News and Research on Tongjitang Chinese Medicines Co. (TCM)
Business Description
Tongjitang Chinese Medicines Company focuses on the development, manufacture, marketing, and sale of modernized traditional Chinese medicines.
The company’s product portfolio consists primarily of Xianling Gubao and three other SFDA-approved modernized traditional Chinese medicines. Its product development pipeline includes potential expanded uses of its existing products for additional medical indications and a range of new product candidates that are intended to address medical needs in China, primarily in the therapeutic areas of women’s health, mental health and dermatology.
Products
The company manufactures 48 products, consisting of 11 modernized traditional Chinese medicines and 37 western medicines. Its principal products are four modernized traditional Chinese medicines: In addition to Xianling Gubao, the company manufactures and markets a portfolio of 10 other modernized traditional Chinese medicines approved by the SFDA, including three principal products: Zaoren Anshen Capsules, an OTC medicine for treating insomnia, Moisturizing and Anti-Itching Capsules, an OTC medicine for treating inflammatory skin conditions, and Dianbaizhu Syrup, a prescription medicine for treating vertigo. It also manufacture 37 western medicines.
Xianling Gubao
The company sells Xianling Gubao both as a prescription and as an OTC medicine. Xianling Gubao is approved by the SFDA for the treatment of osteoporosis, osteoarthritis, ischemic bone necrosis and bone fractures. As an OTC medicine, it is approved for the treatment of osteoporosis. It has conducted two double-blind, placebo-controlled trials of Xianling Gubao for the treatment of osteoporosis. It is conducting a Phase IV, randomized, double-blind trial to evaluate Xianling Gubao for the prevention of ischemic bone necrosis, a common side effect of systemic steroid use.
In July 2005, the company entered into an agreement with the Beijing University of Traditional Chinese Medicine to jointly develop a new generation of Xianling Gubao products with greater potency, therapeutic efficacy and a higher level of dosing convenience.
Zaoren Anshen Capsules
Zaoren Anshen Capsules are an OTC medicine used to treat insomnia and improve sleep quality. Zaoren Anshen Capsules are a formulation comprising three plant extracts and have sedative and sleep-inducing properties. Extract of Zizyphus Hu, one of the plants used in Zaoren Anshen Capsules, has demonstrated inhibitory effects on excitatory signal pathways in the brain of test animals. Another active ingredient in Zaoren Anshen Capsules, beta-sitosterol, has been shown to reduce anxiety in test animals.
Moisturizing and Anti-Itching Capsules
Moisturizing and Anti-Itching Capsules, based on a formulation comprising six plant extracts, are an OTC medicine used for the treatment of itchiness caused by multiple conditions, including dry skin, skin rashes, dermatitis and aging skin. The company conducted clinical trials on Moisturizing and Anti-Itching Capsules involving 53 patients who had been diagnosed with itchiness from various causes. It is designing a clinical trial to investigate the use of Moisturizing and Anti-Itching Capsules for the treatment of vaginal and diabetic pruritus, or itching and intends to commence the trial in 2008.
Dianbaizhu Syrup
Dianbaizhu Syrup is a prescription medicine used to treat vertigo, which is a feeling of dizziness when one’s sense of balance has been disrupted. It is made up of an extract from Gaultheria yunnanensis (Franch) Rehd. The efficacy of Dianbaizhu Syrup might be due to its effect in increasing the volume of blood flow in the patient’s heart and brain. In October 2006, it initiated a Phase IV clinical trial to further evaluate the efficacy and safety of Dianbaizhu Syrup.
Other Medicines
In addition to the four principal products and calcium supplements, the company also produces and sells various other medicines, such as: Compound Glycyrrhiza Oral Solution for the treatment of upper respiratory infections; Jiao Ti Guo Jiao Bi Capsules for the treatment of gastritis and ulcers; Bu Shen Yi Lao Capsules to improve memory, breathing, hearing, and general malaise; Xin Nao Kang Capsules for the treatment of stroke and coronary artery disease; Tong Luo Gu Zhi Ning Plaster for the treatment of joint pain; and Ya Tong Ding Compound for the treatment of toothache, gingivitis and cavities.
Product Pipeline: The company is developing a range of new medicines and formulations that were primarily acquired from third parties, as well as through joint research and development with universities and research institutions. As of December 31, 2006, it is in various stages of developing product candidates. These include Jing Tong Ting would undergo Phase III trials for the treatment of Menstrual pain; Da An Granules would undergo Phase III trials for the treatment of Anxiety; Yushuda Tablets would undergo Phase III design for the treatment of Depression; Dan Xian Kang Gu Capsules would undergo Phase III trials for the treatment of Ischemic necrosis; Methylthioninium Chloride and Procainimide Injection for the treatment of Post-surgical acute pain; OA-008 is in preclinical stage for the treatment of Osteoarthritis; and Xianling Gubao Chewable Tablets is in Pre-clinical stage for the treatment of Osteoporosis.
Calcium Supplements: The company has phased out the production of calcium supplements in order to promote Xianling Gubao for the treatment of osteoporosis.
Subsidiaries
The company conducts its operations through various subsidiaries in China, including Tongjitang Pharmaceutical, a wholly-owned subsidiary and its principal operating company, engaged in the business of developing, manufacturing, marketing and selling of medicines; Guizhou Tongjitang Pharmaceutical Distribution Co., Ltd., or Tongjitang Distribution, a 92.76%-owned subsidiary of Tongjitang Pharmaceutical, engaged in the business of wholesale distribution of medicines; Guizhou Tongjitang Pharmacy Chain Stores Co., Ltd., or Tongjitang Chain Stores, a 96%-owned subsidiary of Tongjitang Distribution, engaged in the business of retail sales of medicines; and Guizhou Tongjitang Chinese Medicines Planting Co., Ltd., or Tongjitang Planting, a 95%-owned subsidiary of Tongjitang Pharmaceutical, engaged in the business of cultivating medicinal herbs, primarily barrenwort, used in the production of its products.
Marketing and Sales
The company sells its products to third-party distributors who resell these products to hospitals and retail pharmacies outside Guizhou province. It also sells its products to retail pharmacies and hospitals in Guizhou province through Tongjitang Distribution and directly to consumers through Tongjitang Chain Stores. The company’s principal OTC markets include Shandong, Shanghai, Jiangsu, Zhejiang, and Liaoning.
Customers
The company’s customers include Beijing Shirentang Pharmaceutical Joint Stock Company, and Shanghai Caitongde Pharmaceutical Co., Ltd.
Competition
The company faces direct competition from other China-based manufacturers of traditional Chinese medicines. The primary traditional Chinese medicines competing with Xianling Gubao are: Qiang Gu Capsules are manufactured by Guizhou Fuhua Pharmaceutical Co., Ltd. and Gu Song Bao Capsules are manufactured by Beijing Qihuang Pharmaceutical Co., Ltd. The western medicines that compete with Xianling Gubao include calcium supplements such as Osteoform, Caltrate and Gai Zhong Gai, hormonal replacement therapies such as Livial, Premarin, Ipriflavone and Ranoxifene, bisphosphonates such as Fosamax, and calcitonin derivatives, such as elcatonin.
History
Tongjitang Chinese Medicines Company was founded in 1995.
