed an agreement with Thermo Fisher Scientific, the world leader in serving science, to ensure non-exclusive commercial access to Thermo Fisher’s Gibco CTS Dynabeads CD3/CD28.
The agreement will support the clinical development and commercial manufacturing of leading CAR-T (Chimeric Antigen Receptor T-Cells) therapies in China, including JW Therapeutics’ lead product relmacabtagene autoleucel (“relma-cel”). Relma-cel is an anti-CD19 CAR-T therapy for third-line treatment for relapsed or refractory (“r/r”) B-cell lymphoma. The therapy’s new drug application (NDA) has been accepted by China's National Medical Products Administration (NMPA). Relma-cel is expected to be the first CAR-T therapy to be approved as a Category 1 biologics product in China.
The CTS Dynabeads platform is part of Thermo Fisher’s proven Cell Therapy Systems (CTS) product portfolio designed to ease the transition from clinical development to commercial manufacturing of T-cell therapies. The CTS product line is a comprehensive portfolio of products designed to work together, from cell isolation/activation and gene transfer to cell expansion, to address cell therapy developers’ manufacturing workflow challenges. Thermo Fisher’s Gibco CTS Dynabeads provide a scalable platform to streamline therapy development and production while ensuring highly reproducible results.
“As JW Therapeutics progresses through the formal acceptance of a New Drug Application (NDA) for relma-cel, and its commercial plans accelerate, we’ll be alongside them ready to rapidly scale,” said Mark Stevenson, executive vice president and chief operating officer, Thermo Fisher Scientific. “Our strategy to support partners ‘in China for China’ ensures that we can provide reliable supply and technical expertise as they scale precision medicines.”
“This partnership is a natural extension of an already strong collaboration,” mentioned Dr. Harry Lam, executive vice president and chief technology officer, JW Therapeutics. “As we approach critical milestones in our commercialization strategy, this partnership will ensure we have the supply to scale up and meet the unmet medical needs of Chinese patients.”
About JW Therapeutics
Co-founded by Juno Therapeutics and Wuxi AppTec, JW Therapeutics (HKEx: 2126) is a leading clinical and pre-clinical stage cell therapy company in China with an integrated platform focusing on developing, manufacturing and commercializing breakthrough cell-based immunotherapies for hematological cancers and solid tumors.
JW Therapeutics’ vision is to develop innovative cell therapies for the China market to transform the treatment of cancer for Chinese patients. The company has built a comprehensive and differentiated cell therapy pipeline covering both hematological cancers and solid tumors. Its lead product, Relmacabtagene autoleucel (“relma-cel”), an anti-CD19 CAR-T therapy for relapsed or refractory (“r/r”) B-cell lymphoma, is expected to be the first CAR-T therapy to be approved as a Category 1 biologics product in China.
For more information, please visit www.jwtherapeutics.com.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
This news release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Stock Exchange of Hong Kong Limited (HKEx) reports filed by the Company. Unless otherwise noted, the Company is providing this information as of February 3, 2021 and expressly disclaims any duty to update information contained in this news release.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims, and certain compliance risks, even sanctions from disputable market activities. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.
In addition, sales of our products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to integrate the operations of companies we have acquired may not be successful. We may experience difficulties, delays or unexpected costs and not achieve anticipated benefits and savings from our ongoing restructuring plan. Our business performance could affect or limit the ability of our board of directors to declare a dividend or the ability to pay a dividend or repurchase our shares.
Cautionary Statement required by Rule 18A.05 of the Rules Governing the Listing of Securities of The Stock Exchange of Hong Kong Limited: JW Therapeutics cannot guarantee that it will be able to develop, or ultimately market Relmacabtagene autoleucel (“relma-cel”) successfully. Shareholders and potential investors of JW Therapeutics are advised to exercise due care when dealing in the shares of JW Therapeutics.