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	Name▼ / Code▼	Industry	Offer Price	Lot Size	Entry Fee	Closing Date	Grey Market Date▼	Listing Date▲
	REFIRE 02570.HK	Electrical Components & Equipment	145-165	20	3,333	2024/12/03	2024/12/05	2024/12/06
	Dmall 02586.HK	Application Software	30.21	100	N/A	2024/12/03	2024/12/05	2024/12/06

Summary

We are a biopharmaceutical company with operations in China and the U.S. focused on innovative CAR-T cell therapies for the treatment of hematological malignancies and solid tumors. We have internally developed novel technologies and a product pipeline with global rights to address major challenges of CAR-T cell therapies, such as improving the safety profile, enhancing the efficacy in treating solid tumors and reducing treatment costs. Our vision is to become a global biopharmaceutical leader that brings innovative and differentiated cell therapies to cancer patients worldwide and makes cancer curable. We believe that we are a key player in the field of CAR-T cell therapies. We have developed an upgraded B cell maturation antigen (“BCMA”) targeted CAR-T product, CT053, which is our sole Core Product Candidate. CT053 has demonstrated favorable safety, as evidenced by the absence of Grade 3 or above cytokine release syndrome (“CRS”) or treatment-related patient deaths, and promising efficacy for the treatment of relapsed/refractory multiple myeloma (“R/R MM”), a type of hematological malignancies, based on the clinical data from investigator-initiated trials, which are clinical trials sponsored and conducted by independent investigators, and our Phase I clinical trials in China and the United States. We are the first in the world to successfully identify, validate and report Claudin 18.2 (“CLDN18.2”) and glypican-3 (“GPC3”) as tumor-associated antigens for CAR-T therapies for gastric/pancreatic cancer and hepatocellular carcinoma (“HCC”), each of which represents significant unmet medical needs. By progressing our CLDN18.2-targeted CAR-T product candidate, CT041, into clinical stage, we may change the treatment paradigm of difficult-to-treat solid tumors. As of the Latest Practicable Date, we had obtained seven IND clearances for CAR-T therapies in China, the United States and Canada, ranking the first among all CAR-T companies in China, according to Frost & Sullivan. In addition, among all CAR-T companies in China, we received the first and only Regenerative Medicine Advanced Therapy, or RMAT, designation from the U.S. FDA for CT053, which brings the benefits of both the Breakthrough Therapy designation and the Fast Track designation. The RMAT designation from the FDA for CT053 provides us with various benefits, such as engaging in enhanced interactions and early dialogues with the FDA to optimize our development plans and accelerate regulatory evaluation. Led by an experienced management team of academic professionals and industry veterans, we have built an integrated cell therapy platform with in-house capabilities that span from target discovery, lead antibody development, clinical trials to commercial-scale manufacturing. Leveraging our platform, we have developed a differentiated pipeline of 11 product candidates, including six at clinical stage. Ten of the 11 product candidates are CAR-T cell therapies, including five at clinical stage. Our CAR-T product candidates target both evidence-based and novel tumor-associated antigens and are carefully designed and optimized to reduce adverse events commonly associated with existing CAR-T therapies. In addition, we are exploring our proprietary allogeneic CAR-T technology, THANK (Target to Hinder the Attack of NK cells)-uCAR, with an aim to overcome inefficient expansion and persistence of allogeneic CAR-T cells and to generate high-quality, universal allogeneic CAR-T cell therapies that are readily available at a lower cost because each batch of allogeneic CAR-T cells could be used to treat multiple patients. We own global rights to our product candidates and technologies, all of which are developed by us in-house. We will continue our endeavor with our technology platforms to identify novel tumor-associated targets and develop potentially first-in-class or best-in-class CAR-T therapies to fulfill significant unmet medical needs. We have established in-house GMP-compliant manufacturing capabilities that cover end-to-end CAR-T manufacturing, including plasmid production, lentiviral vectors production and CAR-T cell product manufacturing. We have launched a manufacturing facility in Xuhui, Shanghai with a total GFA of approximately 3,000 sq.m. and an annual CAR-T production capacity to support the CAR-T treatment of 200 patients. We have also completed the construction of our commercial-scale manufacturing facility