Regent Pacific (575.HK) Announces Senstend™ Received Approval from the NMPA
Expect to Receive US$7 Million in Milestone Payments in 2026
Collaborating with Wanbang Biopharmaceutical to Tackle China’s billion-dollar Male Health’s Market via an Asset-light Model
Hong Kong, 16 June 2026 — Regent Pacific Group Limited (“Regent Pacific” or the “Company” together with its subsidiaries, the “Group”; stock code: 0575.HK), a Hong Kong-listed biopharmaceutical company is delighted to announce that the Group welcomed a major operational breakthrough: New Drug Application (“NDA”) for its innovative therapy, Senstend™, has been approved by the National Medical Products Administration (“NMPA”) inclusive of a 4-year data protection period.
This approval represents a major inflection point for the Company marking its successful transition into a commercial-stage biopharmaceutical leader. Senstend™ is a proprietary metered dose aerosol, which is one of only two drugs now approved by the NMPA for the treatment of premature ejaculation, addressing a significant unmet medical need in China and offering a compelling new therapeutic option for patients.
This approval will immediately inject significant cash flow and financial returns into the Group. According to the exclusive license agreement, the Group expects to receive a total of US$7 million (or approximately HK$54.60 million) in 2026 from two milestone payments from 江蘇萬邦生化醫藥集團有限責任公司(Jiangsu Wanbang Biopharmaceutical Group Co., Ltd.) (“Wanbang Biopharmaceutical”, a wholly-controlled company of 上海復星醫藥（集團）股份有限公司 (Shanghai Fosun Pharmaceutical (Group) Co. Ltd.) ) as the NDA approval triggers the payment of US$5 million (or approximately HK$39 million) to the Group from Wanbang Biopharmaceutical. In addition, Wanbang Biopharmaceutical expects first commercial sale to commence in the second half of 2026 and this will trigger a payment of US$2 million to the Group from Wanbang Biopharmaceutical.
Strong follow-up potential: Additional milestones are payable based on certain sales targets and double-digit royalties are payable
4-year data protection period: NMPA granted 4-year data protection period. During which, no generic or biosimilar competitor can “copy” or rely on the Group’s safety, efficacy, or quality data to secure their own marketing approval without the Group’s explicit consent. Generic or follow-on applicants generally must either wait until the exclusivity period expires, or undertake their own full, independent clinical trials from scratch, creating an extremely high barrier to entry for the Company.
Up to US$25 million (or approximately HK$195 million) in aggregate upon achievement of annual net sales after first commercial sales; and tiered percentage royalties on net sales, ranging from low to mid-teens, providing continuous and high-margin stream of revenue to the Group.
There is a massive potential for premature ejaculation treatment in China. According to World Bank estimates, the disorder affects approximately 20% to 30% of men in China, which translates to a significant initial target population of approximately 55 million men aged between aged 20-59, potentially rising to over 170 million men. Senstend™ has the potential to help about 9 million patients in China during its first year of launch.
Jamie Gibson, Regent Pacific’s Chief Executive Officer, commented:
“This is a truly defining moment for the Company. The approval of Senstend™ by the NMPA underscores the strength of our scientific innovation, the quality of our clinical development, and our unwavering commitment to patients. We believe this milestone not only validates our commitment to the treatment of premature ejaculation but also positions us strongly for sustained growth and long-term value creation. The 4-year data protection period granted by the NMPA is also a strong endorsement of the quality of our clinical data and R&D strategy, and it means that competitors cannot challenge our market position through simple replication. Moving forward, the US is the logical next priority market for Fortacin. Given the scale and attractiveness of the US addressable market, management is actively progressing the necessary workstreams with a view to finalising the regulatory approval pathway for Phase 3 clinical studies during 2026. We consider this to be a key strategic objective and an important potential catalyst in the Group’s broader international growth trajectory.”
Senstend™ has demonstrated robust efficacy and a favourable safety profile with no adverse events in clinical studies. Currently, the Group’s commercial strategic partner, Wanbang Biopharmaceutical, is fully prepared for the commercial launch in China, with comprehensive plans in place covering manufacturing, supply chain, and market access. Leveraging its extensive and well-established network in China, Wanbang Biopharmaceutical will drive commercialisation through multiple channels, including leading e-commerce platforms, hospital systems, clinics and other healthcare institutions, ensuring that patients across China can access Senstend™ in a broad and efficient manner.
Following the milestone NMPA approval of Senstend, the Board believes the Group has entered an important new phase of development. Building on the experience, regulatory, commercial and strategic foundations established through Senstend™, the Board is actively evaluating a range of biopharmaceutical projects, licensing opportunities and strategic collaborations that could complement the Group’ s existing strategic direction, broaden the Group’s pipeline, strengthen its long-term growth profile and enhance shareholder value.
About Senstend™
Senstend™ (the brand name for Fortacin™ in China) is a metered dose aerosol from a proprietary formulation of two marketed drugs, lidocaine and prilocaine, developed for treating premature ejaculation. Plethora Solution Limited signed an exclusive license agreement with Wanbang Biopharmaceutical Co., Ltd to market, distribute, and sell Senstend™ for premature ejaculation in China.
About Regent Pacific Group Limited (Stock code: 0575.HK)
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 since its initial public offering in May 1997.
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