| I.
Industrial Policy |
| |
| Stipulation
on Biological Product Comes Out (Last update: Sept 2000) |
| China Biological Product
Stipulation (year 2000 edition) was published and will come into force since
1st Oct 2000. It is reported that there are 39 products that have been included
in this stipulation. (Source: TCM Business News) |
| |
| China
Decides to Reinforce the Ephedrine Management (Last update: July 2000)
|
| SDA issued paper to
reinforce the management on the ephedrine preparation. It states that the
local government should control the purchasing and the distribution of ephedrine
preparation. No ephedrine preparation enterprise has the right to sell the
preparation directly to the medicine unit (end-uer). All the ephedrine preparation
must be distributed through government-appointed stupefacient distributors.
(Source: Medicine Economic News) |
| |
| SDA
Issued the Regulation on Sales Chain Enterprises (Last update: July
2000) |
| On base of the Drug
Administration Law of P.R.China, SDA issued the regulation on the supervision
and the management on the drug sales network. SDA will consider the sales
chain enterprises from aspects of their key activities, the constitution,
the function of specific department. SDA also supervises how sales chains
enterprises purchase and distribute the drug, including the activities covering
over the province. (Source: Medicine Bulletin) |
| |
| SDA
Restate the Regulation on the formation of Pharmaceutical Enterprise
(Last update: July 2000) |
| Due to the fact that
a lot of pharmaceutical factories/wholesalers formed without legal procedure,
SDA restated the governmental requirement on the foundation of a new pharmaceutical
enterprise and the foundation of the drug wholesalers. According to this
paper, setting up a new factory has to be approved by SDA. In applying to
set up a new factory, the applicant must hold type II new drug that has
not been produced in China (for TCM, applicant must has two type III new
drugs). The new drug must complies with the Regulation on the Preservation
of New Drug and the Technology Convey Protocol. For the production of new
drug in the existent factory, the applicant can not apply for a drug that
has been produced in at least three factories. At the same time, SDA will
not issue the certificate to new drug wholesalers at the moment. (Source:
Medicine Bulletin News) |
| |
| China
will Reform the Medicine Distribution System (Last update: July 2000)
|
| China will reform the
medicine distribution system. The present system of state owned, collective
operation and the four-grade distributing chains will be will be replaced
by multiple ownerships, intensive distributing and chain distributing system.
|
| It is reported that
China will largely decrease the number of medicine distributing enterprises,
eliminating vicious competition and lowing operation cost during the distribution.
The strict from various departments, areas and industries will be broken.
In the coming 5 years, China is determined to encourage: 1) 5-10 mega medicine
distribution enterprises, each with annual sale value of RMB5 billions;
2) 40 local medicine distribution groups, each with annual sales value of
RMB2 billions; 3) 10 famous medicine distribution chains in China. ( Source:
Medicine Economic News) |
| |
| 20
Pharmaceutical Projects That are Prohibited for Repeated Construction (Last
update: Jan 2000) |
|
The State Economic
and Trade Commission published the first Catalogue of Prohibited Repeated
Construction in China. There are 20 items related to the pharmaceutical
industry, including1) Vitamin C 2) Penicillium 3) Chloramphenicol 4) Sulfapyrimidine
5) SMZ 6) Benemicin 7) Norfloxacin 8) Ibuprofen 9) Furazolin 10) Paracetamol
(by p-nitrobenzol or phenol method) 11) Kanamycin 12) One-off Syringe
13) One-off Transfusion apparatus 14) One-off Infusion apparatus 15) Soft
pipe of lead and stannum for pharmaceutical application 16) Natural rubber
tuck for pharmaceutical application 17) Manual capsule 18) Straight ampule
19) Enlargement of tablet production 20) Enlargement of solid capsule
production.(Source: Medicine Economic News)
|
| |
| China
Publish the Development Priority of Pharmaceutical Industry (update:
November 1999) |
| In order to modify
the industrial structure of pharmaceutical industry, to maintain the fast
and healthy development of the economy, as well as to guid the investment
and technical improvement, the State Development & Planning Commission
published the Government-encouraged Industries, Products and Technologies.
