Yahoo Finance News6 Jan 2021 00:42
Regent Pacific Announces Key Progresses On FORTACIN(TM) / SENSTEND(TM) - Solution to Premature Ejaculation
Mon, January 4, 2021, 9:30 PM GMT+8·5 min read
CHINA
Regent Pacific received US$0.72 million (approximately HK$5.62 million, (net of 10% PRC withholding tax) from Wanbang Pharmaceutical on 29 December 2020
The Clinical Trial Approval ("CTA") will be obtained from the Center of Drug Evaluation by the end of Q1 2021
Regent Pacific to receive the following payments from Wanbang Pharmaceutical:
- US$3.20 million* (approximately HK$24.96 million) upon the successful approval from NMPA to commence the clinical trial
- US$ 5 million* (approximately HK$39 million) NMPA has granted import drug licence approval for Senstend™
- US$2 million* (approximately HK$15.6 million) upon first commercial sale of Senstend™ in China
*before deduction of PRC withholding tax
UNITED STATES
Phase II validation study has been completed with a total of 87 subjects being randomised and is target to submit the study to the United States Food and Drug Administration ("FDA") during the first half of 2021
HONG KONG, Jan. 4, 2021 /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 several key updates of Fortacin™ / Senstend™, the first prescription solution to premature ejaculation (PE) that does not act on the central nervous system, in China and the United States respectively.
Regent Pacific received US$0.72 million (approximately HK$5.62 million) from its commercial strategic partner in China -Wanbang Pharmaceutical Marketing and Distribution Co., Ltd. ("Wanbang Pharmaceutical"), a wholly controlled company of Shanghai Fosun Pharma to seek marketing approval of Senstend™ (the marketing name of Fortacin™ in China) in China on 29 December 2020. The Clinical Trial Approval ("CTA") of Senstend™ will be reviewed by the National Medical Products Administration ("NMPA") and is expected to be obtained from the Center of Drug Evaluation by the end of Q1 2021. Upon the successful approval from NMPA to commence the clinical trial, Regent Pacific will receive a payment of US$3.20 million* (approximately HK$24.96 million) from Wanbang Pharmaceutical.
Jamie Gibson, Chief Executive Officer of Regent Pacific, said, "We are delighted by this step toward full commercial approval of Senstend™ in China. Achieving this is a significant milestone which lays a solid foundation for marketing Senstend™ there in the near future."
Gibson added, "We are confident that this successful China initiative not only secures the world's largest market for Senstend™, but will also help us and our strategic partners to expand into other major markets such as the Middle East, India, North America and the Latin America (LATAM) region."
"Using the income generated by Senstend™ i