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KDDF-201410-05 US FDA Phase 2a Completion and KFDA Phase 2b Approval of YPL-001 (Chronic Obstructive Pulmonary Disease Drug)(Respiratory Diseases, Natural) [03.04.2015]

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Development and Market Objectives

• YPL-001 is a natural product developed by Yungjin pharm for COPD treatment. It is the 1st Koran natural products with phase I IND approved by FDA and has been government funded project since 2011. Phase IIa is undergoing in 3 USA hospitals now and we are looking for licensing out partners or co-development partner after phase IIa. 

Unmet Medical Need & Target Patients

Unmet Medical Needs
• Efficacy
The primary unmet medical need of COPD is to find a treatment preventing the disease progression from stage 2 or 3 to stage 3 or 4
• Steroid sensitivity
COPD patients have a tendency of reduced responsiveness to steroids as their disease progresses. So symptoms get worse even using steroids especially for stage 3 or 4 patients. Thus, to reduce corticosteroid resistance in patients is important  in acute or frequent COPD exacerbations.
• Safety
COPD requires long-term treatment. Most of existing treatments for COPD have safety issues. Development of product with less side effects is needed.
• Formulation
Most COPD drugs are inhalant type which need patient education for usage. Oral dosage form is easy and convenient for dosing, usually cheaper than device type drug which is helpful especially in underdeveloped country.
 
Target patients
• COPD patients are classified based on their degree of severity - Mild (Stage 1), Moderate (Stage 2), Severe (Stage 3), Very severe (Stage 4). The ultimate and primary goal of treatments is to prevent exacerbation of COPD. For such purpose, long term safety and prevention the development of resistance should be secured. None of the existing drugs have been proven to stop the disease progression from Stage 1 or 2 to Stage 3 or 4. YPL-001 is for stage 2 or 3 patients to prevent COPD exacerbation.

Status

• Yungjin has completed Phase 1a (Single Ascending Dose Study) and 1b study (Multiple Ascending Dose Study). The IND and IRB have been done for Phase IIa and currently patients recruiting are ongoing. 

Intellectual Property

• Patent registered: total 17 patents completed
- Korea(4), USA(2), Europe(6), Japan(1), China(1), India(1), Canada(1), Australia(1)
• Patent pending: Korea(1), US(1). PCT(2)
- Covering worldwide 

Competitive Advantages

• Unique MoA
- Reduce inflammatory response and increase steroid sensitivity as HDAC2 activator (First In Class)
• Well- controlled CMC
- Phytoequivalence established
- Identified components (> 90 % (w/w))
- Standardized API by GAP*
• Formulation
- Oral dosage form: easy compliance compared to inhalants
• Exclusivity
- Well protected intellectual property through several patent application

Indication

COPD

Research Period

Jan, 2015 ~ Mar, 2018

Company

Yungjin Pharm. Co., Ltd.

Developmental Stage

Phase II

Additional Information

Contact Information

Contact
Address Company Name: Yungjin Pharm. Co., Ltd.
WebSite Homepage: http://www.yungjin.co.kr Contact Person: Yongnam Lee(Research), Insuk Song(BD)
E-mail: nami0209@yungjin.co.kr, issong@yungjin.co.kr Contact: +82-2-2041-8289, +82-31-546-6980

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