CHINA LEX PHARMA LAW NEWSLETTER
Vol. 2 , No.15- June 15, 2001
TOPICS THIS ISSUE:
- PRC Pharmaceutical Market Wrap
- China Trying to Crack Down on Fake Medicine
- Gilead Sciences Targets China for Hepatitis B Research
- Cuba Sells Deafness Diagnostic Equipment to China
- Liver Transplant Operation on Chinese Infant Successful
China Pharma Market Wrap
China's pharmaceutical industry has continued to develop at a relatively rapid pace in the first two months of this year, according to the State Economic and Trade Commission.
The sales income totaled RMB 26.4 billion in January and February, an increase of 7.4 percent over the same period last year. By the end of February, the goods manufactured reached RMB 20.11 billion, up 5.9 percent over the same period last year and maintaining the same level as the fourth quarter of last year.
Gross profits amounted to RMB 1.8 billion, up 23 percent. The industrial sales profit rate was at 6.81 percent; and the gross profits of pharmaceutical industrial enterprises in the first two months of this year continued to go up.
Statistics show that Beijing, Hebei, Liaoning, Zhejiang, Shandong, Jilin, Henan, Hubei, Hunan, Chongqing, Sichuan and Yunnan reported a more than 30 percent increase in gross profits in the pharmaceutical industry for January and February, while Anhui, Gansu, Qinghai and Xinjiang reported losses.
The chemical drug sector ranked first, an increase of 42 percent over the same period last year. It was followed by traditional Chinese medicine, up 34 percent; medical instruments and meters, up 23 percent; and bio-medicine, up 16 percent. The pharmaceutical instruments and meters sector suffered losses during this period.
By the end of February, the net amount of accounts receivable had totaled RMB 47.2 billion, up 10 percent over the same period last year; and the assets/liabilities ratio reached 57 percent, a drop of two percentage points from the same period last year.
The sales revenue totaled RMB 13.6 billion in January and February, an increase of 15.6 percent over the same period last year. By the end of February, goods in stock were valued at RMB 17.39 billion, a drop of 3.77 percent from last year.
According to customs statistics, the import and export value of China's pharmaceutical goods amounted to US $1.058 billion in the first two months of this year, an increase of 24 percent over the same period last year. Exports totaled US $588 million, up 17. 4 percent; and imports were valued at US $470 million US dollars, up 32.6 percent.
The import of medicine totaled US $256 million in February, up 59.5 percent over the same period a year ago, and US $470 million in the first two months, up 32.6 percent.
The import of medical instruments and meters increased 50.5 percent. It was followed by the import of Western medicinal preparations, up 24.8 percent; Traditional Chinese medicine, up 20.9 percent; crude drugs, up 14 percent; medical materials, up 10.1 percent and Traditional Chinese medicinal materials, which were up 6.4 percent.
The export of medical goods came to US $329 million in February, up 38.2 percent over the same period a year earlier, and 588 million US dollars for the first two months, up 17.4 percent for January and February of 2000.
The export of medical instruments and meters was up 40.5 percent; that of traditional Chinese medicine was up 32 percent; that of crude chemical drugs was up 17.3 percent; and that of medical materials, up 1.6 percent.
(Source: Xinhua)
China Trying to Crack Down on Fake Medicine
Local Chinese industry and commerce administration departments have uncovered a number of cases of producing and selling fake medicine and unauthorized medical equipment.
According to a survey of 6,500 companies in twelve provinces, 33 business licenses were revoked and 67,000 boxes of fake medicine were seized.
In early May, the local government in Anhui Province discovered over 600 cases of fake Chinese medicine production.
The local government of Guangdong Province inspected transfusion equipment and found four illegal producers.
(Source: Xinhua)
Gilead Sciences Targets China for Hepatitis B Research
Gilead Sciences, Inc. today announced that it has initiated Phase I trials of adefovir dipivoxil for the treatment of chronic hepatitis B (HBV) infection in China. Gilead is currently evaluating adefovir dipivoxil in Phase III clinical studies in North America, Europe, Asia and Australia.
It is estimated that of the nearly 400 million patients who suffer from chronic HBV infection, more than 100 million live in China.
Gilead was granted Class 1 designation for adefovir dipivoxil in December 1999 by the People's Republic of China State Drug Administration (SDA). In December 2000, Gilead received approval from the SDA to initiate clinical trials in China. To meet the requirements stipulated by the SDA for drug registration in China, clinical trials must be conducted in China within the Chinese population. In addition, Phase I studies are required regardless of existing data from later-stage clinical studies conducted in other parts of the world.
The adefovir dipivoxil clinical program in China will be initiated with three separate Phase I trials (Studies 487, 488 and 489) that will be conducted in sequential order. After the completion of Phase I studies, a final report reviewing the safety and pharmacokinetic (PK) profile of the drug will be submitted to the SDA. The Class 1 designation of adefovir dipivoxil allows for an expedited review of these data. After the SDA's review and subject to its approval, a single Phase II/III study will be initiated.
Gilead anticipates the release or presentation of data from the 48-week analyses of these studies during the latter half of 2001.
(Source: Business Wire)
Cuba Sells Deafness Diagnostic Equipment to China
The Cuban firm Neuronic, which specializes in selling high-technology medical equipment, will supply China with Audix systems to be used in rehabilitation centers for deaf children.
The Audix equipment, which has won prizes in international medical fairs for its technological quality, was especially made for the early diagnosis of deafness in children. It is particularly useful in tests to measure residual hearing, which makes it possible to begin the treatment in time.
Audix has unique characteristics for registering low intensity sound frequencies, which gives a more accurate and exact diagnosis. It was designed to eliminate subjective evaluations of the patient by registering the brain's electrical activity in response to low-intensity hearing stimulation, which is not possible using other instruments currently available on the international market.
At present, the equipment has been installed in health centres in five Chinese provinces: Guangdong, Anhui, Hubei, Henan and Jilin. Local experts have considered the results from the new equipment extremely encouraging.
With the implementation of the recently signed preliminary agreement, the National Rehabilitation Centre for Deaf Children plans gradually to install this equipment in health-care centers in all provinces. The equipment's accuracy makes it an ideal instrument to help infants recover their normal hearing at an early stage.
Neuronic, Ltd. has been operating in China since 1999 when a bilateral cooperation agreement was signed for the creation of a joint Chinese-Cuban enterprise.
The new document states that an unspecified number of units will be supplied in the next three years, with the possibility of expanding the demand in the future.
(Source: Prensa Latina)
Liver Transplant Operation on Chinese Infant Successful
A two-year-old Chinese boy who recently had part of his father's liver transplanted into his body is recovering well, becoming the youngest liver recipient ever in China.
The operation was conducted in Shaanxi's capital of Xijing, in a Hospital affiliated with the No. 4 Medical College of the Chinese People's Liberation Army (PLA).
Liu Xiaojian, from Hebei Province, was suffering from serious liver cirrhosis and splenomegaly, and could only be saved through a liver transplant, doctors said.
During the nine-hour operation on May 4, doctors removed the boy's ailing liver and replaced it with part of his father's.
With his liver function recovering to normal, the boy can exercise freely.
According to statistics, as many as 500 liver transplant operations have so far been conducted in China.
(Source: Xinhua)
Lehman Lee & Xu
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The China Lex Pharma Law Newsletter is intended to be used for news purposes only. It should not be taken as comprehensive legal advice, and Lehman, Lee & Xu will not be held responsible for any such reliance on its contents.
