News and Research on Simcere Pharmaceutical Group (SCR)
Business Description
Simcere Pharmaceutical Group engages in the manufacture and supply of branded generic pharmaceuticals in China. The company focuses on the development of first-to-market generic and pharmaceuticals.
The company, in addition, has obtained approvals from the State Food and Drug Administration, (SFDA) to manufacture and sell 100 other products. As of March 20, 2007, it also had 12 product candidates in various stages of development, including treatments for cancer, cerebrovascular diseases, infections, rheumatoid arthritis, nasal allergies, nausea and vomiting associated with chemotherapy. The company sells products to regional distributors, who then sell them to local distributors, hospitals and retail pharmacies throughout China.
Products
The company manufactures and sells 35 pharmaceuticals marketed under various brands. Of these products, 30 are prescription pharmaceuticals and five are over-the-counter, or OTC, pharmaceuticals. In addition, it is also the exclusive distributor of Yingtaiqing-branded generic diclofenac sodium sustained-release capsules, the Faneng-branded generic alfacalcidol soft capsules and the Yineng-branded generic lentinan injection, all of which are prescription pharmaceuticals manufactured by independent third parties. Furthermore, the company has obtained approvals from the SFDA to manufacture and sell 100 other pharmaceuticals.
Pharmaceutical Endu (Recombinant Human Endostatin Injection)
The company’s pharmaceutical Endu, or recombinant human endostatin, has been granted an invention patent in China and was the recombinant human endostatin injection approved for manufacture and sale in China and has been approved for the treatment of non-small cell lung cancer, or NSCLC.
Branded Generic Pharmaceuticals
The company sells the following five principal branded generic pharmaceutical products: Bicun (edaravone injection); Zailin (amoxicillin capsules, dispersible tablets, granules and injection); Anqi (amoxicillin with clavulanate potassium granules, tablets and injection); Yingtaiqing (diclofenac sodium sustained-release capsules and gelatin); and Biqi (smectite powder).
Bicun: Bicun is the company’s prescription edaravone injection pharmaceutical for the treatment of strokes. Edaravone is a synthetic free radical scavenger and has been to be one of the neuroprotective pharmaceuticals. Bicun, as a first-to-market generic pharmaceutical, has been granted a transitional protection period by the SFDA until December 2007. As of March 20, 2007, edaravone injections were included in the provincial Medical Insurance Catalog of 22 out of 31 provinces, municipalities and autonomous regions in China.
Zailin: Zailin is the brand name for the company’s line of generic prescription amoxicillin antibiotics, which includes capsules, dispersible tablets, granules and injection.
Anqi: Anqi is the brand name for the company’s line of generic prescription amoxicillin with clavulanate potassium antibiotics, which includes granules, tablets and injection.
Yingtaiqing: Yingtaiqing is the brand name for the company’s generic diclofenac sodium in sustained-release capsules and gelatin dosage format, which is an anti-inflammatory pain reliever and analgesic drug used to treat rheumatoid arthritis and osteoarthritis. Yingtaiqing sustained-release capsules are prescription pharmaceuticals and are manufactured by a third-party manufacturer and the company has entered into a distribution agreement with China Pharmaceutical to distribute and sell Yingtaiqing sustained-release capsules in China.
Biqi: Biqi smectite powder is the company’s generic OTC anti-diarrhea pharmaceutical.
Other Branded Generic Pharmaceutical Products
Zaiqi: Zaiqi is the brand name for the company’s azithromycin granules antibiotics for the treatment of infections.
Zaike: Zaike is the brand name for the company’s cefaclor in dry suspension antibiotics for the treatment of infections.
Simcere Kechuanning: Simcere Kechuanning is the brand name for the company’s OTC herbal medicine used for the treatment of coughs. It comes in oral liquid and tablet formulations.
Zaikang: Zaikang is the brand name for the company’s OTC compound zinc gluconate and ibuprofen granules for the treatment of cold symptoms such as fever, nasal congestion, running nose and sneezing.
Faneng: Faneng is the brand name for alfacalcidol soft capsules for the treatment of osteoporosis.
Collaboration in Research
Joint Laboratory for Drug Discovery: The company entered into an agreement with Tsinghua University in February 2006 to establish a Joint Laboratory for Drug Discovery to engage in the research and development of innovative pharmaceuticals.
Shanghai Institute of Materia Medica, Chinese Academy of Science: The company entered into an agreement with Shanghai Institute of Materia Medica of the Chinese Academy of Science, or Materia Medica, in November 2006 to engage in the research of potential indications for Endu.
Joint Anti-Cancer Pharmaceutical Research and Development: The company entered into an agreement in January 2007 with Advenchen, a pharmaceutical research and development company in the United States as a research partner to engage in the research and development of, clinical studies for, and the commercialization of an anti-cancer pharmaceutical based on a chemical compound owned by Advenchen.
Product Candidates
The company is in the process of developing pharmaceuticals through its in-house know-how and through joint research and development efforts with universities and research institutions in China. As of March 20, 2007, the company had 12 product candidates in various stages of development.
Biapenem for Injection: Biapenem is an antibiotic in the carbapenem subgroups that can be used for the treatment of a range of bacterial infections.
Iguratimod Tablets: Iguratimod is a new disease-modifying anti-rheumatoid medication, or a DMARD, which is a category of drugs used in many autoimmune disorders to slow down disease progression and provide faster and more effective relief as compared to traditional DMARDs. The company is in the process of conducting Phase III clinical trials.
Palonosetron for Injection: Palonosetron is used to prevent nausea and vomiting associated with chemotherapy. The company has developed a new delivery system for palonosetron for which it has applied for an invention patent in China.
Levamisole Hydrochloride Nasal Spray: The company is in the process of developing indications for levamisole hydrochloride to be used for the treatment of nasal allergies.
The company, in addition, is in the process of researching and developing a range of products for the treatment of cancer, cerebrovascular diseases, infections and rheumatoid arthritis.
Competition
For Bicun, the main competitive product is Yidasheng, which is manufactured by Jilin Boda Pharmaceutical Co., Ltd. in China.
For Zailin, the main competitive product is Amoxian, which is manufactured by Zhuhai United Laboratories Pharmaceutical Co., Ltd.
For Anqi, the main competitive products are Anmiejun, which is manufactured by North China Pharmaceutical Group Corporation.
For Yingtaiqing, the main competitive products are Votalin, which is manufactured by Beijing Novartis Pharma Ltd.
For Biqi, the main competitive products are Smecta, which is manufactured by Beaufour-Ipsen (Tianjin) Pharmaceutical Co., Ltd., and Kenteling, which is manufactured by Zhejiang Hailisheng Group Co., Ltd.
History
Simcere Pharmaceutical Group was founded in 1995.