|
| The government encourages
the industries, products, and technologies that: a) are complying with the
future development trend and having prosperous prospect in the future; b)
are high tech ones, easy for the quipment upgrade and infrastructure optimization;
c) have potential possibility to begin commercial production from the research
and to form an access to new economics; d) can be developed from a long
term, with energy economizing and less pollution; e) can support the relative
less developed industries or products. |
| There are total 29
areaslisted in the catalogue, totally 440 of products, technologies or foundamental
construction items. 26 items of them are related to the pharmaceuticals
include: 1) Pharmaceuticals listed in the Basic Pharmaceutical Catalogue
of China; 2) Important & strong products in exporting; 3) Bioengineering
pharmaceuticals; 4) Radiation pharmaceuticals; 5) New anti-tumor pharmaceuticals
(including anti-hepatitis pharmaceuticals) and new angiomycardiac pharmaceuticals;
6) Diagnosis reagent for aids and radiation immunity; 7) New pharmaceuticals
for local disease; 8) New antifebrile and analgesic pharmaceuticals; 9)
New Preparations and auxidiaries as well as the preparation made in accordance
with GMP standard; 10) Tightly supplied intermediates and new antibiotics;
11) New Biochemical pharmaceutical series; 12) New packing materials for
pharmaceuticals; 13) New facilities for medicines production and clinics
application; 14) New sanitation materials; 15) Birth Control pharmaceuticals
and materials; 16) Screening technology and screening model for new pharmaceuticals
17) New strains for amino acid; 18) Feed grade biotin; 19) Virginiamycin
and eureomycin; 20) Extraction and purification of penicillium salt; 21)
Fermentation and auto temperature control system; 22) Synthesis and purification
of pharmaceutical polypeptide in mass production; 23) Synthesis and purification
of nucleic acid in mass production; 24) Gene strains with high yield; 25)
Natural pharmaceuticals; 26) R & D of new Chinese medicine |
| |
| II.
News |
| |
| Production
Technology of D-hydroxyphenylglycine Broke Through in China (Last update:
Sept 2000) |
| For a long history
of time, China has been imported the D-p-hydroxyphenylglycine, an intermeditates
for amoxicillin, cefoperazone, from overseas. Since 1998, Shijiazhuang Zhongtian
Chemical Co. Ltd. and Hebei Science & Technology University jointly did
the research work on the synthesis of D-p-hydroxyphenylglycine. They use
synthesis & enzyme technology to produce this intermediate. It is reported
that the yield can reach to 100%. Now Hebei Zhongtian Chemical Co. Ltd.
has set up a production line of 1,000Mt/year to produce this intermediate.
(China Chemicals Industry News) |
| |
| The
Largest Deal of Biochip in China (Last update: Sept 2000) |
| Shanghai Bode Gene
Development Co. Ltd. jointed with Guangdong Zhaoqing Star Lake Biological
Science & Technology Co. Ltd. in end of August, to form the large biochip
company in China. Shanghai Bode Gene Co. use their biochip technology to
evaluate their shares. It is reported that Shanghai Bode Gene Co. has applied
over 2000 patents of gene pharmaceuticals. (Source: China High-Tech Industry
Hareld) |
| |
| The
Largest Dihydrophenylglycine Salt Production Line in China (Last update:
August 2000) |
| The largest Dihydrophenylglycine
salts production line (400Mt/year) was finished in Shandong Shuhua Group.
Shuhua Group invested about RMB36 in this production line. All the technology
comes from China. Dihydrophenylglycine salt is an intermediate for pharmaceuticals.
China relied on the import of this product in past. (Source: China Chemical
Information) |
| |
| The
largest Biological Engineering Production Base in Shenzhen (Last update:
August 2000) |
| The construction of
the largest biological engineering industrial production base began in Shenzhen.
It is invested by Shenzhen Kexing Biological Product Co. Ltd. The total
investment in this base is RMB700 millions. The main products include interferon
(with capacity of 100 million vials), gene engineering insulin. This project
is listed as State High-Tech Illustration Project and One of the Top Ten
High-Tech Project in Shenzhen. (Source: China High-Tech Industry Hareld) |
| |
| Shanghai
Plant Gene Research Center Set up (Last update: August 2000) |
| Shanghai Plant Gene
Research Center(SPGRC) was set up in July 2000. It was jointly set up by
CAS Shanghai Plant Physiology & Zoology Research Institute, Fudan University,
Shanghai Jiaotong University, CAS State Gene Research Center and Shanghai
Agriculture Science Research Institute. The research areas of SPGRC include:
new species screening for GMO crop; Crop gene technology; separation and
clone of functional gene, safety evaluation of GMO product. (Source:China
High-Tech Industry Hareld) |
| |
| EPO
Will be Produced in Shenzhen (Last update: August 2000) |
| Shenzhen Petrochemical
Corp Spike Biopharmaceutical Co. Ltd. will begin to produce EPO this year.
