News & Activities » GenScript ProBio and Neoletix Announce Successful Completion of 200-Liter GMP Production Runs of Recombinant Coagulation FVIII Based on a Novel Production Technology

GenScript ProBio and Neoletix Announce Successful Completion of 200-Liter GMP Production Runs of Recombinant Coagulation FVIII Based on a Novel Production Technology

On February 7th, 2021, GenScript ProBio announced that it has successfully completed 3 X 200 L GMP production runs of recombinant human factor VIII (rhFVIII) for Beijing Neoletix Biological Technology Co., Ltd. (Neoletix). In May 2019, GenScript ProBio and Neoletix, a private company focused on therapies for hemophilia, entered into an agreement in support of Neoletix’s flagship product, NX-01, a highly-expressed rhFVIII. Neoletix has chosen GenScript ProBio to help develop and manufacture NX-01 for its upcoming clinical trial.

Hemophilia A and B are two most common inherited bleeding disorders in which blood does not clot properly due to a lack of required blood-clotting proteins (factor VIII and IX). Hemophilia A is most commonly treated using FVIII replacement therapy, in which FVIII can be derived either from human blood or produced recombinantly. According to the National Bureau of Statistics and the World Federation of Hemophilia, there are 140,000 hemophilia patients in China. Due to limited availability of plasma-derived FVIII and the extremely high price of recombinant FVIII products, most hemophilia patients in China can only afford ‘on-demand’ treatment for acute injury; prophylaxis therapy is still beyond reach of most. With increased access to prophylaxis, the Chinese market will see rapid growth in the future.

"Our track record in biological CMC space makes us the ideal partner to help manufacture of NX-01, an exciting recombinant FVIII product that is an important option for large number of Chinese hemophilia patients. We wish the clinical trial a success and are glad to be part of the improvement of hemophilia A therapy," said Dr. Brian Min, CEO of GenScript ProBio.

"We are partnering with GenScript ProBio, one of the leading CDMO companies in China, to help us manufacture NX-01. Large-scale production and protein stability are great challenges to the rhFVIII CMC process. We appreciate GenScript ProBio's efforts in completing the GMP production of NX-01. Our product will make rhFVIII much more accessible, which in turn will fundamentally reshape the treatment and prevention landscape for patients with hemophilia A and greatly improve their quality of life. We look forward to working closely with GenScript ProBio to bring this exciting product to China as well as to the world." said Dr. Chester Li, CEO of Neoletix.

About NX-01

NX-01 is designed to address the high cost of current coagulation replacement therapy for hemophilia patients. Based on a novel manufacturing process via patents that are granted in both US and China, as well as other patents pending, the recombinant FVIII expression level has been increased more than 20 times, and in some cases, significantly more, as compared to the current international production level. This will make the drug more generally available and considerably more affordable for a greater patient audience on a commercial scale. Neoletix plans to start clinical trials in Q4 2021 and launch the drug in China at the end of 2022.

About Beijing Neoletix Biological Technology Co., Ltd.

Beijing Neoletix Biological Technology Co., Ltd. is a preclinical-stage biotechnology company focused on developing new biological drug therapies for hemostasis, antithrombosis and rare diseases. Neoletix is also engaged in immunotherapy research on a variety of malignant tumors, including unlabeled malignant tumor cells, using its novel nanobody targeting technology for tumor treatment.

About GenScript ProBio

GenScript ProBio is the bio-pharmaceutical CDMO segment of the global biotech company GenScript Biotech Corporation (Stock Code: 1548.HK), proactively providing end-to-end service from drug discovery to commercialization with professional solutions and efficient processes to accelerate drug development for customers.