CMS through its
wholly-owned subsidiary signed a Distribution,
Supply and License Agreement (the “License Agreement”), with medac Gesellschaft für klinische Spezialpr?parate m.b.H (“medac”),
of the standard-care products (the “Products”), marketed in Europe
and/or in USA, on 21 September 2020. The Products include
Methotrexate pre-filled syringe/pen, a first line alternative treatment of
rheumatoid arthritis and other autoimmune diseases and BCG for intravesical
instillation, a gold standard immunotherapy treatment for non-muscular invasive
bladder cancer, both of which treated
conditions are unmet clinical needs in the Territory (as defined below).
In accordance with the License agreement, the Group, through its wholly-owned subsidiary,
will gain an exclusive license to use all relevant intellectual property and intellectual
property rights owned or controlled by medac or its
affiliates for the development, registration and commercialization of the Products in
Mainland China, Hong Kong Special Administrative Region, Macao Special
Administrative Region and Taiwan (Taiwan is not applicable to the product BCG
for intravesical instillation) (the “Territory”). The License agreement
will continue to be valid unless terminated early in certain contractual agreed specific circumstances.
Through this collaboration, the Group’s product portfolio will be
further enriched and extended upon occurrence of the perspective
commercialisation of the Products in the Territory.
About the Products
Methotrexate Pre-filled Syringe/Pen (“MTX-medac”) are Methotrexate (MTX) injectables of multiple low-dose formulations in a small volume,
allowing self-administration subcutaneously by patients. MTX-medac were approved by European Heads of Medicine
Agencies (HMA) or/and the U.S. Food and Drug Administration (FDA) for the
treatment of rheumatoid arthritis (RA), and other autoimmune diseases such as
polyarticular juvenile idiopathic arthritis, psoriasis, psoriatic arthritis,
and/or Crohn’s disease.
RA being one of the major autoimmune disease has a significant unmet clinical need. As stated by the
“Chinese Rheumatoid Arthritis Diagnosis and Treatment Guidelines 2018”, the
incidence of RA in Mainland China is 0.42%, with around 5 million patients in China. It is a life-long chronic
systemic disease characterized by synovitis which can
lead to joint pain, deformities and functional incapacitation. Currently, there is no cure for RA, however, early diagnosis and
appropriate treatment enable many patients to slow the disease progress and
help them to lead full lives.
Among the treatment
options, MTX is internationally well accepted as the first-line gold standard medicine for the systemic treatment for RA and is the most commonly prescribed drug for the condition. It does not only just relieve the pain of patients
with joint inflammation but actually helps to stop and prevent the inflammation and the resulting damage,
subsequently slowing down the effects of an
over-stimulated immune system and thus to control disease activities. While oral application of MTX has long been the standard way of
administration, the parenteral MTX therapy, especially subcutaneous
administration route has been brought more and more into focus due to the
better bioavailability, the significant improvement of clinical efficacious response
and the favourable adverse effect
profile for the patients as well as convenience of dosage management in
MTX injection products nor MTX injectables for the treatment of RA are marketed
in China. As a well-established market leader in the international marketplaces,
medac developed MTX-medac dedicated for the treatment of RA and other
autoimmune diseases with a greater balance of efficacy
and safety, excellent tolerability and compliance. They are easy to use,
ready to self-administration, by the patients at home rather than medical
professionals in the clinical settings. This makes feasible for a long-term
disease management with effective treatment as well as giving more patients
more control and independence. MTX-medac is expected to become
a better alternative choice for RA patients.
BCG for intravesical instillation
BCG for intravesical
instillation is the lyophilised powder of
live Bacillus Calmette-Guérin (BCG) bacteria derived from Mycobacterium
bovis, strain RIVM.
The product is approved, as a biologics by European HMA, for the treatment of
non-invasive urothelial bladder carcinoma, including curative treatment of
carcinoma in situ and prophylactic treatment of recurrence of urothelial
carcinoma limited to mucosa (Ta G1-G2 if multifocal and/or recurrent tumour; Ta
G3), urothelial carcinoma in lamina propria but not the muscular of the bladder
(T1) and carcinoma in situ. It
has been launched in many countries in Europe and beyond, including Germany,
France, Ireland and Italy since 2001.
According to the
“Analysis of the Incidence and Death of Bladder Cancer in China in 2014”, there
were approximately 78,100 new cases of bladder cancer nationwide in 2014, with
an incidence of 5.71 per 100,000, among which non-muscular invasive
bladder cancer (NMIBC) accounts for nearly 80% of all initial diagnoses.
Approximate 63.4% of those patients, about 40,000 per year, with NMIBC are at
intermediate or high risk.
resection for bladder tumour (TURBT) is the standard treatment for NMIBC
currently, usage of BCG plays
a cornerstone role in the prevention of recurrence after TURBT in some patients with NMIBC.
For the high-risk and some intermediate-risk NMIBC patients, postoperative
intravesical BCG is recommended to prevent recurrence and disease progression,
based on both International and Chinese domestic treatment guidelines.
The treatment is a
well-established immunotherapy for bladder cancers. Although the exact mechanism of action of BCG
therapy is not fully understood, it is well known that a strong cellular immune
reaction occurs in the urothelium, starting with the adherence of the
mycobacteria, followed by the cytokine production which stimulates the influx
of inflammatory cells (monocytes and neutrophils). Those immune responses can prevent
tumour growth and reoccurrence.
However, there has
been a worldwide BCG shortage, including China, in recent years that may affect
the care of patients with bladder cancer and pose difficult clinical decisions
to urologists and clinical oncologists. The introduction of BCG for intravesical instillation will greatly improve the
availability of BCG for bladder cancer patients, and bring more
treatment choices for intermediate and high-risk NMIBC patients in
is a privately held, global pharmaceutical company with a growing
pharmaceutical and diagnostics business. Established in 1970 in Northern
Germany, medac is specialised in the treatment of urological, oncological,
haematological and autoimmune diseases as well as in the development of
diagnostic devices. Besides an already established product portfolio, medac is
dedicated to the refinement of existing and the development of new therapeutic
products providing patients with leading-edge individualised treatments. In the
field of urology medac focuses on instillation therapies for non-muscle
invasive bladder cancer.