Regent Pacific's Strategic Partner Receives Approval from NMPA to Submit IND Application
Important Milestone for SENSTEND™, Solution to Premature Ejaculation to Market in China
HONG KONG, Dec. 2, 2020 /PRNewswire/ -- Regent Pacific Group Limited ("Regent Pacific" or the "Company" and together with its subsidiaries, the "Group"; stock code: 0575.HK), a specialist healthcare, wellness and life sciences investment group is pleased to announce that Wanbang Pharmaceutical Marketing and Distribution Co., Ltd. ("Wanbang Pharmaceutical"), a wholly controlled company of Shanghai Fosun Pharma, Regent Pacific's commercial strategic partner in China, has received approval from the National Medical Products Administration ("NMPA") to submit the investigational new drug ("IND") application for human clinical trial of a Licensed Product at NMPA.
Under the terms of the licence agreement with Wanbang Pharmaceutical, Regent Pacific is now entitled to receive a payment of US$800,000 (approximately HK$6.24 million) from Wanbang Pharmaceutical which is payable within 30 business days. NMPA will now formally review for Clinical Trial Approval ("CTA"). It is expected that the CTA will be obtained from the Center of Drug Evaluation by the end of Q1 2021. Another payment of US$3.20 million (approximately HK$24.96 million) will be received upon the successful approval from NMPA to commence the clinical trial.
Jamie Gibson, Chief Executive Officer of Regent Pacific, said, "This is an important milestone in achieving approval to market Senstend™ in China. We will continue to work closely and diligently with our current and prospective commercial partners and will keep shareholders and potential investors informed of any new developments as and when they occur."
Please click the link to view the announcement: https://www1.hkexnews.hk/listedco/listconews/sehk/2020/1202/2020120200347.pdf
About Regent Pacific
Regent Pacific is a diversified investment group based in Hong Kong currently holding various corporate and strategic investments focusing on the healthcare, wellness and life sciences sectors. The Group has a strong track record of investments and has returned approximately US$298 million to shareholders in the 23 years of financial reporting since its initial public offering in May 1997.
About Fortacin™ / Sendstend™
Fortacin™ / Sendstend™ is the first solution to premature ejaculation (PE) that does not act on the central nervous system and offers bona fide therapeutic efficacy that has been validated through extensive clinical trials in Europe, with over 23,500 doses delivered to trial participants. The solution is a topical spray containing low doses of lidocaine and prilocaine that take effect almost immediately upon application, giving users more control without reducing pleasure. Fully approved by the European Medicines Agency (EMA), Fortacin™ is now available in France, Germany, Italy, Portugal, Spain and the UK.