Trinomab's TNM002 Granted Breakthrough Therapy Designation by CDE for Tetanus Prevention

On March 7, 2022, Trinomab announced that its independently developed TNM002 injection had been included in the Breakthrough Therapy Designation program by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. The active ingredient of TNM002 injection is a recombinant fully human monoclonal antibody against tetanus toxin, intended for the prevention of tetanus. This designation was based on its demonstrated significant clinical advantages over existing treatments in terms of safety, efficacy, and accessibility.

Under current policies, drugs designated for breakthrough therapy will benefit from two policy incentives: first, the Center for Drug Evaluation (CDE) will prioritize resource allocation for communication and consultation, strengthen guidance, and facilitate drug development; second, during the marketing application phase, they will be eligible for the priority review pathway, with the review timeline shortened to 130 days, and priority arrangements made for inspection, testing, and approval of the generic drug name.

Dr. Wang Guanmei, Chief Medical Officer (CMO) and Senior Vice President (SVP) of Trinomab“It stated: ‘TNM002 is the only recombinant protein (monoclonal antibody) globally indicated for emergency prophylaxis following tetanus exposure, with the potential to replace human tetanus immunoglobulin (HTIG) and equine tetanus antitoxin (TAT) currently used in clinical practice. In China and Southeast Asia alone, the annual market demand for HTIG and TAT approaches 100 million doses, representing a total market size exceeding RMB 10 billion. We will make every effort to accelerate the clinical development and commercial launch of TNM002, thereby providing patients and physicians with new therapeutic options at an earlier date.’”

Currently, the passive immunization agents used clinically for the prevention and treatment of tetanus include equine tetanus antitoxin (TAT) and human tetanus immunoglobulin (HTIG). However, TAT is an immunoglobulin derived from horse serum and is prone to causing allergic reactions (with an incidence rate of 5%–30%), while HTIG is limited by insufficient plasma supply and carries the risk of transmitting known infectious diseases (such as HIV and hepatitis B) or unknown pathogens.

TNM002 is developed by Trinomab using its HitmAb, a comprehensive technology platform for the development of natural fully human monoclonal antibodies.^®The developed recombinant fully human monoclonal antibody against tetanus toxin will be primarily used for the prevention of tetanus following traumatic exposure. Its main advantages are reflected in the following four aspects:

● In terms of safety:Australian Phase I clinical trials demonstrated that TNM002 injection exhibited a favorable safety and tolerability profile in healthy Australian adults. Following intramuscular administration of TNM002, no subjects experienced serious adverse events (SAEs), no subjects withdrew from the study due to treatment-emergent adverse events (TEAEs), and no deaths occurred. No significant adverse events related to TNM002 were identified.

● In terms of efficacy:TNM002 monoclonal antibody demonstrates potent neutralizing activity against tetanus toxin. Preclinical studies indicate that 1 mg of TNM002 monoclonal antibody (in terms of neutralizing titer) is equivalent to 250 IU of immunoglobulin. Clinical trial data from Australia show that, at a given dose, the plasma concentration exceeds the “minimum protective titer against tetanus” required by the WHO, indicating that TNM002 can rapidly achieve protective levels while providing sustained protection.

● From the perspective of controllability:As a recombinant drug, TNM002 can be manufactured on a large scale in vitro using modern industrial standards. The technology transfer has been successfully completed from WuXi Biologics to Trinomab’s Flex Factory™ located at the Zhuhai International Health Port, and scaled-up GMP clinical sample production has been completed.

● In terms of accessibility:Compared with human-derived tetanus antitoxin, TNM002 offers a better safety profile, lower production costs, and a shorter manufacturing cycle. Compared with equine-derived tetanus antitoxin, TNM002 eliminates the need for skin testing prior to administration, significantly reducing the workload for physicians and nurses, removing the requirement for in-hospital observation, and improving patient compliance. Furthermore, on the supply side, it no longer relies on plasma as a raw material, thereby resolving bottlenecks in raw material supply; on the demand side, there is strong willingness and ability to pay. Consequently, TNM002 demonstrates superior drug accessibility and can meet global supply demands.

Zhuhai Trinomab Biotechnology Co., Ltd. is a global-oriented innovative biopharmaceutical company, primarily engaged in the research and development of original natural fully human monoclonal antibody drugs. Trinomab’s core technology is the “HitmAb” integrated technology platform for the development of natural fully human monoclonal antibodies.^®”, dedicated to the development of novel, highly differentiated, and efficient fully human monoclonal antibody drugs with independent intellectual property rights, particularly leveraging recombinant antibodies as substitutes for plasma-derived immunoglobulins.