Pharmaceutical Industry Opportunity

The Opportunity

Meeting Market Needs

Key Milestones

Summary of Benefits

The Board

The Management

The Opportunity

Stravencon is positioned to capitalize on rapidly intensifying macro trends in the EU and China.

In the European Union (EU)

Healthcare schemes must serve more people at lower cost.

Aging populations are driving ever-increasing demand for pharmaceuticals.
Fiscally constrained EU governments are compelled to reduce costs and increase supply, boosting demand for cheaper generics.
Healthcare providers are introducing new treatment protocols to allow their budgets to go further.
New co-payment schemes are being introduced in some EU markets.

In China

The government has mandated the pharmaceutical industry to move up the value chain.

The Chinese government is committed to moving its manufacturing from labor-intensive, low-wage, low-value-added to higher technology, higher-wage, higher-value-added industries.

Pharmaceuticals are a priority focus.

The first version of Chinese GMP was introduced in 1988 and amended in 1992. Later following the formation of the SFDA in 1998 a new GMP regulation was promulgated on August 1st 1999. This was later revised in September 2006. On 25th June 2010 it was announced by the SFDA that a new cGMP regulation would be introduced imminently throughout the Chinese Pharmaceutical Industry.
In the Spring of 2009 the Chinese Government announced an infusion of US$ 124 billion into the healthcare sector to improve insurance cover, infrastructure and access to vaccination nationwide.
The government is not only subsidizing a wider range of vaccines, but it is also racing to invest in its own R&D. In 2006, The National Development and Reform Commission made new vaccine development a priority. The Ministry of Science and Technology has been providing funding for vaccine research via the National 863 Vaccine and Antibody program, the Pillar Program, and the National Innovative Drug Development Mega Project.
The National 863 program alone is putting nearly $30 million into vaccine R&D, and the Pillar Program is going to fund key platform technologies for vaccine manufacturing.

The standards of the State Food and Drug Administration (SFDA) have been upgraded to international parity

The European Commission signed a 'consultation and cooperation mechanism'between the Directorate-General for Enterprise and Industry and the Chinese State Food and Drug Authority (SFDA) in 2007
In 2007 SFDA agreement with USFDA provides inspection rights in Chinese factories.
In 2010 SFDA regulation requires manufacturing to EU and USFDA standards, and inspections are occurring on a regular basis.
In 2010, the European SFDA and FDA signed an agreement on "Safety of Drugs and Medical Devices" on 11 December 2007 effective until 11 December 2009, which was automatically extended to 11 December 2011.
The European Commission and the SFDA agreed a specific action plan on GMP and GCP inspections
In June 2011 the SFDA implemented new Adverse Drug Reaction (ADR's) monitoring regulations to improve patient safety

The Chinese Pharmaceutical industry produces approximately 70-80% of the worlds’ supply of Active Pharmaceutical Ingredients (API’s). The government is pushing state-owned generics manufacturers to move from exporting API’s (now 97% of exports ) to finished products in order to move up the value chain. Private manufacturers are already investing in improved capacity to meet the new regulatory requirements.

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