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TMCNet:  Chinese FDA Accepts Phase 2 IND for RGN-259 for Dry Eye

[June 23, 2014]

Chinese FDA Accepts Phase 2 IND for RGN-259 for Dry Eye

ROCKVILLE, Md. --(Business Wire)--

RegeneRx Biopharmaceuticals, Inc. (OTC: RGRX) ("RegeneRx") and Lee's Pharmaceutical Holdings Ltd. ("Lee's") today jointly announced that the Chinese FDA has accepted a Phase II IND for RGN-259 (thymosin beta 4-based, preservative-free eye drops) to be tested in patients with moderate to severe dry eye syndrome in China.

Lee's Pharmaceutical Holdings Ltd., headquartered in Hong Kong, is the sponsor of the clinical trial. RGN-259 is one of several product candidates licensed to Lee's by RegeneRx in China, Hong Kong, Macau and Taiwan. On 17th June 2014, Lee's received the official CFDA Acceptance Notice (No. CXHL1400799X) for its application to conduct the Phase II trial, which aims to assess the safety and efficacy of RGN-259.

"Keratoconjunctivitis sicca," commonly known as dry eye syndrome, affects a great number of people in China and can lead to severe consequences such as cornea damage and ocular inflammation. There is clearly an unmet medical need in this area. RegeneRx demonstrated in its Phase II study that RGN-259 is a promising agent in alleviating dry eye syndrome by addressing the underlying pathology with a unique mechanism of action.

"We're pleased with the acceptance of review by the CFDA for this important application," said Dr. Benjamin Li, CEO of Lee's. "The successful submission of Tß4 highlights Lee's research & development capability in developing its product pipeline focused on ophthalmic therapeutic area. We are looking forward to moving the registration process forward and expect to initiate the clinical trial in China in Q1 2015."

"We're very pleased that the Chinese FDA has accepted Lee's IND for a Phase 2 dry eye study. Showing strong safety and efficacy results in China will not only be important to future commercialization in that country, but also validate our results in the U.S. and extend the opportunities for this product throughout the world," stated J.J. Finkelstein, RegeneRx's president & CEO.

About RegeneRx Biopharmaceuticals, Inc.

RegeneRx is focused on the development of a novel therapeutic peptide, Thymosinbeta 4, for tissue and organ protection, repair and regeneration. RegeneRx currently has three drug candidates in clinical development for ophthalmic, cardiac and dermal indications, three strategic licensing agreements in China, Pan Asia (Korea, Japan, and Australia, among others) and the EU, and has an extensive worldwide patent portfolio covering its products. Recently, RGN-259, the Company's ophthalmic drug candidate has been designated as an orphan drug for the treatment of neurotrophic keratopathy, which is the primary focus of RegeneRx's clinical development efforts in the U.S. For additional information about RegeneRx please visit www.regenerx.com.


Forward-Looking Statements

Any statements in this press release that are not historical facts are forward-looking statements made under the provisions of the Private Securities Litigation Reform Act of 1995. Any forward-looking statements, such as the initiation by Lee's Pharm of its Phase II dry eye clinical trial in China, may involve speculation and uncertainties that may or may not prove to be accurate and may be materially different from any results implied by such forward-looking statements. Please view these and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC (News - Alert)"), including those identified in the "Risk Factors" section of the annual report on Form 10-K for the year ended December 31, 2013, and subsequent quarterly reports filed on Form 10-Q, as well as other filings it makes with the SEC. Any forward-looking statements in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable law.

About Lee's Pharmaceutical Holdings Ltd.

Lee's Pharmaceutical is a research-based Hong Kong biopharmaceutical company with over 19 years operation in China's pharmaceutical industry. It is fully integrated with strong infrastructures in drug development, manufacturing, sales and marketing. It has established extensive partnership with over 20 international companies and currently has 14 products in the market place. Lee's focuses on several key disease areas such as cardiovascular, oncology, gynecology, dermatology and ophthalmology. Lee's development program is lauded with 30 products stemming from both internal R&D efforts and collaborations with US, European and Japanese companies and aspiring to combat diseases such as liver cancer and pulmonary hypertension. The mission of Lee's is to become a successful biopharmaceutical group in Asia providing innovative products to fight diseases and improve health and quality of life. Additional information about Lee's, please visit www.leespharm.com.

Safe Harbor Statement

The performance and the results of operation of Lee's during the past years are historical in nature and past performance can be no guarantee of future results of the Lee's. This news release may contain forward-looking statements and opinions that involve risks and uncertainties. Actual results may differ materially from expectations discussed in such forward-looking statements and opinions. Neither Lee's nor the Directors, employees or agents of Lee's assume (a) any obligation to correct or update the forward-looking statements or opinions contained in this news release; and (b) any liability in the event that any of the forward-looking statements or opinions does not materialise or turns out to be incorrect.


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