Overview

Cardio-cerebral Vascular Products

Our leading position in the cardio-cerebral vascular market has provided us with strong brand recognition among neurologists and cardiologists in the PRC. We offer a portfolio of 14 cardio-cerebral vascular drugs, which are used for the treatment of a range of cardio-cerebral vascular diseases. Our best selling cardio-vascular drugs, Kelinao, Anjieli, Chuanqing and Qu'Ao enjoy leading market positions in their respective medical and therapeutic areas in terms of market share. Sihuan Pharmaceutical focuses on two main sub-segments of the cardio-cerebral vascular drug market: cerebral and peripheral vascular therapies and CNS agents for cardio-cerebral vascular diseases. Kelinao and Anjieli have collectively ranked first among all drugs sold in hospitals in the PRC every year since 2007.

• Kelinao and Anjieli (Cinepazide Maleate injection)

  

  Both Kelinao and Anjieli contain the active ingredient cinepazide maleate in injection form. Kelinao and Anjieli are produced in 80mg and 320mg dosages, respectively. Cinepazide maleate is commonly used in stroke therapy in China. It increases blood flow to the brain and acts as a neuro protectant. It is used in the treatment of cardio-cerebral vascular diseases, such as cerebral arteriosclerosis, transient cerebral ischemic attack, cerebral thrombosis, cerebral embolism, cerebral hemorrhage residual, coronary artery disease, angina and myocardial infarction, as well as peripheral blood vessel diseases. At the same time, due to its enhancing effect on adenosine, cinepazide maleate can effectively protect nerve cells and myocardial cells. Cinepazide maleate injection is currently listed in the National Medicine Catalogue. So far, no severe side effects associated with the use of Kelinao or Anjieli have been reported by the National Center for ADR Monitoring.

  Kelinao and Anjieli currently are the only SFDA approved drugs containing the active ingredient of cinepazide maleate in the PRC. We received patent protection for each of the synthesis process, the improved production method and the invention and production method of the crystal of cinepazide maleate in the PRC.

  We obtained the new medicine certificate and manufacture permit for Kelinao in 2002, and commercially launched the product in the PRC in 2003. We obtained the manufacture permit for Anjieli in July 2006 and the product was launched in the same year.

  We have identified and developed new synthesis and purification processes of cinepazide maleate, to reduce the toxicity of the solvent residuals in the API, and hence further improve the efficacy, stability and safety of the drug. We secured a 20-year patent protection for each of the synthesis process, the improved production method and the invention and production method of the crystal of cinepazide maleate in the PRC in 2004, 2006 and 2008, respectively. In June 2010, SFDA approved our application of enhanced quality standards for cinepazide maleate products. Our standards tightly control the existence of certain impurities, which were not monitored in the originator's standards. Through successful patent protection and stringent quality controls, it is technically difficult for our competitors to synthesising products of comparable quality of our products.

• Chuanqing (Ligustrazine Hydrochloride for injection)

  

  Chuanqing is another of our key cardio-cerebral vascular drugs. It is ligustrazine hydrochloride lyophilised powder for injection, which is used in the treatment of ischemic cardio-cerebral vascular diseases related to insufficient blood supply to the brain, such as cerebral thrombosis, cerebral embolism, coronary artery disease and vasculitis. It is clinically proven to be able to inhibit platelet aggregation and expand small arteries thus improving microcirculation. Ligustrazine hydrochloride for injection is currently listed in the National Medicine Catalogue.

  In 2003, we obtained the new medicine certificate and manufacturing permit for Chuanqing and the product was commercially launched in the PRC market the same year. Through our joint research and development with the Chinese Academy of Medical Sciences, we successfully developed and obtained patent registration in the PRC for the preparation of ligustrazine hydrochloride lyophilised powder for injection, which will expire in 2026. We are the first company in the PRC to secure SFDA approval for manufacturing ligustrazine hydrochloride lyophilised powder for injection, which lowers production costs and increases the stability of ligustrazine products compared with traditional liquid injection form. Currently, Chuanqing is the only ligustrazine hydrochloride lyophilised powder for injection available in a 120mg dose (the dosing volume used frequently in clinical settings) in the PRC market.

• Qu'Ao (Cerebroprotein Hydrolysate for injection)

  

  Qu'Ao is cerebroprotein hydrolysate lyophilised powder for injection. It is used primarily in the treatment of traumatic brain injury and cerebral vascular disease sequelae associated with memory impairment and the protection of brain tissue. It is clinically proven to be able to regulate and improve nerve cell metabolism, promote synapse generation, induce nerve cell differentiation and protect nerve cells against damage from ischemia and neurotoxins. Cerebroprotein hydrolysate for injection is currently listed in the Provincial Medicine Catalogue in 11 provinces across the PRC.

  Qu'Ao is the second best selling cerebroprotein hydrolysate drug in the PRC in terms of market share. In 2005, we obtained the new medicine certificate and manufacturing permit for cerebroprotein hydrolysate lyophilised powder for injection and commercially launched the product in the PRC market in the same year. We have obtained patent registration in the PRC for the production method of cerebroprotein hydrolysate lyophilised powder for injection, which will expire in 2026.

• Aogan (Monosialoterahexosylganglioside Sodium injection)

  

  Aogan is monosialotetrahexosylganglioside, or GM1 in injection form. It is one of the most effective drugs currently available in the market for the treatment of vascular or traumatic central nervous system damage and Parkinson's disease. It is clinically proven to have important physiological properties and impacts on neuronal plasticity and repair mechanisms, and the release of neurotrophins in the brain. GM1 in injection form is currently listed in the Provincial Medicine Catalogue in 16 provinces across the PRC.

