（1）Lawful source of drug materials
In Jan 16 2013, to guarantee sources are lawful. According to the rules of related law, company decided to collect the urine and produce together.
（2）Strategy of urine collection
To maintain the national law, let drugs be safe and effective, in 2013, company hold a meeting, requirements as follows:
1. Observe rules, in charge of drugs safe using for people from all over the world.
2. Any lawless urine collection point can cooperate with our company to realizing a win-win result.
Develop 3 lines for urine collection. Try to collect 30 tons urine per month, try to increase collection volume of men urine.
（3）To realize “Two dozen two bulid”
In July 17 of 2013, CFDA hold a meeting about “Two dozen two bulid”, decide to start a especial action for lawless production and lawless operation of drugs between July and Decmber.
In 20 Sep, company hold a meeting which about “Two dozen two bulid”, and started the first battle for rights protection in five provices, such as Shandong, Hebei, Henan, Jiangsu, Anhui in 22 Sep.
The battle aim at sex hormone products.
Must be with “Pharmaceutical production licence”, ”Drug approval number” and “Drug GMP certification”, if enterprise want to sell and import or export drugs.
In June 2011, EU released new drug instruct 2011/62/EU， required manufacturing enterprise must have three certifications to produce even export HCG. If not, that will be lawless, should be prohibited.
However, some factories still produce productions without license, disregarded national related law, this had a strong impact on international reputation of our country. Kangyuan Pharmaceutical CO. is a lawful drug manufacturing enterprise with “Pharmaceutical production licence”, ”Drug approval number” and “Drug GMP certification”. We can’t let these lawless factories continue to produce.
Kangyuan Pharmaceutical CO. is the only and most complete and the largest Bio-pharmaceutical enterprise from Urine to API in the world. Company appeal to let domestic and overseas enterprises not purchase lawless drugs. At the same time, illegal producers should stop to produce drugs.
（4） Fighting is continuing
In July 17 of 2013, after meeting “Two dozen two bulid” company started raw materials collection of HCG , HMG and UK in five provinces. Purpose is to collect pregnant women urine and men urine each 50-60 tons per day, menopausal women urine 150 tons per day. The war is into effective.
Until mid October, almost finished all targets of this war.
（5）Brief of rights protecting action(1)
In Jan 16 of 2013, company decided to collect urine all together to produce productions according to new compendia. That became a good start to the battle of rights protection.
Our company is a new high-tech enterprise with “Pharmaceutical production licence”, ”Drug approval number” and “Drug GMP certification”. We ensured that our sources are lawful according to China compendia.
（6）Brief of rights protecting action(2)
On April 2th, 2013, Kangyuan held a conference attended by all managers. On the conference, the strategic shift of urine collecting had been put forward, which means carrying the urine of pregnant women back to the head office for production.
The Academy of Social Science reported the working method to the central committee of CPC, the State Council, the National People's Congress and the Chinese People’s Political Consultative Conference in the form of National Academy of Newspaper. Meanwhile, it is advised to spread over the whole nation. The national, provincial and municipal Population and Family Planning Commission, as well as the Municipal Committee of the City Hall in Qingdao have issued the papers for promotion according to that suggestion.
Our company is a new high-tech enterprise with “Pharmaceutical production licence”, ”Drug approval number” and “Drug GMP certification”. We ensured that our sources are lawful according to China compendia.
Kangyuan Pharmaceutical CO. is the only and most complete and the largest Bio-pharmaceutical enterprise from Urine to API in the world. Company appeal to let domestic and overseas enterprises not purchase lawless drugs. At the same time, illegal producers should stop to produce drugs.
（7）Brief of rights protecting action(3)
The Pharmaceutical Administration Law of the People's Republic of China has been revised at the Twentieth Meeting of the Standing Committee of the Ninth National People's Congress, and now promulgated the revised edition of the Pharmaceutical Administration Law of the People's Republic of China, and shall enter into force.
The pharmaceuticals supervisory and administrative departments under the State Council shall be responsible for the supervision and control of pharmaceuticals throughout the country. Other relevant departments under the State Council shall be responsible for the supervision and control of pharmaceuticals related to the scope of their functions.
The pharmaceutical supervisory and administrative departments of the provinces, autonomous regions and municipalities directly under the central government shall be responsible for the supervision and control of pharmaceuticals within their administrative regions. Other relevant departments of the provinces, autonomous regions and municipalities directly under the central government shall be responsible for the supervision and control of pharmaceuticals related to the scope of their functions.
The pharmaceutical supervisory and administrative departments under the State Council shall cooperate with the general administrative department of the economy under the State Council to carry out pharmaceutical development plans and industrial policies formulated by the State.
The establishment of a pharmaceutical producing enterprise must be approved by and issued a Pharmaceutical Production License by the pharmaceutical supervisory and administrative department of the province, autonomous region, or municipality directly under the Central government in which the enterprise is located. The establishment shall be registered at the industry and commerce administrative department based on the Pharmaceutical Production License, without which no pharmaceuticals shall be produced.
