No Patient Left Behind
SPES Pharmaceuticals was established in 2017 in North Brunswick, NJ. The company focuses on the research and development of improved specialty injectable products 505(b)(2)and complex generic drugs. The most advanced anti-emetic product candidate has entered the NDA batch stability test phase. More product candidates based on different technology platforms are under different stages of research and development. The main therapeutic areas of SPES products include anti-tumor, antiemetic, CNS, and pain management.
Create clinically advantageous products through innovative formulation technologies and transform reconstitution/dilution needed products to ready to use dosage forms
S4EIS(A Solution System for Extended Release Injectable Suspension)
CPM(Continuous Process for Microparticle manufacturing)
A proprietary platform technology allows the creation of long-acting micro-particulate suspension for extended release injection.
A proprietary continuous manufacturing system and the process for microparticle manufacturing for both multivesicular liposome suspension and microspheres.
Our goal at Spes is to identify and address the overlooked and unmet medical needs of the healthcare industry through patient-focused, innovative products. We are dedicated to providing solutions to improve the clinical benefits of patients and the experience of doctors, nurses, pharmacists. We will reinvigorate existing molecules through innovative science and technologies to build a robust sustainable portfolio of novel and improved pharmaceutical products.
Currently, we have more than 11 high-value products in various stages of development which covers mainly three therapeutic areas, cancer therapy, CNS drugs, and pain management. This product pipeline represents a risk-diversified portfolio of high value, high barrier innovative drug products which will be filed through either NDA 505(b)2 or ANDA 505(j) (Complex Generic) regulatory pathway.
MEET THE TEAM
Jianwei Yu PhD
More than 25 years of injection research and development experience. Graduated from China Pharmaceutical University and Rutgers University School of Pharmacy
Previously held senior research positions or R&D management positions in Wyeth, Baxter, Hengrui USA, Eagle Pharmaceuticals, Antares Pharma Inc., Huahai US.
Developed products cover common injections and a variety of complex injections, such as oil solution, nano suspension, fat emulsion, colloidal solution, and pre-filled automatic injection drug delivery systems, etc.
Yulu Wang PhD
Nearly 20 years of comprehensive experience in solid and liquid product development. Successfully developed more than 60 ANDA and NDA products.
Participated setting up of Huahai US generic business. Established Shanghai R&D Center and lead the products development, scale-up and commercial manufacturing.
The 30 approved ANDA products achieved $150 million in US market in 2018. Of which 20 products were approved and marketed in China.
Previous Pfizer scientist and Mutual Pharmaceutical (Takeda) Sr. scientist, respectively.
SCIENTIFIC ADVISORY TEAM
Eric Xueyu Chen, MD, Ph.D., FRCPC
Dr. Eric Chen graduated from China Pharmaceutical University (BSc), University of Manitoba (Ph.D.), and University of Toronto (MD).
Dr. Chen is currently an attending physician at the Department of Medical Oncology and Hematology, Princess Margaret Cancer, Toronto, Canada, and an associate professor at the Faculty of Medicine, University of Toronto and an adjunct associate professor, Faculty of Pharmacy, University of Toronto. Dr. Chen specializes in the treatment of gastrointestinal cancers. His research focuses on the development of new drugs and treatments in cancer treatment, and he has been the principal investigator of dozens of Phase I-III clinical trials. He has published over 140 papers, including on journals such as Journal of Clinical Oncology, JAMA Oncology, Clinical Cancer Research, Annals of Oncology, and Journal of National Cancer Institute.
In addition to his clinical practices, Dr. Chen has been the principal investigator of more than 2000 bioavailability/bioequivalence and drug interaction studies. Dr. Chen is also experienced in good clinical practice audits of FDA, EMA, and Health Canada.
2/27/2022 FDA has accepted the NDA for SP001
Spes is interested in working with potential partners worldwide for licensing-in and licensing-out opportunities, drug delivery platforms, development collaborations, and strategic alliances that complement and extend our own development and commercial capabilities.
The first candidate product SP001's market rights are available outside the United States
For more information or to discuss potential partnering opportunities, please contact: firstname.lastname@example.org
or send us a message through contact us.