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CSPC

Overview of CSPC

CSPC Group profile

CSPC Holdings Group Co., Ltd. is a national-level innovative enterprise integrating R & D, production and sales of innovative drugs. The group's existing total assets are 41 billion yuan and 27,000 employees. The company listed in Hong Kong (01093.HK) is among the 100 billion market value clubs. It is a constituent stock of the Hang Seng Index and the first pharmaceutical stock in the 50 years of the compilation of the Hang Seng Index. On March 22, 2019, the subsidiary Xinuowei (300765.SZ) was successfully listed on the GEM, and CSPC achieved a new era of "red chip + A" financing pattern.

Since the establishment of CSPC, with the strong support from all walks of life, it has been continuously innovating and forging ahead, and achieved sustainable, healthy and rapid development. Currently, there are more than 10 pharmaceutical production bases in Hebei, Jin, Shandong, Jiangsu, Jiangsu, Tianjin and other provinces and cities. The products are sold in more than 100 countries and regions around the world, with 34 varieties and single varieties sold over 100 million yuan. In 2018, the Group achieved sales revenue of RMB 30.068 billion and paid various taxes of RMB 2.76 billion, which has made outstanding contributions to the development of China's pharmaceutical industry and regional economic construction.

Adhering to the corporate mission of "doing good medicine for China and reporting to the world", CSPC continuously develops innovative products and continuously enhances its production capacity. At present, the group has more than a thousand production documents and a wide product portfolio, which can meet Health needs of people with different diseases. At present, CSPC has established an integrated R & D system at home and abroad, with R & D and clinical centers in Beijing, Shanghai, and Shijiazhuang, and clinical offices in Wuhan, Shenyang, and other 8 cities; in California, Texas, USA There are R & D centers and clinical centers in 4 places, including New Zealand and New Jersey. The annual investment in R & D exceeds 2 billion yuan. The group has 1,800 R & D personnel, including more than 200 doctoral talents and high-end returnees. At present, the Group has about 300 innovative drug product projects, including more than 50 new target large molecular biological drugs, more than 40 new small molecular drugs, more than 20 new formulations, and more than 50 clinical research projects.

Enbipu (chemical name: butylphthalide) is one of the representatives of the research and development of new drugs of stone medicine, and it is the third national first-class drug with independent intellectual property rights in China. It is also a global leading drug in the field of stroke treatment. More than 10 million stroke patients have cured or alleviated the disease. At the same time, CSPC also has a number of new drug products such as Xuanning, Oulaining, Jinyouli, Dumexin, Nuolin, Keyili. The successful listing and rapid growth of these new drugs has promoted the gorgeous transformation of the structure of CSPC's products from general drug operation to innovative drug operation.

Leading Chinese pharmaceutical companies to go abroad is one of the development visions of CSPC. Currently, there are 8 innovative drugs of CSPC in clinical trials in the United States. Butylphthalide soft capsules are already in Phase II clinical stage. Butylphthalide, antibody drug conjugate ADC (DP303c), humanized gap junction protein 43 monoclonal antibody (ALMB-0166) and other 5 products have obtained the orphan drug qualification certification issued by the US FDA and started clinical trials of new drugs, 19 varieties including metformin hydrochloride tablets have been approved by the ANDA and sold in the United States. In addition, CSPC's hypertension treatment drug, L-Amlodipine, passed the US Food and Drug Administration's (FDA) new drug market review, becoming the first new drug approved by the FDA in China.

CSPC has established a complete four-level quality management system, and all medicines have passed the new GMP certification. At present, CSPC has obtained a total of 16 CEP certificates and 33 DMF registration numbers, and 25 products have successfully passed the US FDA on-site inspection.

Undertaking social responsibility is an important embodiment of CSPC's corporate values. For many years, CSPC has been actively involved in public welfare. CSPC has always actively assisted in various events such as SARS, the Indonesian tsunami, the Wenchuan earthquake, the Yushu earthquake, the Tanggu explosion, and the medical treatment of children with serious illnesses. CSPC's main platform for public welfare undertakings--Hebei Stone Drug Punn Charitable Foundation actively carries out activities in the areas of helping the sick, the poor, the poor, the elderly, and funding education, etc., and takes concrete actions to continuously do something to the society Give feedback. Since the establishment of the company, CSPC has invested more than 100 million yuan in public welfare undertakings.

Looking forward to the future, CSPC will continue to intensify innovation and make CSPC a globally respected and respected innovative pharmaceutical company. Contributing to society with more, newer and better medicines, and striding forward on the road of continuously leading innovation and casting excellent stone medicine!


[Comment]

* 1 Antibody drug conjugate ADC: A chemically linked small molecule drug with a biological activity is connected to a monoclonal antibody, and the monoclonal antibody serves as a carrier to target the small molecule drug to the target cell.

* 2 Orphan drugs: "Orphan drugs" are also called rare drugs. They are used to prevent, treat, and diagnose rare diseases. Due to the small population of rare patients, low market demand, and high R & D costs, few pharmaceutical companies pay attention to the development of their therapeutic drugs, so these drugs are called "orphan drugs".

* 3 FDA: FDA is the abbreviation of Food and Drug Administration.

* 4 ANDA: Abbreviated New Drug Application, generic drug application for registration approval in the United States.

* 5 NDA: In the US FDA new drug review process, when the third phase of human trials is completed and the required non-clinical trials have ended, you can apply for approval for the marketing approval of new drugs. The main purpose of NDA is to ensure that marketed drugs are safe, effective and of high quality control.

* 6 CEP certificate: equivalent to COS certification, both represent the European Pharmacopoeia Certificate of Suitability, namely certificate of suitability to monograph of European Pharmacopeia.

* 7 DMF registration number: For drug substance applications for sale in the United States, DMF documents need to be submitted to the FDA. After on-site inspection and approval of registration, the drug can be sold in the United States.

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