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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) was among the 100 billion market cap clubs. It is a constituent stock of the Hang Seng Index and the first pharmaceutical stock in the 50 years of the Hang Seng Index compilation. On March 22, 2019, the subsidiary Xinuowei (300765.SZ) was successfully listed on the GEM, and CSPC realized a new era of "red chip + A" financing pattern.

Since the establishment of CSPC, with the strong support of all sectors of the society, it has continuously developed and innovated, forged 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's sales revenue reached 30.068 billion yuan, and various taxes paid 2.76 billion yuan, which 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 and develops innovative products and continuously enhances its production capacity. At present, the group has more than a thousand production symbols and an extensive 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 8 cities including Wuhan and Shenyang; in California, Texas There are R & D centers and clinical centers in four places, including New Jersey 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, there are about 300 innovative drug product projects of the Group, including more than 50 macromolecular biomedicals under development, more than 40 small molecular new medicines, 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 stone medicines. It is the third national first-class new medicine with independent intellectual property rights in China, and also the world's 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, Dumexol, Nuolin, Keyili. The successful listing and rapid growth of these new drugs has promoted the gorgeous transformation of CSPC's product structure from general drug operation to innovative drug operation.

Leading Chinese pharmaceutical companies to go abroad is one of the development visions of CSPC. At present, eight innovative drugs of CSPC are undergoing clinical trials in the United States. Butylphthalide soft capsules are already in the 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 US FDA's orphan drug qualification and started clinical trials of new drugs. 19 varieties of metformin hydrochloride tablets have been approved by the ANDA and sold in the United States. In addition, CSPC Group's hypertension treatment drug, L-Amlodipine, passed the US Food and Drug Administration's (FDA) new drug market review and became 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 reflection of CSPC's corporate values. For many years, the CSPC has been actively involved in public welfare. In the SARS, the Indonesian tsunami, the Wenchuan earthquake, the Yushu earthquake, the Tanggu explosion, and the medical treatment of children with serious illnesses, the CSPC has always actively assisted. CSPC's main platform for public welfare undertakings-Hebei Pharmaceuticals Puen Charity 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 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 strengthen innovation and make CSPC a globally respected and respected innovative pharmaceutical company. Dedicate to the society with more, newer and better medicines, stride 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. 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 authorization of new drugs. The main purpose of NDA is to ensure that marketed drugs are safe, effective and of acceptable 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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