Andicon Bio's Pediatric "One-Dose Cure" Influenza Drug ADC189 Granules Receives IND Approval in China

Dec 14, 2023 20:53 CST Updated 20:53

Recently, the Investigational New Drug (IND) application for ADC189 Granules, a Class 1 innovative anti-influenza drug independently developed by Andikang for pediatric use, has been accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration. ADC189 Granules are intended for the treatment of acute influenza A and B in patients aged two years and older.

ADC189 is a next-generation innovative anti-influenza drug. The ADC189 tablets have demonstrated excellent safety and efficacy in Phase I and Phase II clinical studies, and positive progress has also been made in the Phase III clinical trials for influenza in adolescents and adults. Professor Qu Jieming, Secretary of the Party Committee of Ruijin Hospital and Chairman of the Respiratory Branch of the Chinese Medical Association, serves as the Principal Investigator (PI) for these clinical trials. Currently, ADC189 granules are the only domestic “pediatric version” novel drug capable of curing influenza with a single dose. It is poised to become China’s first independently developed Class 1 new anti-influenza drug in a pediatric-specific granule formulation, addressing the challenge of medication accessibility for pediatric influenza patients in China.

ADC189 is a cap-dependent endonuclease inhibitor that targets the cap-dependent endonuclease in influenza viruses, thereby blocking viral mRNA transcription and impairing self-replication, delivering a precise antiviral effect at the source. Existing research data demonstrate that ADC189 exhibits significant antiviral activity and a favorable safety profile against influenza A, influenza B, and highly pathogenic avian influenza viruses. Furthermore, compared with drugs in the same class, this candidate drug offers safety advantages, including oral bioavailability unaffected by food intake and a higher safe dosage threshold.Professor Sheng Guoping, Director of the Medical Affairs Department and Deputy Director of the Infectious Diseases Department at Shulan (Hangzhou) Hospital, stated: “The Joint Prevention and Control Mechanism of the State Council has emphasized that China may face a concurrent surge in multiple respiratory diseases, including COVID-19, influenza, and Mycoplasma pneumoniae infections, during the upcoming winter and spring seasons. Notably, influenza activity across both northern and southern regions of China continues to rise, currently reaching its highest level in nearly a decade. Children exhibit the highest incidence rates due to cluster outbreaks in schools. Currently, Andikang Biopharma’s next-generation anti-influenza drug, ADC189 granules, has been accepted for clinical use in pediatric patients, holding promise to provide safer, more efficacious, and more convenient prevention and treatment options for children with influenza in China.”

From the Phase I clinical data,ADC189 Demonstrates an Excellent Safety Profile. Data from healthy subjects showed that after a single oral dose at the target level, plasma drug concentrations remained above the EC90 for influenza B virus (the concentration required to reduce viral load by 90%) for 7 days, and above the EC90 for influenza A virus for 14 days. No cases of drug-related adverse events (AEs) of Grade 2 or higher were observed across all dose groups. Phase II clinical data demonstrated that the high-dose group achieved reductions in viral load and time to symptom relief comparable to those of approved drugs in the same class, with an AE incidence rate lower than that of the placebo group. In light of the mechanism of action of ADC189, available non-clinical and clinical study data indicate that this drug offers many potential clinical therapeutic advantages, includingFull-course treatment requires only a single dose (one pill for cure), with the potential to halt viral shedding within 24 hours (negative conversion in one day), andNot only can it treat influenza, but it can also prevent it, thereby reducing the scope and scale of community transmission of the influenza virus (killing two birds with one stone).。

In October 2023, the Company secured a strategic investment worth tens of millions of RMB from Simcere Pharmaceutical Group (2096.HK) and entered into a cooperation agreement regarding the innovative anti-influenza drug ADC189. Under the agreement, Simcere Pharmaceutical will obtain exclusive commercialization rights for ADC189 in China and will comprehensively accelerate the clinical development, industrialization, and commercialization of the product. Ren Jinsheng, Chairman of Simcere Pharmaceutical, stated, “ADC189 is another anti-infective product with differentiated advantages for Simcere Pharmaceutical, following Xianruoxin. The alternating prevalence of influenza and COVID-19 may have a long-term impact on global public health, presenting a challenge that our pharmaceutical industry must confront. We look forward to working closely with the Andikang team to bring more effective innovative drugs to combat influenza and contribute innovative strength to public health initiatives.”

Currently, Andikang Biotechnology has established a robust pipeline of respiratory and gynecological products leveraging its DMPK platform. Following significant progress in the Phase III clinical trial of ADC189, a novel anti-influenza drug for treating uncomplicated acute influenza in adults and adolescents, the acceptance of the clinical trial application for the pediatric-specific ADC189 granules marks Andikang Biotechnology as poised to become the first and “only” Chinese enterprise to develop a “pediatric version” of next-generation anti-influenza medication. Furthermore, the company’s pipeline includes several innovative drugs targeting respiratory pathogens, such as ADC789 suspension, a novel drug against respiratory syncytial virus (RSV), and ADC101 suspension, a new super-antibiotic against Mycoplasma. It also features ADC308 tablets, an innovative therapy for endometriosis and uterine fibroids that has the potential to fill a domestic gap. Andikang Biotechnology is currently accelerating the R&D progress of these innovative drugs, aiming to provide new treatment options for patients at an early date and contribute Chinese wisdom and solutions that are both “curative” and “accessible” to China’s public health security.

About Andikang (Wuxi) Biotechnology Co., Ltd.

After four years of integration, Andikang Biotech’s scientific innovation team has established a robust framework for developing innovative drugs in anti-respiratory infection and gynecology tailored to Chinese patients. Its product pipeline is progressing smoothly across various stages, securing a significant lead in these specialized sectors. Led by several academicians, the scientific team comprises highly skilled, efficient, and pragmatic experts specializing in different phases of new drug creation, including innovative drug design and synthesis, DMPK technology research and application, development of advanced formulations for special populations, and clinical studies in anti-infective and gynecological fields. To accelerate the clinical development and internationalization of its innovative drugs in respiratory anti-infection and gynecology, Andikang Biotech completed a RMB 100 million Pre-A financing round in April 2022, and its current A-round financing, amounting to hundreds of millions of RMB, has made substantial progress.