Trinomab Announces NMPA Approval of IND for TNM001, a Long-Acting Fully Human Anti-RSV Monoclonal Antibody
Trinomab
Developer of Natural Fully Human Monoclonal Antibody New Drugs
On August 2, 2021, Trinomab announced that the China National Medical Products Administration (NMPA) had officially approved its independently developed TNM001 injection for Investigational New Drug (IND) clinical trials. This drug is a recombinant fully human monoclonal antibody against respiratory syncytial virus (RSV), intended for the prevention of lower respiratory tract diseases caused by RSV.
Respiratory syncytial virus (RSV) is the most significant cause of seasonal lower respiratory tract infections in infants and young children, and a major contributor to neonatal mortality due to viral infections. The peak age for RSV infection ranges from 2 to 8 months. Statistics show that during viral epidemic seasons, 80% of lower respiratory tract infection cases in infants under one year of age are caused by RSV, and the cumulative incidence of RSV infection in children under two years of age reaches as high as 99%. Globally, RSV infection results in approximately 64 million hospitalizations and about 160,000 deaths annually due to lower respiratory tract diseases. Currently, there are no vaccines or specific antiviral drugs approved in China for the prevention and treatment of RSV infection. Palivizumab (Synagis), developed by MedImmune,®) Approved by the FDA in 1998 for the prevention of congenital heart disease or pulmonary disease in premature infants born at less than 35 weeks of gestation, it is not yet marketed in China. During the RSV epidemic season (lasting 5–6 months), palivizumab requires monthly injections, with a single-dose cost ranging from $1,000 to $3,000, making the drug prohibitively expensive.
TNM001 Injection, a long-acting fully human anti-RSV neutralizing antibody drug, is developed by Trinomab using its proprietary fourth-generation antibody technology platform, HitmAb.®The developed specific antibody targets the RSV pre-fusion F protein (Pre-F). The product will initially be used for the prevention of RSV infection in premature infants and young children aged 0–24 months, providing protection throughout the entire RSV season with a single dose. TNM001 is the third recombinant fully human RSV monoclonal antibody drug to enter clinical trials globally, following AstraZeneca/Sanofi’s MEDI8897 and Merck’s MK-1654.
Dr. Wang Guanmei, Chief Medical Officer (CMO) and Senior Vice President (SVP) of Trinomab, stated, “As the first fully human monoclonal antibody targeting RSV in China, TNM001 is poised to address the significant unmet clinical need in the field of RSV infection. The successful approval of the Investigational New Drug (IND) application for the RSV monoclonal antibody (TNM001) by the NMPA also signifies the addition of a key asset to Trinomab’s clinical development pipeline. Our clinical team will go all out to advance the TNM001 project with high efficiency and quality.”
About Trinomab
Zhuhai Trinomab Biotechnology Co., Ltd. (hereinafter referred to as “Trinomab”) is a global, clinical-stage innovative biopharmaceutical company primarily engaged in the research and development of original natural fully human monoclonal antibody drugs. Trinomab’s core technology is the “Integrated Technology Platform for Natural Fully Human Monoclonal Antibody Development (HitmAb®)”, dedicated to the development of highly differentiated, efficient, fully human monoclonal antibody novel drugs with independent intellectual property rights, so as to enhance and improve the prevention and treatment outcomes for infectious diseases, autoimmune diseases, malignant tumors, and other conditions.
Currently, Trinomab has multiple fully human monoclonal antibody new products in the process of rapid industrialization, with some products already entering clinical trial stages. Another key product, "Recombinant Anti-Tetanus Toxin Natural Fully Human Monoclonal Antibody TNM002 Injection," initiated Phase I clinical trials in Australia in November 2020 and recently received IND approvals from both China and the United States. Additionally, the natural fully human monoclonal antibodies against human cytomegalovirus (HCMV), nerve growth factor (NGF), and varicella-zoster virus (VZV) in its product pipeline are scheduled for IND submission by the end of 2022.
Trinomab places great emphasis on the importance of clinical research. Recently, it has consecutively appointed two industry veterans with extensive domestic and international clinical research experience as Chief Medical Officer and Vice President of Clinical Development, respectively. This move strengthens the company’s clinical professional team to more efficiently advance the clinical trial processes of its monoclonal antibody products and to strategize their global rollout through optimized clinical development strategies and risk control management.
Zhuhai Trinomab Biotechnology Co., Ltd.
Zhuhai R&D Center: 2nd Floor, Building 6C, Zhizao Avenue, Hongqi Town, Jinwan District, Zhuhai City
Zhuhai Production Base: Building 9, International Health Port, Sanzao Town, Jinwan District, Zhuhai City
Beijing Clinical Center: W2-911, Oriental Plaza, Dongcheng District, Beijing
US Office: 4307 Forest Edge Trail, Durham, NC 27705, USA
Australian Office: 17 Bungowen Ave, Thornleigh, NSW Australia 2120
Tel: 0756-7263999
Email: trinomab@trinomab.com
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