HONG KONG, Sep 13, 2023 – (ACN Newswire) – Wuhan YZY Biopharma Co., Ltd. (“YZY Biopharma” or the “Company”, together with its subsidiaries, the “Group”, stock code: 2496.HK), a biotechnology company dedicated to developing bispecific antibody (BsAb)-based therapies to treat cancer-associated complications, cancer and age-related ophthalmologic diseases, announced the proposed listing of its shares on the Main Board of The Stock Exchange of Hong Kong Limited (“SEHK”) today.
YZY Biopharma plans to offer an aggregate of 11,001,200 H Shares under the Global Offering (subject to the Over-allotment Option), consisting of 9,901,000 International Offer Shares (subject to reallocation and the Over-allotment Option) and 1,100,200 Hong Kong Offer Shares (subject to reallocation), at a price range between HK$16 and HK$20 per H Share.
The Hong Kong public offering will open at 9:00 a.m. on Wednesday, September 13, 2023 and close at 12:00 noon on Monday, September 18, 2023 in Hong Kong. Dealings in shares on SEHK are expected to commence on Monday, September 25, 2023, with the stock code 2496.HK in board lots of 200 H Shares each.
China Securities (International) Corporate Finance Company Limited is the Sole Sponsor, Overall Coordinator, Joint Global Coordinator, Joint Bookrunner and Joint Lead Manager.
A pipeline of drug candidates with market potential
As a biotechnology company dedicated to developing BsAb-based therapies, YZY Biopharma’s core business model is to in-house discover, develop and commercialize BsAb-based therapies to treat cancer-associated complications, cancer and age-related ophthalmologic diseases. The Company carefully selects potential targets for its BsAbs, and has adopted a differentiated clinical development strategy to maximize the clinical and commercial value of its drug candidates. The Company has designed and developed a pipeline of seven clinical-stage drug candidates, including (i) Core Product M701, a recombinant BsAb that targets human epithelial cell adhesion molecule (EpCAM)-expressing cancer cells and human cluster of differentiation 3 (CD3)-expressing T cells. (ii) M802 and Y150, T cell-engaging BsAbs for cancer treatment, (iii) Y101D and Y332, tumor microenvironment (TME)-targeted BsAbs, and (iv) Y400, a targeted therapy for the treatment of age-related ophthalmologic diseases.
Focusing on the development of BsAbs in China
Since its establishment, YZY Biopharma focuses on the development of BsAbs in China. BsAb is an artificial protein that recognizes and specifically binds two antigens or epitopes. The advantages of BsAbs include the potential effects on various cancers, the application to retarget effector cells of the immune system and stimulate them through the interaction to achieve an efficient lysis of tumor cells. The applications and research of existing BsAbs are mainly focused on the field of oncology therapy, but also extend to other areas such as hemophilia and ophthalmology. At present, the Company has developed three T cell-engaging BsAbs, namely M701, M802 and Y150. T cell-engaging BsAb is a new class of therapeutic agents designed to simultaneously bind to T cells and tumor cells via tumor-cell specific antigens in immunotherapy. In addition, the Company is also focusing on the development of the TME-targeted BsAbs, including Y101D and Y332. The market size of the PRC oncology market has increased from approximately RMB157.5 billion in 2018 to approximately RMB233.6 billion in 2022, and is expected to reach approximately RMB586.6 billion in 2030. With the increasing trend of population aging and growing cancer incidences in China, it is expected that the clinical demands for effective oncology drugs will increase significantly.
Core product M701 helps improve the quality of life of advanced cancer patients
M701 (EpCAM x CD3 BsAb) – YZY Biopharma’s core product, is a recombinant BsAb that targets human EpCAM-expressing cancer cells and human CD3-expressing T cells. The Company is developing M701 primarily for the treatment of malignant ascites (MA) and malignant pleural effusion (MPE), which are severe complications that typically occur in late-stage cancer patients who have widespread metastases to the pleura or peritoneum. It is expected that M701 monotherapy could be used in addition to paracentesis to control MA and MPE, with an aim to improve the effectiveness and reduce the side effects of frequent paracentesis. M701 now has been selected for the “National Major New Drug Innovation” program under the 12th Five-Year Plan, which the Company believes could be an advantage for its future inclusion into the National Reimbursement Drug List.
