Page 152 - 2018 White Paper on the Business Environment in China
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8 White Paper on the Business Environment in China
targeting the causes of the diseases and tailoring them to 2009 and 2015. The FDA’s Center conducted only 468 of
the individual for more effective therapies with fewer side those for Drug Evaluation and Research, but out of those
effects. One of Essex Bio’s best-selling products includes inspections 23 reports called on companies to take official
Beifushu, a series of drops and gels to treat eye injuries, action (Brennan). FDA has issued at least eight warnings to
dry eyes, refractive and cataract surgery. Another product Chinese pharmaceutical companies including:
is Beifuji, a series of sprays and powders that treats surface
wounds including burns, ulcers and cosmetic plastic Beijing Shunxin Meihua Bio-Technical Co.
surgery. They also make Beifuxin, a gel that repairs and China Resources Sanjiu Medical and Pharmaceutical Co.
regenerates cells damaged by bruises, burns, contusions, Novacyl Wuxi Pharmaceutical Co.
cuts, surgery incisions, skin grafts, skin resurfacing, laser Zhejiang Jiuzhou Pharmaceutical Co.
therapy wounds, bedsores, fistulas and cervical erosions. Tianjin Zhongan Phamaceutical Co., Ltd.
The company also sells their products at an affordable price. Yunnan Hande Bio-Technical Co., Ltd.
For example, a 15-milliliter bottle of Beifuji spray costs $5, Wuxi Kaili Pharmaceuticals Co., Ltd.
about $70 less than a 2.5-milliliter bottle of Regranex. The Zhejiang Hisun Pharmaceutical Co.
company’s products are used in more than 4,500 Chinese
hospitals. International Finance Corporation approved The number of inspections and warning letters grew
a $19 million loan to Essex Bio to help it further develop as a result of several members of the House Committee
affordable, high quality pharmaceutical products. The on Energy & Commerce raising concerns over FDA
company plans to introduce around ten more products in investigations into intentionally adulterated Chinese
the next decade, expand its patient base from 1.7 million heparin that led to the deaths of 149 Americans in 2007
to 3.5 million, and increase its total of employees from and 2008 (Brennan).
1,300 to 2,100 (Essex Bio). According to STAT, an online
medical magazine owned by Boston Globe Media, stories Perhaps a direct result of the 2016 findings led to
like these will become more common as Chinese biotech China updating its list of medicines covered by domestic
sector amasses the money, talent, and scientific know- medical insurance programs in 2017. Most of these drugs
how to “flatten the world of biopharma and remind the were kept out of patients’ reach due to high costs. This
U.S. that its place atop the industry’s food chain is hardly first update in eight years included blockbuster drug
guaranteed (Garde). compounds to treat major illness such as cancer, hepatitis
and hemophilia, a flashpoint for the market since many
Regulations and Warnings patients were forced to resort to risky gray markets to get
cheaper medicines. The additional medications include
2016beganwiththeChinesegovernmentimplementing 2,535 Eastern and traditional Chinese medicines, 339 more
a series of tough regulations requiring all generic drugs than the most recent update to the list in 2009. The number
already available in China to be reassessed on whether of Western-style drugs rose by 133 to 1,297. New to the list
their clinical efficacy was consistent with that of important are compounds such as hepatitis B medication tenofovir
brand-name drugs. On face value, the new regulations disoproxil and the lung cancer drug gefitinib (Jourdan
were an attempt to enhance generics’ value and safety, and Marques). The move was designed to reduce the
but for many investors the move also demonstrated the financial burden on patients and help support innovation
country’s determination to upgrade the entire structure and development in China’s pharmaceutical market.
of its pharmaceutical industry by enhancing the domestic Patients had to largely pay out of pocket for any new drug
generics’ international competitiveness and alleviate the approved for sale since the 2009 update. The newly listed
growing payment pressure on the domestic public health drugs can be covered up to 80 percent depending on local
insurance (China in Urgent Need). The new regulations implementation. “For pharma companies this is definitely
may have been a response to three more additional a boost,” said Andrew Chen, Shanghai-based partner at
Chinese pharmaceutical companies being added to the Parthenon EY. He added that addition to the list does not
U.S. Food and Drug Administration (FDA) import alert lists come cheaply, “”Once your drug becomes reimbursed,
for refusing FDA inspections and failing to meet the good your volumes will go up, but your pricing will have to
manufacturing practice standards of the FDA. These three go down, meaning slimmer margins.” Ministry officials
companies along with another 41 Chinese companies were say there are at least 45 “negotiable” drugs that were
banned from entering their products into the U.S. markets. expensive but had high clinical value. More discussions
The FDA conducted 1,389 inspections in China between were necessary before these drugs could be included on
152
targeting the causes of the diseases and tailoring them to 2009 and 2015. The FDA’s Center conducted only 468 of
the individual for more effective therapies with fewer side those for Drug Evaluation and Research, but out of those
effects. One of Essex Bio’s best-selling products includes inspections 23 reports called on companies to take official
Beifushu, a series of drops and gels to treat eye injuries, action (Brennan). FDA has issued at least eight warnings to
dry eyes, refractive and cataract surgery. Another product Chinese pharmaceutical companies including:
is Beifuji, a series of sprays and powders that treats surface
wounds including burns, ulcers and cosmetic plastic Beijing Shunxin Meihua Bio-Technical Co.
