--- title: "REGENT PACIFIC: Senstend™ has received milestone approval from the National Medical Products Administration" type: "News" locale: "en" url: "https://longbridge.com/en/news/289904260.md" description: "REGENT PACIFIC announced that its innovative therapy Senstend™ has been approved by the National Medical Products Administration, accompanied by a four-year data protection period. This move marks the company's transformation into a leader in commercial biopharmaceuticals. The approval triggers a milestone payment of USD 5 million to be paid by Jiangsu Wanbang, with a total of USD 7 million expected to be received by 2026. Jiangsu Wanbang will launch sales in the second half of 2026, which will subsequently trigger up to USD 25 million in commercial milestone payments and royalties" datetime: "2026-06-16T10:44:02.000Z" locales: - [zh-CN](https://longbridge.com/zh-CN/news/289904260.md) - [en](https://longbridge.com/en/news/289904260.md) - [zh-HK](https://longbridge.com/zh-HK/news/289904260.md) --- # REGENT PACIFIC: Senstend™ has received milestone approval from the National Medical Products Administration According to the news from Zhitong Finance APP, REGENT PACIFIC (00575) announced that its innovative therapy Senstend™'s New Drug Application (NDA) has been approved by the National Medical Products Administration (NMPA), accompanied by a four-year data protection period. This approval will take effect 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, signifying its successful transformation into a leader in the commercialization phase of biopharmaceuticals. Senstend™ is indicated for the treatment of premature ejaculation, filling a significant medical need gap in the People's Republic of China (China), and providing patients with an attractive new treatment option as one of only two drugs currently approved by the NMPA for this condition. The approval of the NDA triggers Jiangsu Wanbang Biopharmaceutical Co., Ltd. (Jiangsu Wanbang, a wholly-owned subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd.) to pay the group USD 5 million (approximately HKD 39 million) (before Chinese withholding tax). The group expects to receive two milestone payments from Jiangsu Wanbang totaling USD 7 million (approximately HKD 54.6 million) (before Chinese withholding tax) in 2026. Jiangsu Wanbang is expected to initiate commercial sales in the second half of 2026, which will trigger a payment of USD 2 million (approximately HKD 15.6 million) (before Chinese withholding tax) to the group. Jiangsu Wanbang is also required to make other significant payments to the group for commercial milestones and royalties, including: • Up to USD 25 million (approximately HKD 195 million) after the first commercial sale and achieving annual net sales; and • Royalties calculated as a tiered percentage based on net sales, ranging from 10% to a few tens of percent, except that a lower payment structure will apply in certain circumstances where generic products have successfully entered and impacted the market in China. It should be noted that under the NMPA's trial data protection regulations, Senstend™ enjoys a four-year data protection period. This means that within four years of the NMPA's approval of Senstend™, unless the group agrees, the NMPA shall not grant marketing authorization to other applicants relying on the group's proprietary and unpublished trial data or other data submitted for approval (i.e., generic or biosimilar competitors) and will not accept their supplementary applications. Therefore, during the data protection period, unless the group agrees, applicants for NMPA approval of competing drugs to Senstend™ can only: (i) obtain data independently without relying on the group's protected data (i.e., competitors are not excluded from conducting their independent comprehensive clinical trials from scratch); or (ii) wait for the four-year data protection period to expire. In its first year on the market, Senstend™ is expected to help approximately 9 million patients in China, with the patient population expected to grow to over 170 million by the tenth year post-launch The company's CEO Jamie Gibson stated: "This is indeed a decisive moment for our company. The approval of Senstend™ by the National Medical Products Administration fully validates our research and innovation capabilities, the quality of our clinical development, and our unwavering commitment to patients. We believe this milestone not only affirms our investment in the treatment of premature ejaculation but also lays a solid foundation for our continued development and long-term value creation. Looking ahead, the United States will be the next logical priority market for the expansion of Fortacin™. Given the scale and attractiveness of the target market in the U.S., management is actively advancing the necessary workflows to implement the regulatory approval pathway for Phase III clinical research by 2026. We view this as a core strategic objective and an important potential catalyst in the broader trajectory of international growth for the group." Senstend™ has demonstrated excellent efficacy and good safety attributes in clinical studies, with no adverse reactions reported, and the research results support its potential to become a best-in-class or first-in-class therapy. This approval also highlights the company's ability to successfully execute complex development and regulatory strategies across multiple regions. The group's commercial strategic partner, Jiangsu Wanbang Pharmaceutical, is fully prepared for the commercial launch in China and has developed a comprehensive plan covering production, supply chain, and market access. Jiangsu Wanbang Pharmaceutical is actively engaging with distributors, healthcare service providers, and other key stakeholders to ensure that patients can access the medication widely and promptly. The company has established a solid strategic partnership with Jiangsu Wanbang Pharmaceutical, which will be responsible for marketing, distribution, and sales of Senstend™ in the mainland Chinese market. Jiangsu Wanbang Pharmaceutical will leverage its extensive and mature network to 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, ensuring that patients across China can access Senstend™ in a timely manner. The company believes that this collaboration combines its innovative product capabilities with the partner's proven commercial infrastructure and market expertise, significantly enhancing the speed and scale of the product launch. This partnership is expected to maximize the commercial potential of Senstend™ while supporting strong and sustainable revenue growth through royalty fees and commercial milestone payments. This light-asset commercialization model allows the company to focus on advancing its product pipeline and core R&D capabilities while benefiting from the partner's deep local market knowledge, mature distribution channels, and execution track record in the Chinese market. The board believes that this approval will significantly enhance the company's commercial prospects and shareholder value, solidifying its position as a leading innovator in the biopharmaceutical field. Following the milestone approval of Senstend™ by the National Medical Products Administration, the board believes that the group has entered an important new phase of development. Based on the experience, regulatory, commercial, and strategic foundation established through Senstend™, the board is actively evaluating a range of biopharmaceutical projects, licensing opportunities, and strategic collaborations to complement the group's existing strategic direction, expand its pipeline, strengthen its long-term growth prospects, and enhance shareholder value ### Related Stocks - [00575.HK](https://longbridge.com/en/quote/00575.HK.md) - [600196.CN](https://longbridge.com/en/quote/600196.CN.md) - [02196.HK](https://longbridge.com/en/quote/02196.HK.md) ## Related News & Research - [Rongzun International Sets June Board Meeting to Approve Final Results and Dividend](https://longbridge.com/en/news/289580743.md) - [Novig wins CFTC approval as competition intensifies in sports prediction markets](https://longbridge.com/en/news/289941060.md) - [BeOne Medicines Shareholders Approve All AGM Resolutions and Refresh Board](https://longbridge.com/en/news/289523357.md) - [EVE Health Group Initiates Pilot Study of Libbo Oral Soluble Film to Treat ED](https://longbridge.com/en/news/289843213.md) - [Thyssenkrupp shareholders vote Aug. 7 on spin-off of 49% stake in tk accelis](https://longbridge.com/en/news/289943873.md)