銆�2023 Solid Tumor Cell Therapy Pine Meeting銆慉 complete success
On June 30, 2023, KAEDI and JOINN New Drug jointly held the "2023 Solid Tumor Cell Therapy Pine and Cypress Conference" in Nanjing Jiangbei New District. A number of heavyweight guests in the field of cell therapy came to the conference to discuss the challenges and solutions of solid tumor cell therapy from early research and development to commercialization from multiple dimensions and perspectives, bringing a dry academic feast to the participants.
Shuanghua Xu, Director of Nanjing Jiangbei New Area Life and Health Industry Development Management Office, Shuqin Luo, deputy director of Nanjing Jiangbei New Area Life and Health Industry Development Management Office, Changsong Qi, chief physician of the first ward of Beijing Cancer Hospital, Bin Li, Deputy Director of Scientific Research of Shanghai Institute of Immunology, Yan Xia, technical director of macromolecular analysis of JOINN New Drug, Hongjiu Dai, Founder, CEO and Chairman of KAEDI, Jing Ma, founder and chairman of Taichu Biotechnology, Rui Yang, Vice President of Gaobo Medical Medicine, Yang Cao, director of the pharmacology department of JOINN New Drug, Yunyan Li, Director of Industry Development of Kactus Biosystems, Dichao Hu, assistant deputy general manager of cell therapy process development of PORTON Biologics, Liqun Wang, founder, chairman and CEO of Xingyion, Dan Li, co-founder of Sanqing Biotechnology, Zhigang Guo, Deputy Dean of School of Life Sciences, Nanjing Normal University, Jinming Gu, Vice President of R&D of Legend Biotech China, Xiaoyu Zheng, Vice President of Gobo Medical Clinical Center & Executive CEO of Clinical Executive Center, Fengtao You, President of Boshengji Pharmaceutical Institute of New Drugs, Yinglai Capital partner Fujuan Gao, Haining Wang, founding partner of Longmen Capital, Zhiru Dong, Senior Vice President of Healthcare Industry Group, CITIC Securities Global Investment Banking Committee, Hua Ren, partner of Jingtian & Gongcheng Law Offices, Guangming Zhu, senior partner of Zhonghui Accounting Firm, and other guests were invited to attend the pine meeting and conducted in-depth discussions on promoting the development of domestic solid tumor cell therapy and technological innovation in biomedical production.
Director Shuanghua Xu expressed warm congratulations on the holding of the pine and cypress meeting, and expressed warm welcome and heartfelt thanks to people from all walks of life who have been concerned about and supported the development of life and health industry in Jiangbei New Area! The biomedical industry is known as the eternal sunrise industry, and it is the focus of a new round of scientific and technological revolution and global competitio. For a long time, Nanjing Jiangbei New Area has always regarded the biomedical industry as a key breakthrough in strategic emerging industries, and this year, the biomedical industry in the new area has been approved as a national innovative industrial cluster. As an important growth pole of the life and health industry system in Jiangbei New Area, Nanjing Biomedical Valley aims to focus on high-end innovation, closely follow the industry outlet, aim at the advanced layout of cutting-edge biotechnology such as cell therapy, nucleic acid drugs, new diagnostic technologies, and high-end medical devices, cultivate innovation momentum, build an innovation ecology, and move from "benchmarking innovation" to "leading innovation". Nanjing MAEDI Technology Co., Ltd., the organizer of this conference, is an influential cultivation of unicorns, innovative small and medium-sized enterprises, technology-based small and medium-sized enterprises in Yaogu, and a witness, driver and leader of the development of cell therapy in China. Today, the 2023 Solid Tumor Cell Therapy Pine Conference marks a new process in the development of cell therapy, which will surely empower the in-depth development of the whole biomedical industry chain in Jiangbei New Area and Nanjing.
