CNBG Wuhan Institute of Biological Products Co., Ltd. and Singlomics Signed an Agreement on DXP-604 Project

At the end of December 2021, the Wuhan Institute of Biological Products, an entity of China National Biotech Group Co., Ltd. (CNBG), and Singlomics Biopharmaceuticals Co., Ltd. signed an agreement, allowing CNBG Wuhan to develop, manufacture and commercialize Singlomics’ DXP-604 product globally under its terms and conditions. DXP-604, a monoclonal antibody with broad neutralizing activity against COVID-19, was discovered by the research team led by renowned academician Xiaoliang Xie at Peking University from samples taken from convalescent COVID-19 patients, using their innovative single-cell sequencing technology platform. It is currently undergoing clinical Phase II development for the treatment and prevention of COVID-19. Up to now, CNBG has two antibody drugs for treating COVID-19, providing powerful tools in epidemic prevention and control.  

“The neutralizing antibody DXP-604, co-developed by Xiaoliang Xie’s team at Peking University in collaboration with Singlomics, has shown efficacy in combatting the existing prevalent variants of COVID-19, in addition, it is expected to be effective against future mutations,” said Dr. Qian Shi, CEO of Singlomics. “Singlomics is committed to developing effective and affordable drugs. We share the same philosophy as CNBG who plays a crucial role in the research & development, manufacturing and supply of biological products to fulfil the needs of national health. It is a great pleasure to work with such a partner. We look forward to rapidly bringing DXP-604 to patients in need, both in China and abroad.”

Xiaoming Yang, President and Chairman of CNBG noted, “Current data show that DXP-604, a neutralizing antibody against COVID-19, can effectively combat existing prevalent mutant strains, and will play an active role in the clinical treatment of COVID-19.” “CNBG is a comprehensive, well-established biopharmaceutical enterprise with a history of over 100-years. As a ‘Central enterprise’, we will follow the national COVID-19 prevention policies resolutely and shoulder our responsibilities. We are fully mobilizing clinical resources at home and abroad to overcome difficulties, achieving breakthroughs and accelerating commercialization, so providing an effective therapeutic drug for COVID-19 patients as quickly as possible. 

DXP-604, a neutralizing antibody for COVID-19 with specific binding site on the viral receptor binding domain (RBD), is a full-spectrum antiviral antibody. The Xiaoliang XIE team utilized the yeast display technology to create a library of mutated COVID-19-RBD with a full coverage of all putative mutation sites. Using such a library, the possible mutations in RBD which can escape DXP-604 were explored. The team found that DXP-604 is effective against all RBD single-point mutations. Further, no escaping was observed by any existing prevalent mutant strains, and various future mutations are unlikely to be able to escape either. The study demonstrated that it is already much more effective in preventing antibody escape by using DXP-604 as a single agent, rather than pairing with any other anti-COVID antibodies. The primary cause is that the binding site of DXP-604 on RBD overlaps up to 85% with the binding site of RBD to its host cell receptor, ACE2. Any RBD mutations which can prevent the binding of DXP-604, may also hinder the binding of the virus to host cells via ACE2, hereto effectively reducing the propagation of the virus within the population. Two Phase I clinical trials of DXP-604 have been completed, proving the antibody to be safe, and a phase II trial is currently being conducted. At the end of October 2021, DXP-604 received emergency approval for compassionate use in China.

About Singlomics Biopharmaceuticals

Singlomics Biopharmaceuticals Co., Ltd. was founded in June 2020. It has established single-cell high-throughput drug screening and development platform at its early stage. As a novel drug development strategy, this technology has been used to achieve rapid discovery and development of antibody drugs. The advantages of this technology include taking immune cells with well-defined biological functions as research & development objects and adopting a reverse discovery process with the capacity of higher-volume information gathering and higher-throughput measurements than conventional antibody discovery technologies, leading to superb precision. This technology can greatly shorten the time dedicated for antibody discovery and also reduce the failure rate of ensuing development.

Professor Xiaoliang Xie, the Leading Founder, is an internationally renowned biophysical chemist, a member of the National Academy of Sciences and the National Academy of Medicine, a fellow of the American Academy of Arts and Sciences, and a foreign academician of the Chinese Academy of Sciences. Dr. Qian Shi, CEO, has twenty years research experience in the oncology field, and a deep understanding of the current situation and needs of scientific research, pharmaceutical industry and clinical practice. He also brings rich leadership experience in managing cross-regional and cross-cultural teams. Under the strong leadership of both scientist and entrepreneur, sit our core scientific team members, all graduates of respected universities such as Harvard, PEKING UNIVERSITY and Fudan University, who bring decades of experience in fields such as single-cell genomics, transcriptomics, methylomics and immunology.

Singlomics Biopharmaceuticals has completed series B round financing from investors in the medical and health field in China. In addition to pursuing Phase III clinical development of COVID-19 antibody drugs, the company is further reinforcing its product pipelines to treat infectious diseases and cancer, through strengthening in-house R&D capabilities for novel antibody drugs and licensing-in innovative products from partners globally. Via such a two-pronged approach side by side, the company is aiming to achieve its vision of “Using the single-cell sequencing technology platform to continuously promote innovative drug research for various indications, including infectious diseases and cancer, and developing good drugs that are affordable.

Contact Information:

Liping Zhang
Sr. Director, Business Development and Operations 
Phone: (86) 10 80765087
Email: liping_zhang@singlomics.com