Three New Drug Applications Recommended for Priority Review in China

On September 8, three drug marketing applications were proposed for priority review: Injectable Ropinirole Sustained-Release Microspheres, Norepinephrine Bitartrate Injection, and Ganaxolone Oral Suspension.

Drug Name: Rotigotine Sustained-Release Microspheres for Injection

Company: Jiaao Pharmaceuticals

Indications: Parkinson's Disease

Rotigotine is a non-ergot dopamine agonist (DAs), and its mechanism for treating Parkinson's disease is believed to be related to the activation of dopamine receptors in the caudate putamen of the brain. The rotigotine transdermal patch, developed by the original research company UCB Pharma (UCB), has been approved by the FDA and NMPA for marketing, and is used for the treatment of early and advanced idiopathic Parkinson's disease.

Jiaao Pharmaceutical is a subsidiary of Luye Pharmaceutical. Injectable Rotigotine Sustained-Release Microspheres (LY03003) is an innovative new drug, and the world's first innovative microsphere formulation for the treatment of Parkinson's disease. It has been included in the priority review due to its compliance with the category of "innovative drugs and improved new drugs that are urgently needed in clinical practice for the prevention and treatment of major infectious diseases and rare diseases."

LY03003, developed based on Luye Pharma's globally leading microsphere technology platform, is the world's first long-acting sustained-release microsphere formulation for the treatment of Parkinson's disease. Meanwhile, the product is also being developed simultaneously in the United States and Japan.

Luye Pharma submitted an application to the NMPA for market approval based on multiple Phase I clinical trials and one Phase III clinical trial. The trial results demonstrated that LY03003 is safe and effective in treating Parkinson's disease, providing comprehensive and continuous improvement of motor symptoms in Parkinson’s patients and enhancing their quality of life.

Drug Name: Norepinephrine Bitartrate Injection

Company: Shijiazhuang Siyao

Indications: For the treatment of severe, acute hypotension in adult patients to raise blood pressure.

Norepinephrine Bitartrate is an adrenergic receptor agonist. It is a potent α-receptor agonist and also stimulates β-receptors. Through the stimulation of α-receptors, it causes intense vasoconstriction, increasing blood pressure and coronary artery blood flow; through the stimulation of β-receptors, it enhances myocardial contraction and increases cardiac output.

Norepinephrine Bitartrate Injection is a drug on the national shortage list in China and is the first marketing registration application to seek priority review and approval. It has been included in the priority review and approval process under the category of "(1) Innovative drugs and improved new drugs for clinically urgently needed shortage medicines, and for the prevention and treatment of major infectious diseases and rare diseases."

Currently, in China, the norepinephrine bitartrate injection from three companies has passed the consistency evaluation, coming respectively from Tianjin Jinyao Pharmaceutical, Grand Pharmaceutical, and Yifan Biologics.

Source: PharmaGO Database by Medicine Cube

Drug Name: Ganaxolone Oral Suspension

Company: Yuan Yi Bio

Indications: For the treatment of seizures in patients aged 2 years and older with Cyclin-Dependent Kinase 5 (CDKL5) Deficiency Disorder (CDD)

Naloxone oral suspension is a new type of pediatric medication that has been included in the priority review and approval process under the category "(2) New varieties, dosage forms, and specifications of pediatric medications that meet the physiological characteristics of children."

Ganaxone is a positive allosteric modulator targeting the GABAA receptor. It exerts antiepileptic and anxiolytic effects by acting on synaptic and extrasynaptic GABAA receptors in neurons. GABA is one of the inhibitory neurotransmitters in the central nervous system and is associated with emotional changes such as anxiety, tension, and depression.

Ganaxolone, originally developed by Marinus, was first approved by the FDA on March 18, 2022, for the treatment of seizures in patients aged 2 years and older with Cyclin-Dependent Kinase 5 (CDKL5) Deficiency Disorder (CDD) in the form of an oral suspension, under the brand name Ztalmy. Ztalmy is the first FDA-approved therapy targeting this patient population and has received both FDA Orphan Drug Designation and Rare Pediatric Disease (RPD) Designation.

On November 17, 2022, Tenacia (Yuan Yi Bio) obtained exclusive rights to develop and commercialize oral and intravenous formulations of ganaxolone in mainland China, Hong Kong, Macao, and Taiwan. Tenacia also has the right to negotiate on a priority basis for any future next-generation formulation or prodrug. Under the agreement, Marinus will receive a $10 million upfront payment, up to $256 million in regulatory, development, and sales milestone payments, as well as tiered royalties in the low double digits based on future net sales.

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