dMed Company (Shanghai) Ltd. congratulated the recent approval of a PARP inhibitor (NMS-03305293 capsules) of its collaborator NMS Group, an Italian oncology drug discovery and development company, by the National Medical Products Administration (NMPA) in China, in selected advanced/metastatic solid tumors in adult patients for dose-finding study. NMS-03305293 single agent will be conducted dose-range finding studies in potentially PARP inhibition sensitive, selected patients with advanced/metastatic solid tumors (HER2 negative breast cancer, ovarian cancer, castration-resistant prostate cancer and pancreatic cancer) to confirm its safety.
As a second-generation PARP inhibitor, NMS-03305293 has high selectivity for PARP1 subtype versus other PARP subtypes, with low DNA trapping property and can specifically induce apoptosis in BRCA-mutated tumor cells. Preclinical studies have shown that NMS-03305293, with its high degree of blood-brain barrier penetration, might also have the potential to treat CNS tumors and brain-metastasized tumors.
Mr. Cao Yuping, Chairman of Nanjing Hicin Pharmaceutical Co. Ltd., a major shareholder of NMS Group commented “The IND approval of NMS-03305293 by NMPA is another important milestone for NMS Group. It is a promising step of realization of bringing innovative tumor treatments to patients worldwide, especially to patients in China. With its unique mechanism of action and excellent blood-brain barrier penetration, NMS-03305293 has the potential to play an important role in areas such as glioma treatment and might become the best of its class. We thank our partner dMed team which facilitated the IND approval ahead of schedule, with their dedication and professional support. We look forward to the clinical introduction of NMS-03305293, which I believe will potentially benefit many cancer patients in China and the rest of the world soon.”
Mr. Zhao Jianghua, Partner of V-Capital, another major shareholder of NMS Group stated “NMS Group, as Italy’s largest cancer drug research and development company, has a wealth of experience in target discovery and validation for kinase inhibitors and other classes of small molecules drugs. PARP inhibitor NMS-03305293’s IND approval in China has far-reaching significance. This will establish a new path allowing the innovative drugs created at NMS to directly benefit patients in China. We appreciate dMed in assisting NMS to receive the NMS-03305293 IND approval in China in a shorter time than anticipated. We will continue to work with other shareholders to keep investing in NMS Group’s innovative drug pipeline to provide Chinese cancer patients more treatment options in the future.”
Dr. Nanding Zhao, CEO of NMS Group noted “First of all, we thank our shareholders for their confidence and continuing support to NMS Group. We are also grateful to our collaborator dMed and its highly experienced clinical trial team. The approval of FIH studies of PARP inhibitor NMS-03305293 by NMDA has further confirmed NMS Group’s years of unremitting efforts both from the discovery and development teams as well as the global business operation team. We will carry on with our endeavor to bring more innovative drugs to patients in China and in the rest of the world.”
NMS-03305293 IND application was approved by FDA on June 21, 2019, and by the Italian National Health Authority (AIFA) in Europe on July 9, 2019.
Dr. Tan Lingshi, Founder, Chairman and CEO of dMed, said, “We are honored to collaborate with NMS Group to support the first clinical trial application of its first innovative drug in China. dMed has a strong team with rich experience in the clinical development of oncology drugs. dMed has entered a strategic collaboration with NMS Group at early stage of the project, providing a customized and integrated clinical development services for NMS Group to enter the Chinese market, and delivering high-quality results to accelerate the clinical trials process. I firmly believe that dMed and NMS Group will further work together to bring innovative drugs to Chinese cancer patients in the most steady and efficient manner.”
About NMS Group
NMS Group is Italy’s largest innovative oncological R&D based pharmaceutical company. With more than 400 employees of which more than half are highly educated researchers dedicated to groundbreaking research and development. The NMS kinase inhibitor discovery platform as well as the antibody-conjugated payload platform are the driving forces of the group’s innovation, securing global recognition of NMS in personalized therapy. Entrectinib, discovered by NMS, is a targeted kinase inhibitor to treat NTRK1/2/3 and ROS1 dependent solid tumors that was licensed to Ignyta, now member of the Roche Group, who gained recent approvals for commercialization in all major markets. This is a further evidence of the value and competitiveness of the drug discovery platform at NMS Group. The NMS Group has three subsidiaries: the first, NMS s.r.l. is a FIC / BIC focused, expert drug research and development company, with a robust pipeline of more than a dozen anti-cancer programs ongoing, three of which currently in early clinical stage of development. The other two subsidiaries Accelera and NerPharMa provide preclinical research services, and CDMO services respectively for local and international customers.
dMed is a full-service Clinical Contract Research Organization (CRO), which provides industry solutions to pharmaceutical and medical device companies in China and across the globe. dMed is led by experts in China and the US who originated from leading multinational pharma companies and regulatory agencies. We are uniquely positioned to leverage and integrate China’s new regulatory framework, offer innovative drug development strategies, and help our clients expand globally by tapping into the world’s second largest pharmaceutical market. Our creative and flexible collaboration models will help Chinese and global innovative pharma companies effectively raise efficiency in clinical R&D, scientifically shorten research cycle, and boost success rate. Our business covers consulting, regulatory affairs & strategy, early development & clinical pharmacology, clinical operations, biostatistics & programming, data management, drug safety & pharmacovigilance, clinical science & medical affairs, quality assurance and information solutions. dMed has set up offices in major cities, including Shanghai, Beijing, Wuhan, New York, Washington, San Francisco, and Brussels, and it employs around 600 professionals globally, among them 60% holds master above degree and 25% with more than 10 years working experiences.