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 |
|
Lehman Lee & Xu
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