Yongtai Bio Submits Hong Kong IPO Prospectus; China's First Solid Tumor Cell Therapy Enters Phase II Clinical Trials

According to the disclosure by the Hong Kong Stock Exchange, on September 2, 2019, Immunotech Biopharm Limited submitted its application for listing on the Main Board of the Hong Kong Stock Exchange, with CCB International and Guosen Securities (Hong Kong) serving as joint sponsors.

Immunotech Biopharm, established in 2006, is a high-tech enterprise specializing in the research and application of immunotherapy products. According to its prospectus, the company’s losses for the period and total comprehensive expenses amounted to RMB 16.62 million, RMB 34.89 million, and RMB 50.53 million in 2017, 2018, and the first half of 2019, respectively. Research and development (R&D) expenses were RMB 11.93 million, RMB 31.17 million, and RMB 23.38 million during the same periods. Net cash used in operating activities remained negative, totaling -RMB 12.08 million, -RMB 44.08 million, and -RMB 35.29 million during the reporting periods.

Immunotech Biopharm Financial Data Source: Prospectus

Like many innovative biotech companies, the Company has not generated any revenue, and its losses are primarily attributable to research and development and administrative expenses.

Over its 13-year history, Immunotech Biopharm has witnessed and participated in the entire evolution of China’s cell therapy industry from its inception, establishing a comprehensive R&D system that spans from in vitro experiments to animal studies, and from safety assessments to clinical research.

Image from the prospectus

The prospectus reveals that Immunotech Biopharm’s current product portfolio covers major tumor cell therapy products, including non-genetically modified cells, genetically modified cells, multi-target tumor therapy cells, and single-target tumor cell therapies. According to a report by Frost & Sullivan, its core product, EAL, is the first immune cell product in China approved to enter Phase II clinical trials.

EAL is a multi-target tumor cell immunotherapy product with over 10 years of clinical application experience in cancer treatment. Immunotech Biopharm has been conducting research on EAL since 2006.

Currently, EAL is primarily used for the prevention of postoperative recurrence of liver cancer. According to a report by Frost & Sullivan, apart from surgery and interventional therapies, there are currently no available drugs or methods in China that can prevent the recurrence of early-stage liver cancer or extend recurrence-free survival and overall survival in patients with early-stage liver cancer. In 2019, new cases of liver cancer in China exceeded 400,000, accounting for 44.9% of global new cases. Moreover, the five-year survival rate for liver cancer patients in China is only 12.1%.

In addition to its flagship product EAL, Immunotech Biopharm has a portfolio of cell therapy products, primarily including CAR-T and TCR-T cell series. According to a report by Frost & Sullivan, the market size of China’s cellular immunotherapy market is expected to reach RMB 1.3 billion in 2021 and rapidly grow to RMB 12 billion by 2023, with a compound annual growth rate (CAGR) of 181.5%. Based on its current cellular immunotherapy pipeline and research, Immunotech Biopharm believes that with the commercialization of EAL and other products, the company will hold a strong first-mover advantage in the Chinese market.

The regulatory landscape for China’s cellular immunotherapy industry underwent a significant turning point in 2016, when all cellular immunotherapy products became subject to the drug regulatory framework and required approval through the National Medical Products Administration (NMPA). Based on its understanding and forecasts of the industry’s prospects, Immunotech Biopharm submitted an Investigational New Drug (IND) application for its EAL product in 2015, which was accepted by the NMPA’s Center for Drug Evaluation. In October 2017, Immunotech Biopharm obtained approval for its EAL product, and in September 2018, it enrolled the first patient in the Phase II clinical trial of EAL. To date, the number of patients enrolled in the Phase II clinical trial of Immunotech Biopharm’s EAL has reached 66.

Furthermore, 63 patients have been treated with Immunotech Biopharm’s investigational product CAR-T-19, achieving a complete remission rate of over 90%. The company has submitted an Investigational New Drug (IND) application for CAR-T-19, with B-cell acute lymphoblastic leukemia (B-ALL) as the clinical indication, which was accepted by the Center for Drug Evaluation in September 2019. In its prospectus, Immunotech Biopharm disclosed that multiple products are currently undergoing preclinical studies, and pharmacodynamic studies for the investigational NY-ESO-1 TCR-T cell product have been completed. The company plans to submit IND applications for its investigational products CAR-T-19-DNR, aT19, and NY-ESO-1 TCR-T by the end of 2020.

The Company’s R&D and production center in Beijing covers a total area of over 7,500 square meters. It has established advanced foundational technology platforms required for the development of cell therapy products, including serum-free cell culture and expansion platforms, gene modification and transduction platforms, antigen-specific T cell ex vivo expansion platforms, as well as plasmid and viral vector production and purification platforms. The Company has also set up a clinical trial group management platform, a cell transportation logistics platform, and a GMP-compliant production quality management platform suitable for cell immunotherapy products, thereby laying the groundwork for subsequent clinical trials and commercialization.

The prospectus revealed that, as of August 2019, there were 10 cellular immunotherapy products undergoing clinical trials in China, with only two targeting solid tumors. Moreover, no cellular immunotherapy products had yet been marketed or submitted for New Drug Application (NDA) approval in China. For Immunotech Biopharm, seizing first-mover advantage and maintaining its leading position are particularly crucial.

Moving forward, Immunotech Biopharm will center its business focus on EAL. While accelerating the progress of clinical trials, the company will also expand research into additional indications, striving to advance its commercialization strategy ahead of schedule. For other products, the R&D team will expedite preclinical studies to propel more candidates into the clinical stage. Furthermore, the company plans to expand its outsourced viral vector and early-stage R&D services, broaden strategic collaborations alongside organic growth, and consider selective mergers and acquisitions.