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Public company info - Immunotech Biopharm Ltd , 06978.HK
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Immunotech Biopharm Ltd, 06978.HK - Company Profile
Chairman Tan Zheng
Share Issued (share) 515,000,000
Par Currency U.S. Dollar
Par Value 0.001
Industry Biotechnology
Corporate Profile Business Summary: The group is a leading cellular immunotherapy biopharmaceutical company in China focusing on the research, development, and commercialisation of T cell immunotherapy for 13 years. Performance for the year: The group’s loss for the year increased from RMB34.9 million for the year ended 31 December 2018 to RMB109.1 million for the year ended 31 December 2019. Business Review According to the Frost & Sullivan Report, EAL® — The group’s Core Product Candidate — is the first cellular immunotherapy product in China approved for entry into a Phase II clinical trial, and, as at the Latest Practicable Date, the only that had been approved for application in a Phase II clinical trial for solid tumour treatment. EAL® is a multi-target cellular immunotherapy product with more than a decade of track record of clinical application, and has efficacy in the treatment of various types of cancer. The group’s EAL®-related research began in 2006, and The group have improved upon The group’s cell culture system and methods, and developed The group’s proprietary, patented technology platform for the production of EAL® cells. In its history of clinical application, EAL® has efficacy in preventing tumour recurrence and maintaining long-term survival of patients, and when used in combination with chemotherapy, has shown better therapeutic efficacy than chemotherapy alone. The group have selected the prevention of postsurgical recurrence of liver cancer as the clinical indication for the clinical trial of EAL®. In China, the number of patients newly diagnosed with liver cancer exceeded 400,000 in 2018, accounting for 44.9% of the global liver cancer incidence. In addition, the five-year survival rate for liver cancer in China is as low as 12.1%, far lower than the overall five-year survival rate of 40.5% for cancer on average. According to the Frost & Sullivan Report, other than surgery and interventional therapy, no medication or other methods are available in China to prevent the recurrence of early-stage liver cancer and prolong the recurrence-free survival and overall survival of early-stage liver cancer patients. The group plan to put EAL® for commercialisation in the near-term. According to the Frost & Sullivan Report, the size of China’s cellular immunotherapy market is expected to increase from RMB1.3 billion to RMB10.2 billion from 2021 to 2023 at a CAGR of 181.5%, and is forecasted to reach RMB58.4 billion in 2030 with a CAGR of 28.3% from 2023 to 2030. In China, the cellular immunotherapy industry saw a major shift in regulatory environment in 2016, when new rules were promulgated requiring all cellular immunotherapy products to go through the NMPA authorisation process just like other pharmaceutical products. Leveraging The group’s understanding of and foresight in the industry developed from The group’s long-term experience in the field, The group submitted the IND application for EAL® in 2015 ahead of The group’s competitors, and the IND application was accepted by the CDE for processing. The group obtained the IND approval document in October 2017, and enrolled the first patient for the Phase II clinical trial for EAL® in September 2018. As at the Latest Practicable Date, 161 patients had been enrolled in the Phase II clinical trial for EAL®. The group’s product pipeline features major classes of cellular immunotherapy products, including both non–genetically-modified and genetically-modified products, as well as both multi-target and single-target products. Other than EAL®, The group’s main product candidates include the CAR-T cell series and the TCR-T cell series. The group’s CAR-T-19 injection product candidate was the subject of a researcher-initiated clinical study in which 63 patients were treated from June 2017 to September 2018, and the complete response rate was over 90%. The group’s IND application for the product candidate with B-cell acute lymphoblastic leukaemia (B-ALL) as the clinical indication was accepted for processing by the CDE in August 2019. The group received the feedback from the CDE in November 2019, which suggested us to supplement some materials relating to pre-clinical studies. The group have initiated supplemental research based on the CDE’s feedback. The group expect to submit supplemental research materials by June 2020 to complete the IND application. If the CDE consents to The group’s submission to be made, The group expect to begin the clinical trial of CAR-T-19 product candidate by the end of 2020. Based on the model of The group’s CAR-T-19 injection product candidate used for the treatment of hematologic cancer, The group is conducting research into novel CAR-T cell products that aim to overcome the immunosuppressive mechanisms in the tumour microenvironment (eg CAR-T-19-DNR) and products that aim to overcome the high recurrence rate of CAR-T cell therapy (eg aT19). As for The group’s TCR-T cell product pipeline, The group have a number of candidates under pre-clinical studies. The group have completed the pharmacodynamic studies for The group’s NY-ESO-1 TCR-T cell product candidate. The group plan to submit the IND applications for The group’s CAR-T-19-DNR, aT19, and NY-ESO-1 TCR-T product candidates by mid 2021. Composed of experienced cancer immunologists, The group’s highly-professional core technology team is equipped with industry foresight and sensitivity. Under their leadership, The group completed the pre-clinical study and submitted the IND application for EAL® in 2015 when cellular immunotherapy was still managed as a Class III medical technology in China. As a result, EAL® has gained a significant amount of time for commercialisation as the only cellular immunotherapy product in China approved for application in a Phase II clinical trial for solid tumour treatment as at the Latest Practicable Date. The group’s R&D organisational structure encompasses early research, pre-clinical studies, clinical studies, and commercialised production and management, allowing for rapid implementation of The group’s product R&D efforts. The group have established sophisticated basic technology platforms necessary for the R&D of cellular immunotherapy products, including a serum-free cell culture and expansion technology platform, a gene modification and transduction technology platform, a technology platform for in vitro expansion of antigen-specific T cells, and a production and purification technology platform for plasmids and viral vectors. In addition, The group have in place an organisational and management platform for clinical trials, a cell transportation and logistics platform, and a GMP-compliant production quality management platform appropriate for cellular immunotherapy products. The group have a total area of more than 7,500 square metres for R&D and manufacturing in Beijing. Such facilities are capable of supporting The group’s pre-clinical and clinical R&D of cellular immunotherapy product candidates, as well as the early production needs upon marketing approval for The group’s product candidates. All these facilities have been issued clean facility (area) inspection reports by the Beijing Institute for Drug Control. The group’s Guosheng Laboratory has the capacity to handle approximately 40,000 samples per year, and can satisfy the needs from the clinical trials for The group’s product pipeline for two to three years, as well as the early production needs from the commercialisation of EAL®. In addition, The group have established a research centre in the Republic of Korea primarily focusing on the development of next generation of cancer immunotherapy products. In order to expedite The group’s clinical trials and to prepare for future commercialisation roadmap, The group is planning to establish R&D and production centres in cities such as Shanghai and Guangzhou, covering major population centres in China in view of the six-hour transportation radius for EAL®. Prospects: The group plan to pursue the following business strategies: • Expedite the clinical trial and prepare for commercialisation of EAL® • Expedite the research into the expansion of indications for EAL® • Advance the pre-clinical studies for pipeline products, and accelerate their entry into clinical trials • Enhance The group’s technology platform and strengthen The group’s product pipeline • Develop viral vector production and early-stage R&D services business • Expand strategic collaboration and explore acquisition opportunities on the basis of organic growth

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