Natural Health Products



CARESENG® series is a line of natural health products developed by Pegasus based on over ten years of continuous research work. The active ingredients are a series of compounds extracted from plants, especially araliaceous plants including ginseng using a patented special technique. Currently, Pegasus has the following products on the market: CARESENG® BFG, SG, SG2, SG-40, RH, Pandimex™, Bioseng™#1.

Drug Candidates

PBD-2131B Oral
PBD-2131B Oral is a pharmaceutical product based on the discovery and research made by Panagin, using SMCD Platform technology. Its active ingredients are mainly 20(S)Protopanaxadiol and (20S)Protopanaxatriol.
Panagin has completed pre-IND communications with US FDA. In 2006, the company is preparing to file IND and conduct Phase I clinical studies of PBD-2131 OralB for the treatment of lung cancer and other solid tumours. In 2007, Panagin plans to advance another drug candidate PAM-200 to the clinic for the treatment of brain metastases from original lung cancer.

PBD-2131 INJECTION
PBD-2131 INJECTION has received conditional market approval in China for the treatment of advanced cancers of lung, breast, pancreas, stomach and colon-rectum. PBD-2131 INJECTION can be used as a single agent and combination agent with paclitaxel. A Panagin-controlled joint venture is formed to market PBD-2131B INJECTION, and to upgrade its regulatory status to a full NDA approval.

PBD-2131 CAPSULE and SOLUTION
Based on the same active ingredients as PBD-2131 INJECTION and bioavailability-enhanced with the OBET technology, Pegasus will register in China PBD-2131 CAPSULE and SOLUTION, an oral product for the same indication. In China, Pegasus expects to conduct clinical trials on the oral dosage form and submit new drug approval application as an addition to the previous regulatory documentation in the first half of 2006. The oral dosage form was designed based on the same SMCD platform with improved drug absorption and distribution, theoretically equivalent to those of the intravenous dosage form. PBD-2131 CAPSULE and SOLUTION will provide patients with greater comfort and convenience in use. The market coverage is greatly widened when out-patients can have access to the treatment.

OBET-BASED(ORAL BIOAVAILABILITY ENHANCEMENT TECHNOLOGY) DRUG CANDIDATES
TCM ingredients are traditionally categorized by their material sources. A recent research indicates that there are 12,807 ingredients, among which 11,146 are plant sourced, 1,581 are animal sourced and 80 are mineral sourced. Among the 2,070 approved products on the National Drug List issued by Chinese SFDA, 1,258 are TCM (by the end of 2004). Most healthcare insurance programs also cover TCM products.
In the past 10 years, TCM market in China has experienced an unprecedented increase and grown over 10 times, with an average annual rate of 28%, far above Chinese pharmaceutical industry's growth rate of 20%. In 2000, the Chinese TCM extract product market reached US$ 486 million, accounting for 24% market share of all pharmaceutical products, as opposed to 13% in 1990. Extract products has gradually replaced raw materials and become the dominant TCM segment (75%). A 2003 market survey shows that there are 28 TCM extract products among the top 50 best retail sellers.
Pegasus plans to use the OBET technology and develop bioavailability improved specialty pharmaceutical products. In the next three years, the Company plans to screen over 50 compound groups, more than several hundreds single compounds, of TCM active ingredients belonging to the saponin and flavone families, whose absoption in gastric acid environment are to be significantly enhanced through dosage improvement with OBET technology. Pegasus has focused on about 20 existing TCM extract pharmaceutical products on Chinese market, whose active ingredients are included in the Company's screened ingredient pool. These products are approved by Chinese SFDA, widely recognized for their efficacy and safety, and have broad market demand and remarkable sales each year.
Pegasus has made feasibility studies, intellectual property research and provisional market assessment of an initial group of TCM and plans to file SFDA in the following 3-5 years.

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HIV Reverse Transcriptase Inhibitory Gene Therapy

PepMetric Technologies Inc. has discovered a number of peptides that have inhibitory properties against HIV reverse transcriptase. PepMetric has also constructed lenti-virus vectors and plans to use them as a gene therapy for the treatment of HIV AIDS.

This approach is hoped to genetically modify T cells in AIDS patients, make them immune to HIV infection, and ultimately cure the disease. HIV relies on the activity of reverse transcriptase to complete viral replication, which leads to the death and disintegration of T cells. Many drugs of today for AIDS are reverse transcriptase inhibitors.

Using peptide libraries and proteomic interaction software, PepMetric has discovered peptides that inhibit the activity of HIV reverse transcriptase. With further understanding of the binding mechanisms of these peptides, PepMetric has identified a number of highly specific, effective and low-toxic candidates. PepMetric has also designed and transplanted into lenti-virus vectors DNA constructs which are able to encode these peptides. Lenti-virus is genetically engineered and a non-disease causing strain which belongs to the same family as HIV. Bone marrow stem cells are to be extracted from AIDS patients, infected with the genetically modified lenti-virus and re-infused into the patients. Lymphocytes differentiated from the stem cells are to express inhibitory peptides and make the cells immune to HIV infection. As susceptible T cells are infected and eliminated while the number of immunized T cells increases, the patient is hopeful to accomplish long time survival and recovery.

Compared with current approaches, gene therapy aims to completely cure the disease. Theoretically only one or a few treatments are needed. Patients do not rely on constant drug intake to suppress the disease. Meanwhile, the approach can be used as a prophylactic in the high-risk population. This research is a collaborative effort with the Aaron Diamond AIDS Research Center of the U.S., led by Dr. David Ho. The project is near finish and expected to enter the clinical stage.