I n n o v a t i n g
t o
t r a n s f o r m
t h e
l i v e s
o f
p a t i e n t s
10
Therapeutic areas
20
Pipelines
3
Products to
be/already in China
phase III clinical trials
be/already in China
phase III clinical trials
Pipeline
0
Condition
Candidate
Pre-clinical
Phase I
Phase II
Phase III
NDA
Approved
1
Epilepsy
Cenobamate
2
Epilepsy
IGS-A0302
3
Epilepsy
IGS-A0304
4
Epilepsy
IGS-RD-012*
5
Sleep Disorder
Solriamfetol
6
Parkinson’s Disease(PD)
IGS-RD-011*
7-14
Neuropathic Pain(NP)
IGS-E0301~E0308*
15
Attention Deficit
Hyperactivity Disorder (ADHD)
Hyperactivity Disorder (ADHD)
eTNS
16
Attention Deficit
Hyperactivity Disorder (ADHD)
Hyperactivity Disorder (ADHD)
IGS-L0301
17
Attention Deficit
Hyperactivity Disorder (ADHD)
Hyperactivity Disorder (ADHD)
IGS-RD-002*
18
Major Depressive
Disorder (MDD)
Disorder (MDD)
IGS-RD-004*
19
Schizophrenia
IGS-RD-001*
20
Schizophrenia
IGS-M0301
*Ignis holds global rights to IGS-RD-001, 002, 004, 011, 012, as well as IGS-E0301~E0308.
*IGS-RD-001, 002, 004, 011, 012 are in-house developed candidates of Ignis.
*IGS-RD-001, 002, 004, 011, 012 are in-house developed candidates of Ignis.
Products
Cenobamate
*Cenobamate has not yet been approved in Mainland China
Cenobamate is a prescription medicine used for adjunctive treatment of partial-onset seizures in adult patients. Cenobamate was approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Drug Office of the Department of Health in Hong Kong, China, in 2019, 2021, and 2023, respectively. Up to now, it has been approved for marketing in 22 countries and regions with more than 100,000 treated patients worldwide.
Owing to its proven efficacy and safety performance, Cenobamate was recommended by the National Institute for Health and Care Excellence guidelines (NICE guidelines) in December 2021.
Owing to its proven efficacy and safety performance, Cenobamate was recommended by the National Institute for Health and Care Excellence guidelines (NICE guidelines) in December 2021.
Solriamfetol
*Solriamfetol has not yet been approved in Mainland China
Solriamfetol is indicated for the treatment of excessive daytime sleepiness (EDS) in adults with obstructive sleep apnea as well as in patients with narcolepsy. The medication received approval from the U.S. Food and Drug Administration (FDA) in 2019 and the European Medicines Agency (EMA) in 2020.
Owing to its proven efficacy and safety profile, the product has been recommended by Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline, the European guideline and expert statements on the management of narcolepsy in adults and children, and the Chinese Guideline for Diagnosis and Treatment of Narcolepsy (2022 Edition) issued by the Chinese Medical Association.
Owing to its proven efficacy and safety profile, the product has been recommended by Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline, the European guideline and expert statements on the management of narcolepsy in adults and children, and the Chinese Guideline for Diagnosis and Treatment of Narcolepsy (2022 Edition) issued by the Chinese Medical Association.
eTNS System (Home-use medical device)
*This product has not yet been approved in Mainland China
The first home-use medical device approved by the U.S. Food and Drug Administration (FDA) for the treatment for pediatric ADHD serves as a monotherapy for 7 to 12-year-old patients who are currently not taking prescription ADHD medications. The device's version 2.0 has received FDA approval for market launch in 2024.
R&D
Ignis is committed to leveraging cutting-edge neuroscience research to develop targeted therapies that address the underlying mechanisms of disease progression.
In-house R&D Laboratories
As the scientific engine driving this mission, the company boasts in-house R&D laboratories located in Zhangjiang, Shanghai. The laboratories are staffed by a multidisciplinary team of experts in medicinal chemistry, biology, pharmacology, pharmacokinetics, toxicology, and more. The core management team hails from various innovative multinational pharmaceutical companies globally, bringing with them extensive experience in discovering and advancing multiple drug candidates from concept to clinical stages, including those that have successfully reached the market.
First-in-class/
Best-in-class
Best-in-class
The Ignis R&D Center integrates insights into unmet medical needs with its team's expertise to pioneer First-in-class and Best-in-class medicines. Rooted in human-data-driven hypotheses, the Ignis team harnesses tools such as structural biology, computer- and AI-assisted drug design, alongside in vitro assay and in vivo models for rapid molecule discovery, design, and optimization. Additionally, the team implements biomarker strategies to enhance the efficiency and success rates of early clinical developments.
Strategic Collaborations
The Ignis R&D Center actively cultivates strategic collaborations with both domestic and international pharmaceutical firms and esteemed academic institutions. These partnerships foster groundbreaking innovations in neuroscience, synergizing with Ignis’ internal programs that ultimately enhance the quality of life for patients.
Manufacturing
Ignis GMP manufacturing facilities are located in Suzhou Wu Zhong Biomedical Park, serving as a production site for oral solid formulations of innovative central nervous system (CNS) drugs.
12,300
M2
Manufacturing
Building Spaces
Building Spaces
Adhering to the principles of green, low-carbon, and high-energy efficiency, the GMP facilities have established a comprehensive quality management system. Constructed in accordance with the cGMP standards set by NMPA (National Medical Products Administration), FDA (U.S. Food and Drug Administration), and EMA (European Medicines Agency), it incorporates state-of-the-art automated production equipment with advanced technologies. The facilities are operated by experienced and talented professionals who are dedicated to drug research and development and manufacturing, ensuring the production of safe, efficacious, and cost-effectively managed innovative medicines for patients.
1
billion tablets
Annual Production
Capacity
Capacity
"We anticipate collaborating with partners to unlock the full potential of innovations and jointly forge a blueprint for a vibrant, healthier future."
Contact：
+86 21 6380 8908
info@ignistherapeutics.com
info@ignistherapeutics.com
Address
46F, BM InterContinental Business Center, No.100 Yutong Road, Jing’an District, Shanghai, China