The total investment of this project is RMB200 millions. The capacity of
EPO is 1.5 million vials per year. It is reported that the EPO will mainly
supply the domestic market. The technology of EPO production comes from
PLA military Medicine Research Institute. (Source: China Chemicals Industry
News) |
| |
| Lukang
Makes Benzoic Acid from the Debris of 6APA (Last update: July 2000) |
| The researchers from
Lukang Medicine Group Co. Ltd. is trying to make benzoic acid from the waste
liquid during the production of 6APA. It is expected that they can recycle
the waste by this technology and hence reduce the pollution. (Source: Medicine
Bulletin) |
| |
| Chongqing
Biopharmaceutical Garden Formed (Last update: July 2000) |
| Chongqing Biopharm
Garden opened in July 2000. At present there are 7 manufacturers enter this
garden. These manufacturers are specializing in the biopharm technology.
They include Lab, Sino, Chongqing Haifu, Chongqing Sangtian, etc. (Source:
Medicine Economic News) |
| |
| Protein
Peptide Research & Production Base to be Built in Wuhan (Last update:
July 2000) |
| Sanjiu Group will invest
RMB15 millions in the next two or three years to build a research and production
base in Wuhan Donghua High-Tech Zone. This research work is carried out
by researchers from CAS and peptide experts from Shanghai. (Source: Medicine
Economic News) |
| |
| SDA
Forbids the Illegal Approval of Drug (Last update: July 2000) |
| SDA published a paper
in July forbidding the illegal issue of new drug certificate. 1) All the
local/provincial organizations must stop the approval for drugs. 2) Those
new drugs approved by the local organizations since 1st Nov 1985 must be
registered in SDA by end of 2000. The production must be stopped hereafter.
3) Those copied drugs approved by the local functions since 25th May 1996
must be registered in SDA. The production must be stopped hereafter. (Source:
Medicine Bulletin) |
| |
| Provisional
Regulation on Sildenalfil Citrate (Last update: July 2000) |
| SDA published the provisional
regulation on sildenalfil citrate in July, the bulk pharmaceuticals for
Vigiria. The regulation is summarized as follows: 1)All the manufacturer
of sildenalfil citrate, both bulk chemicals and its preparation (Vigiria),
must submit report to SDA by end of 2000 the production situation. 2) The
preparation manufacturers must sell the product to those enterprises holding
the Certification of Special Drug. The dealer must submit the record to
SDA. 3)Sildenafil citrate preparation must be used under the instruction
of doctor. 4) No advertisement on sildenafil citrate is allowed. (Source:
TCM Business News) |
| |
| United
Gene Begin to Produce Gene Chip (Last update: July 2000) |
| United Gene Science
& Technology Group was set up in Shanghai. It is expected that they will
produce 2 million chips of gene by end of 2000. In 2001 this company will
produce 10 million chips of gene. To date, United Gene Company has applied
over 2,100 gene patents. The United Gene was found on base of Life Collage
of Fudan University. (Source: China High-Tech Hareld) |
| |
| Sanjiu
Biochem Set up Gene Engineering Base in Shanghai (Last update: July
2000) |
| Sanjiu Xuangong Biochemical
will invest RMB150 millions in Shanghai Zhangjiang to build a gene engineering
production base, in order to speed up the application of gene medicines
like TNF. (Source: China High-Tech Industry Hareld) |
| |
| Pharmaceutical
Price Greatly Lowered (Last update: July 2000) |
| The State Planning
Committee published notice that some medicine price will be Greatly lowered.
The average decrement space is 30%. These medicines include cefradine, ceftriaxone
sodium, interferon, etc. There are 9 medicines (about 57 specifications)
are covered in the decrement. It is expected that China will spare about
RMB800 millions on the reimbursement of medicine each year. (Source: Medicine
Economic News) |
| |
| The
First Agricultural Hormone Center Found (Last update: July 2000) |
| Jiangsu Agricultural
Hormone Engineering Technology Research Center was set up in Changzhou.
