Neoletix and Grand Life Group Agree Licensing Deal For Recombinant FVIII

Beijing, Oct. 19, 2022—Neoletix Biological Technology Co., LTD (Neoletix) announced today that it has entered into an exclusive license agreement with Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Grand Life Sciences Group Co., for the development and commercialization of Neoletix's flagship product, NX01, a highly-expressed recombinant factor VIII (rhFVIII) in greater China region. rhFVIII is an expensive molecule, broadly used in hemophilia A treatment, making it difficult to gain access to needed drug treatment especially for low-and middle-income patients. Neoletix has developed a novel manufacturing process covered by patents that are granted and issued in both the US and China, as well as by PCT applications. The recombinant FVIII expression level has been increased more than 20 times, and in some cases, significantly more, as compared to current international production levels. This will make the drug more generally available and considerably more affordable for a greater patient audience on a commercial scale. As the cost of this molecule can be dramatically reduced, it is believed that the rhFVIII developed by Neoletix’ propriety technology will have a major impact on landscape of hemophilia A prophylaxis and on-demand therapy once the product is on the market. Recently, it has been cleared on its Investigational New Drug (IND) application by NMPA (China) for clinical phase studies.  

Under the terms of the license agreement, Neoletix will receive an up-front and milestone payment based upon the achievement of specified development, regulatory and commercialization goals. Upon commercialization, Neoletix will be also entitled to a tiered royalty on sales in defined territories. Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd. will be responsible for all clinical development, manufacturing, and commercialization activities and costs.

About Beijing Neoletix Biological Technology Co., Ltd.

Beijing Neoletix Biological Technology Co., Ltd. is a clinical-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 Grand Life Sciences Group Co., Ltd.

Grand Life Sciences Group Co., Ltd. (“GLS Group”) is state-of-the-art comprehensive pharmaceutical enterprise with focuses on portfolio of immunity, infection, perioperative and critical care management, digestion, metabolism, hematologic system and wound management. GLS Group is committed to the development and production of sophisticated blood products, innovative recombinant vaccines, new generation live biotherapeutic products, nano targeted formulations, biodegradable polymers medical devices and high-value APIs.