New stock news: Innovent Biologics submits application to the Hong Kong Stock Exchange, possessing a pipeline consisting of 12 independently developed ADC candidate drugs.

date
27/08/2024
avatar
GMT Eight
According to the disclosure by the Hong Kong Stock Exchange on August 26, Duality Biotherapeutics, Inc. submitted an application for listing on the main board of the Hong Kong Stock Exchange, with Morgan Stanley, Jefferies, and CITIC Securities as joint sponsors. According to the prospectus, Duality Biotherapeutics is a global leader in the field of antibody-drug conjugates (ADC), dedicated to developing new generation ADC innovative drugs for patients with cancer and autoimmune diseases. The company has established a differentiated pipeline using its own ADC technology platform, and is advancing these pipelines with the aim of revolutionizing cancer treatment and providing therapies that significantly improve treatment outcomes for global patients. Since its establishment in 2019, Duality Biotherapeutics has built a highly innovative and differentiated pipeline consisting of 12 proprietary ADC candidate drugs, including six clinical-stage ADCs that have potential in indications with unmet clinical needs, placing each of them among the world's leading in terms of overall or major indication development progress according to Frost & Sullivan. Additionally, two next-generation bispecific ADCs (BsADC) and one autoimmune disease ADC (Autoimmune ADC) are expected to enter the clinical stage between 2024 and 2026, along with multiple other preclinical ADCs. Among Duality Biotherapeutics' six clinical-stage drug assets, five have received Investigational New Drug (IND) approvals from both the US Food and Drug Administration (FDA) and the China National Medical Products Administration (NMPA). As of the latest feasible date (August 19, 2024), the company has seven Global Multi-Regional Clinical Trials (MRCT) involving more than 1000 patients at over 230 clinical trial centers in 17 countries. The company's innovative ADC assets have attracted leading global biopharmaceutical companies and established several global partnerships, including collaborations with BioNTech SE, BEIGENE Limited, and Adcendo ApS, with a total transaction value exceeding $4 billion. Furthermore, three clinical-stage assets of Duality Biotherapeutics (including its core products DB-1303/BNT323, DB-1311/BNT324, and key product DB-1305/BNT325) have been granted Fast Track designation by the FDA. DB-1303 has also received breakthrough therapy designation from the FDA and NMPA for specific indications. Duality Biotherapeutics has also developed four leading ADC technology platforms: Duality ImmunoToxin Antibody Conjugate Platform (DITAC), Duality Innovative Bispecific Antibody Conjugate Platform (DIBAC), Duality Immune Modulation Antibody Conjugate Platform (DIMAC), and Duality Unique Payload Antibody Conjugate Platform (DUPAC) to push the boundaries of ADC therapy. As of the latest feasible date, the company has not received any marketing approval for its candidate drugs or generated any revenue from product sales. The company expects to achieve commercialization of its late-stage ADCs in the coming years and plans to maximize the commercial value of its candidate drugs by selecting the optimal business model (including establishing internal commercialization capabilities and/or collaborating with third parties such as distributors, contract sales organizations (CSOs), and licensing partners). Financially, Duality Biotherapeutics had revenues of approximately 1.6 million RMB, 1.787 billion RMB, and 641 million RMB for the three months ending March 31 in 2022, 2023, and 2024, respectively. The company reported losses of approximately 387 million RMB, 358 million RMB, and 65.942 million RMB during the same periods. As stated in the prospectus, the company heavily relies on the success of its candidate drugs. If the company fails to successfully complete clinical development, obtain regulatory approval, or commercialize its candidate drugs, or if any of these activities experience significant delays or cost overruns, its business and prospects may be significantly adversely affected.

Contact: contact@gmteight.com