Medicilon assists Palaatu to obtain clinical approval for Class 1 new drug PA9159 for rhinitis

2021-06-08

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On June 2, 2021, the National Medical Products Administration (NMPA) officially announced that the glucocorticoid drug PA9159 nasal spray was approved for clinical use. The PA9159 developed by Zhejiang Palaatu Pharmaceutical Company (Palaatu) is for seasonal and perennial allergic rhinitis.

In addition, Palaatu plans to submit the clinical trial applications of PA9159 for indications of asthma and COPD (Chronic Obstructive Pulmonary Disease), eczema, neurodermatitis, atopic dermatitis and pruritus during the second half of 2021.

As a new chemical entity, the preclinical efficacy test of PA9159 nasal spray showed that PA9159 nasal spray improved the symptoms of rhinitis, and was generally better than Fluticasone Furoate (FF). Preclinical animal data showed that PA9159 nasal spray was safe and had lower side effects than FF. Therefore, it is expected that PA9159 nasal spray can be used clinically to significantly improve the symptoms of rhinitis in patients.

Notably, the development of the API process was assisted by Shanghai Medicilon Inc. (Medicilon). Currently, Medicilon’s Process Department has established a platform for the development of cGMP APIs and has developed GMP APIs for clinical trials for innovative drug companies. Medicilon vigorously develops new technologies such as using green enzyme to resolve the drug synthesis problems and rapidly advance the development of innovative drugs, establishing a safety assessment lab in the process of API synthesis to resolve the safety and efficiency issues, and strengthening the quality research of APIs and able to control the content of genotoxic impurities and metal element impurities in APIs to meet the requirements and ICH guidelines.

❖ Medicilon’s preparation services

Medicilon's preparation laboratory and workshop area is about 4,000 square meters, with 100 professional R&D teams, of which more than 40% are masters/doctors, and more than 95% are undergraduates. The team has rich experience in successful research and development of innovative drugs, consistency evaluation, and improved new drugs, and experience in China-US dual filing and project management. The Medicilon pharmaceutical preparation R&D team has successfully cooperated with well-known large and medium-sized pharmaceutical companies worldwide, and has accumulated 18 years of experience in the research and application of innovative drugs and generic drugs. We provide one-stop and systematic preparation R&D services covering innovative drugs and generic drugs to meet the needs of customers at different stages of R&D.

Medicilon congratulates Palaatu on the research and development outcome, and hopes that the clinical research willproceed smoothly, bringing more treatment options to patients.

About Palaatu

Zhejiang Palaatu Pharmaceutical Company was founded by top scientific research experts and industry elites from the United States and China pharmaceutical industry. The founding team members have worked for Gilead Sciences and GSK for many years. In addition, the founding team also includes senior biomedical professors from Tsinghua University.

Based on its own advantages, Palaatu is committed to be the pharmaceutical company for antiviral and anti-asthma drugs with international standards. Palaatu’s new anti-hepatitis B virus drugs are targeted at 3 different types of targets. There are currently 5 new drugs, all of which have antiviral activities that lead the world with the same target drug. The three types of glucocorticoid drug-device combination drugs under development are used in the fields of anti-asthma, anti-rhinitis and dermatitis. Their drug efficacy is significantly better than the current leading GSK drugs fluticasone propionate and fluticasone furoate.

About Medicilon

Since the founding of our company in 2004, Medicilon (Stock Code: 688202.SH) has grown into one of the professional drug discovery contract research organizations (CRO) in China. Over the years, Medicilon keeps improving their services in biotechnology and pharmaceutical research. Their services now span across medicinal chemistry, process chemistry, in vitro and in vivo DMPK, preclinical development and bioanalytical support. Medicilon grows together with the clients and delivers the new drug research and development services to more than 900 clients globally. Medicilon is proud to contribute to human health in the globe.