"One Pill, One Day": China's Homegrown "Super Flu Drug" Arrives!
On October 19, 2022, the Phase II/III Clinical Investigator Meeting for ADC189 Tablets, a Class 1 innovative anti-influenza drug independently developed by Jiaxing Andikang Biotechnology, was successfully held in Shanghai. Due to the pandemic, the meeting was conducted in a hybrid format combining online and offline participation. The company plans to conduct a multicenter, randomized, double-blind, placebo-controlled Phase II/III clinical study in China to evaluate the safety and efficacy of ADC189 in adult patients with uncomplicated acute influenza. The convening of this meeting marks the full entry of ADC189’s clinical development into the Phase II/III clinical trial stage.
ADC189 is a novel anti-influenza drug with a new mechanism of action, independently developed by Jiaxing Andikang Biopharma, a China-based innovative pharmaceutical R&D enterprise. Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, serves as the lead site for the Phase II/III clinical study of ADC189, with Professor Qu Jieming, Director of the Chinese Thoracic Society and affiliated with Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, serving as the Leading PI.
The meeting was chaired by Professor Qu Jieming. Professor Qu Jieming and Dr. Jiang Weiping elaborated on the clinical value of ADC189 in the field of major infectious diseases, expressed strong confidence in the success of this clinical trial, and extended their welcome and gratitude to all institutions participating in the trial. Experts from various institutions, including Professor Cao Bin from China-Japan Friendship Hospital, Director Xu Jinfu from Shanghai Pulmonary Hospital, Director Zhang Jing from Zhongshan Hospital Fudan University, Director She Danyang from the Chinese PLA General Hospital (301 Hospital), the Director from Huadong Hospital Fudan University, Director Ye Feng from the First Affiliated Hospital of Guangzhou Medical University, and Professor Fan Hong from West China Hospital Sichuan University, engaged in in-depth discussions on protocol design, patient enrollment, and implementation, thereby clarifying subsequent work arrangements.
ADC189 shares the same mechanism of action as Roche’s baloxavir, inhibiting the cap-dependent endonuclease in influenza viruses, thereby blocking viral mRNA transcription and impairing self-replication, thus delivering a precise strike against the virus at its source. Research data indicate that ADC189 exhibits significant antiviral activity against influenza A, influenza B, and highly pathogenic avian influenza viruses, along with an excellent safety profile. Compared with baloxavir, ADC189 demonstrates best-in-class characteristics, including oral absorption unaffected by food intake and a higher safe dosage window.
Wu Bing, Senior Clinical Manager at Andikang: “Andikang is about to initiate a multicenter, randomized, double-blind, placebo-controlled Phase II/III clinical study to evaluate the safety and efficacy of ADC189 tablets in treating adults with uncomplicated acute epidemic influenza. Phase I clinical data for ADC189 demonstrated that after a single oral dose, serum drug concentrations in subjects remained above the EC90 against influenza B virus for 7 days and above the EC90 against influenza A virus for 14 days at the target dose. Furthermore, no drug-related adverse events (AEs) of Grade 2 or higher were observed across all dose groups. These findings highlight the characteristics of a ‘super flu drug’ capable of achieving a ‘one-pill cure.’ Consequently, ADC189 presents a low clinical risk and a high likelihood of successful market approval, positioning it to potentially become the first domestically developed and approved Class 1 innovative anti-influenza drug in China.”
Jiang Weiping, Founder and Chairman of Andikang: “The clinical advantages of ADC189 can be summarized as ‘Three Ones’: ‘One Pill for Cure’—requiring only a single dose throughout the entire course of treatment; ‘One Day to Negative Conversion’—with the potential to halt viral shedding within 24 hours; and ‘Killing Two Birds with One Stone’—not only treating influenza but also reducing the scope and scale of community transmission. The successful convening of this conference marks a key milestone in the Phase III clinical trials of ADC189. The smooth progress of these trials will bring Chinese wisdom and solutions that make influenza both ‘curable’ and ‘accessible,’ thereby safeguarding China’s public health security.”
About Jiaxing Andikang Biotechnology Co., Ltd.
Anticon Biotech is led by a number of top Chinese scientists and academicians. Its project team, with an international perspective, operates efficiently and pragmatically. Leveraging the company’s platform advantages in DMPK-driven new drug discovery, Anticon is committed to improving the accessibility of innovative drugs in China for respiratory anti-infective and gynecological indications. The company’s pipeline includes urgently needed oral therapeutics for the cure of endometriosis and uterine fibroids, a novel 3CL protease inhibitor for COVID-19, and a new drug against RSV. These candidates offer clear clinical value in niche areas with limited treatment options, highlighting their significant commercial potential. As a leading biotech company in the fields of respiratory anti-infectives and gynecology, Anticon has gained recognition from numerous renowned investment institutions.