Respiratory Syncytial Virus (RSV)

RSV is the most significant viral pathogen globally causing acute lower respiratory tract infections in children under 5 years old. It is also the primary cause of hospitalization for infant virus-related respiratory infections. In recent years, mounting research has demonstrated that RSV also plays a pivotal role in severe lung diseases in adults, primarily the elderly. It is estimated that in 2019, there were approximately 33 million cases of RSV-ALRTI (RSV viral infection with symptoms of acute lower respiratory tract infection) in children under 5 years old worldwide, which resulted in approximately 3.6 million hospitalizations and 100,000 deaths. Currently, there are no effective treatments specifically for RSV. 

AK0529 is the first anti-RSV drug that has successfully completed a phase 3 pivotal clinical study globally. Its NDA has been accepted and granted Priority Review by NMPA

Idiopathic Pulmonary Fibrosis (IPF)

IPF is a special manifestation of idiopathic interstitial pneumonia, which is a chronic progressive fibrotic lung disease of unknown etiology. In May 2018, it was included in "the first batch of rare disease list of China". The global incidence of IPF is estimated to increase from 1.4 million in 2015 to 1.7 million by 2022.  IPF patients have a median survival time of only 3-5 years, with a five-year survival rate estimated to be around 20%, even lower than many types of cancer. Existing treatments have poor tolerance and side effects, which may lead to treatment discontinuation. 

AK3280 is a new generation of broad-spectrum anti-fibrotic molecule optimized based on the marketed product pirfenidone, with better safety and tolerability and potentially stronger efficacy. Currently, AK3280's phase II clinical study on IPF patients is being conducted in China.

Hypertrophic Scars (HS)

Hypertrophic scar is a type of pathological scar that results from overgrowth of skin tissue after a traumatic injury. In normal wound healing process, collagen synthesis and degradation are balanced, but in pathological scarring, this balance is disrupted, leading to excessive scar formation. Hypertrophic scars most commonly occur after surgery, burns, and other deep skin injuries. It is estimated that there will be approximately 27.38 million new cases of hypertrhphic scars worldwide in 2022, with China accounting for approximately 7.81 million of those cases. Current treatment options for hypertrophic scar are limited and recurrence is common, necessitating the development of a drug that can address fibrosis at its source. 

AK3287 is an innovative topical cream formulation designed specifically for the treatment of hypertrophic scars. Currently, it is undergoing phase I/II clinical trial in China to determine its effectiveness in treating patients with hypertrophic scars.

Chronic Obstructive Pulmonary Disease (COPD)

COPD is a chronic inflammatory lung disease and the world's third leading cause of death, with an estimated three million deaths recorded worldwide in 2020, equivalent to approximately 5% of global deaths in the same year. It is characterized by persistent respiratory symptoms and airflow limitation due to airway and/or alveolar abnormalities, usually caused by cigarette smoking, respiratory viral infection, and significant exposure to noxious particles or gases. There were approximately 218.2 million COPD patients worldwide and 114.7 million COPD patients in China in 2020, respectively. There is currently no cure for COPD, and the existing treatment drugs mainly rely on bronchodilators, which can modulate airway smooth muscle but only relieve the symptoms of COPD and delay disease progression. Anti-inflammatory agents such as inhaled corticosteroids (ICS) are also commonly used to reduce the severity of exacerbations, but have shown no clinical evidence in modifying the long-term decline in lung function and disease progression.

AK0705 is a highly promising innovative drug candidate for the treatment of COPD. It specifically targets significant proteases in the inflammatory pathway of immune cells, forming reversible covalent bonds with the target. Additionally, it exhibits exceptional inhibitory activity against the target proteases at picomolar levels. Phase I clinical trial of AK0705 is expected to be conducted in China in 2024.

Attention Deficit Hyperactivity Disorder (ADHD)

Attention deficit hyperactivity disorder (ADHD) is a common chronic neurodevelopmental disorder that affects attention and impulse control, with a prevalence of 7.2% globally and 6.3% in China. Despite high prevalence, but only 10% of children with ADHD have received proper diagnosis and treatment. 

AK0901 is an innovative treatment medication for ADHD in children aged six and above. Compared to currently available ADHD medications in China, AK0901 has advantages in terms of safety and treatment mechanism. AK0901 has been approved for marketing in the United States since July 2021. NMPA has approved its IND application.

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