China -  Chinese law firm

Vol.2, No.24

CHINA LEX PHARMA LAW NEWSLETTER

Vol. 2 , No.24 - September 20, 2001

TOPICS THIS ISSUE:

  • Pharmagenesis Receives SDA Certificate for PG2 Bone Marrow Stimulant
  • Infant Mortality Rate Decreases Dramatically
  • U.S.-ASEAN Business Council Supports an ASEAN-China Free Trade Zone
  • Gene Technology Research May be Key to a Safe Male Contraceptive
  • Peregrine and Medipharm Cooperate to Produce TNT
  • List of GMP Facilities (Continued)

Pharmagenesis Receives SDA Certificate for PG2 Bone Marrow Stimulant

The State Drug Administration (SDA) awarded Pharmagenesis Inc. a drug certificate for PG2, its cancer therapy drug.

PG2 is a plant-derived hematopoiesis enhancer that restores bone marrow activity after a patient has received chemotherapy. PG2 was approved earlier in the year. The China State Drug Administration adheres to strict regulations and issues drug certificates only following rigorous review of clinical trial and other data.

Nicolas Druz, the CEO of Pharmagenesis, said that "In addition to restoring blood cells, PG2 helps patients feel better, eat better, sleep better and have more energy. As such, PG2 will have a strong appeal on Chinese physicians and patients. Pharmagenesis also plans to develop derivatives of PG2 for the Western world."

The next step for Pharmagenesis is to obtain a Good Manufacturing Practice (GMP) certificate, which the SDA will grant only after a comprehensive inspection and review of the facility used to manufacture the medicine. Upon receiving the GMP certificate, Pharmagenesis can then begin to manufacture and market PG2, hopefully in the first six months of 2002.

(Source: Business Wire)

Infant Mortality Rate Decreases Dramatically

At the 23rd International Congress of Pediatrics, health experts revealed that the infant mortality rate in China has fallen to 33 per 1,000 and they believe it will continue to fall.

In Shanghai and Beijing, the rate has been reduced to as low as 5.05 per 1,000, a rate congruent with various medically advanced nations. For instance, the infant mortality rate in Japan and Sweden is less than 4 per 1,000.

Infant mortality rates, calculated by counting the number of children per 1,000 that die before reaching one year old, are commonly used to measure the level and quality of a country's health care system.

Official statistics show that in the 1940's, the infant mortality rate was as high as 300 per 1,000 in China.

However, much progress has been made as China has worked to ensure the health of the 400 million children under the age of 18 in China. Jiang Zaifang, President of the International Congress of Pediatrics, admitted that China has made large contributions in the fields of disease prevention and child medical treatment.

Several levels of government have been focusing on vaccinating children. Official statistics show that children are being vaccinated at a rate of 96% in rural areas and 80% in urban areas.

The majority of infant deaths in China are blamed on labor complications, pneumonia and diseases linked to nutrition deficiency. In the large cities, congenital heart disease is considered the most common cause of infant death, killing 83 of 50,000 babies born in Beijing.

The most common cause of deaths for children under the age of 14 in Beijing was accidents, in which suffocation, poisoning and traffic accidents are included.

Health Minister Zhang Wenkang said that although China has progressed, more investment and medical research are needed to promote child health care in rural areas.

Also at the conference, which brought over 5,000 pediatric experts from 99 regions in the world, Jiang Zaifang announced that China will formally promote the use of OPAT (Out Patient Parenteral Antibiotic Therapy). She told experts that the use of OPAT assists in the reduction of drug resistance in bacteria, and is especially useful in the field of pediatric infections.

Official statistics showed that children suffering from infections, including pneumonia and bronchitis, account for most cases at pediatric clinics.

(Source: Xinhua News Agency)


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U.S.-ASEAN Business Council Supports an ASEAN-China Free Trade Zone

Chairman of the U.S.-ASEAN Business Council, Ernest Bower, recently expressed his support for negotiations between the Southeast Asian Nations (ASEAN) and China to create a possible free trade area between them.

Bower said the ASEAN-China free trade area would prove useful for U.S. investors in the area, as it would create a larger market of roughly 2 billion people if ASEAN members keep working towards securing national treatment for U.S. investment.

Officials of ASEAN have declared that the council will discuss a plan that will shorten the deadline for investment liberalization for non-ASEAN investors by five years from the original 2020 deadline. Previously, ASEAN countries all agreed to provide national treatment for ASEAN investors by 2010 and for non-ASEAN investors, 2020.

