China Medical System: An Innovative Drug, ILUMETRI 'Tildrakizumab Injection'
Approved for Marketing in China
SHENZHEN, CHINA, May 30, 2023 (GLOBE NEWSWIRE) --
* CMS is pleased to announce the NDA of Tildrakizumab Injection under the
brand name of ILUMETRI, a monoclonal antibody specifically targeting the
p19 subunit of IL-23, has been approved in China. ILUMETRI is indicated
for the treatment of adults with moderate-to-severe plaque psoriasis who
are candidates for systemic therapy or phototherapy.
* The extended study of ILUMETRI’s Phase III clinical trial in China,
demonstrated that the primary efficacy assessment indicator PASI 75
response rate continued to increase over treatment time. The PASI 75
response rate reached a high level after 28 weeks of treatment with
ILUMETRI and maintained at 91.3% at week 52, and ILUMETRI showed good
long-term safety and tolerance.
* ILUMETRI only needs to be administered 4 times a year during maintenance
treatment period, which may bring higher patient compliance.
* ILUMETRI will synergize with CMS Aesthetics’ marketed products, Hirudoid,
Aethoxysklerol and pipeline products, to solidify comprehensive
competitiveness of CMS in the dermatology field.
* This is CMS’s second innovative drug approved for marketing in China this
year following the approval of Methotrexate Injection.
On May 30, China Medical System Holdings Limited ("CMS" or the "Group")
announced that on 26 May 2023, the New Drug Application (NDA) of Tildrakizumab
Injection under the brand name of ILUMETRI has been approved by the National
Medical Products Administration of China (NMPA). ILUMETRI is indicated for the
treatment of adults with moderate-to-severe plaque psoriasis who are
candidates for systemic therapy or phototherapy.
ILUMETRI is a humanized lgG1/κ monoclonal antibody designed to selectively
bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction
with the IL-23 receptor, leading to inhibition of the release of
pro-inflammatory cytokines and chemokines. ILUMETRI has patents on composition
and formulation in China.
The results of the extended study of its Phase III clinical trial in China
demonstrated that the primary efficacy assessment indicator PASI 75 response
rate continued to increase over treatment time. The PASI 75 response rate
reached a high level after 28 weeks of treatment with ILUMETRI and maintained
at 91.3% at week 52, and ILUMETRI showed good long-term safety and tolerance.
ILUMETRI only needs to be administered 4 times a year during maintenance
treatment period, which may bring higher patient compliance.
Psoriasis is an autoimmune disease with complex causes, where IL-23 is
regarded as one of the important driving factors of the pathogenesis of
psoriasis. The incidence of psoriasis in China is about 0.47%, with the number
of patients exceeding 7 million, of which more than 30% have developed into
moderate-to-severe disease. ILUMETRI will provide moderate-to-severe plaque
psoriasis patients with a safe and effective treatment option.
It took only 14 months from obtaining the approval for the drug clinical trial
to submitting the NDA for ILUMETRI in China, with the enrollment of 220
subjects completed in only 2.5 months (which included the Spring Festival),
highlighting CMS’s highly efficient clinical development capabilities
supported by its commercialization strength.
ILUMETRI is CMS’s second innovative drug approved to be marketed in China in
2023, following the recent approval of Methotrexate Injection. CMS has
invested in, and collaborated with, innovative companies globally over the
last 5 years to jointly develop innovative products with academic value and
differentiated advantages, in order to meet unmet clinical needs and enhance
the accessibility of global innovative drugs for Chinese patients. Starting
from 2023, CMS’s innovation development is stepping into the harvest period.
ILUMETRI has been approved for marketing in the Hong Kong Special
Administrative Region of China in April 2022. Tildrakizumab Injection has also
been approved for marketing in the U.S., EU, Japan, UK, Switzerland, Canada,
Australia and other countries/regions.
About CMS
CMS is a platform company linking pharmaceutical innovation and
commercialization with strong product lifecycle management capability,
dedicated to providing competitive products and services to meet unmet
healthcare needs. In 2022, the Group recorded a turnover of RMB9,150 million;
in the case that all medicines were directly sold by the Group, the turnover
reached RMB10,498 million. Profit for the year reached RMB3,276 million.
CMS focuses on developing first- or best-in-class innovative products and has
made the layout of 30 differentiated pipeline products with strong market
potential. CMS deeply engages in specialty therapeutic fields, and has
developed proven commercialization capabilities, extensive networks and expert
resources, resulting in leading academic and market positions for its major
marketed products. CMS continues to strengthen the competitiveness of its
cardio-cerebrovascular/gastroenterology business, and independently operated
dermatology and medical aesthetic business, and ophthalmology business, whilst
enhancing the scale and efficiency. CMS also entered into the Southeast Asian
market to create new opportunities to further enhance the sustainable
development of the Group.
Media Contact
Brand: China Medical System Holdings Ltd.
Contact: CMS Investor Relations
Email: ir@cms.net.cn
Website: https://web.cms.net.cn/en/home/
Source: China Medical System Holdings Ltd.