  In 2008, we obtained the manufacturing permit for GM1 and commercially launched the product in the PRC market in the same year. Our API supplier is required to ensure the API's purity and quality by complying with the most stringent quality control standards in the GM1 manufacturing process.

• Qingtong (Edaravone injection)

  

  Qingtong is edaravone for injection, which is used primarily in the treatment of ischemia-reperfusion injury in patients with cerebral infarction. It is clinically proven to act as a potent antioxidant and strong scavenger of free radicals and to protect against oxidative stress and neuronal apoptosis. Edaravone injection is listed in the National Medicine Catalogue.

Anti-infective Drugs

As of now, we market and sell 11 anti-infective drugs.

• Kanglixin, Aolang and Xiboao (Cefpiramide Sodium for injection)

  

  We market and sell cefpiramide sodium for injection in three dosages under three brands: Kanglixin, Aolang and Xiboao. The cefpiramide sodium for injection is a third generation cephalosporin antibiotic lyophilised powder for injection, which is used in the treatment of microbial infections. It has a long plasma half-life and is a biliary excretion drug, which makes it safe for patients with renal dysfunctions. Cefpiramide sodium for injection is currently listed in the Provincial Medicine Catalogue in 12 provinces across the PRC.

  Kanglixin is the first generic version of cefpiramide sodium drug approved in the PRC. Kanglixin, Aolang and Xiboao are collectively the best selling injectable cefpiramide products in the PRC in terms of market share. The manufacturing permit for cefpiramide sodium for injection was issued in June 2004 and the product was commercially launched in the PRC market in the same year.

• Anjiejian (Cefmenoxime Hydrochloride for injection)

  

  Anjiejian is a third generation cephalosporin antibiotic in lyophilised powder in injection form, which is used in the treatment of microbial infections. Cefmenoxime hydrochloride for injection is currently listed in the Provincial Medicine Catalogue in 13 provinces across the PRC. Anjiejian is the fastest growing injectable cefmenoxime drug in the PRC in terms of annual growth in China in 2009. The manufacturing permit for cefmenoxime hydrochloride for injection was issued in January 2007 and the product was commercially launched in the PRC market in May 2007.

• Pojia (Sulbenicillin Sodium for injection)

  

  Pojia is a broad spectrum semi-synthetic penicillin antibiotic in injection form, which is used in the treatment of microbial infections. Sulbenicillin sodium for injection is currently listed in the National Medicine Catalogue.

Other Products

We have been seeking to diversify our product portfolio to include pharmaceutical products in other therapeutic fast-growing areas. Specifically, in addition to cardio-cerebral vascular drugs and anti-infective drugs, we also manufacture and sell respiratory, CNS, oncology and other pharmaceutical products.

Respiratory System

• Zhuo'Ao and Bi'Ao (Ambroxol Hydrochloride for injection)

  

  Zhuo'Ao and Bi'Ao are ambroxol hydrochloride for injection in two dosages, 15mg and 30mg, respectively, which is mainly used to relieve respiratory symptoms and for the prevention of post-operative bellows complications and treatment of acute or chronic respiratory diseases. Ambroxol hydrochloride is clinically proven to increase respiratory tract secretion, enhance pulmonary surfactant production and stimulate ciliary activity. Administration of ambroxol hydrochloride together with antibiotics leads to higher antibiotic concentration in the lung tissue. Ambroxol hydrochloride for injection is currently listed in the National Medicine Catalogue.

  The manufacturing permit for ambroxol hydrochloride for injection was issued in [2006] and the product was commercially launched in [2005]. Our API supplier for ambroxol hydrochloride has obtained EU COS certification, which represents higher quality standards than the average industry standard in the PRC.

• Naloxone Hydrochloride

  

  Naloxone hydrochloride is used in the acute treatment of respiratory depression and unconsciousness caused by opioid drug overdose or alcohol intoxication. We manufacture two formulations of naloxone hydrochloride: naloxone hydrochloride lyophilised powder and naloxone hydrochloride injection. Both are currently listed in the National Medicine Catalogue and the National List of Essential Drugs.

  Naloxone hydrochloride lyophilised powder: Xinpuao
  Naloxone hydrochloride injection: Feidiao, Pudiao and Quxinao

  In April 2005, we obtained the manufacture permit to produce naloxone hydrochloride lyophilised powder, which we commercially launched in the PRC market in the same year. In 2006, we further obtained the new medicine certificate and manufacturing permit for naloxone hydrochloride injection and commercially launched the product in the PRC market the same year.

CNS

• Ren'Ao (Oxcarbazepine tablets)

  

  Ren'Ao is an anti-epileptic drug used to produce blockade of voltage-sensitive sodium channels, and thereby decreases nerve impulses that cause seizures. It has high bioavailability and a low protein binding rate. We are one of the only two companies manufacturing oxcarbazepine in the PRC. With the growth of the anti-epileptic drug market in the PRC, we believe that the potential market of oxcarbazepine tablets is huge. Oxcarbazepine tablets is listed in the National Medicine Catalogue. The new medicine certificate and manufacturing permit for oxcarbazepine tablets were issued in August 2005 and the product was commercially launched in the PRC market in 2006.