Bower believes that ASEAN advantages in the life sciences sectors, particularly in the biotechnology and agriculture industry are set to take full advantage of the growth in China. He also added that ASEAN is capable of becoming a leader in the fields of health care services and medical device manufacturing.

The U.S.-ASEAN Business Council encouraged ASEAN members to realize unfinished reforms and move forward on regional economic integration.

In the year 2000, the U.S. invested over US $51 billion in the 10 ASEAN member countries (Malaysia, Indonesia, Thailand, the Philippines, Singapore, Brunei, Vietnam, Cambodia, Laos and Myanmar), while only investing US $9.5 billion in China.

(Source: Japan Economic Newswire)

Gene Technology Research May be Key to a Safe Male Contraceptive

According to scientists at the annual academic meeting of the Chinese Association for Science and Technology (CAST), study in gene technology is leading to the possibility of developing a new safe male contraceptive.

Zhang Yonglian, an academic at the Chinese Academy of Sciences (CAS), said that "research on the maturing mechanism at the molecular level of sperm in the epididymis and disclosing the organ's gene group code will help to make an effective male contraceptive."

Zhang went on to explain that because the process of genetic recording finishes before the sperm enters the epididymis, drugs targeting this area will not lead to serious side effects nor to hereditary diseases.

Liu Yixun, another CAS academician, explained that part of the reason that more than 80 percent of those using contraception are women is because men are worried about the safety of contraceptive drugs.

The study of gene technology is considered to be a useful aid in the development of a safer male contraceptive drug as scientific study is beginning to focus on research on the forming, maturing and discharging of sperm and ova.

Both Liu and Zhang expressed their eagerness in using gene technology to develop a safe male contraceptive to contribute to humanity.

(Source: BBC Monitoring Asia Pacific)

Peregrine and Medipharm Cooperate to Produce TNT

Peregrine Pharmaceuticals Inc., a NASDAQ-listed company, has signed an agreement with Medipharm Biotech Co. Ltd of Shanghai to produce Tumor Necrosis Therapy (TNT).

According to the agreement, Peregrine will offer product development services in order to prepare TNT for commercial manufacturing. Subject to the authorization of the Chinese State Drug Administration (SDA), Peregrine will also act as a contract manufacturer.

Peregrine revealed in a statement that the contract totals roughly US $1.8 million. The TNT technology is part of Peregrine's collateral targeting agent portfolio. The agents connect to sections of a tumor that are common to all solid tumors, and are thus useful in that it can treat many types of solid tumors.

The TNT antibody targets the antigens related to DNA or the DNA itself in the cancer cells nucleus.

(Source: Asia Pulse)

 

List of GMP Facilities (Continued)

Name of Enterprises

Certified Scope

101 Suzhou Fifth Pharmaceutical Factory

Raw materials

102 Hainan Qingqi Pharm. Co., Ltd (Haikou Pharmaceutical Factory)

Tablet, Capsule, Granule

103 Fujian San Ai Pharm.Co., Ltd

High Dose Injection

104 Harbin Liyahar Biological Products Co., Ltd

Recombinant Human Interferon a2b Production Workshop, Cellula / Megalophage Colony Stimulating Factor Production Workshop

105 Jilin Dongsheng Pharmaceutical Co., Ltd

Human Refined Rabies Vaccine Production Workshop, Freeze-dried Powder-Injection, Low dose Injection

106 Taifeng (Jiangxi) Pharmaceutical Co., Ltd

Eye Drops, Nose Drops, Ear Drops

107 Beijing Medical University United Pharm. Co., Ltd

Recombinant Human Granulocyte / Megalophage Colony Stimulating Factor, Tablet, Capsule, Granule

108 Lanzhou Institute of Biological Products

The First Vaccination Production Workshop (Measles Attenuated Live Vaccine, Mumps Attenuated Live Vaccine, Rubella Attenuated Live Vaccine, Cephelitis B Attenuated Live Vaccine) The Third Vaccination Production Workshop

109 An-Qing Pharmaceutical Co., Ltd

High Dose Injection

110 Fujian Fuqing Pharmaceutical Co., Ltd

High Dose Injection

111 Zhejiang Lishui Zhenan Pharm. Co., Ltd

Freeze-dried Powder-Injection (Anti-tumor)

