Regent Pacific (00575) announced that the company's commercial strategic partner, Jiangsu Wanbang Biochemical Pharmaceutical Group Co., Ltd. (Jiangsu Wanbang Pharmaceutical, a wholly-owned subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd.), Jiangsu Wanbang Pharmaceutical Marketing Co., Ltd. (Jiangsu Wanbang Marketing, an affiliated company of Jiangsu Wanbang Pharmaceutical), Genetic S.p.A. (Genetic), and Plethora Solutions Limited (Plethora, the company's wholly-owned subsidiary) entered into a manufacturing and supply agreement after the close of market today. According to the agreement, Genetic will manufacture and supply SenstendTM to Jiangsu Wanbang Pharmaceutical in China, pursuant to the terms of the agreement. The initial term of the agreement is five years, with automatic renewal for two years thereafter, unless terminated.

The signing of the agreement removes a major obstacle in the Chinese regulatory approval process, which will enable Jiangsu Wanbang Pharmaceutical to complete the submission of the new drug application registration dossier to the National Medical Products Administration, and is expected to be approved within 12 months of the submission. According to the terms of the agreement, Jiangsu Wanbang Pharmaceutical will submit a new drug application to the National Medical Products Administration as soon as practicable, but in any event no later than 3 months after receiving the manufacturing data.

Jamie Gibson, Group CEO, said, "We are pleased to have signed the agreement, as it clears the final obstacle for us to submit a new drug application to the National Medical Products Administration. We look forward to our commercial partners in China submitting a new drug application to the National Medical Products Administration as soon as possible and expect approval within 12 months of submission."

SenstendTM (branded as FortacinTM in China) is a proprietary formula of two marketed drugs, lidocaine and prilocaine, distributed through a metered aerosol for the treatment of premature ejaculation. In December 2018, Plethora signed an exclusive license agreement with Jiangsu Wanbang Pharmaceutical to sell SenstendTM for the treatment of premature ejaculation in China.

Jamie Gibson further stated, "It is estimated that SenstendTM may help an initial target market of approximately 9 million patients in its first year of launch in China, growing to over 0.17 billion patients by the tenth year. Our strong partner, Jiangsu Wanbang Pharmaceutical, is part of the Fosun network and has established mature marketing expertise, e-commerce platforms, and unparalleled national logistics and distribution through the hospital, clinic, and pharmacy network of China's largest pharmaceutical and medical care distributor, China National Pharmaceutical Group Corporation (Sinopharm), ensuring the commercial success of SenstendTM in China."