surgery. They also make Beifuxin, a gel that repairs and China Resources Sanjiu Medical and Pharmaceutical Co.
regenerates cells damaged by bruises, burns, contusions, Novacyl Wuxi Pharmaceutical Co.
cuts, surgery incisions, skin grafts, skin resurfacing, laser Zhejiang Jiuzhou Pharmaceutical Co.
therapy wounds, bedsores, fistulas and cervical erosions. Tianjin Zhongan Phamaceutical Co., Ltd.
The company also sells their products at an affordable price. Yunnan Hande Bio-Technical Co., Ltd.
For example, a 15-milliliter bottle of Beifuji spray costs $5, Wuxi Kaili Pharmaceuticals Co., Ltd.
about $70 less than a 2.5-milliliter bottle of Regranex. The Zhejiang Hisun Pharmaceutical Co.
company’s products are used in more than 4,500 Chinese
hospitals. International Finance Corporation approved The number of inspections and warning letters grew
a $19 million loan to Essex Bio to help it further develop as a result of several members of the House Committee
affordable, high quality pharmaceutical products. The on Energy & Commerce raising concerns over FDA
company plans to introduce around ten more products in investigations into intentionally adulterated Chinese
the next decade, expand its patient base from 1.7 million heparin that led to the deaths of 149 Americans in 2007
to 3.5 million, and increase its total of employees from and 2008 (Brennan).
1,300 to 2,100 (Essex Bio). According to STAT, an online
medical magazine owned by Boston Globe Media, stories Perhaps a direct result of the 2016 findings led to
like these will become more common as Chinese biotech China updating its list of medicines covered by domestic
sector amasses the money, talent, and scientific know- medical insurance programs in 2017. Most of these drugs
how to “flatten the world of biopharma and remind the were kept out of patients’ reach due to high costs. This
U.S. that its place atop the industry’s food chain is hardly first update in eight years included blockbuster drug
guaranteed (Garde). compounds to treat major illness such as cancer, hepatitis
and hemophilia, a flashpoint for the market since many
Regulations and Warnings patients were forced to resort to risky gray markets to get
cheaper medicines. The additional medications include
2016beganwiththeChinesegovernmentimplementing 2,535 Eastern and traditional Chinese medicines, 339 more
a series of tough regulations requiring all generic drugs than the most recent update to the list in 2009. The number
already available in China to be reassessed on whether of Western-style drugs rose by 133 to 1,297. New to the list
their clinical efficacy was consistent with that of important are compounds such as hepatitis B medication tenofovir
brand-name drugs. On face value, the new regulations disoproxil and the lung cancer drug gefitinib (Jourdan
were an attempt to enhance generics’ value and safety, and Marques). The move was designed to reduce the
but for many investors the move also demonstrated the financial burden on patients and help support innovation
country’s determination to upgrade the entire structure and development in China’s pharmaceutical market.
of its pharmaceutical industry by enhancing the domestic Patients had to largely pay out of pocket for any new drug
generics’ international competitiveness and alleviate the approved for sale since the 2009 update. The newly listed
growing payment pressure on the domestic public health drugs can be covered up to 80 percent depending on local
insurance (China in Urgent Need). The new regulations implementation. “For pharma companies this is definitely
may have been a response to three more additional a boost,” said Andrew Chen, Shanghai-based partner at
Chinese pharmaceutical companies being added to the Parthenon EY. He added that addition to the list does not
U.S. Food and Drug Administration (FDA) import alert lists come cheaply, “”Once your drug becomes reimbursed,
for refusing FDA inspections and failing to meet the good your volumes will go up, but your pricing will have to
manufacturing practice standards of the FDA. These three go down, meaning slimmer margins.” Ministry officials
companies along with another 41 Chinese companies were say there are at least 45 “negotiable” drugs that were
banned from entering their products into the U.S. markets. expensive but had high clinical value. More discussions
The FDA conducted 1,389 inspections in China between were necessary before these drugs could be included on
152