Highlights of the guest speakers
Director Changsong Qi Speech Title: "Difficulties and Future of the Application of Cell Therapy in Solid Tumors from the Perspective of PI"Director Shuanghua Xu expressed warm congratulations on the holding of the pine and cypress meeting, and expressed warm welcome and heartfelt thanks to people from all walks of life who have been concerned about and supported the development of life and health industry in Jiangbei New Area! The biomedical industry is known as the eternal sunrise industry, and it is the focus of a new round of scientific and technological revolution and global competitio. For a long time, Nanjing Jiangbei New Area has always regarded the biomedical industry as a key breakthrough in strategic emerging industries, and this year, the biomedical industry in the new area has been approved as a national innovative industrial cluster. As an important growth pole of the life and health industry system in Jiangbei New Area, Nanjing Biomedical Valley aims to focus on high-end innovation, closely follow the industry outlet, aim at the advanced layout of cutting-edge biotechnology such as cell therapy, nucleic acid drugs, new diagnostic technologies, and high-end medical devices, cultivate innovation momentum, build an innovation ecology, and move from "benchmarking innovation" to "leading innovation". Nanjing MAEDI Technology Co., Ltd., the organizer of this conference, is an influential cultivation of unicorns, innovative small and medium-sized enterprises, technology-based small and medium-sized enterprises in Yaogu, and a witness, driver and leader of the development of cell therapy in China. Today, the 2023 Solid Tumor Cell Therapy Pine Conference marks a new process in the development of cell therapy, which will surely empower the in-depth development of the whole biomedical industry chain in Jiangbei New Area and Nanjing.
Highlights of the guest speakers
Director Bin Li The topic of the speech was "Development Status and Trend of Tumor Immunotherapy"
General Manager Yan Xia Speech Topic: "Bioanalysis of Cell Therapy"
Dr. Hongjiu Dai Speech Title: "Development History of NKG2DL Target CAR-T Cell Drugs"
Dr. Jing Ma Speech Title: "Non-clinical Evaluation Strategy of CAR-T Cells in Solid Tumors"
General Manager Rui Yang Speech Topic: "Sharing of Solid Tumor CAR-T Clinical Study Design Strategy"
General Manager Cao Yang Speech Title: "Analysis of Key Points and Ideas of Preclinical Evaluation of Immune Cell Therapy Products in IND Stage from Practical Perspective"
General Manager Li Yunyan Speech Title: "Breaking the Barriers of Raw Materials and Helping Solid Tumor Cell Therapy"
Dr. Hu Dichao Speech Topic: "Development Strategy and Key Points of CAR-T CMC for Solid Tumors"
General Manager Wang Liqun Speech Title: "Commercialization Feasibility Analysis of Immune Cell Therapy Drugs for Solid Tumors"
Roundtable discussion
In the roundtable forum, guests expressed their unique insights on the development, commercialization and listing of CAR-T cell drugs. The discussion topics were the development strategy of CAR-T cell drugs for solid tumors, the commercialization strategy of CAR-T cell drugs, and the listing strategy of CAR-T cell new drug companies. 
Strategic cooperation
KAEDI and JOINN New Drug reached a strategic cooperation on cell drug IND application safety assessment, IND application registration, clinical CRO services and clinical biological sample analysis, cell bank testing and product quality testing technical services.
KAEDI and PORTON Biologics have reached a strategic cooperation on cell drug development, clinical and commercial manufacturing.
KAEDI and Kactus Biosystems reached a strategic cooperation on the overseas business promotion of synthetic biology products.
KAEDI and Humphries Pharmaceutical Consulting reached a strategic collaboration on FDA application for cell drugs.
KAEDI and Sanqing Biologics reached a strategic cooperation on the application of cell drug CDE
KAEDI and Zhonghui reached a strategic cooperation agreement on domestic listing
KAEDI and Jingtian & Gongcheng reached a strategic cooperation on legal support, document preparation and listing meeting
The successful holding of this pine and cypress meeting has built a bridge for communication between technical and policy experts in the industry, and has received positive comments from the guests and audience. Industry experts believe that the huge demand for clinical treatment of solid tumors is also driving the rapid growth of the pipeline, and in recent years, solid tumor cell therapy has shown a significant upward trend in terms of the number of registered clinical trials and the number of target developments. At present, many domestic pharmaceutical companies have made a number of breakthroughs in the field of solid tumor cell therapy. In March 2023, the clinical trial application (IND) of Class 1 biological product NKG2D CAR-T cell injection independently developed by KAEDI obtained the clinical implied license of the Center for Drug Evaluation (CDE) of the National Medical Products Administration, which is the first cell therapy product approved for targeting NKG2DL in China, with the indication of NKG2DL-positive solid tumors, including colorectal cancer, liver cancer, glioma and others. In March last year, the CAR-T cell candidate CT041 independently developed by Keji Pharmaceutical was approved by the Drug Review Center of the State Food and Drug Administration to enter confirmatory phase II clinical trials, leading the world. As one of the leading enterprises in the CAR-T track of solid tumors in China, KAEDI has the world's leading autologous and allogeneic CAR discovery platform, and is committed to creating breakthrough CAR-T products to solve unmet clinical needs. In addition, KAEDI has made a number of major breakthroughs in the field of CAR-T in solid tumors, successfully developed a number of new R&D pipelines for class I cell drugs for malignant solid tumors, and its core product NKG2D-CAR-T combined with DKK1 inhibitor WAY-262611 in the animal model of gastric cancer xenograft. Another core product, KD-496, entered the clinical stage of IIT as the world's first new dual-targeted CAR-T cell injection, showing excellent efficacy. In the future, KAEDI will continue to strive for disruptive technological innovation and bring more excellent clinical products to patients.
