Public company info - JW (Cayman) Therapeutics Co. Ltd , 02126.HK
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JW (Cayman) Therapeutics Co. Ltd, 02126.HK - Company Profile
Chairman Yiping James Li
Share Issued (share) 394,000,000
Par Currency U.S. Dollar
Par Value 1.0E-5
Industry Biotechnology
Corporate Profile Business Summary: The group is a leading clinical and pre-clinical stage cell therapy company in China. Performance for the year: With RMB272.6 million for the year ended December 31, 2018 and RMB633.3 million for the year ended December 31, 2019. Business Review The group is a leading clinical and pre-clinical stage cell therapy company in China. the group’s vision is to develop innovative cell therapies for the China market to transform the treatment of cancer for Chinese patients. Since the group’s founding in 2016 by Juno and WuXi AppTec (through its wholly-owned subsidiary WXAT Shanghai), the group have built an integrated platform focused on developing, manufacturing and commercializing breakthrough cell-based immunotherapies for hematological cancers and solid tumors. Relmacabtagene autoleucel (“relma-cel”), the group’s lead product candidate, is an autologous anti-CD19 CAR-T therapy for relapsed or refractory (“r/r”) B-cell lymphoma. In June 2020 the NMPA accepted for review the group’s NDA relating to relma-cel as a third-line treatment for DLBCL, and in September 2020 the NMPA granted priority review status to the group’s NDA relating to relma-cel and Breakthrough Therapy Designation for relma-cel as a treatment for FL. Relma-cel is expected to be the first CAR-T therapy to be approved as a Category 1 biologics product in China, and has potential to be a superior CAR-T therapy. The group is an early entrant into the field of cell-based immunotherapy in China. Cell-based immunotherapy is a field which represents a paradigm shift and the latest advancement in the treatment of cancer. Cell-based immunotherapies, including CAR-T treatments, are an innovative treatment method that uses human immune cells to fight cancer. Supported by multiple clinical studies, cell-based immunotherapies could lead to long-lasting remissions of B-cell lymphomas and leukemias which are refractory to other treatments. According to Frost & Sullivan, the target indications for relma-cel, namely 3L DLBCL, 3L FL and 3L MCL, had an addressable market estimated to have a prevalence of approximately 28.7 thousand, 5.2 thousand and 3.4 thousand patients respectively in China in 2019, after taking into account the effectiveness of prior lines of treatment in China. Given the unmet medical needs that can be effectively addressed by CAR-T therapies, according to Frost & Sullivan, the market for CAR-T therapies in China is expected to grow from RMB0.6 billion in 2021 to RMB5.4 billion in 2024, and to RMB24.3 billion in 2030. the group believe that The group is well positioned to take advantage of this rapidly growing market. CAR-T therapies are considered to be significantly high-risk in nature, as they represent emerging approaches to cancer treatment that face significant challenges and hurdles. The group have developed a comprehensive and differentiated cell-based immunotherapy pipeline, with a risk-balanced approach that has shown clear benefit in the field of cell therapies for hematological cancers and provides an opportunity to expand into the nascent field of cell therapies for solid tumors. the group’s product pipeline features a mix of product candidates targeting both proven and novel tumor antigens. the group have strategically designed and are developing a cell-based immunotherapy product pipeline of autologous cell therapy candidates, covering both hematological cancers and solid tumors, and the group also have an option to acquire two allogeneic cell therapy candidates for treatment of hematological cancers and solid tumors. Historically the group have not conducted in-house product discovery, and have instead accessed discovery capabilities through the group’s relationships with counterparties such as Juno, Eureka and Acepodia. In the medium- to longer-term, however, the group intend to establish the group’s own in-house product discovery capability, including through leveraging the ARTEMIS platform that the group in-licensed from Eureka in June 2020. The group’s cell-based immunotherapy product candidates for treatment of hematological cancers include the following: • Relma-cel, the group’s lead product candidate, is a potential superior autologous CAR-T product for the treatment of various B-cell malignancies. The registrational clinical trial for relma-cel for treatment of heavily pre-treated, poor prognosis r/r DLBCL patients, demonstrated efficacy results of best ORR of 75.9% and best CRR of 51.7% as of data cut off date June 17, 2020. Relma-cel demonstrated a potentially superior safety profile relative to CAR-T therapies currently approved for treatment of DLBCL based on reported data. In the registrational trial, sCRS or sNT were observed in 5.1% or fewer of treated patients, and no treatment-related deaths were reported. The NDA for relma-cel for the third-line treatment for DLBCL was submitted and accepted for review by the NMPA in June 2020. If the group’s NDA is approved on the timeline that the group currently anticipate, relma-cel is expected to be the first CAR-T therapy approved as a Category 1 biologics product in China, and has potential to be a superior CAR-T therapy. To fully explore the clinical potential of relma-cel, the group intend to develop relma-cel for a number of other hematological indications, including