According to the Hong Kong Stock Exchange, Arnold Pharmaceutical Group Co., Ltd. (Adlai Nortye Ltd.) China International Capital Corporation and Bank of America Securities are co-sponsors to submit a listing application to the main board of the HKEx.
Arnold Pharmaceuticals uses its in-depth understanding of cancer biology, especially the cancer immune cycle, to design new candidate products through cutting-edge research and development and global clinical execution capabilities. Its "cocktail therapy" systematically uses the immune system through the combined use of multiple drugs, which aims to achieve excellent efficacy and safety while overcoming drug resistance, bringing greater clinical benefits.
The company's mission is to turn cancer into a chronic disease and eventually a curable disease. At present, a highly differentiated oncology product portfolio has been developed, including the following combinations that have the potential to become clinical drug candidates of the same kind.
AN2025 (buparlisib), a key product of Arnold Pharmaceuticals, is the fastest-growing clinical candidate in the pipeline and is a pan-PI3K inhibitor in a global registered trial. Through a license agreement with Novartis, a multinational pharmaceutical company, the company has the exclusive global right to develop and commercialize AN2025. AN2025 is a widely studied molecule, and Novartis has conducted more than 80 clinical trials on more than 4000 patients to verify its safety. Because of FDA's fast-track qualification, AN2025 is expected to be the first drug of its kind in the treatment of recurrent or metastatic HNSCC.
Another core product, AN0025, is in the clinical stage and has the potential to become the first EP4 antagonist of its kind to regulate the tumor microenvironment. The key product AN1004 (pelareorep), which has obtained the fast-track qualification of FDA, is an intravenous oncolytic virus that is in the registration trial stage and has the potential to become the first of its kind to treat metastatic breast cancer.
The company also owns AN4005, the fastest-growing drug candidate for self-development in the clinical stage, and a potential oral small molecule PD-L1 inhibitor with the potential to become the first of its kind. The IND license issued by FDA in June 2021 has granted AN4005 for the treatment of advanced tumors, and the recommended dose for phase II is expected to be determined in the second half of 2022.
In ongoing clinical trials, the triple therapy of AN2025, AN0025 and PD-L1 inhibitors presents the company's cocktail therapy. According to Frost Sullivan, cocktail therapy serves as the third wave of immune tumor therapy, combined with immune checkpoint inhibitors and two or more other cancer treatments. The synergistic and calibrated anticancer effect is expected to be achieved, and the overall remission rate is significantly higher than that of other combined therapies.
In addition to the above four clinical drug candidates, Arnold Pharmaceuticals' product line includes seven preclinical drug candidates. From target discovery and verification to preclinical and clinical development, the company's in-house drug discovery platform deploys a strong and professional set of technology and knowledge, including the following two professional platforms: the PAINT-2DTM platform (Arnold's immunotherapy discovery and development platform) and the ANEAT-IdTM platform (Arnold's efficient antibody recognition / development technology).
Financially, Arnold Pharmaceuticals currently has no products approved for commercial sale and does not generate any revenue from product sales. There was no profit and operating loss during the track record period (2019-May 2021).
The Company's losses for the years ended 31 December 2019 and 2020 and for the five months ended 31 May 2021 were RMB 123.2 million, 437.5 million and 79.4 million respectively. Almost all operating losses are caused by changes in the fair value of R & D expenses, administrative expenses and financial liabilities at fair value to profit or loss.
Arnold Pharmaceutical has previously listed in the new third board, Matrix Partners China, Credit Suisse, Wuxi Biologics and other institutions for the company's shareholders. The company received nearly US $100 million in D-round financing at the beginning of this month, which was jointly led by CIC Merchants and Tigermed. Lenovo Star, Wuxi Biologics Industrial Fund, Qinzhi Capital, Qingdao Mukui, League of Nations Industrial Investment, a state-level famous investment institution, a well-known investment institution, and Tien Pigeon Interactive participated in the investment, while the original shareholders ATCG Holdings and Ruihe Capital continued to participate.
The funds raised by the company's D-round financing will be used to advance the progress of clinical trials of the project, launch new drug research and development projects aimed at more targets, and further expand the R & D pipeline and team.