The Company:

Based in New York and New Jersey, HYWE Pharmaceuticals Inc. is a clinical stage company focusing on oncology therapeutics. The Company’s leading product, Elemene, with existing strong safety and efficacy human profiles represent a major advance in the field of primary and secondary brain tumor treatments, with > 40% in CR + PR rate. CR denotes complete response in tumor shrinkage and PR denotes partial response in tumor shrinkage > 50%. Elemene suppresses cancer cell growth by inducing apoptosis and G2-M cell cycle arrest. Elemene (65% pure) has been in the China market since 1993, with more than 10,000 patient data, in a variety of solid tumor indications.

Business Model:

The Company is currently conducting Phase I/II clinical trial on brain tumor patients in China on Elemene (98% pure) (mono-therapy and combination therapy) under the following oversight:

1. Protocol designed and trial monitored by neuro-oncologists from Memorial Sloan Kettering Cancer Center;
2. CRO company: China branch of US Kendle company, trial conducted under GCP/ICH guideline;
3. Principle investigator in China: Dr. Yan Sun at Xie-he Hospital, who has >40 years of distinguished medical career in China. Dr. Sun is currently the Director of China GCP Center, Vice Chairman of Asia Clinical Tumor Association, Member of International Anti-cancer Committee (UICC), Member of Global Health Organization Cancer Expert Consulting Committee.

The Company plans to start its US IND next year. The initial indication will be in secondary brain tumor from non-small cell lung cancer, with more than 170,000 patients each year. This indication has tremendous un-met medical needs, with no drugs approved in the US, potentially granting us “fast track” status.

We will conduct Elemene trials in other solid tumors, including lung cancer, colon cancer, breast cancer, ovarian cancer, and prostate cancer. In addition, Elemene will be tested in combination with other traditional chemotherapy drugs, since Elemene has been shown in vitro to reverse Multi-Drug Resistance of cisplatin, 5-FU, or Taxol.

When Elemene is fully developed, its annual revenue could be over $3 Billion USD.

Management Team and Advisory Board Members:

Management

Hai Xu Chairman, Founder

• Serial Entrepreneur, financed all China clinical trials, GMP facility for Elemene production.

Michael Chen, Ph.D. CEO & President, Founder

• > 15 years of experience from large pharmaceutical companies in clinical trial design, IND, and NDA filings.

Lan Huang, Ph.D. Chief Scientific Officer, Founder

• > 10 years of research experience in cancer drug discovery field, with publications in Science and Nature.

Kala Paul, M.D. Senior Consultant, Clinical Development

• > 15 years of experience from large pharmaceutical companies in clinical trial design and monitoring.

Advisory Board

Eric Holland, M.D., Ph.D.

Professor and Neuro-surgeon, Department of Cell Biology, Department of Surgery, Department of Neurology,Memorial Sloan Kettering Cancer Center (MSKCC)

Sung-Hou Kim, Ph.D.

Professor, Department of Chemistry, University of California at Berkeley; Member, National Academy of Sciences; Co-Founder, Plexxikon Inc. (with Dr. Joseph P. Schlessinger, Former Founder of Sugen)

Qingdi Li, M.D., Ph.D.

Professor, Department of Cell Biology, West Virginia Medical School

Frank McCormick, Ph.D., FRS

David A. Wood Endowed Chair in Tumor Biology and Cancer Research, Microbiology and Immunology; Director, UCSF Comprehensive Cancer Center & Cancer Research Institute, University of California at San Francisco (UCSF); Fellow of Royal Society

Jin Wang, Ph.D.

Venture Capitalist (VC), Manhattan Fund, China; Former VC at Paramount, which invested in Arsenic Trioxide, a drug licensed from China, on its clinical trial at Memorial Sloan Kettering Cancer Center and NDA approval in the US.

Prospects:

The Company is seeking to raise $5 M USD in order to 1) complete its China Phase II clinical trials to generate data for USA FDA evaluation and lower US clinical trial development risks, and 2) initiate US clinical studies.

Contact:

Dr. Lan Huang, lan.huang@hywe.com, Tel: 646-528-4184