New stock news | Maiwei Bioscience (688062.SH) submitted documents to the Hong Kong Stock Exchange, with a loss of approximately 864 million yuan in the first ten months of 2024.

On January 6, Maiwei (Shanghai) Biotechnology Co., Ltd. (Maiwei Biotech) submitted an application for listing to the Hong Kong Stock Exchange, with CITIC SEC and HAITONG INT'L as joint sponsors. Maiwei Biotech's A shares have been listed on the Shanghai Stock Exchange Sci-Tech Innovation Board (stock code: 688062) since January 2022. According to the prospectus, Maiwei Biotech is a pharmaceutical company mainly focused on independently developing drugs for tumors and age-related diseases in the commercialization stage. Over the years, the company has established a competitive and multi-layered pipeline product portfolio, including more than 10 drug assets covering different varieties, focusing on tumors and age-related diseases such as immunology, ophthalmology, and orthopedics. Maiwei Biotech's core product 9MW2821 (an antibody-drug conjugate targeting Nectin-4) embodies the strength of the company's ADC technology and extensive expertise in the field. According to data from Frost & Sullivan, as of the most recent feasible date (December 30, 2024), in terms of clinical development stage, 9MW2821 is the fastest progressing ADC targeting Nectin-4 developed in China for the treatment of urothelial carcinoma, second only to Padcev (the only FDA-approved ADC targeting Nectin-4) globally, and it is the first and only ADC to enter a pivotal Phase III trial for cervical cancer. The company is conducting multiple clinical trials on 9MW2821, including Phase III trials for 9MW2821 as monotherapy and in combination with trastuzumab for the treatment of urothelial carcinoma, Phase III trials for 9MW2821 as monotherapy for cervical cancer, and Phase II trials for 9MW2821 as monotherapy or in combination with trastuzumab for triple-negative breast cancer. As of the most recent feasible date, Maiwei Biotech has obtained 124 patents globally and submitted 239 patent applications, including 22 patents and 20 patent applications related to core products. In terms of other ADC products, 7MW3711 is a novel ADC targeting B7-H3 (also known as CD276, an immune checkpoint protein). B7-H3 is a member of the B7 ligand family and plays a critical role in helping cancer cells evade immune surveillance and in the cytotoxic activity of T cells and natural killer cells. 7MW4911 is a specificity-targeted ADC targeting CDH17. CDH17 is a cell adhesion protein identified as a potential target in cancer therapy through comprehensive pan-cancer multi-omics analysis. In terms of market competition, according to Maiwei Biotech, the global ADC market has tremendous potential. In 2023, the annual sales of the top five commercialized ADC drugs all exceeded $1 billion. The global ADC market has rapidly grown from $2.8 billion in 2019 to $10.4 billion in 2023, with a compound annual growth rate of 38.4%, expected to continue growing strongly at a compound annual growth rate of 30.6% from 2023, reaching $115.1 billion by 2032. The Chinese ADC market started to grow after the approval of the first ADC (Hesai Lei) by the National Medical Products Administration in 2020, and is expected to grow from $400 million in 2023 to $17.4 billion by 2032, with a compound annual growth rate of 54.3%. Financially, for the ten months ending on October 31 in 2023 and 2024, Maiwei Biotech achieved revenues of approximately RMB 1.28 billion and RMB 1.60 billion, respectively, with losses of approximately RMB 1.059 billion and RMB 8.64 billion, respectively. As mentioned in the risk factors section of the prospectus, the development of innovative drugs is time-consuming and expensive, with uncertain results. If the company fails to develop and commercialize new products (including core products), its business prospects may be adversely affected.