ADC189, a Class 1 Anti-Influenza Drug by Andicon Biotech, Receives IND Approval in China for Treatment and Prevention of Influenza A and B

Recently, the Investigational New Drug (IND) application for ADC189, a candidate drug independently developed by Andikang (Wuxi) Biotechnology Co., Ltd. for the treatment and prevention of influenza A and B, received implicit approval from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration.

ADC189 features a novel mechanism of action against influenza, directly inhibiting viral replication. It is a cap-dependent endonuclease inhibitor that acts by blocking the cap-dependent endonuclease in the influenza virus, an enzyme essential for viral replication.

Antikang Biopharma designed and developed ADC189 to combat influenza A and B viruses, including oseltamivir-resistant strains and avian influenza strains (H7N9, H5N1). Data from head-to-head studies demonstrate that, compared with another investigational drug targeting the same mechanism, ADC189 offers safety advantages such as absence of central nervous system side effects, food-independent oral absorption, and a higher safe dosage, thereby exhibiting best-in-class characteristics.

Notably, this investigational new drug can block influenza virus replication within 24 hours with a single oral dose (“one pill”), which is expected to greatly facilitate medication for patients.

According to Dr. Jiang Weiping, founder of Andikang Biopharma, the approval of ADC189 for clinical trials marks a milestone achievement for the company. The Andikang Biopharma team has currently initiated a Phase I clinical study, led by top clinical experts in the field of anti-infective therapies, to evaluate the clinical efficacy of ADC189 in neonates, adolescents, adults, and elderly populations for indications including the treatment and prevention of influenza A and B.

“We will accelerate the clinical development of ADC189, striving to make it the first Class 1 innovative anti-influenza drug independently developed and approved for marketing in China, thereby providing a novel solution that is both curative and accessible for patients in China and around the world,” said Dr. Jiang Weiping.

Anticon Biologics’ team of scientists has long been dedicated to the research and development of innovative small-molecule drugs in the anti-infective field. Since the company’s inception, its pragmatic and highly efficient R&D team has established a pipeline comprising eight drug candidates within just two years. The company has been granted two Chinese patents and has filed multiple international PCT patent applications. Numerous academicians and industry experts are deeply involved, providing comprehensive support for research, development, and clinical trials.

Andikang Biotech is currently conducting its Series A financing, with Qingjie Capital serving as the exclusive financial advisor for this round. Inquiries are welcome.