112 Beijing Bitosi Pharmaceutical Co., Ltd

Low Dose Injection

113 Beijing Bitosi Pharmaceutical Co., Ltd

Freeze-dried Powder-Injection

114 Xianju Biochemistry Pharm. Co., Ltd

Freeze-dried Powder-Injection, Freeze-dried Oral Powder

115 Guilin Second Pharmaceutical Factory

High Dose Injection

116 Guangdong Zhenjiang Pharm. Factory

High Dose Injection

117 Datong Xinghuo Pharmaceutical Factory

High Dose Injection

118 Fujian Xingyuan Group (Futian) Pharm. Co., Ltd

High / Low Dose Injection

119 Beijing Taiyang Pharmaceutical Co., Ltd

Raw Materials (Arithromycin), Capsule, Granule

120 Shanghai Dajiang (Group) Co., Ltd Bio-Pharmaceutical Company

External Use Freeze-dried Recombinant Human Epidermal Growth Factor Production Workshop

121 Beijing Feifan Pharmaceutical Factory

Capsule

122 Beijing Sihuan Pharm. Science and Technology Co., Ltd.

Tablet, Low Dose Injection, Ointment, Solution (External Use)

123 Shanxi Kangbao Biological Products Co., Ltd.

Tablet, Freeze-dried Powder-Injection, Low Dose Injection, Oral Liquid

124 Tianjin Zhongxin Pharm. Group Co., Ltd. Le Ren Tang Pharmaceutical Factory

Tablet, Capsule, Granule, Pill

125 Guangxi Wuzhou Pharmaceutical (Group) Co., Ltd.

Freeze-dried Powder-Injection, Powder-Injection

126 Chaohu Zhengda Pharmaceutical Co., Ltd.

Tablet, Capsule, Granule (Cephalosporin)

127 Guoyao Group Guorui Pharm. Co., Ltd.

Powder-Injection (Penicillin / Cephalosporin)

128 Anhui Chaoyang Pharmaceutical Co., Ltd.

High Dose Injection

129 Beijing Enzejiashi Pharm. Co., Ltd.

Tablet, Capsule, Granule

130 Beijing Enzejiashi Pharm. Co., Ltd.

Raw Materials

131 Hunan Kangpu Pharmaceutical Co., Ltd.

Tablet, Capsule

132 Shijiazhuang Kedi Pharmaceutical Co., Ltd.

Capsule

133 Shanghai Kaibao Pharmaceutical Co., Ltd.

Tablet, Capsule

134 Heilongjiang Zhaodong Huafu Pharm. Co., Ltd.

High Dose Injection

135 Shanxi Pude Pharmaceutical Co., Ltd.

Powder Injection, Freeze-dried Powder-Injection

136 Handan Zhaodu Pharmaceutical Factory

High Dose Injection

137 Lanzhou Dadeli Bio-Pharmaceutical (Factory) Co., Ltd.

Freeze-dried Powder-Injection

138 Zhengzhou Biological Project Co., Ltd.

Exosomatic Diagnostic Reagent Production Workshop

139 Guangdong Global Dazhong Pharm. Co., Ltd

Tablet, Capsule, Granule, Ointment

140 Shanghai Pharmaceutical (Group) Co., Ltd. (Xian Feng Pharm. Company)

Asepsis Raw Materials (Cephalosporin), Freeze-dried Powder-Injection

141 Huaian Zhao (Ming Kong) Yuan Pharm.Co., Ltd.

High Dose Injection

142 Wuhan Bio-Pharmaceutical Pharm. Factory

Freeze-dried Powder-Injection, Ointment

143 Shangsu Changzheng Kaixin Pharm. Co., Ltd.

Low Dose Injection, Tablet

144 Fujian Tianshen Pharmaceutical Co., Ltd.

Red Nocardin Cell Wall Skeleton Production Workshop

145 Heibei Xingtai Zhong Xing Pharm. Factory

High Dose Injection

146 Guangzhou Bei Shi Pharmaceutical Co., Ltd.

Powder Injection (Cephalosporin)

147 Guangdong Ming Xing Pharmaceutical Factory

Freeze-dried Powder-Injection (Anti-tumor)

148 Jiangmen Biological Technique Development Center Pharm. Co., Ltd.

Freeze-dried Powder Injection, Low Dose Injection

149 Gansu Jiu Quan Pharmaceutical Factory

High Dose Injection

150 Shenzhen Haiwang Interlong Biological Technique Co., Ltd.

Recombinant Human Interferon a2b Production Workshop

 


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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.

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