China Medical System: NDA for Additional Rheumatoid Arthritis Indication of Methotrexate Injection Approved in China
06 August 2024 - 12:04AM
China Medical System Holdings Limited (the “Company”, together with
its subsidiaries, the “Group” or “CMS”) is pleased to announce that
on 30 July 2024, the New Drug Application (NDA) for an additional
indication of Methotrexate Injection (the “Product”) has been
approved by the National Medical Products Administration of China
(NMPA). The Product is a small-volume methotrexate injection with
various strengths for the treatment of active rheumatoid arthritis
(RA) in adult patients. The Group was granted a certificate of drug
registration on 5 August 2024.
Methotrexate is recognized internationally as
the first choice first-line and anchor drug for RA. The Product is
the first methotrexate prefilled injection to treat RA by
subcutaneous administration in China, providing a safer, more
effective, more convenient and more accurate administration scheme
for RA adult patients.
According to the communication with NMPA, the
bridge clinical trial of the Product in China (the “Study”) aims to
compare the changes of DAS28-ESR score of patients with RA treated
by methotrexate injection and methotrexate tablets compared with
the baseline at week 12, and to judge whether the non-inferiority
is established. The Study reached the preset primary endpoint, and
the experimental group (given the Products) was not inferior to the
control group (given methotrexate tablets). In addition, the
results of secondary efficacy indicators suggest that the product
has a tendency to have better efficacy than methotrexate tablets.
The results also show that some of the curative effects that can be
observed in the early stage of the Product are more obvious than
those of methotrexate tablets, suggesting that the curative effect
of the Product appears earlier. The Product has acceptable safety
and tolerability, and is basically consistent with the safety
characteristics observed in previous studies. No new safety risks
have been found, and it has certain advantages over methotrexate
tablets in terms of gastrointestinal adverse
reaction[1].
In March 2023, the Product was approved for
marketing in China for the treatment of severe recalcitrant
disabling psoriasis, which is not adequately responsive to other
forms of therapy such as phototherapy, PUVA, and retinoids. The
Product was also announced as a Reference Listed Drug by NMPA. This
indication has already entered into large-scale clinical
application. After the approval of the additional RA indication, it
can be directly applied to clinical application, which can improve
the bioavailability and convenience of clinical treatment for RA
patients, reduce gastrointestinal side effects. At the same time,
it also reduces the burden of treatment on doctors and patients, so
as to satisfy the demand for the basic gold standard drug for RA
patients.
The Product has been approved by 21 European
national competent authorities including Switzerland and United
Kingdom. At present, the Product has been approved for marketing in
47 countries and regions around the world, including the European
Union, Australia, China, etc.
The Group obtained a long-term effective and
exclusive license for the Product from medac Gesellschaft für
klinische Spezialpräparate m.b.H on 21 September 2020.
The rich innovation pipeline stands as a key
driver for CMS’s long-term development. As of now, the Group's
newly approved innovative portfolio has been expanded into five
products (including six indications), continuously injecting new
momentum into sustained and healthy growth of the Group's operation
performance. The approval for the additional RA indication of the
Product is a reaffirmation of CMS's innovation strategy, and also a
continuation and deepening of its strategic declaration of "New
CMS, New Rise", marking another milestone on its path of
innovation.
About CMSCMS 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 medical needs.
CMS focuses on the global first-in-class (FIC)
and best-in-class (BIC) innovative products, and efficiently
promotes the clinical research, development and commercialization
of innovative products, enabling the continuous transformation of
scientific research into clinical practices to benefit
patients.
CMS deeply engages in several 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 promote the in-depth development of its
advantageous specialty fields and expand business boundaries. While
strengthening the competitiveness of the
cardio-cerebrovascular/gastroenterology business, CMS independently
operates its dermatology and medical aesthetics business, and
ophthalmology business, aiming to gain leading positions in
specialty therapeutic fields, whilst enhancing the scale and
efficiency. At the same time, CMS has expanded its business
territory to the Southeast Asian market, striving to become a
"bridgehead" for global pharmaceutical companies to enter the
Southeast Asian market, further escorting the sustainable and
healthy development of the Group.
Reference:
- The results of the bridge clinical trial in China was published
and can be found at:
https://web.cms.net.cn/en/2023/12/china-medical-systems-innovative-drug-progress-nda-for-additional-ra-indication-of-methotrexate-injection%ef%bc%88pre-filled-syringe%ef%bc%89accepted-in-china/
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