The center will carry out the research, development and promotion of agricultural
hormone. The center will focus on the research on inset growth regulator,
inset behavior controlling substance, plant grow regulator and plant growth
controlling substance. (Source: China High-Tech Industry Hareld) |
| |
| DNA
Cell Project Started up (Last update: July 2000) |
| Shanghai government
assigned 20 research units to carry out 7 subprojects of cell project. These
units include State Gene Group Southern Research Center, Shanghai Haematology
Research Institute and CAS Shanghai Metallurgy Research Institute and Shanghai
Fudan Zhangjiang Biological Medicine Co. Ltd. (Source: China High-Tech Industry
Hareld) |
| |
| Cell
Engineering Center Found (Last update: July 2000) |
| Xi'an Cell Engineering
Development Center was set up in July 2000. This center is a joint research
unit by No.4 Military Medicine University and Shaanxi High-Tech Enterprise
Investment Co. Ltd. It is a professional cell engineering pilot production
base in China, also a national biological technology research base. The
aim of this center is to combine biological technology withventure investment
and to speed up the research on bio technology. (Source: China High-Tech
Industry Herald) |
| |
| D-p-hydroxybenzoglycid
Potassium Production Began (Last update: July 2000) |
| The p-hydroxybenzoglycic
potassium project in Zhejiang Jiayuan Pharmaceutical Co. Ltd. was approved
by local province. P-hydroxybenzolycic potassium is an intermediate for
the production of amoxicillin and cefalexin. In the past China had to import
this material. Now Zhejiang Jiayuan design their own production technology
to produce this material. The production capacity is 1,300Mt/year. (Source:
China Medicine News) |
| |
| D-p-hydroxybenzoglycin
Research Succeeded (Last update: July 2000) |
| The research on D-p-hydroxybenzoglycin
in China got success. It is jointly carried out by State Biochemical Engineering
Research Center and Nanjing Tiancheng Biochemical Engineering Co. Ltd..
D-p-benzoglycin is an intermediate for cefadroxil. (Source: China Chemical
Industry News) |
| |
| Tianjin
Pharmaceutical Science & Technology Institute is to Set up (Last update:
July 2000) |
| Tianjin Pharmaceutical
Research Institute, a famous research unit on pharmaceutical in the world,
signed agreement in June 2000 with Tianjin University, the famous University
in the world, to set up Tianjin Pharmaceutical Science & Technology Collage.
(Source: China Medicine News) |
| |
| Antibiotics
Price Went up in first half 2000 (Last update: July 2000) |
| The price of Antibiotics
preparation breaks through the slag condition and began to go up. The Chinese
manufacturers raise the price in Jan, March and June. The price of pennicillium
injection has increased by 10%. There are a few reasons for this phenomena:
1) Chinese government renovated the medicine market this year; 2) The Price
of raw material like starch, glucose went up this year. 3) Domestic manufacturers
united in order to share the market together. (Source: China Chemical Industry
News) |
| |
| State
Basic Reimbursement Catalogue of Medicine Published (Last update: July
2000) |
| Catalogue of Basic
Medicine for Reimbursement was published by Ministry of State Labor and
Society Security in June 2000. The catalogues include 913 western medicines,
575 patented Chinese medicines and 130 Chinese medicines. (Source: Medicine
Economic News) |
| |
| China
is Ready to Product Loratidine (Last update: June 2000) |
| The protection on loratidine
will be expired by Sept 2001. Many Chinese pharmaceutical manufacturers
or researchers is doing research on the synthetic technology of this pharmaceuticals.
It is reported that Jiangxi Pharmaceutical Research Institute is doing research
on this product. (Source: Medicine Economic News) |
| |
| China
Highlights the Guidance for Medicine Industry (Last update: May 2000)
|
| Officer from State
Economic & Trading Committee stated that China will encourage the investment
in medicine industry, especially in high technology, new product and important
science-technology projects during the Tenth-Five-Year. China will first
consider the conversion research to the commercial production. The target
for medicine industry is: 1) The turnover of medicine industry increases
at 11-12% per year; 2) Medicine commerce increases at 9-10% per year;3)
Medicine export value increases at 9-10% per year; 4) Industry sales profit
increase at 7% per year, etc. (Source: Beijing Science & Technology
News) |