□ National Class-ⅠBiological Drug-- KH901, Used for Solid Tumor Treatment

Mechanism: KH901 is a new-generation autologous therapeutic cancer vaccine for treatment of cancers. It not only has an oncolytic effect that kills tumor cells through specific replication in the tumor cells, but also produces an anti-tumor immune response by expressing GM-CSF in the tumor cells to stimulate the immune system. KH901’s novel design is an organic integration of tumor virotherapy and autologous tumor vaccine.

Research Progress: phase II clinical trial has started.

Comparison with the Similar Products at Home and Aboard: China is the first country in the world that approves gene therapy drugs. Compared with the first and second generations of anti-tumor gene therapy drugs approved by the State Food and Drug Administration, KH901 exhibits characteristics of broad anti-tumor spectrum (> 90% solid tumor), strong selectivity (a small effect on normal cells), and promotion of the immune system by expressing cytokines to attack the distant metastatic tumors.  As a leading cancer therapy in the world, it has opened up a new way of thinking in term of anti-tumor design.
 

□ National Class-ⅠBiological Drug-- KH902, Used to Treat Age-related Macula Degeneration and Diabetic Retinopathy (DR)
Mechanism: The development of age-related macular degeneration, diabetic retinopathy and other fundus diseases is closely related with angiogenesis. KH902 is a targeted genetically engineered protein, that effectively block the VEGF-mediated signal transduction, as well as inhibit lesion neovascularization. KH902 is expected to be used for the treatment of age-related macular degeneration, diabetic retinopathy and other fundus diseases. Its patent has already been authorized.

Research progress : phsae I trial is ongoing

Comparison with the Similar Products at Home and Aboard: Currently, approved drugs with the same mechanism in the world are Macugen and Lucentis. The Technology Center has discovered a way of molecular design that enables proteins to form a more stable three-dimensional structure and to bind more effectively to VEGF, thus enhancing inhibition of VEGF-mediated angiogenesis signals. Related studies have shown that the affinity of KH902 to VEGF is 20-50 times higher than that of similar products. KH901 can not only bind to VEGF-A, but also bind to various VEGF subtypes (such as type B, C and PIGF). In vivo animal experiments have further shown that KH902 has a significant treatment effect on macular degeneration and diabetic retinopathy.

□ National Class-ⅠBiological Drug-- KH903, Used for the Treatment of Various Solid Tumors

Mechanism: KH903 is a targeted genetically engineered antibody-like drugs, that specifically binds to vascular endothelial growth factor (VEGF) with high affinity, and inhibits tumor vascularization and tumor nutrition supply, leading to killing of tumor cells. Combined with the traditional chemotherapy or radiotherapy, it can produce a significant anti-tumor synergy. The animal model experiments have shown that KH903 has a curing effect on the majority of solid tumors, including intestinal tumor, breast tumor, liver tumor, lung tumor, brain tumor, and stomach tumor.

Research Progress: phase I clinical trial is under way in 2008.

Comparison with the Similar Products at Home and Aboard: Compared with aproved similar anti-tumor drugs aboard, KH903 has the following several advantages: ◇ High affinity to VEGF. The affinity of KH903 to VEGF is at least 50 times higher than that of similar products. ◇ Strong anti-tumor capability. In the tumor animal model, the anti-tumor effect of KH903 is more significant than that of the similar product Avastin approved in the United States. ◇ Highly human . Out of the amino acid sequence of Avastin, 93% is from human, whereas 7% is from mice. On the contrary, KH903 molecule has 100% human amino acid sequences, which lowers the drug-resistance probability due to immunogenicity in patients.

□ National Class-ⅠChemical--Tumor Multi-drug Resistance Reversal Drug W198

Mechanism: By inhibiting activity and expression of a sugar protein that plays a key role in tumor multi-drug resistance, Wl98 inhibits excretion of anti-tumor drugs from the tumor cells, and increases accumulation of anti-tumor drugs in the tumor cells, thus leading to  apoptosis of tumor cells and reversal of the tumor multi-drug resistance (MDR).

Research Progress: Currently, the Ⅰ(b)-phase clinical trial research is under way.

Comparison with the Similar Products at Home and Aboard: There is no approved drug with the same mechanism of Wl98 at home or abroad. Outside China, such drugs are still in different phases of clinical research or pre-clinical research, whereas in China, Wl98 is the first anti-tumor MDR reversal agent to enter clinical trial. It has protected intellectual property rights with issued patents in China and the United States. Wl98 is a new chemical entity modified from compounds screened from the Chinese medicines, and has a different structure from the similar drug candidates developed by overseas companies. W198 is characterized by high efficiency and low toxicity.