GLOBAL BIOPHARMA, INC. is a biotechnology company established in October of the 102nd year of the Republic of China (October 2013), focusing on the development of immunotherapy as its primary product. GLOBAL BIOPHARMA, INC.'s primary product, "ADXS-HPV immunotherapy", is exclusively licensed from Advaxis, Inc. (NASDAQ: ADXS) of the United States. ADXS-HPV won the VIE Award (Vaccine Industry Excellence Award) for "Best Therapeutic Vaccine: Approved or in Development" at the World Vaccine Manufacturing Congress in 2012. GLOBAL BIOPHARMA, INC. holds the exclusive rights to develop, manufacture, commercialize, and sublicense this immunotherapy for the treatment of diseases associated with human papillomavirus (HPV) infection across Asian countries (including China and Japan), Eastern Europe (including Russia), and African countries (including South Africa and Nigeria), covering a population of approximately 4 billion.

ADXS-HPV immunotherapy targets the treatment of various HPV infections and related precancerous lesions that currently lack effective treatments. ADXS-HPV is an immunotherapy composed of a highly attenuated live Listeria monocytogenes (Lm) vector carrying a plasmid with the LLO-E7 fusion gene. Its mechanism of action uses LLO as an adjuvant to stimulate a strong innate immune response against tumor cells expressing tumor-associated antigens (the E7 tumor-associated antigen of the HPV16 subtype), thereby producing a tumor-killing effect.

HPV infection has been recognized as the second leading carcinogenic factor, second only to smoking. It is estimated that approximately 7-10% of cancer tissues may express HPV oncogene (E6 and E7) antigens. Although not every tumor of every patient with any type of cancer will express HPV tumor-associated antigens, a significant proportion of tumors in patients with cancers related to mucosal tissues and skin will express HPV tumor-associated antigens; these include cervical cancer (99%), head and neck cancer and oropharyngeal cancer (30%), lung cancer (25%), anal cancer (84%), and genital cancers (40%-70%). These patients expressing HPV tumor-associated antigens are all potential therapeutic targets for ADXS-HPV immunotherapy. The greatest difference between this and other targeted drugs is that the targets of many targeted drugs are also expressed in normal cells. The target of ADXS-HPV is the HPV tumor-associated antigen (E7), which is not expressed in normal cells, and therefore does not harm normal cells. In addition to the Phase II clinical trial for lung cancer, GLOBAL BIOPHARMA, INC. and Advaxis plan to jointly conduct a multinational, multicenter Phase III clinical trial this year using ADXS-HPV to treat advanced cervical cancer.