MabPlex International Ltd. confirms securing United States Food and Drug Administration (FDA) Investigational New Drug (IND) clearance for Encure Biopharma Co., Ltd.’s (Beijing) YH001 project. Following this successful FDA IND clearance, MabPlex will also submit an IND for YH001 to the Chinese National Medical Products Administration (NMPA). This FDA IND clearance is MabPlex’s 3rd successful IND application secured by the company for its clients in 2019.
MabPlex International Ltd., (MabPlex), a leading, full-service, global Contract Development and Manufacturing Organization (CDMO), today announced that the company has completed Chemistry, Manufacturing and Controls (CMC) work for Encure Biopharma Co., Ltd.’s (Encure) lead project YH001.
MabPlex also assisted Encure in submitting an Investigational New Drug application (IND) to the United States Food and Drug Administration (FDA) and confirmed that the FDA has cleared Encure’s IND application. This approval is the third FDA IND application MabPlex has secured for its clients in 2019.
MabPlex led the IND filing on behalf of Encure, for the company’s lead drug candidate, YH001, an innovative, proprietary, antibody-based drug molecule with an initial indication for the treatment of cancer.
“The FDA’s acceptance of our IND is a major milestone in transitioning Encure Biopharma from a pre-clinical to a clinical-stage biotechnology company,” said Dayao Zhao, MD, Ph.D., Chief Executive Officer of Encure.
“YH001, our lead project, seeks to address an important unmet medical need. We believe the novel mechanism of action (MOA) of YH001 may become one of the most important new treatments for a broad range of cancers,” Zhao added.
As a fully integrated international CDMO service provider, MabPlex has been able to help Encure to successfully secure a U.S. FDA IND for the company’s YH001 Project.
In late 2017 MabPlex and Encure established a strategic partnership to develop YH001, one of several projects in which the two companies cooperate. As part of the agreement, MabPlex provided a fully integrated CDMO service, from vector construction to the IND submission, in both China and the United States.
Based on the gene sequence provided by Encure, MabPlex successfully completed vector construction, cell line screening, established a research cell bank (RCB), a master cell bank (MCB) and a working cell bank (WCB) under current Good Manufacturing Practice (cGMP) compliance. The company also provided process development (cell culture process, purification process, virus removal and formulation screening and Fill/Finish), analytical method development and established quality standards, developed toxin batch production and reference preparation, as well as IND batch sample production, testing release and stability studies of the related samples.
MabPlex also assisted Encure with the compatibility test of clinical samples and delivery devices, designing of clinical sample labeling, the preparation of Pre-IND conference and development of pharmaceutical research materials.
After successfully obtaining FDA IND approval, MabPlex will, by the end of 2019 and on behalf of Encure, submit an IND application to the National Medical Products Administration (NMPA), the Chinese agency that is responsible for regulating drugs and medical devices (formerly the China Food and Drug Administration or CFDA) for YH001. At the same time MabPlex is expected to start a new FDA IND application process for a second project being developed by Encure. The FDA IND application for this drug is expected to be submitted by the end of 2019.
“I would like to thank MabPlex for helping us achieve these milestones and I’m grateful for their excellent work. The professional services offered by MabPlex, their technical ability and customer-oriented service makes me look forward to continuing our ongoing collaboration. As a result of our efforts we expect to obtain FDA IND approval for additional investigational agents in the near future,” Encure’s Zhao said.
“I would like to congratulate Encure Biopharma on successfully passing the FDA’s review and obtaining the IND approval, a significant milestone in the development of their new drugs,” Wei Chen, Ph.D., Chief Executive Officer of MabPlex, said.
“As a full-service CDMO service provider, we help our customers’ new drug research and development and assist them in successfully accelerating the IND and BLA, while saving costs. We look forward to helping Encure Biopharma reach important developmental milestones and advance their investigational compounds,” Chen concluded.
MabPlex International Ltd (MabPlex), a leading and fully integrated, global Contract Development and Manufacturing Organization (CDMO), offers an advanced biologics platform and comprehensive and integrated solutions to global (bio-) pharmaceutical developers. Founded in 2013, MabPlex currently has two sites in China (Yantai and Shanghai) and one site in the United States (San Diego, CA) offering high quality services from biologics drug development to commercial manufacturing. MabPlex currently has over 60,000 square meters of R&D and production facilities, a total of 9 monoclonal antibody (mAb) Drug Substance (DS) production lines, 2 Antibody-drug Conjugate (ADC) DS production lines, as well as mAb formulation and ADC formulation lines. The commercial production service is designed to help customers accelerate the progress of clinical trials and support market launch. MabPlex has established a talented team of more than 400 employees provideding Contract Development and Manufacturing Organization (CDMO) services to more than 40 pharmaceutical companies around the world resulting in more than 12 Investigational New Drug application (IND) approvals with the United States Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA) and China’s National Medical Products Administration (NMPA). For more information, please visit our website at https://mabplexinc.com/