（8）Brief of rights protecting action(4)
Qingdao Jiulong Biopharmaceutical Co., Ltd was founded in Nov, 1998. The registered capital is 100 million RMB. Company has 3 subsidiaries ,such as Kangyuan Pharmaceutical Co. Ltd., Qingdao Pharmax Pharmaceutical Co., Ltd. and Qingdao Guanlong Pharmaceutical Co., Ltd.. Company already set up a complete industrial chain which products are extracted from basic materials, such as human urine, porcine intestinal mucosa and marine organism organ, to be proceeded into purified API, finally to be preparations.
Qingdao Jiulong Biopharmaceutical Co., Ltd was founded in Nov, 1998. QJBC is a national high-tech enterprise of scientific research, produce and sale of bio-pharmaceuticals API causing heparin sodium, chondroitin sulfate, enoxaparin, dalterparin, heparan sulfate, dermatan sulfate.
The company has purchased Shandong Yishui Fuhuang Pharmaceutical Factory, Qingdao Pharmax Pharmaceutical Co., Ltd, Suzhou Xinbao Pharmaceutical Co., Ltd and invest 100 million RMB to establish formulation plant in Qingdao Hi-tech Park.
The processes of QJBC's Heparin Sodium and Chondroitin Sulfateare are identified as international advanced level by Qingdao Science and Technology Bureau experts. Now QJBC have won the second prize for “ Qingdao Science and technology and National Torch Plan project”. It also got more than 8 million RMB special supporting policies from High-tech Industrialization Project” and “Technology SME Innovation Fund”. Since 2011, the quantity and quality exporting to USA rank the first, and the export quantity of Heparin Sodium API ranks in the top three in domestic industry. At present QJBC is authorized with 30 patents for invention and another 115 patents are under acceptance status.
Kangyuan is a national high-tech enterprise, Qingdao key enterprise to be listed and it is also the honorary chairman of Qingdao Jiaozhou Bio-pharmaceutical association and the vice- chairman of Shanghai Bio-pharmaceutical association. Kangyuan is the first and the only enterprise in China who passed the FDA inspection, recognized as the only and most complete and the largest Bio-pharmaceutical enterprise from Urine to API in the world. Passed the Chinese new drug GMP certificate in 2015.
HCG API had passed the FDA inspection in Jan 2013 , and this makes us to be the first company who passed the FDA inspection in China; We had successfully passed the FDA recertification in April 2016.
Qingdao Pharmax Pharmaceutical Co., Ltd. was founded in July 29, 2004. The company is a manufacturer of pharmaceutical formulations which was acquisited in 2011 by Qingdao Jiulong Biopharmaceutical Co. Ltd. Has the domestic advanced level production line of freeze-dried powder injection and solid preparation. Leading products is the three state-level new medicine Torsaemide for Injection (lyophilized powder). In May 2015, Pharmax passed the national inspection of new drug GMP certification.
The technology of HCG, HMG and other products is leading to the international advanced level and be added in the “National Torch Plan project” by Chinese government. Kangyuan won the Ministry of science and technology development of private scientific and technological contribution award, scientific and technological progress second prize of Qingdao. 100 patents applications of company have been accepted by State Intellectual Property Office, 18 of them have been authorized.
Related rules and laws
Article 7 The establishment of a pharmaceutical producing enterprise must be approved by and issued a Pharmaceutical Production License by the pharmaceutical supervisory and administrative department of the province, autonomous region, or municipality directly under the Central government in which the enterprise is located.
Article 8 To establish a pharmaceutical producing enterprise, the following requirements must be met: It shall be staffed with legally certified pharmaceutical technical personnel, engineering technical personnel, as well as corresponding skilled workers.
Article 37 The process for preparing traditional Chinese medicines into ready-to-use forms must conform to the national pharmaceutical standards, and in the absence of such standards, the process must conform to the processing standards stipulated by the supervisory and administrative departments of pharmaceuticals of the provinces, autonomous regions, or municipalities directly under the central government.
Article 38 Pharmaceutical producing enterprises must trade in pharmaceuticals in accordance with the "Standards for Quality Control of Pharmaceutical Trading" stipulated by the pharmaceutical supervisory and administrative departments under the State Council on the basis of this Law. Pharmaceutical supervisory and administrative departments shall certify whether pharmaceutical trading enterprises meet the requirements of the "Standards for Quality Control of Pharmaceutical Trading" in accordance with relevant regulations, and issue certifications to qualified enterprises.
1) It shall be staffed with legally certified pharmaceutical technical personnel.
2) It shall have business premises, equipment, storage facilities and a sanitary environment suitable for the pharmaceuticals in which it trades.
3) It shall have a quality control organ or personnel suitable for the pharmaceuticals in which it trades.
Reference materials：http://www.sda.gov.cn/WS01/CL0458/29083.html
The raw and supplementary materials used for the production of pharmaceuticals must conform to the requirements for medicinal use.
A Pharmaceutical Trade License shall bear a scope of trade and a period of validity, and upon expiration a new license shall be issued after examination for its renewal.
Human parathyroid hormone is a polypeptide hormone which is secreted from the parathyroid glands and composed of many amino acids.
Many proteins(FSH)including most extra-cellular proteases and some hormones , aresynthesized as precursors with pro
The export business operators shall present the certificate of quotas issued bythe administrative