FL, MCL, CLL, second-line DLBCL and ALL. According to Frost & Sullivan, the target indications for relma-cel, namely 3L DLBCL, 3L FL and 3L MCL, had an addressable market estimated to have a prevalence of approximately 28.7 thousand, 5.2 thousand and 3.4 thousand patients respectively in China in 2019, after taking into account the effectiveness of prior lines of treatment in China. The group have developed relma-cel using the group’s own optimized processes, which the group originally established in collaboration with Juno, a global leader in cell therapy and the group’s largest shareholder; and relma-cel is based on a CAR construct that the group have in-licensed from Juno for China, Hong Kong and Macau. • JWCAR129 is an autologous CAR-T therapy The group is developing for the treatment of multiple myeloma (“MM”). JCAR129 targets B-cell maturation antigen (“BCMA”), a protein which is highly expressed in a number of hematological malignancies including MM. MM is a highly aggressive disease representing approximately 10 percent of all hematological malignancies. There is a significant unmet medical need for the treatment of MM since patients eventually become refractory to existing treatments after relapse. The group is conducting IND-enabling pre-clinical pharmacology and toxicology studies as well as manufacturing process development studies for this candidate, with the intention of commencing clinical studies as early as the first half of 2021. In addition to being a leader in hematological cancer treatments in China, the group adopt a differentiated approach to address the unmet medical needs in solid tumors. Based on the group’s collaborations with Eureka and Lyell Immunopharma, Inc. (“Lyell”), The group is developing T-cell therapy candidates that are designed to enhance T-cell functions, persistence and infiltration into solid tumors with an improved safety profile. the group’s cell-based therapy product candidates for the treatment of solid tumors include the following: • JWATM203, a potentially superior autologous T-cell receptor mimic T-cell therapy targeting alpha-fetoprotein (“AFP”) for the treatment of hepatocellular carcinoma (“HCC”). Treatment of HCC represents a huge unmet medical need in China. the group believe JWATM203 has the potential to be a promising treatment option for patients with AFP-positive HCC. Eureka has advanced its AFP TCRm T-cell therapy product candidate into a Phase I/II clinical trial in the United States. Through the group’s collaboration with Lyell, The group is developing another autologous TCRm T-cell therapy targeting AFP for the treatment of HCC, JWATM213, which may further enhance T-cell function and improve efficacy. • JWATM204, a novel autologous T-cell therapy product candidate targeting glypican-3 (“GPC3”). the group believe JWATM204 has the potential to be a promising treatment option for patients with GPC3-positive HCC. Similar to JWATM203 and JWATM213, the group will use the Lyell technology to develop another autologous GPC3-targeting T-cell therapy product candidate, JWATM214. These product candidates are based on novel technology platforms, which form the foundation of the group’s differentiated approach to address the significant unmet needs in solid tumors in China: • Eureka’s ARTEMIS platform is the basis for JWATM203 and JWATM204. It is a novel technology platform that is intended to create potentially more effective and safer T-cell therapies than are currently available. As part of the group’s agreement with Eureka in June 2020, the group acquired the rights to develop, manufacture and commercialize JWATM203 and JWATM204 for China, Hong Kong, Macau, Taiwan and the member countries of ASEAN, the right to use the ARTEMIS platform in connection with the group’s improvements to those products, as well as exclusive rights to commercialize in those jurisdictions all products that Eureka develops using the ARTEMIS Platform. For further details, please see “— Collaboration and License Agreements — Asset Purchase Agreement with Syracuse Cayman and License Agreement with Eureka” in this section. • Lyell’s technology is designed to increase T-cell functionality and reduce T-cell exhaustion in the tumor micro-environment to potentially improve the anti-tumor effects. the group obtained access to the Lyell technology to develop novel product candidates based on JWATM203 and JWATM204. For further details, please see “— Collaboration and License Agreements — Lyell Collaboration Agreement” in this section. In addition to the group’s China, Hong Kong, Macau, Taiwan and the member countries of ASEAN rights to commercialize products that Eureka develops using the ARTEMIS platform, the group have opportunities to in-license additional product candidates from Juno and product candidates from Acepodia. These opportunities, together with the group’s strong business development capabilities, will support further expansion of the group’s pipeline. the group’s opportunities to in-license include the following next generation cell-based therapy product candidates: • Juno Pipeline: the group have a right of first negotiation to develop and commercialize five Juno engineered T-cell products in China, Hong Kong and Macau. These highly novel candidates target promising pathways including CD22, WT1, CD171, MUC16 and ROR1. These candidates cover a wide range of hematological cancer and solid tumor indications. • Acepodia Pipeline: the group have an option to acquire from Acepodia the right to develop and commercialize in China, Hong Kong and Macau an allogeneic natural killer (“NK”) cell therapy product that