RSV is an enveloped RNA virus that is highly prevalent and infectious, which causes respiratory tract illness, especially in vulnerable populations such as children, the elderly and the immunocompromised.
RSV infection is the number one cause of LRTI in young children worldwide, infecting 90% of children under two years old with approximately 3.3 million infected and hospitalized children globally each year. In 2020, incidence of severe RSV infection in children under five years old reached 34.6 million and 3.0 million globally and in China, respectively. RSV is also estimated to infect 5.5% of adults aged 65 years or above globally each year, as their immune system gradually deteriorates due to aging. In 2020, incidence of severe RSV infection in adults aged 65 years or above reached 4.9 million and 1.2 million globally and in China, respectively.
Despite decades of clinical efforts, no RSV vaccine or effective treatments specifically targeting RSV has demonstrated efficacy or been approved globally. Ziresovir, a novel drug that targets the RSV F protein, is the first RSV drug worldwide to enter phase III clinical trial in hospitalized infants and young children and is currently in phase III registration trial in pediatric patients, with substantial near-commercial opportunities. Due to its clinical and safety profile, ziresovir is the first non-oncology drug to receive “breakthrough designation” from the NMPA.
IPF is a specific form of chronic, progressive fibrosing pneumonia of unknown cause. IPF is a rare disease that affected approximately 1.6 million persons worldwide in 2020, and is estimated to account for 20% to 50% of all cases of interstitial lung disease (ILD), a group of disorders which commonly feature progressive scarring of lung tissue. On May 11, 2018, IPF became one of the 121 rare diseases designated by the First Catalogue of Rare Diseases in China.
IPF occurs primarily in older adults, characterized by progressive worsening of dyspnea and lung function. In recent years, mortality from IPF has been increasing steadily worldwide. Given its unpredictable but progressive evolution, the prognosis of IPF remains generally poor, with a median survival time of three to five years from the time of diagnosis and a five-year survival rate estimated at around 20%, even lower than those observed in many types of cancer. There are currently only two drugs approved for IPF in the US and China, both with poor tolerability and side effects, such as GI intolerance, phototoxicity and liver toxicity, which could lead to discontinuation of the treatment.
AK3280 is a phase II-ready drug designed with a potentially superior efficacy and safety profile and improved patient compliance, for the treatment of lung fibrosis, especially IPF.
Hypertrophic scars are pathological scars resulting from abnormal responses to trauma and can be itchy and painful, causing serious functional and cosmetic disability. They are the most common type of clinical scarring, typically caused by abnormality of the repair process, which can lead to excessive tissue proliferation. Incidence rates vary from 40% to 70% following surgery to up to 91% following burn injury, depending on the depth of the wound. There were an estimated 25.9 million new cases worldwide and 7.3 million new cases in China in 2020, respectively.
There is no cure for hypertrophic scars, and the current first line treatments such as intralesional corticosteroid injection and silicone elastomer sheeting, are limited by uncertain efficacy, high rate of recurrence, or severe adverse reactions, which create significant need for new treatment options.
AK3287 is a topical formulation for the treatment of hypertrophic scars. It has demonstrated favorable effect in pre-clinical animal studies and has the potential to become an effective preventive and therapeutic drug for hypertrophic scars.
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 potent and selective small molecule inhibitor of an enzyme implicated in the pathogenesis of COPD and other inflammatory lung diseases. It displays pico-molar activity in the enzymatic assay and maintains activity in the presence of patient sputum.
Hepatitis B is a widespread and infectious liver disease caused by chronic infection of HBV, an enveloped DNA virus affecting more than 236.4 million people worldwide. Hepatitis B can become a chronic disease, especially if infected in children, which can lead to liver fibrosis and liver cancer. According to the Guideline for Primary Care of Chronic Hepatitis B (2020) published by Chinese Medical Association in February 2021, among Chinese patients with liver cirrhosis and hepatocellular carcinoma (HCC) – the most common type of primary liver cancer – 77% and 84%, respectively, were infected with HBV.
While there are long-term standard of care treatments for HBV infection that suppress HBV replication, none of them can achieve functional cure, defined as seroconversion of HBsAg, in the majority of patients.
AK0706 is a novel HBV RNA destabilizer drug that reduces hepatitis B surface antigen (HBsAg) level for treatment of hepatitis B.