REGENT PACIFIC(00575): Senstend receives a milestone approval from the National Medical Products Administration.

REGENT PACIFIC (00575) announced that its new drug application for the innovative therapy Senstend has been approved by the National Medical Products Administration (NMPA) with a four-year data protection period. The approval will be effective on June 10, 2026, and the company will be notified after the market closes on June 15, 2026. This approval marks a significant turning point for the company, signaling its successful transformation into a leader in the commercialization stage of the biopharmaceutical industry. Senstend is used for the treatment of premature ejaculation, addressing a significant medical need in China and providing one of only two drugs approved by the NMPA for this indication, offering patients a new and attractive treatment option. The approval of the new drug application triggered Jiangsu Wanbang Biochemical Pharmaceutical Group Co., Ltd. (Jiangsu Anhui Wanbang Pharmaceutical Technology, a wholly-owned subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd.) to pay the company $5 million (or approximately HK$39 million) (pre-tax in China), and the company expects to receive two milestone payments totaling $7 million (or approximately HK$54.6 million) (pre-tax in China) from Jiangsu Anhui Wanbang Pharmaceutical Technology in 2026. Jiangsu Anhui Wanbang Pharmaceutical Technology is expected to initiate commercial sales in the second half of 2026, which will trigger a payment of $2 million (or approximately HK$15.6 million) (pre-tax in China) to the company. Jiangsu Anhui Wanbang Pharmaceutical Technology is required to make other significant payments to the company for commercial milestones and royalty fees, including: Up to a maximum of $25 million (or approximately HK$195 million) in total after the first commercial sale and annual net sales; and Royalty fees based on a tiered percentage of sales, ranging from ten to teens, except for lower payment structures that will apply in certain circumstances, such as generic products successfully entering and affecting the Chinese market. It should be noted that Senstend benefits from a four-year data protection period according to the NMPA's data protection regulations. This means that within four years of the NMPA's approval of Senstend, the NMPA cannot issue marketing approvals to other applicants (i.e., generic or biosimilar competitors) based on the company's protected data that was obtained and not publicly disclosed, or for other data submitted for approval without the company's consent. Therefore, during the data protection period, unless the company agrees, the NMPA-approved generic drugs or follow-up applicants competing against Senstend can only: (i) obtain data on their own without relying on the company's protected data (i.e., excluding the possibility of competitors conducting their independent full-scale clinical trials); or (ii) wait for the expiration of the four-year data protection period. Senstend is expected to help approximately 9 million patients in China in its first year on the market, with the patient population growing to over 170 million by its tenth year on the market. Jamie Gibson, CEO of the company, stated: "This is indeed a decisive moment for our company. The approval of Senstend by the NMPA is a testament to our research and innovation capabilities, the quality of our clinical research and development, and our unwavering commitment to patients. We believe that this milestone not only affirms our dedication to the treatment of premature ejaculation, but also lays a solid foundation for our continued development and long-term value creation. Looking ahead, the U.S. will be the next priority market for Fortacin. Given the size and attractiveness of the U.S. target market, management is actively advancing necessary workflows to secure regulatory approval for the third phase of clinical research by 2026. We view this as a core strategic goal and a significant potential catalyst for the company in a broader international growth trajectory." Senstend has demonstrated outstanding efficacy and good safety attributes in clinical studies without adverse reactions, supporting its potential to become the best in its class or a first-in-class therapy. This approval also highlights the company's ability to successfully execute complex development and regulatory strategies across multiple regions. The company's strategic business partner, Jiangsu Anhui Wanbang Pharmaceutical Technology, is fully prepared for commercial launch in China and has developed a comprehensive plan covering production, supply chain, and market access. Jiangsu Anhui Wanbang Pharmaceutical Technology is actively engaging with distributors, healthcare service providers, and other key stakeholders to ensure widespread and timely access to the medication for patients. The company has established a strong strategic partnership with Jiangsu Anhui Wanbang Pharmaceutical Technology in China, which will be responsible for marketing, distributing, and selling Senstend in mainland China. Leveraging its extensive and mature network, Jiangsu Anhui Wanbang Pharmaceutical Technology will drive commercialization through multiple channels, including leading e-commerce platforms, hospital systems, clinics, and other healthcare institutions. This integrated strategy is expected to achieve broad and efficient market penetration to ensure that patients across China have timely access to Senstend. The company believes that this partnership, combining its innovative product capabilities with the proven commercial infrastructure and market expertise of its partner, will significantly accelerate the speed and scale of the launch. This collaboration is expected to maximize the commercial potential of Senstend and support strong and sustainable revenue growth through royalty fees and commercial milestone payments. This asset-light commercialization model allows the company to focus on advancing its product pipeline and core research capabilities while benefiting from its partner's deep local market knowledge, mature distribution channels, and track record in executing in the Chinese market. The Board believes that this approval will significantly enhance the company's business prospects and shareholder value, consolidating its position as a leading innovator in the biopharmaceutical industry. Following the milestone of Senstend receiving approval from the NMPA, the Board sees the company entering a new important stage 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 partnerships to complement the company's existing strategy, expand its pipeline, strengthen its long-term growth prospects, and enhance shareholder value.