located in Jinshan, Shanghai which is expected to support CAR-T treatment of up to 2,000 patients annually and obtained the first Manufacture License for Pharmaceutical Products (“Manufacturing License”) issued in China for CAR-T cell therapy. For additional information, see “— Manufacturing.” To support our global expansion, we are planning for the construction of a second-phase of our Jinshan facility and building up GMP-compliant commercial manufacturing facilities in the United States, which collectively will be able to expand our manufacturing capacity to support the treatment of over 10,000 patients annually. By building end-to-end manufacturing capabilities, we expect to significantly reduce the manufacturing costs because the use of CDMO and CRO is more expensive, and reduce the process turnaround time or the vein-to-vein time by eliminating extra transportation time and release time due to the third-party testing. In anticipation of the upcoming commercialization of our product candidates once approved, we are assembling a dedicated in-house sales and marketing force to support the initial product launch at the top hospitals capable of administering CAR-T cell therapies in China. Our experienced management team collectively covers every step of cell therapy discovery and development cycle. Led by our co-founder, CEO and Chief Scientific Officer, Dr. Zonghai Li, our senior management team brings extensive research and development experience from academia, governmental agencies and multinational pharmaceutical companies to our Company. Dr. Li is one of the leading researchers in the field of CAR-T cell therapies and has published over 100 peer-reviewed scientific papers in renowned scientific journals. Dr. Li spearheaded the discovery of CLDN18.2 and GPC3 as solid tumor-associated targets for the development of CAR-T therapies. In charge of our regulatory affairs, Dr. Yong Fan, our Senior Vice President, Global Regulatory Affairs, has decades of product development, manufacturing and regulatory experience and previously served at the U.S. FDA in several roles in charge of reviewing medical devices used in the manufacturing of cellular therapy products, performing prelicensing inspections and CBER and CDRH compliances. In addition, members of our world-class research and development team have cross-disciplinary expertise in a variety of fields, including chemistry, biology, pharmacology, toxicology, pharmacovigilance, regulatory and translational and clinical research, and possess in-depth expertise in multiple cell therapy and disease areas. We intend to build on the extensive progress we have made to date to rapidly advance the clinical development and commercialization of our lead product candidates. We have been focusing on four primary aspects in our research and development to produce improved CAR-T cell therapies and will continue our efforts in these areas to expand our product portfolio: (1) developing the next-generation CAR-T technologies to enhance the efficacy and safety of our products; (2) developing allogeneic CAR-T products (CAR-T cells manufactured with non-self T cells) with our THANK-uCAR technology, which are readily available “off-the-shelf” at lower costs than autologous CAR-T cell therapies (CAR-T cells manufactured with the patients’ own T cells); (3) exploring potential combination approaches to boost the therapeutic effects of single agents; and (4) identifying new targets and approaches to tackle new indications. In addition, we plan to further expand our manufacturing and commercialization capabilities. Source: CARsgen-B (02171) Prospectus (IPO Date : 2021/06/07)
Listing Market	MAIN
Industry	Biotechnology
Background	Others
Major Business Area	N/A

Corporate Information

Substantial Shareholders	LI Zonghai & Associates (38.08%)
Directors	LI Zonghai (Chairman and Chief Executive Officer and Chief Scientific Officer and Executive Director) WANG Huamao (Chief Operating Officer and Executive Director) Hua JIANG (Executive Director) GUO Bingsen (Non-Executive Director) GUO Huaqing (Non-Executive Director) XIE Ronggang (Non-Executive Director) YAN Guangmei (Independent Non-Executive Director) Xiangke ZHAO (Independent Non-Executive Director) Wen ZHOU (Independent Non-Executive Director)
Company Secretary	LUI Wing Yat Christopher
Principal Bankers	Bank of Hangzhou
Solicitors	Davis Polk & Wardwell
Auditors	Ernst & Young
Registered Office	5th Floor, Manulife Place, 348 Kwun Tong Road, Kowloon, Hong Kong
Share Registrars	Computershare Hong Kong Investor Services Ltd. [Tel: (852) 2862-8628]
Share Registrars Tel No	(852) 2862-8628
Internet Address	http://www.carsgen.com
Email Address	[email protected]
Tel No	(86 21) 6450-1828
Fax No

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