Technology platforms fueling the R&D of drug candidates
YZY Biopharma has successfully built four platforms, including the self-developed YBODY,
Check-BODY and Nano-YBODY(TM) platform, and the UVAX platform developed in collaboration with WIV. YZY Biopharma’s core technology platforms enable to effectively select innovative targets, optimize molecule structure design and accelerate the drug development process. Leveraging the technologies of these platforms, YZY Biopharma is able to design and generate different antibody structures. As such, the Company can select targets and signaling pathways with clinical and commercial value and design and modify the structure of its BsAbs to bind such targets. Therefore, the Company is able to quickly expand its pipeline to include additional BsAbs that direct toward a wide range of targets and signaling pathways, optimize the use of resources and expertise, and achieve the maximized value of the Company’s pipeline candidates.
A GMP-compliant CMC platform
The Company has established a GMP-compliant chemistry, manufacturing and control (CMC) platform to leverage its extensive experience in the CMC for BsAbs with various structures. The Company believes such platform will serve as a solid foundation for its large-scale commercial production in the future. CMC refers to activities to properly define methods for manufacturing processes, product characteristics and testing, product storage and release to clinical usage in order to ensure that a pharmaceutical product is safe, effective and consistent among different batches. Although the discovery and protein engineering techniques of BsAbs are now relatively advanced, the development of BsAbs still faces many challenges in the CMC compared to the development of typical mAb drugs, including low expression titer of the target BsAbs, more impurities to remove, less stability of the intermediates, and hurdles in process scale-up. Therefore, the execution of an appropriate CMC development strategy is vital to the success of the overall drug development program. Its CMC strategies include evaluating the stability of the candidate BsAb molecules at the early development stage, choosing the monoclonal cells with high titer and high purity for BsAb production, tailoring purification methods fit for the molecule characteristics, and using sustainable scale-up strategies for large-scale production.
Execution-driven management and R&D teams
The Company’s core management team is composed of industry veterans with an average of more than ten years of experience and a track record of discovery, development and commercialization of innovative drugs. The co-founder, chairman and CEO of the Company, Dr. Zhou Pengfei, has over 33 years of extensive experience in the healthcare and pharmaceutical industries, focusing on oncology treatment and innovative drug development. In addition, the Company’s department heads and other key technical personnel have served various roles in leading multinational pharmaceutical companies, having complementary experience covering various stages of the entire development lifecycle of drug products, including pre-clinical studies, clinical development, manufacturing and commercialization.
In 2018, NBP Pharmaceuticals, a subsidiary of CSPC Pharmaceutical Group Limited (“CSPC”), a well-known pharmaceutical company in China and YZY Biopharma, reached a equity investment cooperation. With the combined resource of CSPC, the Company’s R&D pipeline construction and clinical research will be improved, and a new situation in the field of tumor immunotherapy will be created.
Looking forward, the Company will adhere to the mission of “discover and develop innovative drugs for the healthier lives of patients”, continue to accelerate the development of drug candidates for cancer treatment and invest more resources in clinical development and preclinical studies of these drug candidates At the same time, the Company will continue to expand its pipeline through in-house R&D efforts and collaborations, continue to enhance manufacturing capabilities and build its commercialization capabilities, and is committed to developing new therapeutic drugs for Chinese patients.
About Wuhan YZY Biopharma Co., Ltd.
Wuhan YZY Biopharma Co., Ltd. is a biotechnology company dedicated to developing bispecific antibody (BsAb)-based therapies to treat cancer-associated complications, cancer and age-related ophthalmologic diseases. Since its establishment in 2010, YZY Biopharma has designed and developed seven product pipelines of drug candidates that have entered the clinical stage. The Company carefully selects potential targets for its BsAbs, and has adopted a differentiated clinical development strategy to maximize the clinical and commercial value of its drug candidates. Adhering to the mission of “discover and develop innovative drugs for the healthier lives of patients”, the Company has been deeply involved in the research and development of BsAb-based therapies for more than ten years, to treat cancer-associated complications, cancer and age-related ophthalmologic diseases.
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