About JOINN New Medicine
Founded in 1995, Beijing JOINN New Drug Research Center Co., Ltd. (JOINN New Drug, stock code: 603127.SH/ 6127.HK) is an industry-leading professional and integrated drug R&D service platform. Headquartered in Beijing, it has subsidiaries in Beijing, Suzhou, Chongqing, Guangzhou, Wuxi, Wuzhou, Nanning, Yunnan, Shanghai, California and Boston, and currently has a professional and technical team of more than 2,500 people. JOINN New Drug has established a quality management system that meets international standards, (CNAS/ILAC-MRA certification), with China's NMPA, the U.S. FDA, PMDA, South Korea's MFDS and OECD GLP qualification and international AAALAC (animal welfare) certification qualification, and the evaluation data meets the global drug registration requirements. It can provide customers with one-stop services of drug screening and optimization, quality research and verification, non-clinical safety evaluation, clinical trial and pharmacovigilance, and can also provide veterinary drugs, pesticides and medical device evaluation services.
About PORTON Biotech
Founded in December 2018, based in Suzhou Industrial Park, Suzhou PORTON Biopharmaceutical Co., Ltd. has built a CDMO platform integrating plasmids, viral vectors and cell therapy products based on the listed company - Chongqing PORTON Pharmaceutical Technology Co., Ltd. (stock code: 300363), providing clinical and new drug clinical trial applications (IND), registered clinical trial samples and commercial production services from early research, investigator-initiated clinical trial applications (INDs), registered clinical trial samples and commercial production services, accelerating the process of drug research and transformation.
On the basis of the successful experience of PORTON Co., Ltd., with world-class professionals as the core, adhering to the service tenet of "customer first", taking "compliance, professionalism, focus, openness and collaboration" as the brand concept, continuing the parent company's strong IP protection and project management mechanism and perfect quality management system, making full use of the core team's successful experience in promoting gene and cell therapy products to the clinic to the market, providing high-quality and efficient services to global customers, so that good drugs can benefit the public earlier.
About Kactus Biosystems
Founded in early 2018, Kactus Biosystems is a protease raw material company focusing on the upstream field of biological drugs and driven by independent innovation. Relying on the unique protein R&D platform SAMSTM, Kactus Biosystems entered the antibody drug market from the field of difficult transmembrane proteins to solve the unmet market demand.
In the field of gene therapy, Kactus Biosystems provides localized GMP-grade Cas9 enzymes that can meet the clinical needs of gene editing, while Kactus Biosystems provides GMP-grade totipotent nucleases for AAV and vaccine industries, cytokines for cell therapy and raw enzymes for mRNA vaccine production, and several products have completed FDA DMF filing. The GMP products of Kactus Biosystems are developed and verified in strict accordance with the pharmacopoeia for testing methodology, equipped with MES digital production management system, and the products have good batch-to-batch stability and consistency, which meets the declaration requirements.
With a technical and professional team of nearly 250 people, the main operation location is located in the R&D and production center of Shanghai Pujiang Caohejing Development Zone and the tens of thousands of square meters of GMP-grade protease industrialization base in Lingang New Area, and has established overseas market commercial operation and logistics centers in Boston, USA.
About Humphries Pharmaceutical Consulting
Nanjing Hewo Business Consulting Co., Ltd. is a branch of Humphries Pharmaceutical Consulting Co., Ltd. (HPC), which was founded in 2004 and is headquartered in Maryland, USA, with branches in Beijing and Nanjing. The company focuses on FDA registration and consulting services, providing a series of services such as project evaluation, application writing, data editing, eCTD, communication with FDA, overseas clinical trials and project management. At present, it has provided services for nearly 100 domestic pharmaceutical enterprises. Successful project experience includes Car-T, oncolytic virus, microbial drugs, antibody drugs, ADC, Car-NK, oncolytic bacteria, peptides, botanical drugs, chemical drugs, and assistance in mergers and acquisitions.