targets HER2. This novel candidate is designed to treat certain types of breast cancer and other malignancies, including gastric cancer, which have a significant unmet medical need in China. JWACE002 is designed as an allogeneic product, an “off-the-shelf” ready-made cell therapy that is manufactured from cells of a “cell line” unrelated to the patient. In the field of cellular immunotherapy, the manufacturing process significantly influences product characteristics, and accordingly the group believe that in cellular immunotherapy, even more than in other contexts, “the process is the product.” the group have proven translational research, analytical development and manufacturing process development capabilities. the group have developed a proprietary commercial-scale manufacturing process for relma-cel which has been proven during the registrational clinical trials of relma-cel, with a 100% manufacturing success rate of the relma-cel products used in the Phase II registrational clinical trial. Moreover, The group is developing a set of new technologies and platforms to enable the next generation CAR-T product and manufacturing processes with a shorter production cycle time, higher quality, better product characterization and improved product efficacy and safety profile, at a lower cost. the group believe that this will establish a foundation for the group’s next-generation anti-CD19 CAR-T product, as well as other products in the group’s pipeline. The group’s cell therapy development platform also includes robust clinical development capabilities. Having completed Phase I clinical trials and a registrational Phase II clinical trial in ten hospitals across China relating to relma-cel, the group have involved more sites in the group’s clinical trials in China than any other CAR-T company, according to Frost & Sullivan. In addition, the group believe the group have enrolled more patients in the group’s IND anti-CD19 CAR-T trials in China than any other company. Moreover, the group have a proven track record in clinical execution, having progressed relma-cel from IND to NDA filing to NDA acceptance in a short time frame. The group’s industry-leading commercial manufacturing infrastructure is centered on the group’s newly constructed manufacturing facility in Suzhou, which provides approximately 9,976 square meters for commercial-scale manufacturing. The Suzhou facility is designed to house four independent modules, of which two are currently constructed, qualified and operating in compliance with international cGMP and QMS standards. It can support a wide range of cell platforms, including those using gene-modified autologous T-cells and NK cells, gene-modified or non-gene-modified tumor-infiltrating lymphocytes (“TIL”) and gene-modified allogeneic immune cells, as well as facilities to produce clinical grade viral vectors that are used to genetically modify these cells. the group’s current design has estimated capacity to support treatment of up to 5,000 patients per year. The degree of automation and in-process control designed into the group’s commercial manufacturing processes lead to reliable product supply, and the group’s manufacturing operations are optimized for high capacity and labor utilization, allowing cost-effective manufacturing. The group’s plan to commence revenue generation centers on the commercialization of relma-cel. Having achieved NMPA acceptance of the group’s NDA for relma-cel, the group intend to drive full-scale commercialization of relma-cel upon approval. the group plan to establish a focused in-house sales force to market relma-cel to the top hematology hospitals in China, including a specialized team in medical affairs to build on the group’s strong existing relationships with physicians and KOLs in the field of hematology in China and to provide the necessary site support for healthcare providers and patients to manage all steps in the safe delivery of this product. The group’s history can be traced back to 2016, when the group’s principal operating subsidiary, JW Shanghai, was co-founded by two global pharmaceutical research and development companies, Juno and WuXi AppTec, through its wholly-owned subsidiary WXAT Shanghai. Since inception, the group’s success has been guided predominantly by the efforts of the management team under the leadership of the group’s executive Director, chairman of the Board and CEO, Dr. Li. the group’s management team has expertise gained from extensive experience in the international biopharmaceutical industry as well as in-depth local knowledge of the China market including access to top-tier hospitals, PIs and KOLs in the field of immuno-oncology. Prospects: The group’s goal is to develop innovative therapies to address significant unmet medical needsglobally. the group intend to achieve the group’s goal by implementing the following strategies: • Drive full-scale commercialization of relma-cel and build upon the group’s significant firstmover advantage; • Solidify the group’s leadership in hematological cancers by progressing and expanding clinicaldevelopment of relma-cel for earlier lines of treatment and additional indications, aswell as clinical development of JWCAR129; • Leverage the group’s integrated cell therapy platform to expand into the emerging solid tumor market; • Continuously enhance the group’s manufacturing and supply chain through innovation and scale; and • Grow the group’s business through in-licensing opportunities, partnerships and selective acquisitions, as well as in-house research and development.

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