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Sihuan Pharma's non-PVC solid-liquid double chamber bag for ceftazidime/sodium chloride injection receives Chinese approval
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Hong Kong
May 29 , 2019
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Sihuan Pharmaceutical Holdings Group Ltd, one of the largest
cardio-cerebral vascular drug manufacturer in China’s prescription drug
marke, announced that the “non-PVC solid-liquid double chamber bag for
ceftazidime/sodium chloride injection” jointly developed by the Group
and its associated company Beijing Ruiye Drugs Manufacture Co. Ltd has
been granted drug registration approval by the National Medical Products
Administration (NMPA) of the People’s Republic of China. All the
ceftazidime currently approved for production in China are powder
injection. The Group is the first company that has been granted drug
registration approval for “non-PVC solid-liquid double chamber bag for
ceftazidime/sodium chloride injection” in China.
Non-PVC
solid-liquid double chamber infusion soft bag has high technology
barriers and long development cycle. This Formulation is currently one
of the technological advanced new formulation of intravenous solution.
Currently, products of this Formulation have only been manufactured by
pharmaceutical companies in the United States and Japan. Non-PVC soft
bag infusion products are the mainstream in the intravenous solution
market of countries such as the United States and Japan. The annual
number of intravenous solution consumed in the United States is
approximately 1 billion bags/bottles, with non-PVC soft bag infusion
products accounting for 90% of the market share. In Japan, market share
of this Formulation also exceeds 40%. Compared with overseas market,
utilization rate of non-PVC soft bag infusion products in China only
accounts for approximately 20%, and this Formulation is still untapped
in China. It can be foreseen that this Formulation has broad market
prospect and huge market potential.
Beijing Ruiye has been
dedicated to the research and development of the Formulation since 2005
by introducing Japan’s cutting-edge technology, and was the first and
only in China that has been granted drug registration approval by the
NMPA. This Formulation utilises specific processes and uses non-PVC
multi- layer co-extrusion film as packaging materials and encloses the
drug and solvent injection into the two chambers of the same packaging,
which are separated by empty solder. Before infusion, the user only
needs to squeeze the bottom of the chambers making themconnected,
allowing the drug powder and the solvent injection to be mixed with each
other. The Formulation avoids secondary contamination in the dispensing
process caused by microorganisms and particles. It also solved
potential drug allergies of medical staff that occur during the infusion
preparation. It has significant strengths in the application of
emergencies and extreme situations. It has been recognized as the safest
and most convenient infusion product and is considered as one of the
new formulations with great development potential in the pharmaceutical
industry.
The product is an exclusive formulation of
ceftazidime/sodium chloride injection. Ceftazidime is a semi-synthetic
third-generation cephalosporins antibiotics. Ceftazidime is primarily
used for treating sepsis, lower respiratory tract infection, abdominal
and biliary tract infection, complicated urinary tract infection and
severe skin and soft tissue infection caused by sensitive gram-negative
bacilli. In particular, it is applicable with explicit efficacy to the
infection of immunodeficiency patients caused by multiple resistant gram
negative bacilli, nosocomial infection and central nervous system
infection caused by gram negative bacilli or pseudomonasaeruginosa.
Beijing
Ruiye has other subsequent products of this formulation, which includes
four varieties and six specifications of cefuroxime and cefodizime that
are under review and are expected to be launched to market after
obtaining the approval for drug registration. The subsequent products
portfolio includes a majority of first-line antibiotics in China’s
current market. In addition, a number of products under research and
development in 2019 will be filed for assessment and review.
According
to MENET database, the sales of antibacterial drugs for full
application in 2017 was RMB128.73 billion. Among which, the sales of
cephalosporins was RMB67.02 billion, accounting for 52.3% of the market
share of antibacterial drugs for full application. Currently, all the
ceftazidime currently approved for production in China are powder
injection which achieved annual sales of RMB4.52 billion, accounting for
6.7% of the market share of cephalosporins. The launch of the Group’s
solid-liquid double chamber bag product is expected to replace some of
the existing products and have promising market prospect.
The
approval of the product will further enrich the Group’s product line in
the area of anti-infective drugs, as well as firmly establish the
Group’s leading position in the area of non-PVC solid-liquid double
chamber infusion soft bag, thus contributing the Group’s development in
the antibiotic intravenous solution market. In addition, Sihuan and
Beijing Ruiye are expanding their existing production capacity and
constructing a new manufacturing base for therapeutic-use solid-liquid
double chamber infusion soft bag. The Group expects its future
production capacity will meet the demand from the patients in China. The
manufacturing cost is expected to further decrease as a result of
economies of scale, giving the Group competitive advantages in tender
and procurement. The Group is expected to gradually become a leading
company in the therapeutic solid-liquid double chamber infusion industry
in China, while satisfying patients’ demand for drugs will reward the
Group with good returns.
Founded in 2001, Sihuan Pharmaceutical
Holdings Group Ltd. has become the largest cardio-cerebral vascular drug
manufacturer in China’s prescription drug market by market share since
2007. The Group was the 11th largest pharmaceutical company in terms of
hospital purchase in the Chinese prescription drug market in 2018.
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