About Sanqing Biotechnology
Sanqing Biotech is a R&D-oriented CRO company that is guided by new drug application, transformed into an industry goal, and realizes common innovation. Mainly provide new drug registration application/consulting and technical outsourcing services: new drug registration application/consulting services participate in the whole process of new drugs from R&D to IND application in a companionship innovation mode, and can provide customers with technical consultation, regulatory consultation, registration application and data writing services in pharmaceutical research, quality control, non-clinical research, clinical design and others. The company's technology outsourcing services include early drug screening, druggability studies (efficacy, pharmacokinetics, PK/PD), method development and transfer, biological sample analysis and quality testing.
About Zhonghui
Founded in 1992, Zhonghui Chuang can engage in securities industry audit and appraisal business with the record of the Ministry of Finance and the China Securities Regulatory Commission, tax assurance business with the filing of the State Administration of Taxation, project price appraisal and assurance business with the approval of the Ministry of Construction, and central enterprise audit business with the approval of the State-owned Assets Supervision and Administration Commission. Zhonghui Accounting ranked 11th in the comprehensive ranking of the top 100 domestic firms in 2021 (excluding the top four). As of May 2023, Zhonghui Capital Market has 160 listed companies, ranking 10th in the number of audit clients in the annual reports of listed companies by the China Securities Regulatory Commission. It has 168 companies listed on the New Third Board, and the Hong Kong office has undertaken the annual report audit business of more than 90 customers of Hong Kong listed companies, and the Los Angeles office has 15 NASDAQ-listed customers. So far, Zhonghui has helped more than 100 customers to successfully IPO, with 39 A-share customers since 2022, ranking sixth in the number of audit service customers, successfully helped the total number of listed customers to 30, ranking sixth. At present, Zhonghui Services has 44 IPO clients under review, ranking sixth.
About Jingtian Gongcheng
Jingtian & Gongcheng is a law firm legally established and existing in accordance with the laws of the People's Republic of China, and Jingtian & Gongcheng is a leading position in many professional fields, especially in the field of securities and capital market legal services.
About KAEDI
KAEDI is a clinical-stage drug discovery and development company dedicated to developing novel cell drugs with unmet clinical needs in patients with solid tumors using a leading synthetic biology technology platform. Relying on KD-SmCAR™ and KD-ScCAR™, the company's independent CAR library screening platform, and KD-ScCAR™, a dual-targeted CAR development platform. KAEDI has successfully developed a number of new cell drug pipelines for solid tumors, including next-generation autologous and allogeneic CAR-T/CAR-NK pipelines. At present, more than 30 CAR-related patents have been declared and 15 patents have been authorized, among which the core pipeline KD-025, KD-496 and other patents are authorized for the first time in China and the United States. The product development results of KD-025 CAR-T targeting NKG2DL for liver cancer, colorectal cancer and glioma have been published in the international authoritative journal "Journal for ImmunoTherapy of Cancer", "Cancer Immunology Research" and the American annual cancer clinical meeting ASCO. The KD-025 CAR-T IIT clinical trial carried out in a well-known clinical center in China has completed a number of low-dose administrations without obvious toxic side reactions, and the product is safe and effective, and it is the first domestic KEDI is headquartered in Nanjing, China. For more information, please visit the official website of Nanjing KAEDI Medical Technology Co., Ltd.:targeting CAR-T (KD-025) cells targeting NKG2DL solid tumors. The company that IND applied for CDE clinical approval is currently negotiating with a number of partners to start the first clinical phase of KD-025 registration, and at the same time, the company's core product KD-496 has entered the IIT clinical stage as the world's first new dual-targeted CAR-T cell injection. In addition, KAEDI is promoting the layout of the next generation allogeneic universal CAR-T/CAR-NK, and is expected to build KAEDI into a world-renowned solid tumor cell therapy company in the near future. The company has built a 3,000 square meters GMP cell drug R&D and production center, completed nearly 100 million yuan of financing, and is carrying out B round financing, At the same time, the company is rapidly advancing the development and commercialization of synthetic biology products through strategic cooperation.