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SPES PHARMACEUTICALS

Better Medicines, Better Life

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ABOUT US

ABOUT US

SPES Pharmaceuticals was established in 2017 in North Brunswick, NJ.

 

The company is dedicated to delivering medications with safety, convenience, compliance, and efficacy to improve patient’s quality of life. Spes Pharma currently focuses on developing proprietary new formulations which allow the commercial development of value-added drug products with improved safety profile and clinical application/handling efficiency and developing new extended-release injectable drug delivery technologies which enable the creation of long-acting injections of a range of drug molecules.

The first product, FOCINVEZ (FOSAPREPITANT DIMEGLUMINE), NDA 216686 was approved in August 2023.

 

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.

Technology

TECHNOLOGY PLATFORMS

RTU (Ready-To-Use) 

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)

A proprietary platform technology allows the creation of long-acting micro-particulate suspension for extended release injection.

PIPELINE

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 multiple 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 high value, high barrier innovative drug products portfolio, which will be filed through either NDA 505(b)2 or ANDA 505(j) (Complex Generic) regulatory pathway.

PROJECT

THERAPEUTIC

AREA

IND

PRE-CLINICAL

CLINICAL
TRIAL or BE

NDA BATCH

NDA SUBMISSION

APPROVAL

PARTNER

SP001

Antiemetic

SP201

Antiemetic

SP004

Antiemetic

SP101

Anti-cancer

SP006

SCZ

PIPELINE1

MEET THE TEAM

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Jianwei Yu PhD

CEO

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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.

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Yulu Wang PhD

COO

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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.

TEAM

SCIENTIFIC ADVISORY TEAM

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Eric Xueyu Chen, MD, Ph.D., FRCPC

​Medical Advisor

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.

Advisor

MEDIA

 

8/22/2023 FDA has approved SP001, FOCINVEZ (FOSAPREPITANT DIMEGLUMINE). FOCINVEZ is a ready-to-use injection. The innovative formulation removed the Polysorbate 80 and improved the use-time stability for short-term room temperature storage and logistics. 

Media

BUSINESS DEVELOPMENT

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.

For more information or to discuss potential partnering opportunities, please send us a message through contact us. 

BUSINESS DEVELOPMENT
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FIND US

31 Schalks Crossing Road, Suite 111, Plainsboro, New Jersey 08536, USA

 

spescorp@spespharma.com


Tel: 1-732-354-3630

Please be aware that we may not be able to respond to every inquiry.

CONTACT
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