On 5 July, 2016, Zhejiang Zhenyuan
Pharmaceutical Co., Ltd. (Zhenyuan Pharm) announced its plan to expand
S-ademetionine (SAM) production capacity in the near future, mainly due to the
growing market demand.
Source: Baidu
"Our supply of SAM is relatively tight
so far. We expect the full-year 2016 sales to reach about USD3.01 million
(RMB20 million) and to be around USD7.52 million (RMB50 million) after the
production expansion project completes next year," disclosed Zhenyuan
Pharm.
SAM is a physiological active element that
exists in all human tissues and body fluids. It is the predecessor of many
substances, like cysteine, taurine, glutathione and coenzyme A, and therefore
plays an important role in many biochemical reactions (such as the transfers of
methyl, aminopropyl and sulfenyl) as well as the survival and functional
activities of normal cells.
SAM is mainly applied as an
anti-inflammation cholagogue for the treatment of liver cholestasis caused by
viral hepatitis, alcoholic liver disease and damages of hepatic cells or
biliary tract. It also has certain efficacy on treating liver cholestasis in
gestation period. Notably, it even works to mitigate major depressive disorder,
according to some clinical researches.
At present, domestic demand for SAM-B API
(all products should be made into SAM-B due to the instability of SAM) for pharmaceutical use (priced over USD751.92/kg – RMB5,000/kg) reaches 10+ tonnes,
and the figure may get above 200 tonnes if API for feed use are counted.
However, there are only 3 domestic enterprises approved to sell SAM-B API,
namely Zhejiang Hisun Pharmaceutical Co., Ltd. (Hisun Pharmaceutical), Zhenyuan
Pharm and Kaiping Genuine Biochemical Pharmaceutical Co., Ltd.
Prior to this, in 2010, pharmaceutical SAM merely depended on import from
Abbott Laboratories. It SAM products, Transmetil for injection and
enteric-coated tablet, were launched in the Chinese market in 2000.
In 2009,
the consumption of the two products began to increase, after they were listed
on the catalogue of adjuvant drugs for liver diseases treatment covered by the
national health insurance (i.e. patient responsible for a certain amount of the
medical fees and the rest paid by national health insurance funds), for serious
cirrhosis patients and the ones with employment injury insurance only.
In March 2010, Hisun Pharmaceutical obtained approvals from the State Food and
Drug Administration (CFDA) to officially launch its first-time generic SAM
drugs:
Ximeixin for injection (0.5g*5/package):
USD46.24/package (RMB307.5/package), vs. Transmetil for injection at
USD45.72/package (RMB304/package)
Ximeixin enteric-coated tablet
(0.5g*20/vial): USD61.66/vial (RMB410/vial), vs. Transmetil enteric-coated
tablet at USD61.51/vial (RMB409/vial). Notably, Hisun Pharmaceutical has been
the only enterprise approved to sell this drug till now
Hisun Pharmaceutical is the first domestic SAM API producer who has managed to
extend its business into SAM preparations and therefore to break the monopoly
of foreign enterprises. As of 2013, the company’s sales from Ximeixin for
injection achieved USD25.11 million – RMB167 million (a sales volume of
approximately 1.5 tonnes of pure SAM), 1/3+ of the domestic market shares.
According to Hisun Pharmaceutical's full-year 2015 financial report, it sold
altogether 7.32 million SAM-B injections, up 36.87% YoY, vs. an output of 8.30
million, up 39.87% YoY. All these injections were purchased by hospitals
through tenders, with bids for each injection between USD7.64 (RMB50.81) and
USD8.72 (RMB58.00). Therefore, it can be estimated that the company generated
revenue of around USD55.94 million-63.91 million (RMB372 million-425 million).
At present, some hospital are said to have fully substituted the Chinese made
Ximeixin for the imported Transmetil. This suggests that domestic hospital will
further reduce consumption on imported SAM drugs, which is favorable for the
development of domestic SAM market.
So far, in addition to Zhenyuan Pharm, another 7 pharmaceutical enterprises
have managed to apply for Production Approval Certificates for SAM preparations
and are waiting for the following reviews by the CFDA. For instance, Shandong
Jincheng Pharmaceutical & Chemical Co., Ltd. (Jincheng Pharmaceutical) is
one of those enterprises.
"We are waiting for the administrative reviews
on production approvals for our SAM API and preparations. Meanwhile, our SAM
plant has been ready for pilot production," disclosed Jincheng
Pharmaceutical.
This article comes from Amino Acids China E-News 1607, CCM
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Tag: pharmaceutical